专利摘要:
The invention relates to a nerve cuff electrode arrangement (1) for fitting around a nerve (N), with a flexible sheath (2) surrounding the nerve (N) in an operating position with at least one electrode (3) arranged on the inside electrically conductive material, and at least one lead connected to each electrode 3 (4). To create such a nerve cuff electrode assembly (1), which can be easily implanted and removed atraumatically, a housing (5) for receiving 'at least a portion of the jacket (2) is provided in a mounting position, which housing (5) with a handle part (6) containing at least one supply line (4) is connected to a unit (7) for locking the jacket (2) in the operating position.
公开号:AT512534A4
申请号:T501462012
申请日:2012-04-26
公开日:2013-09-15
发明作者:Winfried Ddr Mayr;Ewald Ing Unger
申请人:Univ Wien Med;
IPC主号:
专利说明:

E014.il priiiiecf: .27 ^ 0442012 • 1
Die.Erfindung relates to a nerve cuff electrode assembly for conditioning around a nerve, with a surrounding in a working position, flexible jacket with at least one arranged on the inside electrode of electrically conductive material, and at least one connected to each electrode lead. For the derivation of biosignals and stimulation of nerves and muscles, the use of implantable electrodes is required. One differentiates between three types of electrode concepts, namely 1. electrodes in the form of rings or active tips of metal cylinders, which are selectively fixed to the surface of nerves or muscles; 2. cuff electrodes that enclose the tissue to be inferred or irritated; and 3. electrodes in the form of tips or wires that are invasively buried in nerve or muscle tissue.
The second type of electrodes, the so-called cuff electrodes, developed from the problem of dislocation, as the simply placed in the tissue tips, especially with movement of the area, easily slip and thus difficult targeted application in Ableit'- or stimulation area or even impossible. Furthermore, the insulation of the electrode contacts against the surrounding tissue can be advantageous with regard to low-noise conduction or selective stimulation.
The development of a cuff also resulted from the need to apply electrode arrays in an annular or matrix arrangement around the nerve. These defined electrode arrangements require in particular the stable position around or along the nerve, which, apart from the epineural electrodes, which are sewn in a limited number of electrodes directly to the nerve, can only be realized with cuff electrodes. To ensure the positional stability of the cuff electrodes, they are often sutured after sheathing the nerve. However, this suturing of the loop involves the risk that the nerve in the course of 2
Einheilphase or constricted in inflammation. By swelling the area or an increased connective tissue reaction, the inner lumen of the sewn cuff is reduced, which can traumatize the nerve by the increased contact pressure.
With regard to the explantation of the electrodes, the sewn cuff electrodes can only be removed by the reopening of the implantation area and the direct access to the point of application. This results in an additional operation and an increased risk for the patient when removing the electrode.
EP 843 574 Bl, for example, describes a cuff electrode for applications in neuroprosthetics, the jacket having finger-shaped formations with electrodes arranged thereon, which surround the nerve correspondingly.
WO 99/24109 A2 shows another cuff electrode for use in the biological and medical fields using flexible, self-curling layers, which adapt to the cross-section of the nerve accordingly.
US 2008/0065184 A1 shows a fixed diameter cuff electrode and electrode contacts projecting from the inside of the shell.
US 2005/0021102 A1 describes a system and method for stimulating the phrenic nerve for diaphragmatic training using intramuscularly placed stimulation electrodes.
The object of the present invention is to provide an above-mentioned nerve cuff electrode assembly which can be easily applied and removed easily and quickly after temporary use without the risk of damaging the nerve. Disadvantages of known nerve cuff electrode arrangements should be avoided or at least reduced.
The object of the invention is achieved by an above-mentioned nerve cuff electrode assembly, wherein a housing for receiving at least a portion of the jacket, which in the
iMitted: 27-04 ^ 2012 E014.1 10 201.2 / 50146 3
Operating position surrounds the nerve, is provided in a mounting position, which housing is connected to a at least one supply line containing 'handle part with a unit for locking the shell in the operating position. The nerve cuff electrode arrangement according to the invention thus makes it possible to introduce the housing into the vicinity of the nerve or nerve to be stimulated, from which signals are to be derived, wherein in the assembly position at least a part of the jacket is arranged in the housing. Due to the fact that, in the assembly position, the jacket is arranged at least partially, preferably completely, in the housing, the arrangement can be introduced and / or removed from the operation area for implantation and explantation more easily and without substantial damage to the surrounding tissue. During implantation, after placement of the housing next to the nerve, the sheath is moved out of the housing and placed around the nerve. In this position, the so-called operating position, the jacket is locked. The removal of the nerve cuff electrode assembly after a temporary application is analogous, i. the locking of the jacket solved,. whereupon the coat can be removed from the nerve and at least partially accommodated in the housing. Thereafter, a simple atraumatic explantation of the nerve cuff electrode assembly can take place. The new nerve cuff electrode arrangement makes it possible to securely fix the electrodes to the nerve and to provide a simple solution without surgery. In particular, the contact pressure of the electrodes against the nerve can be set optimally for good stimulation or discharge results by wrapping the nerve around the jacket with the electrodes.
The Verrieglungseinheit may be formed by a displaceably arranged latch, wherein the free end of the shell has a latch in the operating position receiving opening. According to this embodiment variant, the jacket consists essentially of a band-shaped section with an opening at the free end, through which opening after wrapping the nerve with the band-shaped jacket, a latch of the locking unit is pushed, whereby the jacket is held in the operating position around the nerve. Such an embodiment can be made relatively small and simple. 4
If the housing has at least one slot over which the jacket is movable into and out of the housing and in the housing a means for rolling up the shell is arranged, it can be achieved that the jacket is accommodated in the mounting position particularly space-saving in the housing and In the operating position, the electrodes arranged on the inside are optimally pressed against the nerve surface.
It is advantageous if the retractor has a spring element to support the rolling of the shell in the mounting position and to determine the contact pressure of the shell to the surface of the nerve in the operating position. With the help of the spring element, the contact pressure of the jacket or the electrodes arranged on the inside can be adjusted to the surface of the nerve.
It is advantageous if the spring force of the spring element is preferably adjustable via an actuating element arranged on the grip part of the nerve cuff electrode arrangement. Thus, an adjustment, for example, in case of insufficient contact pressure or excessive contact pressure, be made to the respective diameter of the nerve.
The retractor may include a motor, wherein an actuating element connected to the motor may be arranged in the handle part. In this way, by activating the actuating element on the handle part, the motor for winding and unwinding the jacket can be activated or deactivated and an automatic application and removal of the nerve cuff electrode arrangement can be achieved.
If the motor is equipped with a torque limiter, the nerve can be protected from an inadmissibly high contact pressure of the sheath.
A device for limiting the contact pressure of the jacket to the nerve in the operating position is advantageous. Such a device may be formed for example by a slip clutch. 5
Advantageously, the handle part of the housing is removable, wherein in the case of the removed grip part, the locking unit is actuated for locking the jacket in the operating position and the set contact pressure remains fixed. In this way, during a temporary application of the nerve cuff electrode assembly, the housing may remain in place in the body. By replacing the handle part, the released sheath diameter or the contact pressure can be readjusted if necessary. After application, the handle portion is reconnected to the housing and the nerve cuff assembly is explanted. After the connection of the grip part with the housing, the locking unit can be actuated again and thus the jacket for the assembly position can be unlocked again and rolled up in the housing.
A sensor for detecting the contact pressure of the jacket on the nerve in the operating position is advantageous because it can provide information as long as the nerve is subjected to undue stress or insufficient pressure is exerted on the nerve and consequently the electrodes do not make optimal contact with the surface of the nerve.
Such a sensor is preferably connected to a display disposed in the handle part, so that in particular during assembly of the nerve guff electrode assembly but also during the particular application, a control of the contact pressure of the jacket on the nerve can be done.
The sensor can be formed in a simple manner by a measuring diaphragm, which measuring diaphragm is connected to a fluid-filled hose, the end of which forms the display arranged in the handle part. Such a purely mechanical embodiment of the sensor for detecting the contact pressure is particularly robust and advantageously requires no supply of electrical energy. Of course, suitable electronic or optical sensors can be used.
The sensor for detecting the contact pressure of the jacket on the nerve is preferably connected to the reeling unit, so that a 6 6 102012/50146
Printed: 27-04-2012 corresponding control circuit can be formed and a deviation in the contact pressure of a desired setpoint readjustment by appropriate activation of the retractor is possible.
If the jacket comprises two parts, which are movable from two oppositely disposed slots in the housing and connectable in the operating position, the sheath of the nerve can be facilitated. The free ends of the two shell parts can be connected to each other in various ways, for example by appropriate hooks or eyelets, or by means of magnets.
Advantageously, the sheath is formed from a material which has a bias, so that the sheath in the operating position can be arranged independently around the nerve. By such a bias of the jacket is achieved that the jacket, as soon as it is moved out of the housing, moves independently around the nerve until the free end of the shell arrives again at the other side of the housing or with the free end of the second Shell part (in the case of a two-part design of the shell) coincides. The bias of the shell can be achieved by a suitable layer structure or appropriate choice of material, but also by mechanical pre-treatment of the shell.
On the side of the housing facing the nerve in the operating position, at least one electrode may be arranged on the inside of the jacket in addition to the electrode (s). Thus, the shell receiving housing forms part of the nerve cuff electrode assembly having at least one electrode, whereas the further electrode (s) is disposed on the inside of the flexible shell. For optimal signal derivatives and stimulation patterns, it is advantageous if an electrode Ar-ray is arranged on the inner surface of the jacket. Such electrode arrays comprise a certain number of electrodes in a specific arrangement.
The housing preferably has means for securing a surgical thread, e.g. Eyelets, clamps or the like., Arranged via which the nerve cuff electrode assembly fixed to the tissue and thus shifts of the electrodes on the nerve can be prevented. Prior to explanting the housing, the appropriate surgical sutures must be removed, which can usually be done by a quick, brief surgical procedure. A remotely controlled solution of such a seam, for example by means of a cut through the thread and pulling the seam, would be particularly advantageous. Another retractable into the housing mechanical fixation is conceivable.
If a cushion or the like. Is provided to seal against the ingress of germs at the passage of the skin and for receiving a germicidal or antibiotic substance, such as a disinfectant on the nerve cuff electrode assembly, a corresponding infection barrier, especially in the Skin passage, are produced. The cushion with the germicidal or antibiotic substance must be placed so that it is placed at the point of penetration of the skin and can destroy invading germs there. For longer-lasting applications, subcutaneously growing porous pillows, for example made of Dacron®, can also be used. However, these pads must be removed again prior to explantation of the nerve Cuf f electrode assembly with increased surgical effort.
In order to ensure that the surface of the nerve cuff electrode assembly remains lubricious and tissue does not adhere or grows on it, it is advantageous if the lying in the tissue parts of the housing and possibly the handle portion of the nerve cuff electrode assembly at least partially a corresponding coating made of a suitable biocompatible material or made of a suitable biocompatible material. In this case, polytetrafluoroethylene (PTFE), polyimide (PI) or polyethylene (PE) is particularly suitable. The coatings must consist of correspondingly smooth hydrophobic biomaterials.
The present invention will be explained in more detail with reference to the attached drawings, which show an embodiment of a nerve cuff electric arrangement.
Show:
Fig. 1 is a perspective view of a nerve cuff electrode assembly with the nerve surrounding jacket in operating position;
FIG. 2 a perspective view of a grip part which can be connected to the housing of the nerve cuff electrode arrangement according to FIG. 1; FIG.
FIG. 3 shows a view of the nerve cuff electrode arrangement according to FIG. 1 in the assembly position; FIG.
4 shows the housing of the nerve cuff electrode assembly in the assembled position according to FIG. 3 in a partially opened form; FIG.
FIG. 5 shows the nerve cuff electrode arrangement in the operating position; FIG.
FIG. 6 shows the nerve cuff electrode arrangement in the operating position according to FIG. 5 with the housing partially opened; FIG.
7 shows a variant of the nerve cuff electrode arrangement with sensor in the region of the housing;
8 shows the nerve cuff electrode arrangement with sensor in the region of the grip part; and
9 and 10 a variant of the nerve cuff electrode assembly with a variant embodiment for limiting the contact pressure.
Fig. 1 shows a perspective view of a nerve cuff electrode assembly 1 of the subject invention with a in an operating position the nerve N (shown in phantom) surrounding flexible sheath 2 with extending on the inside of the electrodes 3. The electrodes 3 may be arranged annularly or form an array of a plurality of electrodes 3. The electrodes 3 are connected to corresponding electrode leads 4. In a mounting position for implantation and explantation, the sheath 2 is at least partially accommodated in a housing 5. The housing 5 is connected to a handle part 6 (see Fig. 2) with a unit 7 for locking the jacket 2 in the operating position. The housing 5 may also include a sheath 5 'for the required leads etc. and be made integral with the sheath 5'. A separate embodiment of shell 5 'and housing 5 is also possible. The locking unit 7 may be designed in various ways, but should ensure that the jacket 2 is held in the operating position around the nerve N. In the illustrated embodiment, the locking unit 7 may be formed for example by a latch 15 on the housing 5, which latch 15 projects into an opening 16 at the free end 14 of the shell 2. The bolt 15 is actuated via a corresponding slide 7 'on the handle part 6.
FIG. 3 shows a view of the housing 5 of the nerve cuff electrode arrangement 1 according to FIG. 1 in the assembly position, in which at least part of the jacket 2 is accommodated, in particular rolled up, in the housing 5. As can be seen from the partially sectioned illustration according to FIG. 4, the jacket 2 made of flexible material is rolled up in a particularly space-saving manner inside the housing 5. The bolt 15 for locking the shell 2 in the operating position is retracted or not actuated in this case, so that the opening 16 is not blocked at the free end 14 of the shell 2.
In the operating position of the nerve cuff electrode arrangement according to FIGS. 5 and 6, the jacket 2 is looped around the nerve and the latch 15 of the locking unit 7 protrudes into the opening 16 at the free end 14 of the jacket 2.
Fig. 7 shows a variant of the nerve cuff electrode assembly 1 according to the invention, wherein in the housing 5, a measuring diaphragm 21 is arranged, which is connected via a corresponding hose 22 with a display 12- on the handle part 6. Thus, with such a sensor 11, the contact pressure of the jacket 2 on the nerve N can be measured. On the display 12 on the handle part 6 can be shown whether the contact pressure is sufficient.
FIGS. 9 and 10 show a variant of the nerve Cuf f electrode arrangement 1 according to the invention. which the contact force over
Pritited: 27-04-2012 £ 014.1 102012/50146 10 a torsion element 24 can be adjusted from the handle part 6 in the housing 5. The torsion element 24 may, for example, consist of a cylindrical winding body for the casing 2 with a centrally arranged longitudinal slot 25 and a leaf spring 26 which fits in the latter and which in turn is rigidly connected to a rod-shaped control probe 27. By moving the control probe 27 from the handle part 6 in the direction of the housing 5, the leaf spring 26 is pushed further into the longitudinal slot 25 and thereby hardens the Torsionsfederwirkung so that on the coat 2 to the nerve N (not shown) transferable contact pressure is increased. Conversely, by pulling out the leaf spring 26 from the longitudinal slot 25, which would be achieved by pulling on the control probe 27, the spring effect softer and the transferable contact pressure of the shell 2 is reduced.
权利要求:
Claims (20)
[1]
1. nerve cuff electrode assembly (1) for conditioning around a nerve (N), with a in a position of operation the nerve (N) surrounding flexible sheath (2) with at least one electrode arranged on the inside (3) of electrically conductive material, and at least one lead (4) connected to each electrode (3), characterized in that a housing (5) for receiving at least a part of the jacket (2) is provided in a mounting position, which housing (5) is connected to a at least one supply line (4) containing the handle part (6) with a unit (7) for locking the jacket (2) in the operating position.
[2]
2. nerve cuff electrode assembly (1) according to claim 1, characterized in that the locking unit (7) by a displaceably arranged latch (15) is formed, and that the free end (14) of the jacket (2) a the latch (15) in the operating position receiving opening (16).
[3]
3. nerve cuff electrode assembly (1) according to claim 1 or 2, characterized in that the housing (5) has at least one slot (13) through which the jacket (2) into or out of the housing (5). is movable, and that in the housing (5) means (8) for rolling up the jacket (2) is arranged.
[4]
4. nerve cuff electrode assembly (1) according to claim 3, characterized in that the retractor (8) has a spring element (9) to support the rolling up of the jacket (2) and determining the contact pressure of the jacket (2) on the nerve (N) in the operating position.
[5]
5. nerve cuff electrode assembly (1) according to claim 4, characterized in that the spring force of the spring element (9) preferably via an on the handle part (6) arranged actuating element (10) is adjustable.
[6]
6. nerve cuff electrode assembly (1) according to claim 3, characterized in that the retractor (8) includes a motor (17), and in that one with the motor (17) connected to the transmission element (18) in the handle part (18). 6) is arranged.
[7]
7. nerve cuff electrode assembly (1) according to claim 3, characterized in that the motor (17) is equipped with a torque limiter.
[8]
8. nerve cuff electrode assembly (1) according to one of claims 3 to 7, characterized in that a device for limiting the contact pressure of the jacket (2) on the nerve (N) is provided in the operating position.
[9]
9. nerve cuff electrode assembly (1) according to one of claims 1 to 8, characterized in that the handle part (6) from the housing (5) is removable, wherein in the case of the removed grip part (6), the locking unit (7) Locking of the jacket (2) is actuated in the operating position.
[10]
10. nerve cuff electrode assembly (1) according to one of claims 1 to 9, characterized in that a sensor (11) for detecting the contact pressure of the jacket (2) on the nerve (N) is provided in the operating position.
[11]
11. nerve cuff electrode assembly (1) according to claim 10, characterized in that the sensor (11) is connected to a in the handle part (6) arranged display (12).
[12]
12. nerve cuff electrode assembly (1) according to claim 11, characterized in that the sensor (11) by a measuring membrane (21) is formed, which measuring membrane (21) is connected to a liquid-filled tube (22), whose end the in the handle part (6) arranged display (12).
[13]
13. nerve cuff electrode assembly (1) according to any one of claims 10 to 12, characterized in that the sensor (11) is connected to the reeling unit (8).
[14]
14. nerve cuff electrode assembly (1) according to one of claims 1 to 13, characterized in that the jacket (2) comprises two parts (2 ', 2 , ), which consists of two oppositely disposed slots (13 *, 13 '') are movable in the housing (5) and connectable to one another in the operating position.
[15]
15. nerve cuff electrode assembly (1) according to one of claims 1 to 14, characterized in that the jacket (2) is formed of a material having a bias, so that the jacket (2) in the operating position independently to the Nerve (N) can be arranged.
[16]
16, nerve cuff electrode assembly (1) according to one of claims 1 to 15, characterized in that at the nerve (N) in the operating position facing side of the housing (5) at least one electrode (3) is arranged.
[17]
17 nerve cuff electrode assembly (1) according to one of claims 1 to 16, characterized in that on the inner surface of the jacket (2) an electrode array (19) is arranged.
[18]
18. nerve cuff electrode assembly (1) according to one of claims 1 to 17, characterized in that on the housing (5) means (20) for attaching a surgical thread, e.g. Eyelets, clamps or the like., Are arranged.
[19]
19 nerve cuff electrode assembly (1) according to one of claims 1 to 19, characterized in that a cushion (23) or the like. For receiving a germicidal or antibiotic substance is provided.
[20]
20. nerve cuff electrode assembly (1) according to one of claims 1 to 19, characterized in that at least parts of the housing (5) and possibly the handle part (6) at least partially with a coating of biocompatible materials, eg, polytetrafluoroethylene (PTFE ), Polyimide (Pl) or polyethylene (PE), or are made of biocompatible materials.
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同族专利:
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WO2013159136A1|2013-10-31|
引用文献:
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US8923970B2|2008-12-09|2014-12-30|Nephera Ltd.|Stimulation of the urinary system|FR3059476A1|2016-11-30|2018-06-01|Commissariat A L'energie Atomique Et Aux Energies Alternatives|ELECTRICAL CONNECTION DEVICE|
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法律状态:
2017-12-15| MM01| Lapse because of not paying annual fees|Effective date: 20170426 |
优先权:
申请号 | 申请日 | 专利标题
AT501462012A|AT512534B1|2012-04-26|2012-04-26|Nerve cuff electrode assembly|AT501462012A| AT512534B1|2012-04-26|2012-04-26|Nerve cuff electrode assembly|
PCT/AT2013/050096| WO2013159136A1|2012-04-26|2013-04-22|Nerve cuff electrode arrangement|
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