WO2016034910A1 - Device for assisting in the detection of body cavities - Google Patents

Device for assisting in the detection of body cavities

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Publication number
WO2016034910A1
WO2016034910A1 PCT/IB2014/001684 IB2014001684W WO2016034910A1 WO 2016034910 A1 WO2016034910 A1 WO 2016034910A1 IB 2014001684 W IB2014001684 W IB 2014001684W WO 2016034910 A1 WO2016034910 A1 WO 2016034910A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
electrode
electrodes
stylet
means
needle
Prior art date
Application number
PCT/IB2014/001684
Other languages
Spanish (es)
French (fr)
Inventor
BELTRÁN Andrés Ernesto SALGUERO
RESTREPO Augusto BUENDÍA
Original Assignee
Salguero Beltrán Andrés Ernesto
Buendía Restrepo Augusto
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Detecting, measuring or recording bioelectric signals of the body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode

Abstract

The invention relates to a medical device for the detection of body cavities, comprising electronic means for measuring the bio-impedance of the tissue in contact with the tip of penetrating means, by means of electrodes that are removably inserted, using a stylus, in the hollow portion of said penetrating means.

Description

DEVICE TO ATTEND IN cavity detection

BODILY

1. FIELD OF THE INVENTION

The present invention relates to a device for detection of body cavities by means of puncturing elements. For example, this device can be used to assist in the detection of the epidural space.

2. BACKGROUND OF THE INVENTION

In the prior art, the correct location of body cavities closed to perform some diagnostic or therapeutic procedure such as the provision of a pharmacological agent, or on-site surgical procedures is performed indirectly through instrumental support. In rare cases the doctor may make a finding of such a location, solely through their senses. Anesthesia is one of the most common medical procedures, in particular the epidural anesthesia used in the preparation of major procedures such as labor pains and various types of surgery, are these gynecological, urological or orthopedic; priority being given to elderly patients. Epidural anesthesia is high occurrence because the rate of births worldwide exceeds 134 million people 1 and in developed countries , 60% of deliveries are performed with epidural 2, while in developing countries the percentage reaches up to 40%.

1 The World Factbook 2013-14. Washington, DC: Central Intelligence Agency, 2013, USA.

2 Michelle JK Osterman, MHS; and Joyce A. Martin, MPH "Epidural and Spinal Anesthesia Use During Labor: 27 State Reporting Area, 2008". In Reports National Vital Statistics, Vol. 59, No. 5, April 6, 2011. US Dept. ofhealth & Human Services. Hyattsville, -MD, USA. The application requires locating epidural space leaving the spinal cord in its journey through the inner conduit has the spine. Said space contains mainly nerve roots projected from the spinal cord, artery, an extensive vascular network of smaller vessels, connective tissue and fat distributed semiliquid.

The insertion of the epidural needle is a surgical procedure during which the physician experienced sensory feedback of mechanical resistance by tissues to the passage of the needle, which can be modified, in some cases, by softening ligaments maternity cases and in others, excess fat in obese patients or particular pathological conditions. However, the most important component is the sensory experience loss resistance injection means, liquid or gas, through the needle. Such conditioned sensory feedback to multiple variants makes the epidural puncture is risky for the high probability of causing perforating traumatisms to the meninges. Reduce this risk is the responsibility of the anesthesiologist, which for this purpose must develop surgical skills are challenged by anatomical and physiological variations depending on the patient's condition. The loss of resistance as the main evidence in locating the epidural space is a practical method with a high success rate. However, the risk of accidental perforation of the meninges is also high for the following reasons:

- First, it is common in its route needle drag inward tissue detritus as fat, muscle or ligament fragments, creating a blockage which will not allow the flow resistance in air or liquid is reduced, bringing the medical to erroneously conclude that it has not reached the space and therefore to continue advancing the needle to pierce the meninges.

Another cause is the penetrating uncontrolled movement due to abrupt change of the force exerted by the doctor on the needle through the ligamentum flavum, as the advancing direction of the needle, this is a dense but thin tissue, drilling is abrupt and transient to pass a force control one position in manipulating the needle, can cause a delay in the recovery of movement control, which results in unwanted puncture of the meninges.

-The second event occasionally lead to an erroneous conclusion doctor, it is the intra-vascular puncture that occurs when the tip of the needle enters a blood vessel, against the pressure exerted by the doctor on the syringe plunger, the pressure there will be low presenting loss of resistance, so the doctor may conclude that in the epidural space and proceed with the application of anesthetic will be injected into the blood vessel without coming to the nerve roots that seek to block.

In seeking instrument solutions to these problems have been disclosed based on two main mechanisms methods: First, as in the loss of resistance is based on differential pressure and the second is based on the characterization of the electrical impedance the surrounding tissue at the tip. Embodiments in these categories are presented:

Mechanisms based on differential pressure (pressure loss) is that described in US patent 4,175,567. In said patent a device indicated by a membrane deflection, if the pressure differential between the tip of the epidural needle facing the outside is negative or positive is revealed. In particular, when using such a device, when it reaches the epidural space the membrane as a minus differential emulating will technique of "hanging drop" based on the pressure in the epidural space is negative with respect to atmospheric pressure.

Similarly, there are other patent documents such as US Patent No. 4,801, 293 and US 9,653 4.9 teaching respectively, detecting the negative pressure for injecting a pressurized gas and a sensor for detecting the pressure drop on entering the epidural space and with said signal means and retract the sharp piercing avoid meninges. Similar mechanisms are disclosed in US 5,205,828, US 5,902,273, US 6,773,417 patent and patent application publication number US 201 1/0060229.

In EP058259 patent application pressure meter device with auditory indicator, which adapts to the syringe and needle with which the technique of loss of resistance is performed occurs. Another embodiment is disclosed in US201 1/0224623 publication using a sealing chamber, wherein a plunger and spring mechanism and flow conducting means to an epidural needle, incorporates the mechanism applies pressure to the plunger so that when the tip of needle no blocking liquid is injected and an alarm is generated. A method and device for monitoring pressure change occurs in the publication WO2008 / 03890.

However, devices based solely on mechanisms using pressure differentials are subject to the same sources of error in the detection of the pressure change, such as plugging of the perforating means due to the accumulation of tissue detritus and puncture intra - accidental vascular. Another disadvantage of such methods is the elimination of sensory feedback anesthesiologist in detecting loss of resistance, excluding their expertise in the correct evaluation of the phenomenon, and relegating to said detection mechanism drive.

On the other hand, between the mechanisms based on bioimpedance they are disclosed the same in the following patents and patent applications:

- US 3682162 patent discloses the device comprising a syringe and a hypodermic needle electrodes and means for electrical stimulation. - The US patent 18 64 401 discloses a device based on bioimpedance and manufacturing methods of special needles to carry the electrodes for such measures. - Patent application US 2010/0286507 with publication No. reveals an epidural needle with electros permanently incorporated for bioimpedance measurements.

- Patent Application Publication Number WO20090 9707 relates to a medical team hand, replacing the materials and methods of the technique of loss of resistance and those for measuring the impedance by means of a hollow needle electrodes incorporated therein. Such devices are also disclosed in US patent application No. 2003/0083641 and US2006 / 0167404 and the latter has the main purpose to detect entry into blood vessels.

However, the embodiments are based on the measurement of bioimpedance, above, require special perforating means permanently integrated drivers and measurement electrodes, thereby resulting in the modification of the usual media such as epidural needles. Another important aspect not addressed by such embodiments is the measurement error associated with the application and measurement of electrical signals through electrode size reduced in biological media. In some such embodiments the electrical means for calculating the bioimpedance are incorporated in a hand held unit which the physician must hold modifying ergonomics of traditional medical technique. In other embodiments, external cables are used to connect electrical bioimpedance calculating means with the drive means incorporated in the piercing means, adding complexity in the assembly and possible sources of error in the measurement.

From the technical problems presented with devices, methods and mechanisms known for detecting the epidural space in the prior art such as the risk of entraining into the needle device detritus tissue as fat, fragments muscle or ligaments, penetrating uncontrolled movement due to abrupt change of the force r.

exerts the doctor on the needle through the ligamentum flavum, increased incidence of punctures in the meninges and intravascular puncturing occurs when the tip of the needle enters a blood vessel against the pressure exerted by the doctor on the plunger of syringe, a need exists for a device for detecting the epidural space that does not have these undesirable consequences and not to increase the uncertainty in the detection of said space or requires an increase in process complexity compared to traditional detection method the loss of resistance.

3. GENERAL DESCRIPTION OF THE INVENTION

The problem addressed in this application is the need to provide a device to assist the anesthetist in timely detection of the epidural space that complements the standard technique of loss of resistance increasing safety of the procedure, both for the patient, as for the anesthesiologist, is this expert or are in early stages of their learning curve. Consequently, it said device allowing the proper location of the epidural space. While e | device user (anesthesiologist) continues to run the traditional technique of loss of resistance, this provides increased accuracy in detecting the epidural space because the device indicates the discontinuity of tissue that occurs on reaching the epidural space. The minimum dimensions of the device allow mounting within the traditional needle non-disruptively. Therefore, one can continue using the syringe and the epidural needle of standard and commercially available method. Moreover, advantageously, the device does not require wire connections to electrodes, for example, external reference, or cannulas beyond this protocol. Menara such that the user (anesthesiologist) continues the normal handling of the needle and syringe and once located the epidural space, the device is removed from the needle and disposed to continue the administration of the anesthetic. The invention presented herein provides a number of advantages that allows inclusion in the standard discovery protocol of the epidural space in a slow manner. The experienced anesthesiologist still applying process control and increasing its expertise while the anesthesiologist in training or with little experience still forming in the standard technique with additional information to support their decisions. The inclusion of the device in the standard package for epidural does not require modification of existing materials and supplies. Device fabrication is performed using standard materials and methods in the medical supply industry, so their cost is low. Similarly, it is considered to be a single use, maintaining safe conditions for the patient. The above features allow it to be used in facilities and clinical situations of varying complexity. A first aspect in which the present invention is directed to reduce the accumulation of biological material on the stimulus electrodes / registration when the needle is penetrating the tissue on its way to the epidural space. The main adverse effects that such accumulation is the formation of short circuits between electrodes due to body fluids conductive film therebetween, and the shield electrode due to the accumulation of tissue detritus. In both cases they are blocked or distorted electrical signals either, stimulation or recording on the tissues, thus preventing its bioimpedance characterization. Another aspect in which the present invention addresses is appropriate for the doctor to perform the technique of loss of resistance in the presence of the embodiment described herein constructive characteristics. This implies that the air or liquid can flow into the syringe without the device resisting the flow of air or fluid from the syringe when the doctor applies pressure to the plunger rod.

In particular, to solve the technical problems above, the present application provides a medical device for detection of body cavities, with electronic means for measuring the bioimpedance of the tissue in contact with the tip piercing means by means of electrodes which are inserted, removably, by means of a stylet; in the hollow portion of said piercing means within the stylet and no conductive means connecting the electrodes with said electronic means, which in turn produce a signal indicating detection of the body cavity. Said medical device comprising:

An arrangement of electrodes are not coplanar each embedded in one plane or another facet, the surface of each facet is formed with a rigid substrate which is electrically insulating, which embeds the electrode and leaves only exposed region electrode contact biological tissue, so that the substrate forms a surrounding area from the electrode to the edges of the side that contains it. The plane formed by the surface of each facet is not coplanar with the planes formed by the surfaces of the other facets of the array. The planes formed by the surfaces of adjacent facets with common edge, has an angle, measured in the normal plane (625) to said common edge, greater than 180 °, wherein said faceted arrangement (612) of non-coplanar electrodes reduces the creation short circuits between electrodes due to the formation of conductive films of body fluids.

Centering means for the stylet scroll concentrically of the hollow portion piercing means creating lumen between the inner wall of said piercing means and the stylus, so that the gas or liquid injected from the syringe to flow with little opposition. Thus, the anesthetist continues in performing the process control technique of loss of resistance.

4. BRIEF DESCRIPTION OF THE DRAWINGS

The invention to assist in the detection of body cavities, for example the epidural space presented herein, it is understood more easily with the detailed description accompanied by the following set of drawings, in which: Figure 1 illustrates how the doctor takes in their hands epidural needle and syringe for the execution of the technique of loss of resistance to detection of the epidural space. Figure 2 illustrates the line of temporary assembly of the invention between the syringe and the epidural needle and a perspective view of how the system with the detection device of the epidural cavity mounted in the kit is a syringe and needle. Figure 3 illustrates how the detector incorporated into the epidural space pair of syringe and needle does not affect the way the doctor takes in hand assembly said pair compared to the traditional technique (illustrated in Fig.

Figure 4 shows three views of the device: (i) the first perspective, (ii) the second is a cutaway view of the assembly of syringe detector and syringe, and (iii) the third is a sectional view of how the hollow needle shaft concentrically contains the stylet detector device.

Figure 5 shows a longitudinal section of the temporary assembly of the syringe, the detector device and the epidural needle.

Figure 6 shows three views of the tip of the epidural needle electrode array assembly whose substrate is faceted, wherein said arrangement having two electrodes for measuring bioimpedance

Figure 7 shows two views of the tip of the epidural needle assembly facetted electrode arrangement, wherein said arrangement has four electrodes for bioimpedance measurement. 5. DETAILED DESCRIPTION OF THE INVENTION

In Figure 1 the prior state of the art, to the location shown. the epidural space in which the traditional pair jeringa10-needle 20 is used (which constitutes a penetrating means). In this technique, as the anesthetist pushes the clamping wings 201 of the needle into the body, presses the plunger 101 of the syringe to treat inject air or liquid. If no such content flow, the piston returns to its initial position due to the elastic air decompression, or in case there is only liquid shall not be moved by the incompressibility of the same. The physician considered as evidence of such resistance than the surrounding tissue plugs the needle tip and has not reached the epidural space and always when the depth reached by the needle and the specific conditions of the patient support such a conclusion. Therefore, it continues sinking the needle until no lock on the tip and no resistance to air flow, or liquid, as appropriate; which generally indicates that it has reached the epidural space.

Figure 2 shows a preferred embodiment 60 of the present invention is shown, in which is inserted between the syringe 10 and epidural needle 20 with the assembly 50 and the doctor performs the manipulation described above more but now the handset will signal through the indicators 606 of the needle tip 203 is in the epidural cavity. With this information the doctor will have more evidence to conclude whether it has reached the epidural space. Once it reaches this conclusion, the device and the syringe are removed and discarded, to continue the application of anesthetic. Figure 3 shows that the inclusion of the device is minimally disruptive, allowing the physician to perform maneuvers standard protocol.

In Figure 4A a view of the embodiment 60 is shown whose outer body has a base 601, indicators 606, a hub 610 with outputs 609 flow, stylet 602, trim tabs 61 1 and the tip 603 the electrode array 620 . a sectional view of the assembly shown 50 comprised of a syringe 10 in figure 4B, the device for detecting the epidural space 60 and epidural needle 20, which shows in detail how the tip 102 of the syringe sealingly engages the port 607 in the base 601. this port connects with conduits 608 of hub 610 which, in turn, sealingly engages the Luer connection port 204 of the epidural needle type in this port row 204 is created continuity flow into the syringe through the perforations 609 of the hub 610 of the device. The hub serves as a support from which the stylet 602 is projected to its distal end in the tip 603 an electrode array 620, described later, which in turn is aligned with the needle tip 203. staying detail view 65 of figure 4C, the cross section 652 of the needle shown that concentrically embedded to the cross section 651 of the stylet 602, De latter radiairnente projecting at least three trim tabs 61 1 which position the stylet all the way to be concentric with the hollow needle and a corridor 653, by which the resistance to flow with low air or liquid in the syringe is formed. The constructive features mentioned, allow the physician to continue running the technique of loss of resistance in the presence of the preferred embodiment 60 described herein.

In Figure 5, detailed in the base 601 is a concentric chamber 632 which houses the electronic means with its power source, for bioimpedance measurements, which are widely known in the prior art, so no they are detailed herein. A said means arrangement of electrodes 620 and the metal shaft 202 of the needle through the conduit means 630, embedded along Stiletto, all as a whole for measurement of bioimpedance tissue contact tip connected around the assembly 50. Trim tabs 61 1 proximal to the hub device 610, electrodes 631 are exposed, which made electrical contact with the metal shaft 202 of the epidural needle. Preferred embodiments of the present invention are characterized by certain identifying the epidural space. To achieve this it is necessary to reduce the pollution sources of stimulus signals / measurement. One of the main causes of pollution lies in the accumulation of tissue debris on the electrodes. When it comes to blood or other bodily fluid, liquid layers appear that shorted, causing a false low impedance measurement. The inventive principle, exemplified below, is applied to break the continuity of such conductive layers. An embodiment of this principle is presented in Figure 6 and in section A, the electrode array 620 inserted into the tip 202 of the epidural needle and surrounded by bezel 204, where the two electrodes 621 shown is observed and 622 are embedded in facets / planes 620i and 620j different, respectively, the rigid layer faceting which is electrically insulating, only exposing the region of the electrode for contact with the biological tissue. Each facet forms a polygon with adjacent edges with other facets, when one of these imbibes an electrode, this does not touch any of the edges thereof, remaining or both substrate areas guard extending from the respective electrode to the facet edges containing them. From the set of views .of Figure 6 shows how the plane formed by the surface of each facet is not coplanar with the planes formed by the surfaces of the other facets of the array. In the profile view of Figure 6C it is shown as adjacent facets 620i and 620j, with common edge, have an angle Θ greater than 180 °, measured in a plane normal to said common edge 625. This angulation between facets prevents the continuity of conductive layers between two or more electrodes as in the boundaries between facets forces are created that are larger than the surface tension of the liquid.

In the embodiment shown in Figure 6, with at least two electrodes 621 and 622, these are aligned with the longitudinal axis 618 of the needle. Such alignment divided into two symmetrical portions of faceted layer of the electrode arrangement, the first portion 620a with facets to 620d, and the second portion with symmetrical facets 620E to 620H. Between distal electrode 621 and the stylet tip, the substrate has two symmetrical facets 620a and 620E with adjacent common edge. This arrangement, as a keel, has the purpose of removing body tissue as the needle is advanced into the epidural space, so that by entering this, any remaining tissue is removed from the electrodes.

While it is possible to bioimpedance measurements using only two electrodes 621 and 622, is known in the prior art 3 '4 which in this configuration

3 Yela OS, D., houses or., BRAGÓS, R. and Rosell, J. (1999) Improvement of a Front End for Bioimpedance Spectroscopy. Annals of the New York Academy of Sciences, 873: 306-312. the measured impedance includes tissue impedance of interest plus the impedance that occurs at the electrode interface / tissue, which is generally much higher than the tissue impedance. This phenomenon is exacerbated for electrodes with small contact area and in preferred embodiments of the present invention, the diameters of the electrodes are between 100μιη to 200μηι. This is because the sizes epiduraies needles, reguiar use, are less than 17Ga. For example, an epidural needle 18ga, has an approximate internal diameter of 0,84mm; with less than 0.55 mm 2 and further equivalent cross - sectional area, the electrodes must be spaced approximately twice its diameter to establish viable tissue impedance in the presence of pollution sources measurement. To improve the measurement of the impedance of the medium of interest, another embodiment of the present invention uses the metal shaft of the epidural needle, connected to the electrical means, and a third electrode 631, and reference electrode (see Figures 5 and 6 ). Thus, the bevel 204 at the tip of the needle, forms an electrode elliptic geometry which surrounds the electrode array, and given its proximity to the same, receives the majority of the flow of current injected by the active electrode current source, which for this embodiment is defined as the electrode 622. Similarly, for the present embodiment measuring the voltage between the electrode 621 and the electrode formed by the bevel 204 is defined.

Another preferred embodiment for the arrangement of electrodes in the present invention is shown in Figure 7 in which four electrodes 622.623, 624, and 625, are aligned with the longitudinal axis 618 of the needle, using the same inventive concepts described above to remove contaminants on the electrodes (both tissue detritus as liquid films). In this embodiment, the configuration of four electrodes for impedance measurement, well known in the prior art, where the electrodes 622 and 625 are used as input and output stimulus current and between the electrodes 623 is used and 624 the voltage is measured. In other possible embodiments of the present invention, Steendijk, P .; ur, Gerrit; van der Velde, ET; Baan, Jan "The four-electrode resistivity technique in media anisotropic: theoretical analysis and application on myocardial tissue in vivo", Biomedical Engineering, IEEE Transactions on, On page (s): 1138-148 Volume: 40, Issue 11, Nov . 1993 the metal shaft of the needle can be connected or not, to function as electrical ground of the system or leave unconnected.

Claims

What is claimed
1. A medical device for detection of body cavities, with electronic means for measuring bioimpedance of the tissue in contact with the tip piercing means, by electrodes which are inserted in a re ovible, by a stylet, in a hollow portion of said piercing means; within the stylet no conductive means connecting the electrodes with said electronic means, which in turn produces a detection signal indicating the body cavity, wherein said device comprises:
- An array of non-coplanar electrodes each embedded in one plane or another facet, wherein the surface of each facet is formed with a rigid substrate which is electrically insulating, which embeds the electrode, leaving exposed only the electrode region for contact with biological tissue, such that the substrate forms a surrounding area from the electrode to the edges of the side that contains the plane formed by the surface of each facet is not coplanar with the planes formed by the surfaces other facets of the array; and the planes formed by the surfaces of adjacent facets with common edge, has an angle, measured in the normal plane (625) to said common edge, greater than 180 °, wherein said faceted arrangement (612) of non-coplanar electrodes reduces creation of short circuits between electrodes due to the formation of conductive films of body fluids.
2. A device according to claim 1, wherein the stylet (602) has fins for centering (611) in at least the distal end, an intermediate point and the proximal end portion of the walking the hollow shaft (202) of the piercing means, whereby the stylet is embedded concentrically in said piercing means without touching its inner surface except for the points where the trim tabs are supported, with the cross-sectional area (651) of the lower stylet sectional area ( 652) of the hollow section of said piercing means, thereby allowing the flow of gas or liquid through a hole (653) thus formed corridor.
3. A device according to claim 1 or 2 wherein the base (610) has a port (607) for sealing engagement with a syringe, and that via conduits (608) creates flow continuity with said syringe through a hub (610) which is sealingly inserted into the connector piercing means.
4. A device according to claim 1 wherein the electrode array has only two electrodes (621, 622), which are aligned with the longitudinal axis (618) of the piercing means, wherein:
- that alignment defines a longitudinal axis for the sensor, which divides it into two portions faceted layer (620) symmetrical on each side of the electrode arrangement, - the substrate between the distal electrode (621) and the stylus tip has two symmetrical facets (620a, 620E) whose adjacent edge is aligned with the longitudinal axis of the sensor, said common edge to the axis (618) as it approaches it approaches the tip of the stylet wherein said symmetrical arrangement of the substrate around the alignment of electrodes and at the top, separates the body tissue removing tissue debris that acumulen- on the electrode array during insertion of the piercing means with the stylet.
5. A device according to any of claims 1, 2, 3 and 4 wherein the proximal portion of the stylet (602) has at least one electrode (631) making electrical contact with the metal hollow shaft (202) of the piercing means, so that the bevel (204) on the tip becomes an elliptical electrode surrounding the electrode array (620).
6. A device according to claim 5 wherein a syringe with air or liquid is connected and whose stylet is inserted into an epidural needle so penetrating means, for insertion into the body tissue, and to jointly technique loss resistance to location of the epidural space simultaneously with the detection device based on bioimpedance.
MGM \ MG \! D-270912 \ WPC21370
PCT/IB2014/001684 2014-09-02 2014-09-02 Device for assisting in the detection of body cavities WO2016034910A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10004450B2 (en) 2016-05-03 2018-06-26 Texas Medical Center Tactile sensing device for lumbar punctures

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5205828A (en) * 1991-10-24 1993-04-27 Dan Kedem Epidural needle location indicator assembly
EP0608659A1 (en) * 1993-01-28 1994-08-03 Du Kedem Technologies Ltd. Epidural needle location indicator assembly
US20110060229A1 (en) * 2009-08-19 2011-03-10 Mirador Biomedical Systems, methods, and devices for facilitating access to target anatomical sites or environments
US20110224623A1 (en) * 2008-09-12 2011-09-15 Velez Rivera Hector De Jesus Epidural space locating device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5205828A (en) * 1991-10-24 1993-04-27 Dan Kedem Epidural needle location indicator assembly
EP0608659A1 (en) * 1993-01-28 1994-08-03 Du Kedem Technologies Ltd. Epidural needle location indicator assembly
US20110224623A1 (en) * 2008-09-12 2011-09-15 Velez Rivera Hector De Jesus Epidural space locating device
US20110060229A1 (en) * 2009-08-19 2011-03-10 Mirador Biomedical Systems, methods, and devices for facilitating access to target anatomical sites or environments

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10004450B2 (en) 2016-05-03 2018-06-26 Texas Medical Center Tactile sensing device for lumbar punctures

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