WO2023191748A1 - Multiple fenestrated interfascial block catheter - Google Patents

Multiple fenestrated interfascial block catheter Download PDF

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Publication number
WO2023191748A1
WO2023191748A1 PCT/TR2023/050285 TR2023050285W WO2023191748A1 WO 2023191748 A1 WO2023191748 A1 WO 2023191748A1 TR 2023050285 W TR2023050285 W TR 2023050285W WO 2023191748 A1 WO2023191748 A1 WO 2023191748A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
peripheral nerve
interfascial
nerve block
openings
Prior art date
Application number
PCT/TR2023/050285
Other languages
French (fr)
Inventor
Yahya YILDIZ
Bahadir ÇİFTÇİ
Haci Ahmet ALICI
Mürsel EKİNCİ
Original Assignee
Istanbul Medipol Universitesi
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 Istanbul Medipol Universitesi filed Critical Istanbul Medipol Universitesi
Publication of WO2023191748A1 publication Critical patent/WO2023191748A1/en

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Classifications

    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers

Definitions

  • the invention relates to the peripheral nerve block catheter suitable for use for the interfascial blocks.
  • peripheral nerve blocks which are one of the types of regional anesthesia, is that they have little effect on respiration and hemodynamics compared to general anesthesia and central blocks and that the recovery time is short.
  • peripheral nerve blocks are mostly used to provide anesthesia and analgesia after surgery, they are also used for cancer-related pain, complex regional pain syndromes, ischemia-induced pain, ulcer-induced pain, or phantom limb pain.
  • interfascial plan blocks have been increasingly used in recent years as important components of acute postoperative pain management due to their lack of limitations and side effects of other analgesic methods, as well as the ease, speed, safety, and low cost of applying the interfascial plane block method.
  • the interfascial plane block occurs when the injected local anesthetic solution is delivered to the fascial area as the endpoint and spreads to this interfascial area, which is the potential space to affect one or more neural targets.
  • interfascial plane block is a block in which the neural target is not mostly imaged by ultrasound. Local anesthetic distribution is important for analgesia efficacy.
  • the present invention relates to a peripheral nerve block catheter (A) suitable for use in interfascial plan blocks or for use in interfascial plan blocks, characterized in that;
  • Figure 1 Illustration of the peripheral nerve block catheter according to the invention.
  • the present invention relates to a peripheral nerve block catheter (A) suitable for use for interfascial blocks, characterized in that:
  • the length of the peripheral nerve block catheter body (3) according to the invention may be in the range of 6-9 cm, preferably 7 cm or 8 cm.
  • the body openings (2) may be located one on the upper side and one on the lower side on succession, or four of the openings may be on one side and two on the other side, or two openings may be on the upper side, two openings may be on the lower side and then two openings may be on the upper side in succession.
  • Peripheral nerve block catheters in the prior art are used only for nerve blocks.
  • the nerves are blocked by direct visualization and the catheter can find free space around the nerve.
  • the application targeted by the present invention is fascial plane blocks. Fascial plane blocks are different from classic nerve blocks.
  • the fascia is a thin layer located between two muscles and cannot find free space around the catheter applied to this area and is occasionally compressed between the muscles. Therefore, when the peripheral nerve block catheters present in the prior art are used for interfascial blocks, ruptures occur in the catheter, and/or the drug can only be delivered to a single point of the fascia.
  • another factor to consider in applications to the fascia region is that the nerve blocks in the fascia are not localized and are widely distributed throughout the fascia. Therefore, it is important to ensure the spread of analgesic agents to this area for effective anesthesia.
  • the catheter (A) according to the invention, a more effective application can be made by ensuring that the drug to be delivered by the catheter, for example, the analgesic drug, is distributed throughout the fascia and more nerve fiber is affected by the body openings (2) on the catheter body (3), instead of being delivered only to the fascia point corresponding to the endpoint of the catheter.
  • the drug to be delivered by the catheter for example, the analgesic drug
  • the catheter (A) structure is more resistant to ruptures, even if the catheter (A) structure is compressed between two muscles, due to the fact that the body openings (2) on the catheter (A) according to the invention are located on the lower side and/or the upper side and between them at intervals of 0.8 cm and 1.2 cm.
  • the diameter of the body openings (2) on the catheter body (3) is between 0.1 and 0.3 mm.
  • the diameter of the catheter body (3) is in the range of 0.70 mm to 1.0 mm, preferably 0.80 mm.
  • the opening of the distal end (1) of the catheter (A) is in the range of 0.70 mm to 1.0 mm, preferably 0.80 mm.
  • radiopaque material may be located at the distal tip (1) of the catheter (A) and/or at the alignment of the body openings (2) in the catheter body (3) and/or at the central tip (4) of the catheter (A).
  • the catheter according to the invention may be made of a material selected from beryllium, brass, copper, perylene, polyisoprene, or binary, ternary combinations thereof.
  • kits Another element of the invention relates to a kit is that the catheter (A) according to the invention in the kit can be found in a kit with the apparatus in the state of the art that will help its use during application.
  • the apparatus herein may be the cover system ( Figure 2) through which the catheter passes and/or the bacterial filter ( Figure 3) that provides the connection between the cover system and the catheter.
  • the cover system ( Figure 2) in the kit is used to inject drugs during the use of the catheter (A) according to the invention.
  • the bacterial filter ( Figure 3) in the kit both provides the connection between the catheter according to the invention and the cover system and prevents contamination that may occur during this process.
  • the cover system and the bacterial filter contained in the kit according to the invention can be connected to each other by a screwing system or similar known method.
  • the catheter (A) according to the invention can be produced in different types and sizes for each age, height, and weight, for example; in accordance with the anatomy of the newborn, child, or adult, that is, people of different sizes.
  • Embodiments of the invention may be combined, where technically appropriate.
  • Embodiments are disclosed herein to include certain features/elements. The description also encompasses other embodiments comprising or consisting essentially of said features/elements.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention relates to the peripheral nerve block catheter suitable for use for the interfascial blocks.

Description

MULTIPLE FENESTRATED INTERFASCIAL BLOCK CATHETER
Technical Field
The invention relates to the peripheral nerve block catheter suitable for use for the interfascial blocks.
State of the Art
The advantage of peripheral nerve blocks, which are one of the types of regional anesthesia, is that they have little effect on respiration and hemodynamics compared to general anesthesia and central blocks and that the recovery time is short.
Although peripheral nerve blocks are mostly used to provide anesthesia and analgesia after surgery, they are also used for cancer-related pain, complex regional pain syndromes, ischemia-induced pain, ulcer-induced pain, or phantom limb pain.
On the other hand, interfascial plan blocks have been increasingly used in recent years as important components of acute postoperative pain management due to their lack of limitations and side effects of other analgesic methods, as well as the ease, speed, safety, and low cost of applying the interfascial plane block method.
The interfascial plane block occurs when the injected local anesthetic solution is delivered to the fascial area as the endpoint and spreads to this interfascial area, which is the potential space to affect one or more neural targets.
Unlike peripheral nerve blocks, there may be more than one interfascial area for the same neural target due to the connection of the interfascial areas around the body. Each fascia has more than one layer, and these layers represent the potential area for an interfascial plane block. Ultrasound has revolutionized the ability to find fascial planes in the body and is essential for the performance of interfascial plane blockade. The interfascial plane block is a block in which the neural target is not mostly imaged by ultrasound. Local anesthetic distribution is important for analgesia efficacy.
Continuous infusion of local anesthetic at the wound site or perineural is used for postoperative analgesia. It is a very controversial issue that the catheters used effectively provide local anesthetic distribution. Confusion about the local anesthetic distribution continues. The soaker catheters developed for the wound site have holes in a wider area of 15 cm, but this is designed to be placed externally on the wound site. There are one or more holes in the tip of the epidural catheters placed in the needle, which we think does not provide a sufficient spread for the interfascial area. Therefore, there is a need for catheters suitable for application by placing them in the needle, which can provide a sufficient spread for the interfascial area.
Brief Description of the Invention
The present invention relates to a peripheral nerve block catheter (A) suitable for use in interfascial plan blocks or for use in interfascial plan blocks, characterized in that;
• it comprises at least six catheter body openings (2) positioned on the catheter body, on the lower side and/or on the upper side of the body; and
• there is a distance of 0.8 cm to 1.2 cm between each catheter body opening (2).
Descriptions of the Figures
Figure 1: Illustration of the peripheral nerve block catheter according to the invention.
The abbreviations in the figures are as follows:
1 : Distal tip
2: Body opening 3 : Catheter body 4: Central tip Detailed Description of the Invention
As mentioned above, the present invention relates to a peripheral nerve block catheter (A) suitable for use for interfascial blocks, characterized in that:
• it comprises at least six catheter body openings (2) positioned on the catheter body, on the lower side and/or on the upper side of the body; and
• there is a distance of 0.8 cm to 1.2 cm between each catheter body opening (2).
The length of the peripheral nerve block catheter body (3) according to the invention may be in the range of 6-9 cm, preferably 7 cm or 8 cm.
In case the catheter body openings (2) are located both on the lower side and the upper side of the catheter body (3), the body openings (2) may be located one on the upper side and one on the lower side on succession, or four of the openings may be on one side and two on the other side, or two openings may be on the upper side, two openings may be on the lower side and then two openings may be on the upper side in succession.
Peripheral nerve block catheters in the prior art are used only for nerve blocks. In this application, the nerves are blocked by direct visualization and the catheter can find free space around the nerve. The application targeted by the present invention is fascial plane blocks. Fascial plane blocks are different from classic nerve blocks. The fascia is a thin layer located between two muscles and cannot find free space around the catheter applied to this area and is occasionally compressed between the muscles. Therefore, when the peripheral nerve block catheters present in the prior art are used for interfascial blocks, ruptures occur in the catheter, and/or the drug can only be delivered to a single point of the fascia. In addition, another factor to consider in applications to the fascia region is that the nerve blocks in the fascia are not localized and are widely distributed throughout the fascia. Therefore, it is important to ensure the spread of analgesic agents to this area for effective anesthesia.
Thanks to the catheter (A) according to the invention, a more effective application can be made by ensuring that the drug to be delivered by the catheter, for example, the analgesic drug, is distributed throughout the fascia and more nerve fiber is affected by the body openings (2) on the catheter body (3), instead of being delivered only to the fascia point corresponding to the endpoint of the catheter.
Furthermore, the catheter (A) structure is more resistant to ruptures, even if the catheter (A) structure is compressed between two muscles, due to the fact that the body openings (2) on the catheter (A) according to the invention are located on the lower side and/or the upper side and between them at intervals of 0.8 cm and 1.2 cm.
In a preferred embodiment of the invention, the diameter of the body openings (2) on the catheter body (3) is between 0.1 and 0.3 mm.
In a preferred embodiment of the invention, the diameter of the catheter body (3) is in the range of 0.70 mm to 1.0 mm, preferably 0.80 mm.
In a preferred embodiment of the invention, the opening of the distal end (1) of the catheter (A) is in the range of 0.70 mm to 1.0 mm, preferably 0.80 mm.
In the catheter according to the invention, there may be markings made with radiopaque material. Said radiopaque material may be located at the distal tip (1) of the catheter (A) and/or at the alignment of the body openings (2) in the catheter body (3) and/or at the central tip (4) of the catheter (A).
The catheter according to the invention may be made of a material selected from beryllium, brass, copper, perylene, polyisoprene, or binary, ternary combinations thereof.
Another element of the invention relates to a kit is that the catheter (A) according to the invention in the kit can be found in a kit with the apparatus in the state of the art that will help its use during application.
The apparatus herein may be the cover system (Figure 2) through which the catheter passes and/or the bacterial filter (Figure 3) that provides the connection between the cover system and the catheter. The cover system (Figure 2) in the kit is used to inject drugs during the use of the catheter (A) according to the invention.
The bacterial filter (Figure 3) in the kit both provides the connection between the catheter according to the invention and the cover system and prevents contamination that may occur during this process.
The cover system and the bacterial filter contained in the kit according to the invention can be connected to each other by a screwing system or similar known method.
The catheter (A) according to the invention can be produced in different types and sizes for each age, height, and weight, for example; in accordance with the anatomy of the newborn, child, or adult, that is, people of different sizes.
In the context of this description, the expression "comprises" is intended to denote the expression "covers".
Embodiments of the invention may be combined, where technically appropriate.
Embodiments are disclosed herein to include certain features/elements. The description also encompasses other embodiments comprising or consisting essentially of said features/elements.

Claims

1. A peripheral nerve block catheter (A) suitable for use in interfascial plan blocks, characterized in that:
• it comprises at least six catheter body openings (2) positioned on the catheter body (3), on the lower side and/or on the upper side of the body; and
• there is a distance of 0.8 cm to 1.2 cm between each catheter body opening (2).
2. A peripheral nerve block catheter (A) according to Claim 1, characterized in that the length of the catheter body (3) is in the range of 6-9 cm.
3. A peripheral nerve block catheter (A) according to any one of Claims 1 or 2, characterized in that the body openings (2) on the catheter body (3) are between 0.1 mm and 0.3 mm in diameter.
4. A peripheral nerve block catheter (A) according to any of Claims 1-3, characterized in that the diameter of the catheter body (3) is in the range of 0.70 mm to 1.0 mm.
5. A peripheral nerve block catheter (A) according to any of Claims 1-4, characterized in that the opening of the distal tip (1) is in the range of 0.70 mm to 1.0 mm.
6. A peripheral nerve block catheter (A) according to any of Claims 1-5, characterized in that there are signs of radiopaque material at the distal tip (1) of the catheter (A) and/or at the level of the body openings (2) in the catheter body (3).
7. A peripheral nerve block catheter (A) according to any one of Claims 1-6, characterized in that it is made of a material selected from beryllium, brass, copper, perylene, polyisoprene, or binary, triple combinations thereof.
8. The kit according to any one of Claims 1-7, comprising a peripheral nerve block catheter (A) and a valve system through which the catheter passes and a bacterial filter connecting the valve system and the catheter.
PCT/TR2023/050285 2022-03-31 2023-03-27 Multiple fenestrated interfascial block catheter WO2023191748A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TRTR2022/005007 2022-03-31
TR2022005007 2022-03-31

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140025039A1 (en) * 2011-05-18 2014-01-23 Solodex Llc Continuous anesthesia nerve conduction apparatus, system and method thereof
ES1108930U (en) * 2014-03-13 2014-05-08 Mario Inaudis FAJARDO PÉREZ Multi-perforated catheter for continuous neural infusion (Machine-translation by Google Translate, not legally binding)
WO2019132920A1 (en) * 2017-12-28 2019-07-04 Avent, Inc. Incisional tunneler
WO2021026641A1 (en) * 2019-08-09 2021-02-18 Safa Behnam Coiled over-the-needle catheter and methods of use thereof for performing continuous nerve block procedures

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140025039A1 (en) * 2011-05-18 2014-01-23 Solodex Llc Continuous anesthesia nerve conduction apparatus, system and method thereof
ES1108930U (en) * 2014-03-13 2014-05-08 Mario Inaudis FAJARDO PÉREZ Multi-perforated catheter for continuous neural infusion (Machine-translation by Google Translate, not legally binding)
WO2019132920A1 (en) * 2017-12-28 2019-07-04 Avent, Inc. Incisional tunneler
WO2021026641A1 (en) * 2019-08-09 2021-02-18 Safa Behnam Coiled over-the-needle catheter and methods of use thereof for performing continuous nerve block procedures

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