IT202200020976A1 - MEDICAL DEVICE FOR PERCUTANEOUS DISCECTOMY - Google Patents

Description

DESCRIPTION of the industrial invention entitled:

?MEDICAL DEVICE FOR PERCUTANEOUS DISCECTOMY?

DESCRIPTION TEXT

The present invention falls within the technical sector of medical devices for the minimally invasive treatment of herniated discs.

In particular, the present invention concerns a medical device and a kit for performing a percutaneous discectomy operation.

In particular, the present invention relates to a medical device to be used in hospital by qualified medical personnel, for the minimally invasive treatment of chronic intradiscal pain of a benign nature due to protruded and contained hernias, via the percutaneous route.

The bones of the spine are interspersed with tissue components called intervertebral discs. The intervertebral discs act as joints between the bones of the spine, allowing them to move.

Each intervertebral disc has a nucleus pulposus with viscoelastic properties and an outer covering, known as the annulus fibrosus.

A herniated disc is a pathological protrusion of the disc into the spinal canal. As it protrudes, the herniated disc presses on the adjacent nerve root, causing the onset of various symptoms, such as localized or diffuse pain, paresthesia, localized sensory deficits, weakness, decreased strength, difficulty grasping objects, and autonomic deficits (particularly in terms of bladder and intestinal dysfunction caused by the compression exerted by the prolapsed disc on nervous structures in the lumbar region).

In particular, a herniated disc occurs because the disc nucleus forces, due to the lesion, the annulus that surrounds it, thus exerting pressure on the surrounding nerve root which determines the onset of inflammatory and therefore painful situations.

Herniated discs can be classified based on their appearance into:

- protrusion;

- prolapse;

- extrusion;

- seizure.

In case of protrusion or prolapse, the annulus is deformed, but remains intact.

Otherwise, in case of extrusion or sequestration, a real rupture of the annulus is found.

Depending on the location of the lesion, a herniated disc can also be classified as:

- paramedian or lateral;

- central;

- intraforaminal;

- extraforaminal.

In many cases, the onset of herniated discs is facilitated by the loss of flexibility and elasticity of the intervertebral discs over time. This phenomenon in fact helps to increase the fragility of the ligaments surrounding the intervertebral discs, making them more prone to tearing and consequent unwanted leakage of material from the nucleus pulposus.

A herniated disc can also result from traumatic causes, such as excessive physical effort or traumatic injuries to the spinal column.

In less serious situations, characterized by a condition of pain that is not particularly acute for the patient, a first therapeutic approach consists in the administration of conservative therapies that include the administration of anti-inflammatory and analgesic pharmacological aids (including cortisone), preferably in combination with targeted physical therapy.

The use of orthopedic devices such as braces and similar can assist pharmacological therapeutic treatment, providing additional benefits for the patient.

However, in more compromised clinical situations, characterized by more serious and/or prolonged symptoms, a conservative therapeutic approach may prove insufficient.

In such cases, it is therefore necessary to resort to surgical treatment.

A well-known surgical approach to the treatment of herniated discs involves the removal of the hernia via the interlaminar approach.

However, this is a substantially invasive procedure, resulting in rather long recovery times for the patient.

In addition, if too aggressive an intervention is performed on the disc, there is a risk of accentuating the surgical scarring, further slowing down the patient's post-operative recovery.

More recently, surgical techniques for the treatment of herniated discs have been developed that are less invasive and are thus able to overcome the above-mentioned drawbacks of the interlaminar removal technique.

Similar techniques also allow the surgeon to perform manipulations characterized by improved precision and delicacy.

A well-known minimally invasive approach to treating herniated discs involves performing microsurgical interventions. In particular, the use of a microscope allows the surgeon to intervene in a targeted manner, operating at the nerve root level with a high level of precision.

This last aspect is particularly advantageous because, considering that the exposed area around the nerve root is only a few millimetres, it makes it possible to greatly contain the size of the post-operative healing zone in a sensitive area.

Microsurgery also allows for intervention by making a rather small skin incision, in the order of 3-5 cm.

Microsurgical interventions have a high success rate, estimated at around 95% of cases.

Another less invasive approach is endoscopy.

However, this technique is not always easy and appropriate in the treatment of herniated discs because, unlike other endoscopic applications, movement between the various muscular and bone structures is particularly difficult.

On the other hand, the removal of bony and ligament parts using an endoscopic technique is rather complex, especially when these bony and ligament parts contribute to the conflict with the nerve root.

For this reason, the endoscopic technique has not shown the same efficacy as the microsurgical technique in the treatment of herniated discs.

A further evolution in the direction of minimally invasiveness is represented by the percutaneous treatment of herniated discs.

Such techniques are considered particularly promising and are currently being studied and improved.

To date, percutaneous techniques have shown completely satisfactory results in terms of efficacy, accompanied by notable advantages such as a significantly reduced post-operative hospital stay (on average, in the order of 1-2 days), in addition to the almost total absence of scars.

Furthermore, given the possibility of performing it under local anesthesia, this type of treatment does not present significant contraindications, even in the case of elderly patients or those with pathologies or hypersensitivity.

A particularly effective and minimally invasive surgical technique for the treatment of herniated discs is percutaneous discectomy.

The procedure, performed using a fluoroscopic-guided technique, involves the mechanical removal of material from the nucleus pulposus using the aspiration principle of the worm screw.

This technique, performed under local anesthesia or conscious sedation, can be easily implemented at each vertebral level and allows for a noticeable reduction in post-operative recovery times, as well as a significant reduction in the VAS (visual analogue pain scale).

The target site is accessed through an introducer needle, leaving no scars and without the need for stitches. In ordinary cases, the patient is discharged within a few hours of the procedure, which therefore does not require hospitalization.

Preferably, before proceeding with the treatment, a discography is performed through the injection of a contrast medium (Fig.1). This allows to verify the exact positioning of the tip of an insertion cannula inside the intervertebral disc, as well as the height and the tightness of the intervertebral disc itself.

These parameters can also be confirmed by radiological images performed using an image intensifier during treatment, as well as by provocative discography with contrast medium, also performed during treatment.

The treatment requires substantially limited time, on average between 15 minutes up to a maximum of one hour, and consists in the removal of a portion of the nucleus pulposus not yet extruded from the herniated disc, as schematically illustrated in Fig.2.

The amount of material removed varies from 0.5 cc up to a maximum of 2 cc, depending on the physiological characteristics of the patient.

The treatment is performed in the operating room by specialized medical personnel, after premedication and monitoring of essential patient parameters.

Percutaneous discectomy is performed using a medical device including, inter alia, a transcutaneous intradiscal needle and a handle.

The intradiscal needle has an internal cavity, inside which is housed a stylet featuring metal spirals or worm screws, as illustrated in detail in Fig.3.

These metal spirals or worms extend substantially along the entire length of the intradiscal needle.

By rotating the stylet (for example, by means of motors placed inside the handle), a vacuum is generated which causes the aspiration of material from the nucleus pulposus according to the physical principle of the Archimedes screw.

When the medical device is activated (for example, by means of a power button, switch or similar, placed in a suitable position on the external surface of the handle), the stylet is rotated, thereby causing percutaneous aspiration of material from the nucleus pulposus of the intervertebral disc due to protruded and contained hernias.

In this way, the intradiscal pressure is significantly decreased, causing the hernia to re-enter and allowing the disc to assume its natural morphology again. This results in a significant decrease in pain for the patient.

The intradiscal needle is introduced into the patient's body and guided to the target site using a disc insertion cannula.

A fixed collection reservoir is provided to allow collection of percutaneously aspirated nucleus pulposus material.

However, such known collection tanks are not suitable for use for biopsy purposes.

Despite the undisputed efficiency of percutaneous discectomy operations according to the known technique, there is still room for improvement.

In particular, there is a need for improvements that allow for the prevention of contamination by bacteria or other microorganisms, especially during the approach to the target site using the insertion cannula, in order to prevent the onset of infections in the vicinity of the target site.

In light of the above, it is an object of the present invention to provide an improved medical device for percutaneous discectomy which allows to significantly reduce the risk of contamination by bacteria or other microorganisms during the insertion of an intradiscal cannula and needle towards a target site.

These and other objectives are achieved by a medical device for percutaneous discectomy according to claim 1.

Further advantageous aspects of the invention are defined in the dependent claims.

The present invention provides a medical device for percutaneous discectomy.

The medical device according to the present invention constitutes an instrument for clinical use, sterile and non-resterilisable, for temporary use.

The device is suitable for use in performing percutaneous discectomy at any intervertebral level.

In particular, the device can be used for the treatment of protruded or contained herniated intervertebral discs in the lumbar, thoracic and cervical regions.

The device is configured for single access to an intervertebral disc and should not be used to access different intervertebral levels. Where the procedure requires access to multiple intervertebral levels, a separate device should be used for each level involved.

The device is not configured for the system.

The device includes a hollow handle.

In particular, said hollow handle defines a housing for one or more components of the device.

For example, this housing may be used to house one or more electrical/electronic components for the operation and control of the device.

The medical device also includes a transcutaneous intradiscal needle.

Said intradiscal needle comprises a proximal end, connected to said handle.

This intradiscal needle also includes a free distal end, configured for insertion into a subject's body.

In particular, the subject is a patient suffering from a herniated disc.

This intradiscal needle has an internal cavity.

Inside this internal cavity of the intradiscal needle is placed a stylet.

This stylet has a plurality of spirals.

Alternatively, this stylet features endless screws.

Said plurality of spirals or worms extend substantially for the entire length of said stylet.

This stylet can advantageously be made of medical steel.

This allows for an appreciable level of structural solidity, while at the same time ensuring full compatibility with the biological environment with which it is intended to come into contact during the intervention.

The medical device also includes motorized means.

These motorized devices are configured to rotate the stylet during use and thereby cause the removal by suction of material from the nucleus pulposus of an intervertebral disc, due to the presence of a herniated disc.

Advantageously, said motor means are placed inside said housing defined in the handle.

The medical device also includes an electrical control circuit.

Said electrical control circuit is operationally connected with respect to said motor means.

Advantageously, the electrical control circuit is also located in the said housing defined in the handle.

The medical device also includes means of powering said motor means and said electrical circuit.

Advantageously, said means of power supply may include a 9V battery.

In particular, the battery is also placed in the aforementioned housing defined in the handle.

The placement of said motor means, said electrical control circuit and said power supply means (battery) in the housing defined in said handle makes it possible to significantly reduce the overall dimensions.

The medical device also includes a disc insertion cannula.

Advantageously, this disc cannula has a telescopic configuration composed of a plurality of cannulas and counter-cannulas.

This allows for a progressive approach to a target site to be treated (i.e., an area affected by a herniated disc).

By progressively approaching the target site, made possible by the telescopic structure of the disc cannula, it is possible to significantly reduce the risks of contamination of the disc cannula and the intradiscal needle by bacteria and other microorganisms.

In fact, during the approach to the target site, each cannula is always protected by a respective counter-cannula without it ever coming into contact with the patient's skin.

This helps to significantly reduce the risk of infection of the nucleus pulposus of the intervertebral disc (e.g., discitis).

Advantageously, the disc cannula can have a diameter of 1.5 mm.

The medical device may also comprise a potentiometer, located in said handle and operationally connected to said electrical control circuit.

In this case, the control circuit is implemented with an electronic board configured to receive a signal from said potentiometer and control the rotation speed of the stylus based on said signal, received from said potentiometer.

In this way, the speed of execution of the procedure can be automatically adjusted according to the surgical target, the anatomy and morphology of the disc.

The result is a further improvement in the overall efficiency of the intervention.

Advantageously, the medical device also includes a removable, sterile-sealed collection tank configured for the collection of nucleus pulposus material for biopsy.

This reservoir can be easily removed from the medical device and closed bilaterally with appropriate hermetic and sterility sealing devices at the end of the discectomy, and transported to a designated analysis laboratory for the performance of a biopsy examination.

Sterile sealing prevents the risk of contamination of the collected pulpy material by bacteria or other microorganisms.

Advantageously, said collection tank comprises bayonet connection means configured for engagement with corresponding connection means provided at the distal end of the handle.

This allows for easy connection and subsequent separation of the collection tank from the medical device.

The medical device may also include means of indicating the battery charge status.

In this way, the operator can view the battery charge status in a convenient and immediate way.

In particular, said means of indicating the battery charge status may be placed on the external surface of said handle.

This allows information about the battery charge status to be provided in an even more convenient way for the operator.

On the other hand, the solution also presents significant advantages from a construction point of view.

Preferably, said battery charge status indication means are configured to emit a light signal.

Preferably, said means of visual indication of the battery charge status comprise LED type light signalling means.

In particular, when the light signalling devices (e.g. LEDs) are lit, this means that the battery has a sufficient charge level for the use of the medical device in the prescribed manner and in safe conditions.

Otherwise, the medical device must not be used.

Advantageously, said transcutaneous needle includes means of visual indication of insertion depth.

This allows the operator to monitor, with an appreciable level of precision, the depth of insertion of the needle into the patient's body, towards the target site.

Advantageously, this handle can have an ergonomic shape.

This greatly facilitates the operator during the procedure.

In particular, the handle may have a configuration that allows the operator to easily use the device in any position respectively at the percutaneous angle of approach.

In this way, it is possible to avoid the operator having to maintain uncomfortable positions during the procedure, potentially causing pain or other uncomfortable conditions.

The device can be easily operated by means of a power button or a switch, preferably located on the outside of the handle so that it can be operated with just one hand.

The handle can also be provided with a slot for the passage of a plastic tab placed between the battery poles and the electrical circuit.

This allows the electrical circuit to be completely inactive before using the device, thus avoiding losses in terms of capacity and efficiency of the initial battery charge.

The device can easily be made suitable for use by removing the tab by the operator.

The present invention also provides a kit for performing a percutaneous discectomy operation.

This kit includes:

- a medical device as described above;

- a trocar, and

- a cleaning spatula.

The features and advantages of the present invention will become more apparent from the detailed description of an exemplary embodiment of the invention, provided below and referring to the drawings, in which:

Fig. 1 is an image obtained by contrast discography illustrating the insertion of a disc cannula into an intervertebral disc. Performing a contrast discography at the beginning of percutaneous discectomy procedures is important in order to determine the exact placement of the disc cannula, as well as the height and tightness of the intervertebral disc;

Fig. 2 illustrates a three-dimensional model reproducing a portion of the spinal column containing a herniated disc, which is the target site for a percutaneous discectomy. A disc cannula is introduced at the target site for placement of an intradiscal needle;

Fig. 3 is a three-dimensional, partial sectional view of the distal end of a known transcutaneous intradiscal needle. A stylet operating on the Archimedes screw principle is inserted into an internal cavity of the needle;

Fig. 4 is a schematic front elevation view of a medical device for transcutaneous discectomy according to an embodiment of the present invention. Detail IV shows, on a larger scale, a detail of the distal end of the intradiscal needle, identical to that of Fig. 3;

Fig. 5 is a photographic reproduction of a disc cannula and a percutaneous intradiscal needle used in the medical device according to the invention;

Fig. 6 is a partial three-dimensional view of the medical device according to the invention, illustrating: handle, removable collection tank for collecting nucleus pulposus material for biopsy culture, and part of the intradiscal needle, connected to said handle;

Fig. 7 is a three-dimensional, enlarged-scale view illustrating the handle and collection tank of the medical device according to the invention;

Fig. 8 is a three-dimensional view illustrating the handle of Fig. 7 in an open state. Inside the handle is defined a housing for one or more components of the medical device, in this case: motor means, electrical control circuit and power battery.

Fig. 1 schematically illustrates a medical device for percutaneous discectomy according to an embodiment of the present invention.

The said medical device is identified, as a whole, with 100.

The medical device 100 includes a hollow handle 10, illustrated in detail in Figs. 7-8.

In particular, the handle 10 defines a housing 10.1 for one or more components of said medical device 100 (Fig.8), described in detail below.

The medical device 100 further comprises a transcutaneous intradiscal needle 11, illustrated in detail in Fig.5.

The intradiscal needle 11 has a proximal end connected to said handle 10 and a free distal end, configured for insertion inside the body of a subject (Figs. 4 and 6).

In the illustrated embodiment, the transcutaneous intradiscal needle 11 includes visual indication means 19 of insertion depth (Fig.4).

The intradiscal needle 11 has an internal cavity 11.1, in which a stylet 12 is placed (Fig. 4, detail IV).

In the illustrated embodiment, said stylet 12 comprises a plurality of spirals (Fig. 4, detail IV), extending substantially for the entire length of the stylet 12.

In the present embodiment, said stylet 12 is advantageously made of medical steel.

The medical device 100 further comprises motor means 13, configured to rotate the stylet 12 during use and thereby cause the removal by suction of material from the nucleus pulposus of an intervertebral disc, due to the presence of a herniated disc.

In the illustrated embodiment, said motor means 13 are advantageously located in said housing 10.1, as illustrated in Fig.8.

The medical device 100 further comprises an electrical control circuit 14, operatively connected to said motor means 13.

In the illustrated embodiment, said control circuit 14 is also located in said housing 10.1, as illustrated in Fig.8.

The medical device 100 further comprises means for supplying electricity to said motor means 13 and said electrical circuit 14.

In particular, in the present embodiment, said electrical power supply means comprise a 9V battery 17 (Fig.8).

In the illustrated embodiment, said battery 17 is also located in said housing 10.1, as illustrated in Fig.8.

The medical device 100 is based, as per the known art, on the physical principle of the Archimedes screw. When activated, said stylet 12 is rotated by said motor means 13, thus allowing the percutaneous removal by aspiration of material from the nucleus pulposus due to the presence of a protruded and contained herniated disc.

This allows for a significant reduction in interdiscal pressure, with the resulting reduction in pain for the patient.

The medical device 100 further comprises a disc cannula 15 for the introduction of said intradiscal needle 11.

This disc cannula 15 is illustrated in detail in Fig.5.

In particular, the disc cannula 15 has a telescopic configuration composed of a plurality of cannulas and counter-cannulas, thus allowing a progressive approach to the target site.

Therefore, during the approach to the target site, each cannula is always protected by a respective counter-cannula, without it ever coming into contact with the patient's skin.

This allows a significant reduction in the risk of contamination of the disc cannula 15 and the intradiscal needle 11 by bacteria and other microorganisms, potentially harbingers of infections of the nucleus pulposus of the intervertebral disc (e.g., discitis).

In the present embodiment, the medical device 100 further comprises a potentiometer (not illustrated), located in the handle 10 and operatively connected with respect to said electrical control circuit 14.

In particular, the electrical control circuit 14 is implemented with an electronic board configured to control the rotation speed of the stylus 12 based on a signal received from said potentiometer.

In the present embodiment, the medical device 100 further comprises a removable, sterile-sealed collection reservoir 16 configured for the collection of nucleus pulposus material for biopsy (Figs. 4 and 7).

In particular, in the illustrated embodiment, the collection tank 16 is provided with bayonet connection means (not visible in the figures) configured for engagement with corresponding connection means provided at the distal end of the handle 10.

It is obviously understood that different means of connection, provided they are suitable for the purpose, also fall within the scope of the present invention.

In the present embodiment, said disc cannula 15 conveniently has a diameter of 1.5 mm.

In the illustrated embodiment, the medical device 100 further comprises means 18 for indicating the charge status of the battery 17 (Fig.4).

In particular, in the present embodiment, said means 18 for indicating the charge status of the battery 17 are provided on the external surface of said handle 10 (Fig. 4).

In particular, in the present embodiment, said means 18 for indicating the charge status of the battery 17 are configured to emit a light signal.

In particular, in the present embodiment, said means 18 for indicating the charge status of the battery 17 comprise LED type light signalling means (Fig. 4).

In the present embodiment, the handle 10 has an ergonomic shape, which facilitates the operator in carrying out the procedure, while also avoiding the onset of painful sensations or in any case uncomfortable sensations for the operator.

The medical device 100 is operated by a switch 20, located on the handle 10 (Fig.7).

Alternatively, the medical device 100 may include a power button (variant not shown).

The placement of said switch 20 (or power button) in said handle 10 allows the operator to operate and control the medical device 100 with the same hand with which he works.

In the illustrated embodiment, the handle 10 has a slot 21 for the passage of a plastic tab (not illustrated) placed between the poles of the internal battery 17 and the electrical circuit 14 (Fig.6).

This allows the electrical circuit 14 to be rendered completely inactive before using the medical device 100, thereby avoiding losses in terms of capacity and efficiency of the initial charge of the battery 17.

The medical device 100 can easily be made suitable for use by removing said tab by the operator.

Medical device 100 is intended for distribution in single packaging under sterile conditions.

The medical device 100 features a laser marking (e.g., made on the external surface of the handle 10), including at least the following information: product batch; size; product code; CE marking followed by the number of the European Union certification body.

The present invention also provides a kit for performing a percutaneous discectomy operation.

In particular, this kit includes:

- a medical device as described above;

- a trocar, and

- a cleaning spatula.

The package is accompanied by instructions for using the medical device.

Use of a kit according to the present invention in performing a percutaneous discectomy procedure

We proceed below with the exemplary description of a percutaneous discectomy procedure using a kit according to the present invention.

The procedure must be performed under local anesthesia or conscious sedation to allow monitoring of the patient's symptoms indicative of irritation of a segment of the spinal nerves.

Performing the procedure under general anesthesia is not recommended.

Where there is an infection in the spine, particularly near the target site, it is necessary to treat the infection before proceeding with percutaneous discectomy.

In particular, this kit includes:

- a medical device as described above;

- a trocar;

- a cleaning spatula.

The kit is intended for use only by an operator (surgeon) specifically trained in spinal surgery, particularly with reference to procedures relating to discography, interdiscal therapies and percutaneous disc access.

Each medical device is intended for use in relation to a single segment of the intervertebral disc.

If treatment is required at multiple interdiscal levels, a single device must be used for each level being treated.

The percutaneous discectomy procedure includes the following steps:

- Check the integrity of the package. If there is damage or other anomalies that compromise the sterility conditions of one or more components, the device must not be used;

- Remove the kit components from the packaging and place them on a sterile field (tray), further checking for any visible damage;

- Operate the medical device, checking that the LED light signaling devices light up correctly (this is an indicator of a sufficient battery charge level). If any anomalies are found, the device must not be used and must be returned to the manufacturer according to the defined procedures;

- Remove the disc cannula from the removable collection reservoir (e.g., by rotating the cannula wings) and fill the disc cannula with sterile saline;

- Insert the trocar inside the disc cannula;

- Administer local anesthesia or conscious sedation to the patient;

- Introduce the disc cannula and the trocar inserted into it inside the patient's body, following a predefined trajectory to reach the target site with extrapedicular access up to the center of the intervertebral disc undergoing treatment. The disc cannula is not configured for a transdural approach;

- Check radiologically (using antero-posterior and lateral X-rays) the position of the disc cannula in the intervertebral disc. The trocar may be removed from the disc cannula only after this check. Removing the trocar from the disc cannula before this operation may in fact cause damage to the health of the patient undergoing treatment (in terms of lesions or similar);

- Inject a nonionic contrast medium along with an antibiotic agent to visualize the boundaries of the nucleus pulposus. This allows the operator to clearly visualize the nucleus space and adequately limit the discectomy;

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- Insert the intradiscal needle into the insertion cannula and connect the collection reservoir to the intradiscal needle (e.g., using the Luer fitting provided in the insertion cannula);

- Under visual control by fluoroscopy, maintain at least one complete turn of the needle tip, so that it extends beyond the end of the disc cannula. If this does not occur, gently rotate the disc cannula in conjunction with the collection reservoir. At each step, it is advisable to carefully avoid applying excessive pressure to the disc cannula and intradiscal needle, in order to avoid structural damage and/or tissue injury to the patient;

- Activate the medical device by pressing a switch provided in the handle and determine the slow and progressive advancement of the intradiscal needle. As a guide, it is advisable to determine an advancement of approximately 1 cm every 10 seconds. This allows for effective removal of the nucleus pulposus material, while at the same time avoiding possible injuries to the patient. It is recommended to operate for a maximum period of 15 seconds. The advancement limit can be controlled and adjusted by means of visual indication of the insertion depth. The total period of the percutaneous discectomy procedure is between 1 and 5 minutes. In any case, the overall duration of the procedure must not exceed 5 minutes;

- Visually inspect the connection between the disc cannula and the collection reservoir for accumulation of material from the nucleus pulposus. If no material is observed within the collection reservoir after 3 minutes or 6-8 passes through the nucleus pulposus after the device has been activated, withdraw the intradiscal needle from the disc cannula and visually inspect for any nucleus pulposus material within the intradiscal needle. Any tissue debris or similar should be removed from the intradiscal needle using the cleaning spatula before reintroducing the intradiscal needle into the disc cannula and resuming the procedure. It is important to avoid bending the intradiscal needle in any way during cleaning;

- Stop the procedure and remove the intradiscal needle from the disc cannula when any of the following conditions occur:

- the operator finds that a sufficient quantity of pulpy material has been removed;

- the collection tank is full;

- no material is present in the intradiscal needle after 3 minutes from activation of the device and/or after 6/8 passages through the nucleus pulposus;

- The maximum procedure duration (10 minutes) has elapsed.

- Remove the device from the patient?s body. At this stage, it is not necessary to operate the device. The disc cannula and intradiscal needle can be removed from the patient?s body together. Alternatively, the intradiscal needle can be removed before the disc cannula to allow a contrast medium to be injected into the disc through the disc cannula after the procedure is completed. In this case, it is advisable to use a contrast medium containing antibiotics, if it was not injected before starting the procedure;

- Perform skin disinfection after the procedure and place a sterile field at the insertion point.

It is important that the operator maintains an active view of the position of the intradiscal needle end under radiological control throughout the procedure. This is particularly intended to avoid repeatedly coming into contact with the fibrous ring of the disc.

It is also advisable to avoid excessive rotation of the intradiscal needle in order to prevent possible trauma, particularly to the fibrous ring of the disc.

Similarly, it is advisable to avoid applying excessive force to the intradiscal needle during the procedure in order to avoid structural damage or cause breakage.

Once removed, the collection tank can be sent to a special location for histological examination of the removed nucleus pulposus material. At this stage, particular attention must be paid to the integrity of the sterile conditions. It is in fact essential to preserve the nucleus pulposus material to be biopsied from possible contamination by bacteria or other microorganisms.

The handle, containing the motor and other electrical/electronic components of the device, must not be opened in any way, even once the procedure has been completed.

Environmental conditions for operation, storage and transport of the device Following laboratory experiments, the following parameters for operation, storage and transport of the medical device according to the present invention have been established:

? It is therefore possible to observe how the medical device according to the invention is suitable for operation, transport and/or storage in easily obtainable environmental conditions, without particular difficulties or high costs.

Failure to comply with the above parameters may result in damage to the health of the patient undergoing treatment.

The device must not be immersed in liquids.

The device is unsuitable for use in the treatment of pain conditions originating from structures other than herniated discs, such as loose fragments, severe bone stenosis, severely degenerated discs, or severe and rapidly progressing neurological deficits.

Sterility?

The medical device is sterilized with ethylene oxide (C2H4O).

The medical device must be stored in its original sterile packaging until it is used, according to medical-hospital procedures.

Manufacturing materials

Medical device

- Pomalux? (Polyoxymethylene (POM)), compliant with ASTM F 1855 Standard Specification for Polyoxymethylene (Acetal) for Medical Applications;

- Silicone foam, compliant with F2038-00e1 Standard Guide for Silicone Elastomer, Gels and Foams used in Medical Applications Part I ? Formulations and Uncured Materials;

- Stainless steel compliant with NBR ISO 5832-1 Implants for surgery ? Metallic materials ? Part 1: Formed Stainless Steel and ASTMF 138 Standard Specifications for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants;

- 304 stainless steel compliant with AISI 304 NBR ISO 5601 Stainless steels ? Classification for chemical composition ASTMF899 ?class 3 Standard Specifications for Stainless Steels for Surgical Instruments;

- Polyethylene, compliant with NBR ISO 5834-2 Implants for High Molecular Weight Polyethylene Surgery - Part 2 (ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants);

- Polycarbonate compliant with NBR ISO 11886 Polycarbonate plastic for use in disposable medical, dental and hospital products.

The use of latex is not foreseen.

Trocar

Disposable trocar with ?Luer? type connection, compliant with NBR ISO 594-1? conical assembly with 6% taper (Luer) for syringes, needles and other medical devices. Part 1: General Requirements.

Manufactured from AISI 304 stainless steel compliant with NBR ISO 5601 Stainless Steels ? Chemical composition classification (ASTMF899 ? class 3 Standard Specification for Stainless Steels for Surgical Instruments).

Cleaning spatula

Polyoxymethylene (POM) compliant with ASTM F 1855 ? Standard Specification for Polyoxymethylene (Acetal) for Medical Applications.

Packaging

The medical device is sterilized with ethylene oxide (C2H4O) and individually packaged in sterile-tight packaging.

In particular, the package features four levels of primary, secondary, tertiary and quaternary packaging.

The tertiary packaging features a security seal.

Between the secondary packaging and the tertiary packaging there are four traceability labels to be inserted, respectively, in the following archives: of the healthcare professional, of the hospital structure, of the patient undergoing treatment and of the supplier.

Finally, the primary packaging features an indicator sensitive to ethylene oxide (C2H4O) sterilization.

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List of references

100 Medical device for percutaneous discectomy

10 Grip

10.1 Housing (handle)

11 Intradiscal needle

11.1 Cavities? internal (intradiscal needle)

12 Stiletto

13 Motor vehicles

14 Electrical circuit

15 Disc cannula

16 Collection tank

17 Battery

18 Battery charge status indicator (LED) 19 Visual insertion depth indicator 20 Switch

21 Loophole

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Claims (11)

1. Medical device (100) for percutaneous discectomy comprising: - a hollow handle (10) which defines a housing (10.1) for one or more components of said medical device (100); - a transcutaneous intradiscal needle (11), having a proximal end connected to said handle (10) and a free distal end, configured for insertion inside the body of a subject, said intradiscal needle (11) presenting an internal cavity (11.1); - a stylet (12), placed inside said internal cavity (11.1) of the intradiscal needle (11), said stylet (12) presenting a plurality of spirals or worms which extend substantially for the entire length of said stylet (12); - motor means (13), placed inside said housing (10.1) defined in said handle (10), configured to rotate said stylet (12) during use and thereby determine the removal by suction of material from the nucleus pulposus of an intervertebral disc, due to the presence of a herniated disc; - an electrical control circuit (14), located inside said housing (10.1) defined in said handle (10) and operationally connected with respect to said motor means (13); - means of powering said motor means (13) and said electrical circuit (14), and - a disc cannula (15) for insertion of said intradiscal needle (11), wherein said disc cannula (15) has a telescopic configuration composed of a plurality of cannulas and counter-cannulas, so as to allow a progressive approach with respect to a target site to be treated. 2. Medical device (100) according to claim 1, wherein said medical device (100) further comprises a potentiometer, located in said handle (10), operatively connected with respect to said electrical control circuit (14), and ?? ? ????? ??? ?????????? wherein said electrical control circuit (14) is implemented with an electronic board configured to control the rotation speed of said stylus (12) based on a signal received from said potentiometer. 3. Medical device (100) according to one or more of the preceding claims, wherein said medical device (100) further comprises a removable, sterile and hermetically sealed collection tank (16), configured for the collection of nucleus pulposus material to be subjected to biopsy examination. 4. Medical device (100) according to claim 3, wherein said collection tank (16) comprises bayonet connection means configured for engagement with corresponding connection means provided at the distal end of the handle (10). 5. Medical device (100) according to one or more of the preceding claims, wherein said electrical power supply means comprise a 9V battery (17). 6. Medical device (100) according to claim 5, wherein said medical device (100) further comprises means for indicating (18) the charge status of the battery (17); preferably wherein said means of indicating (18) the charge status of the battery (17) are provided on the external surface of said handle (10); preferably wherein said means for indicating (18) the state of charge of the battery (17) are configured to emit a light signal; preferably wherein said means of visual indication (18) of the charge status of the battery (17) comprise light signalling means of the LED type. 7. Medical device (100) according to one or more of the preceding claims, wherein said transcutaneous needle (11) comprises visual signaling means (19) of insertion depth of said transcutaneous needle (11). ?? ? ????? ??? ?????????? 8. Medical device (100) according to one or more of the preceding claims, wherein said stylet (12) is made of medical steel. 9. Medical device (100) according to one or more of the preceding claims, wherein said handle (10) has an ergonomic shape. 10. Medical device (100) according to one or more of the preceding claims, wherein said disc cannula (15) has a diameter of 1.5 mm. 11. Kit for performing a percutaneous discectomy operation, including: - a medical device (100) according to one or more of the preceding claims; - a trocar, and - a cleaning spatula.