WO2020152570A1 - Dispositif universel d'anesthésie rachidienne continue - Google Patents

Dispositif universel d'anesthésie rachidienne continue Download PDF

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Publication number
WO2020152570A1
WO2020152570A1 PCT/IB2020/050420 IB2020050420W WO2020152570A1 WO 2020152570 A1 WO2020152570 A1 WO 2020152570A1 IB 2020050420 W IB2020050420 W IB 2020050420W WO 2020152570 A1 WO2020152570 A1 WO 2020152570A1
Authority
WO
WIPO (PCT)
Prior art keywords
spinal
needle
catheter
anesthesia
universal device
Prior art date
Application number
PCT/IB2020/050420
Other languages
English (en)
Inventor
Roberto STARNARI
Original Assignee
I.N.R.C.A.
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
Application filed by I.N.R.C.A. filed Critical I.N.R.C.A.
Priority to EP20704357.1A priority Critical patent/EP3914170A1/fr
Publication of WO2020152570A1 publication Critical patent/WO2020152570A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3401—Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0007—Epidural catheters

Definitions

  • the present invention relates to a universal device for continuous spinal anesthesia.
  • the present invention relates to a universal device for continuous spinal anesthesia, of the type suitable for use for subarachnoid anesthesia.
  • the continuous spinal anesthesia is a method that allows a neuraxial anesthesia/analgesia with small doses of local anesthetic and adjuvant drugs administered as a bolus during surgery and through an elastomeric pump in the post-operative period.
  • the presence of the catheter allows to titrate the dose of local anesthetic (AL) , to prolong the anesthesia and to allow a valid post-operative analgesia.
  • peridural anesthesia it is easier to perform, has fewer complications, is faster to be established and is more effective.
  • over-needle systems comprising a catheter that is carried over the needle
  • intra-needle systems where the catheter is instead introduced through said needle
  • the seat of the fold or compression can be internal, between the bone structures of the spine, or external, i.e. in proximity to the exit from the skin and along the course on the patient's back .
  • the intra-needle systems currently known don't consider, on the contrary, anti-kinking solutions.
  • a first example of known system is described by the patent application US2010331794A1 which discloses a flow element for use with flexible needles and flexible needle assemblies to minimize flow occlusion within a flexible needle is provided.
  • the flow element is particularly suited for uses with a flexible needle for minimizing incidence of post-dural puncture headache.
  • the flow element includes a body having an internal flow path for conducting a fluid through a flexible needle, and an anti-restriction member.
  • the anti-restriction member includes an elongated body, a proximal end coupled to the body within the internal flow path, and a distal end for positioning at least a portion of the elongated body within a flexible needle.
  • a flexible spinal needle assembly for minimizing flow occlusion through an internal flow path of a flexible needle by unintended kinking that is potentially caused by ligament or muscle layer movements is also provided, hi other embodiments, a flexible spinal needle assembly, a flexible spinal needle assembly kit, a method for installing a flexible spinal needle assembly, and a process for producing a flow element are provided.
  • WO9314710A1 describes a needle or cannula comprising a hollow shaft with an interface hub, the shaft having a fine gauge portion at its distal end and a reinforced portion at or near its proximal end.
  • a cannula sleeve is provided to reinforce a standard cannula.
  • a large bore cannula and an insertion means are disclosed, with insertion means causing a small puncture wound and reducing the risk of an accidental injury.
  • Improved needles and cannulas for nerve stimulation and needles to minimize the risk of puncture damage are also disclosed.
  • the patent application W02005044335 discloses an apparatus and a method to insert a spinal catheter and minimize the incidence of post-operative headache.
  • the apparatus typically includes a support needle with a non-cutting piercing tip and an externally mounted catheter.
  • the size of the catheter is small and the external assembly facilitates its use.
  • the patent application WO2017032912 describes a needle for the application of a neuroaxial anesthesia, in which said needle can act both as a spinal and an epidural needle, and comprises: a first handle covered, over its free end, by a mandrel and containing a first cannula.
  • the first handle includes, in a central upper part, a semi-spherical magnifying glass that amplifies the field of view, allowing the detection of the outflow of CSF at a higher resolution.
  • the rear part of the mandrel has a rounded shape so as to allow a better adherence and a slight upward inclination to allow the user to take the needle from a work table by a single hand.
  • the ergonomic structure allows to guide the needle with an absolute precision and orientation on the puncture area.
  • the wings can also be coupled to the needle so as to allow its use as an epidural needle.
  • the purpose of the present invention is to provide a universal device for continuous spinal anesthesia that avoids the difficulties and the complications related to the preparatory finding of the peridural space, while maintaining the convenience of a normal subarachnoid puncture .
  • a further purpose of the present invention is to provide a universal device for continuous spinal anesthesia that avoids an obstruction due to folds and compressions caused by a small caliber.
  • the universal device for continuous spinal anesthesia according to the invention therefore has characteristics that overcome the limits that still affect the current devices for spinal anesthesia, with reference to the prior art .
  • a universal device for continuous spinal anesthesia is provided, as defined in claim 1.
  • FIG. 1 shows an overall view of the universal device for continuous spinal anesthesia, according to the invention
  • figure 2 shows a view of the components of the universal device for continuous spinal anesthesia, according to the invention
  • - figure 3 shows a spinal catheter comprised in the universal device for continuous spinal anesthesia, according to the invention.
  • a universal device for continuous spinal anesthesia 100 comprises:
  • an introducer needle 101 able to be led as a first component, among the components that implement the universal device for continuous spinal anesthesia 100, into the ligaments of the spinal column of a patient ;
  • the spinal needle 103 is able to be introduced by means of the introducer needle 101.
  • the bridge cannula 102 is made of teflon or a similar plastic material.
  • the universal device for continuous spinal anesthesia 100 comprises a spinal catheter 105 able to be introduced by means of the bridge cannula 102 that advantageously allows the positioning of said spinal catheter 105 by means of a single subarachnoid puncture.
  • the universal device for continuous spinal anesthesia 100 comprises a coating sheath 106 made of polyethylene able to prevent obstructions of the spinal catheter 105.
  • the spinal catheter 105 has a length comprised between 90 centimeters and 100 centimeters. According to another aspect of the invention, the length of the spinal catheter 105 may be less than 90 centimeters depending on the connecting system used in the final connector/ filter system.
  • the introducer needle 101 has a 25-gauge internal diameter
  • the bridge cannula 102 has a 22-gauge internal diameter
  • the spinal catheter 105 has a 24-gauge internal diameter.
  • such dimensions allow an easy and effective mutual sliding of the aforementioned components.
  • a method of use of the universal device for continuous spinal anesthesia 100 comprises the steps: - of inserting the introducer needle 101 between the ligaments of the spine of a patient;
  • CSF cerebrospinal fluid
  • the puncture of the dura mater is performed as for a normal subarachnoid puncture, advancing the spinal needle 103 - bridge cannula 102 assembly by means of the introducer needle 101, such a needle having a short and adequate diameter.
  • the reduced caliber of the spinal needle 103 allows to limit the occurrence of postoperative headache for a patient.
  • the bridge cannula 102 is mounted over the spinal needle 103, while the spinal catheter 105 is introduced through said bridge cannula 102 so as to achieve the advantages and limit the inconveniences of the currently known systems.
  • the use of the universal device for continuous spinal anesthesia 100 avoids the preparatory finding of the peridural space and thus prevents the difficulties and the complications related to this procedure, maintaining the convenience of a standard subarachnoid puncture in all aspects.
  • the universal device for continuous spinal anesthesia 100 thanks to the cannula bridge 102, allows to introduce the spinal catheter 105 through a dural breach made by a spinal needle 103 having a small diameter.
  • the calibers of the spinal needle 103, of the bridge cannula 102 and of the spinal catheter 105 allow to use the bridge cannula 102 as a temporary "bridge" to introduce the spinal catheter 105, so that it is possible to place a catheter having dimensions slightly larger than those of the spinal needle 103.
  • the positioning procedure with respect to that of the known over-needle system which requires the preparatory finding of the peridural space, generally more complex and riskier than a subarachnoid puncture especially in pregnant women, is also facilitated.
  • the spinal catheter 105 is covered with a coating sheath 106 made of polyethylene which covers the spinal catheter 105 in its external part, except for the first 10-15 centimeters coming out from the skin.
  • the coating sheath 106 is supplied pre assembled on a spiral guide which allows an easy positioning made by an operator.
  • the universal device for continuous spinal anesthesia 100 has three different lengths related to the spinal needle 103:
  • the atraumaticity of the tip of the spinal needle 103 and its small diameter, together with the diameter of the spinal catheter 105 being greater than the size of the hole made are synergistic factors that limit the post-dural puncture headache, frequent among young patients and pregnant women.
  • the coating sheath 106 is housed and fixed into the end connector of the spinal catheter 105, ensuring solidity and safety to one of the most critical points of the system.
  • the initial portion of the spinal catheter 105, left uncovered, is arranged in the desired manner and covered with a transparent adhesive medication .
  • the universal device for continuous spinal anesthesia 100 prevents the obstruction caused by bends and compressions due to the small caliber, allowing the insertion of a short catheter without a cone and connected to the external line through a miniaturized system making it more comfortable for the patient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif universel d'anesthésie rachidienne continue (100) comprenant : une aiguille d'introduction (101) permettant l'anesthésie sous-arachnoïdienne ; une aiguille spinale (103) coaxiale avec l'aiguille d'introduction (101) et munie d'un mandrin (104) ; un cathéter spinal (105) ; et une canule de pont (102) chevauchant une partie terminale de ladite aiguille spinale (103) et ayant une longueur plus courte que la longueur de l'aiguille spinale (103), ladite canule de pont (102) étant capable de faciliter l'insertion du cathéter spinal (105) et d'être insérée, conjointement à l'aiguille spinale (103) munie du mandrin (104) et à l'aide de l'aiguille d'introduction (101), dans les ligaments du rachis d'un patient jusqu'à ce qu'elle atteigne l'espace sous-arachnoïdien.
PCT/IB2020/050420 2019-01-21 2020-01-20 Dispositif universel d'anesthésie rachidienne continue WO2020152570A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20704357.1A EP3914170A1 (fr) 2019-01-21 2020-01-20 Dispositif universel d'anesthésie rachidienne continue

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT201900000843 2019-01-21
IT102019000000843 2019-01-21

Publications (1)

Publication Number Publication Date
WO2020152570A1 true WO2020152570A1 (fr) 2020-07-30

Family

ID=66286641

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2020/050420 WO2020152570A1 (fr) 2019-01-21 2020-01-20 Dispositif universel d'anesthésie rachidienne continue

Country Status (2)

Country Link
EP (1) EP3914170A1 (fr)
WO (1) WO2020152570A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991008785A1 (fr) * 1989-12-11 1991-06-27 Brigham And Women's Hospital Procede et dispositif d'anesthesie
WO1993014710A1 (fr) 1992-01-29 1993-08-05 Al Rawi Muthafar Muflih Canules et aiguilles de petit diametre
WO2005044335A2 (fr) 2003-10-27 2005-05-19 Epimed International, Inc. Catheter rachidien sur
US20100331794A1 (en) 2008-01-14 2010-12-30 Racz N Sandor Flow elements for use with flexible spinal needles, needle assemblies and methods thereof
US20140039414A1 (en) 2012-08-06 2014-02-06 Smiths Medical Asd, Inc. Needle Assembly
WO2017032912A1 (fr) 2015-08-21 2017-03-02 CASTELLÓN HERNÁNDEZ, Beatriz Aiguille pour pratiquer une anesthésie neuroaxiale

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991008785A1 (fr) * 1989-12-11 1991-06-27 Brigham And Women's Hospital Procede et dispositif d'anesthesie
WO1993014710A1 (fr) 1992-01-29 1993-08-05 Al Rawi Muthafar Muflih Canules et aiguilles de petit diametre
WO2005044335A2 (fr) 2003-10-27 2005-05-19 Epimed International, Inc. Catheter rachidien sur
US20100331794A1 (en) 2008-01-14 2010-12-30 Racz N Sandor Flow elements for use with flexible spinal needles, needle assemblies and methods thereof
US20140039414A1 (en) 2012-08-06 2014-02-06 Smiths Medical Asd, Inc. Needle Assembly
WO2017032912A1 (fr) 2015-08-21 2017-03-02 CASTELLÓN HERNÁNDEZ, Beatriz Aiguille pour pratiquer une anesthésie neuroaxiale

Also Published As

Publication number Publication date
EP3914170A1 (fr) 2021-12-01

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