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Title:
INTRODUCER DEVICE WITH A SPHERICAL JOINT FOR ELECTRO - CATHETERS
Document Type and Number:
WIPO Patent Application WO/2013/110973
Kind Code:
A1
Abstract:
The application concerns a device (1) for the hypodermic introduction of needles, electro catheters, neurological electro catheters or percutaneous instruments in general, comprising a module (2) suited to be positioned on the patient's skin and a rotatable body (3) for forming part of a spherical joint, the body suited to be rotated with respect to said module (2) and provided with at least one through hole or seat (31) for the through insertion of said needle and/or electro catheter and/or percutaneous instrument in general, wherein said body can be rotated and locked.

Inventors:
REVERBERI CLAUDIO (IT)
CENTIN SNICHELOTTO EUGENIO (IT)
CELEGATO ENRICO (IT)
Application Number:
PCT/IB2012/050343
Publication Date:
August 01, 2013
Filing Date:
January 25, 2012
Export Citation:
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Assignee:
CARDIAC IMPULSE SRL (IT)
REVERBERI CLAUDIO (IT)
CENTIN SNICHELOTTO EUGENIO (IT)
CELEGATO ENRICO (IT)
NEURIMPULSE SRL
International Classes:
A61B17/34; A61M25/02; A61B19/00
Foreign References:
US5263956A1993-11-23
US4809694A1989-03-07
US20030055436A12003-03-20
US5354283A1994-10-11
Other References:
None
Attorney, Agent or Firm:
BENETTIN, Maurizio (Via Sorio 116, Padova, IT)
Download PDF:
Claims:
CLAIMS

1. Device (1) for introducing needles, electro catheters, neurological electro catheters or percutaneous instruments in general beneath the skin, characterized in that it comprises:

• at least one module (2) suited to be positioned on the patient's skin;

• at least one spherical joint (3) suited to be rotated with respect to said module (2) and provided with at least one through hole or seat (31) for the through insertion of said needle and/or electro catheter and/or percutaneous instrument in general,

and wherein said spherical joint can be rotated in order to vary the direction (X) of said seat or hole (31) and consequently the hypodermic introduction direction (X) of said needle, catheter or instrument, and can be locked in order to fix said direction (X) univocally.

2. Device (1) according to claim 1, characterized in that said module (2) comprises a box-shaped body (21) with a substantially flat lower surface or portion (22) directly or indirectly resting on the patient's skin, said box- shaped body (21) in turn comprising two opposite openings (231, 232), respectively on said flat surface (22) and in the opposite position, said openings (231, 232) being in communication with a cavity (24) in which a spherical joint (3) is housed.

3* Device (1) according to claims 1, 2, characterized in that said spherical joint (3) comprises a substantially spherical body suited to be rotated 360° inside said cavity (24) in the module (2) until reaching a maximum inclination with respect to the plane where said flat surface or portion (22) of the module (2) lies, and said at least one through insertion hole (31) between said two opposite openings (231, 232) in the module (2), with an upper inlet (311) of the hole (31) for the introduction of said needle, electro catheter or instrument, and a lower outlet (312) from which said instrument exits to be introduced beneath the skin.

* Device (1) according to claim 3, characterized in that said upper inlet

(311) of said through hole (31) in the joint (3) is defined by a projection (32) created on said spherical joint (3) and suited to limit the rotation of the joint (3) to a maximum inclination with respect to said plane where said flat surface or portion (22) of the module (2) lies.

5. Device (1) according to the preceding claims, characterized in that it comprises at least one means (4) suited to lock the rotation of said spherical joint (3), said locking means (4) comprising at least one fixing dowel or screw (41) suited to be screwed in a seat (25) provided in said box-shaped body (21) of the module (2) and resting on the wall (33) of said joint (3).

6. Device (1) according to claims 3, 4, 5, characterized in that inside said through hole (31) in the joint there are one or more narrowed portions (313) suited to guarantee the correct introduction of the instrument in the hole (31).

7. Device (1) according to the preceding claims, characterized in that it comprises at least one supporting plate (5) constrained to said lower flat surface (22) of the module (2) and suited to be interposed between said lower flat surface (22) of the module (2) and the patient's skin, said supporting plate (5) having the function of guaranteeing adherence between said device (1) and the patient's skin.

8. Device (1) according to claim 7, characterized in that said supporting plate (5) is made of a biocompatible material, for example biocompatible silicone, and comprises an opening at least at the level of said lower outlet

(312) of the through hole (31).

9* Device (1) according to the preceding claims, characterized in that said through seat or hole (31) is suited for the introduction, in the given order, of a hollow needle, a stimulation needle through said hollow needle, a tube made of a biocompatible material or dilator after the withdrawal of said hollow needle and in such a way that said stimulation needle is contained therein, a percutaneous electro catheter in said tube and beside said stimulation needle, and wherein, once said percutaneous electro catheter has been correctly positioned, said stimulation needle, said dilator and said device can be removed.

Description:
INTRODUCER DEVICE WITH A SPHERICAL JOINT FOR

ELECTRO - CATHETERS

DESCRIPTION

The orientable introducer device for percutaneous neurological electro catheters comes within the field of techniques and implantable devices for antalgic neurostimulation.

Specifically, the new device comprises a silicone plate on which there is an orientable introducer module through which it is possible to introduce, beneath the skin, first a nerve needle, then one or more introducer cannulas or dilators and finally the stimulation electro catheter, so that it is positioned beneath the skin with fixed and stable angle and depth.

Neurostimulation has been successfully used for years in the treatment of chronic pain; antalgic stimulation allows, for example, to relieve if not even to neutralize chronic pain through the electrical stimulation of specific nerve fibres.

Clinical cases relating to the stimulation of the femoral, tibial, ulnar, sciatic, occipital (greater and lesser), peroneal, radial nerve show the effectiveness of neurostimulation for pathologies like cervical pain, foot causalgia, migraine, carpal tunnel and pain deriving from surgical failures.

The effect perceived by the patient is a feeling of "numbness" that replaces the feeling of pain.

In the field of neurostimulation systems two families of devices are typically used: the neurostimulator and the electro catheter.

The neurostimulator is essentially an electronic circuit, powered by means of a battery or a rechargeable accumulator, enclosed within a tight container made of a biocompatible material, typically titanium.

The electronic circuit placed inside the neurostimulator is telemetrically programmable and is a generator of multi-channel electric pulses with programmable duration, frequency and amplitude.

The electro catheter is the means through which the electric pulses generated by the neurostimulator are carried to the nerves. Electro catheters are usually provided on one side with a series of stimulation electrodes, which are to be positioned in proximity to the nerve to be stimulated, and on the other side with a series of contact electrodes, equal in number to the stimulation electrodes, which are to be connected to the neurostimulator through a suitable connector. The effectiveness of stimulation essentially depends on the distance between the stimulation electrodes and the nerve: the shorter the distance, the lesser the energy that the electro stimulator has to supply to give the patient the same relief.

In the field of neurostimulation implants are usually made by neurosurgeons, through open surgery, or by anaesthesiologists, without open surgery.

The operation performed by the anaesthesiologist, even if it is easier to carry out in certain respects, is however rather difficult when it comes to finding the correct position of the electro catheter.

The correct positioning of the electro catheter is of fundamental importance, as it guarantees effective stimulation, thus granting relief from pain, and efficiency as, given the vicinity of the electro catheter to the nerve, less energy is required for stimulation, which consequently increases the useful life of the electro stimulator.

At present, in order to position a percutaneous electro catheter neurosurgeons use a Tuohy needle, that is, a hollow needle: the needle is first introduced beneath the skin and successively the electro catheter is introduced through the hollow needle until reaching the correct stimulation point.

Once the electro catheter has been positioned, the Tuohy needle is extracted and the neurosurgeon continues the implant by connecting and positioning the electro stimulator.

The use of the Tuohy needle as described above is critical in some respects. As schematically shown in Figures 1 and 2, the needle (A), even if it is positioned beneath the skin, can move with respect to the skin (C) both on the horizontal and on the vertical plane, making the positioning of the electro catheter difficult and not univocal.

To remedy all the above drawbacks a new type of orientable introducer device for percutaneous neurological electro catheters has been designed and implemented.

The main object of the present invention is to provide a device suited to guide the introduction of percutaneous electro catheters along a prefixed direction.

Another object of the present invention is to optimize and facilitate the implant of percutaneous electro catheters, with no risk of accidental and undesired deviations from the intended direction.

These and other direct and complementary objects are achieved by the new orientable introducer device for percutaneous neurological electro catheters, comprising in its main parts at least one module provided with a joint suited to be oriented and locked in order to univocally fix the position of the stimulation needle for searching the nerve and successively of the electro catheter.

The introducer module is constituted by a spherical joint provided with a through insertion hole.

Said joint is fixed to a plate made of a biocompatible material, so that the hole through which the stimulation needle, the introducers and the electro catheters pass can rotate 360° with a fixed maximum inclination with respect to the horizontal plane.

Once having ascertained that the position of the stimulation needle he/she has passed through the through hole is correct, the doctor will be able to lock the spherical joint, guaranteeing a constant position and a constant angle with respect to the horizontal plane, that is, the plane with which the plate rests on the patient's skin.

The operation of the orientable percutaneous introducer device during implant of the electro catheter is described here below:

1) A Tuohy needle is introduced through the through hole in the spherical joint of the introducer module and successively, with the introducer module applied in this way, said needle is introduced beneath the skin.

2) A thin stimulation needle, whose tip only is not insulated, is passed through the Tuohy needle; said stimulation needle, used together with an external stimulator, makes it possible to look for the stimulation point and find it.

3) Once the stimulation point has been found, the silicone base of the introducer module is fixed in a stable manner on the patient's skin. After further verifying the effectiveness of stimulation, the spherical joint must be fixed in such a way as to guarantee a constant position and a constant angle of the needle that has been introduced with respect to the patient's skin.

4) Once the Tuohy needle has been removed, a small tube in a biocompatible material or dilator is introduced in the through hole in the spherical joint, so that the stimulation needle is contained therein.

5) The percutaneous electro catheter is passed inside the tube and beside the stimulation needle, until it reaches the correct position, that is, the same position as that of the stimulation needle.

6) Once the electro catheter has been positioned, the stimulation needle and the dilator are extracted and the orientable introducer system is successively removed.

The above description shows that the orientable introducer device for percutaneous electro catheters will make it easier for the doctor who carries out the implant to find the stimulation point and position the percutaneous electro catheter, so as to guarantee effective and at the same time efficient stimulation.

The characteristics of the new orientable introducer device for percutaneous neurological electro catheters will be highlighted in greater detail in the following description, with reference to the drawings attached as non- limiting examples.

Figures 1 and 2 schematically show a Tuohy needle (A) being introduced beneath the skin (C) without the orientable introducer device.

Figure 3 shows a three-dimensional view of the new device (1), while Figures 4a and 4b show two views of the new device (1), respectively a three-dimensional and a side view.

Figure 5 shows a side cross-sectional view of the new device (1).

The invention is a device (1) for introducing beneath the skin needles, electro catheters or percutaneous instruments in general, comprising in its main parts at least one module (2) suited to be positioned on the patient's skin and at least one rotatable spherical joint (3) provided with at least one through hole or seat (31) for the through insertion of said needle and/or electro catheter and/or percutaneous instrument in general, and wherein said spherical joint (3) can be rotated in order to vary the direction (X) of said hole (31) and consequently the hypodermic introduction direction (X) of said needle, catheter or instrument, and can be locked in order to univocally fix said direction (X).

In further detail, the new device (1) comprises at least one module (2) in turn comprising a box-shaped body (21), preferably hemispherical, with a substantially flat surface or portion (22) suited to be directly or indirectly rested on the patient's skin.

Said box-shaped body (21) comprises two opposite openings (231, 232), respectively on said flat surface (22) and in the opposite position, said openings (231, 232) being in communication with a cavity (24) in which a spherical joint (3) is housed.

Said spherical joint (3) comprises a substantially spherical body suited to be rotated 360° inside said cavity (24) until reaching a maximum inclination with respect to the supporting plane, that is, the plane on which said flat surface or portion (22) of the module (2) lies.

Said spherical joint (3) comprises at least one through insertion hole (31) between said two opposite openings (231, 232) of the module (2) and comprises an upper inlet (311) for the introduction of an instrument like a needle, a catheter or the like, and a lower outlet (312) from which said instrument exits.

According to the invention, inside said hole (31) there may be one or more narrowed portions (313) intended to guarantee the correct introduction of the instrument in the hole, said narrowed portions (313) being for example formed by one or more gaskets (314).

Said upper inlet (311) is defined by a projection (32) provided on said spherical joint and suited to limit the rotation of the joint (3) to a maximum inclination with respect to the supporting plane of the device (1). The rotation of said spherical joint (3) can be locked in any position through at least one locking means (4), for example comprising a fixing dowel or screw (41) suited to be screwed in a seat (25) provided in said box-shaped body (21) of the module (2) and resting on the wall (33) of said joint (3). Said device (1) preferably comprises also at least one supporting plate (5), made of a biocompatible material, constrained to said flat surface (22) of the module (2) and suited to be interposed between said lower flat surface (22) of the module (2) and the patient's skin.

Said supporting plate (5) has the function of guaranteeing adherence between the device (1) and the patient's skin.

Said supporting plate (5), made for example of biocompatible silicone, comprises an opening at least at the level of said lower outlet (312) of the through hole (31).

Therefore, with reference to the above description and the attached drawings, the following claims are expressed.