WO2024123286A1

WO2024123286A1 - J-tip catheter for nerve, fasial or interfasial plan, epidural and spinal block analgesia or anesthesia

Info

Publication number: WO2024123286A1
Application number: PCT/TR2023/051270
Authority: WO
Inventors: Yahya YILDIZ
Original assignee: Istanbul Medipol Universitesi
Current assignee: Istanbul Medipol Universitesi
Priority date: 2022-12-06
Filing date: 2023-11-08
Publication date: 2024-06-13
Anticipated expiration: 2025-06-06

Abstract

The invention is a catheter or epidural, spinal nerve or fasial block catheter (10) for epidural and spinal anesthesia, characterized in that it comprises a J-shaped tip, shaped in a blunt and curved form, through which the anesthetic needle moves to prevent vessel rupture; hole (14) positioned on the outer side of the J-shaped tip, through which the fluid exits and expands outwards, i.e., hydrodissection, in order for the block catheter (10) to advance without damaging the surrounding tissue.

Description

DESCRIPTION

J-TIP CATHETER FOR NERVE, FASIAL OR INTERFASIAL PLAN, EPIDURAL AND SPINAL BLOCK ANALGESIA OR ANESTHESIA

Technical Field

The invention relates to a catheter for epidural and spinal analgesia or anesthesia or an epidural, spinal J-tip nerve block catheter or fasial plan block catheter.

In particular, the invention relates to a J-tip nerve block catheter consisting of a region with holes on it, a curved region without holes and a transition region with holes on it to increase the local anesthetic spread, which is piercing or damaging, non-venous and thus facilitates or makes the hydrodissection process possible.

State of the Art

Local anesthesia is the temporary numbing of a small area of the body so that it can be operated on. The mechanism of action of local anesthesia is to block the transmission of stimuli from the area where it is given with a needle through the nerves in the area. During local anesthesia, unlike general anesthesia, the patient is awake and conscious, that is, the patient is aware of everything There are 4 different types of local anesthesia: tissue penetrating/spreading (infiltration), absorbed from the skin or mucous surface (topical), and nerve or plan or fasial plan block. Tissue penetrating/spreading (infiltration) anesthesia is the desensitization of that area by injecting a local anesthetic under the skin or into other superficial tissues with a needle. Topical anesthesia, which is absorbed from the skin or mucous surface, is the anesthesia applied to the skin or soft tissue by impregnating and applying or dripping local anesthetic into a cotton or absorbent, without using any needle or disrupting the integrity of the body. It is also done when a local anesthetic is applied to the gum, or by dropping it into the eye or ear, or applying cream to areas with mucous membranes, such as the mouth and inside of the nose. In order to prolong the effect of local anesthesia, some substances such as dexamethasone or adrenaline can also be added to it and their effects can be prolonged. Plan block is the blockage of the fascia located in the area where the nerve or nerve endings spread or between two muscles, also called the interfasial block.

After a needle reaches the target area where local anesthesia will be administered, the catheter is advanced through the needle to the target. In order for peripheral nerve blocks or interfasial plan blocks to be continuous, local anesthesia should be given continuously to the target area with a catheter. In other words, the nerve block catheter is used for regional anesthesia. Continuous administration of local anesthesia to the target area with a catheter is used for regional anesthesia. In this method, the catheter is placed next to the nerve sheath with the help of a needle and effectiveness is achieved by giving a local anesthetic. The advantage of this method is that it allows continuous use by re-injecting through the catheter when the patient needs anesthesia or painkillers.

The structures of the existing nerve block catheters in use today are rigid. During their advancement, they can damage the surrounding tissue, that is, the vessels and nerves, causing injuries, complications such as the introduction of the catheter into the vessel, and rupture of the pleura. Nerve damage is one of the possible complications, although it is controlled that the catheter is sufficiently far from the nerve using the nerve stimulation method while inserting the nerve block catheter. In addition, the distribution of the catheter or drug can be controlled with ultrasound. Even if all of these measures are taken, there may be nerve damage due to the catheter. Although the catheter is placed in the target tissue by hydrodissection, if the catheter is advanced or moves spontaneously, it can enter the surrounding artery or vein and vascular damage may occur. With the aspiration of the catheter, whether it is in the vein is checked before each drug is given, and if there is no blood, the drug is given. If the vessel is thin or the amount of blood in the catheter is insufficient or low when aspirated, blood may not come in the aspiration of the catheter, even if the catheter is in the vein, and when the drug is given, the patient has local anesthetic toxicity called LAST. Since the fascia in the paravertebral area are particularly delicate, they may be traumatized by the hard-tip catheter, resulting in fascial damage, or tearing. When the fascia or pleura is punctured, the catheter can enter other areas or the chest cavity and cause complications such as bleeding. There are holes spaced at a distance of approximately 2 cm from the tip of the existing or commercial nerve block catheter, that is, there is an opening at the tip of the catheter for local anesthetic to exit. In this case, the distribution of holes on the catheter limits the spread of local anesthetic. A failure rate of 6.1% in adults has been reported for paravertebral block complications caused by the current nerve block catheter. Undesirable vascular puncture (6.8%), hypotension (4%), epidural or intrathecal spread (1%), pleural puncture (0.8%), and pneumothorax (0.5%) were recorded complications.

Fluid is given by entering the appropriate interfasial area with a block needle and the gap is widened. This process is called hydrodissection. If the area needs to be expanded further, since the existing block catheter is hard when hydrodissection is required with the use of a block catheter, the above complications may occur during this procedure. In other words, advancement by opening the interfasial area or epidural area by giving fluid from the existing catheter, that is, by hydrodissection, and the effort to expand the local anesthetic spread area may cause damage.

Regional anesthesia is performed as spinal anesthesia and epidural anesthesia. There is cerebrospinal fluid (spinal fluid) surrounded by a membrane in a channel formed by the vertebra (spinal canal). During or during the spinal anesthesia procedure, the local anesthetic drug is given to the spinal space by passing through the membranes surrounding the spinal cord and spinal fluid to the neck (cervical), chest (thoracic) or waist (lumbar) area through the skin, subcutaneous, muscles, tendons or through a thin needle. Painful stimuli are stopped at the level of the spinal cord and are not transmitted to the brain. The surgery of the area can be performed painlessly and comfortably. The effect of this local anesthetic given by injection may wear off after 4-6 hours depending on the dose and type. A catheter called spinal catheter is placed in the spinal canal to prolong the pain relief effect. According to the needs of the patient, painkillers are given through this catheter and the continuity of the patient's comfort is ensured. Epidural anesthesia is the cessation of pain in the target area or the administration of anesthesia by placing a catheter in the epidural cavity and administering a local anesthetic. It is an anesthesia application in which a very thin plastic catheter is placed in the space known as the epidural space between the membranes surrounding the spinal cord between the vertebrae in the neck, waist or back region and the tissue in this region and the pain is eliminated by giving a local anesthetic drug through this catheter. In both methods, the effect is created by injecting local anesthetic drugs into the relevant area. Although the injection site looks the same from the outside, it is two different methods in terms of anatomy and effect. Catheter-related complications may occur in spinal and epidural anesthesia. Since the existing catheters are hard and pointed, there may be damage to the surrounding tissue, nerve damage, and paralysis due to the inability of the nerve to receive messages from the stimulated area. There may be vascular injuries due to the catheter. Bleeding may occur with the advancement of the existing catheter during spinal or epidural catheter application or insertion. The approach to the patient with a tendency to bleeding, low platelet count, and long PT and aPTT is quite risky. If the existing hard and pointed tip catheter is used in these patients, it may cause tissue, vessel, and nerve damage as well as hematoma formation in the region. Bleeding disorders limit the use of spinal and epidural anesthesia. The application of regional anesthesia to patients with bleeding disorders is contraindicated with the existing hard and pointed catheter.

Spinal, epidural, regional, and local anesthesia is the preferred anesthesia approach to general anesthesia. It has been frequently preferred in recent years, reducing the morbidity and mortality of surgeries or anesthesia. Regional anesthesia methods significantly reduce hospital stay and hospital costs; in this respect, they are especially preferred. Especially regional anesthesia methods are preferred in patients who may be inconvenient to receive general anesthesia and who are unlikely to leave general anesthesia. It is quite inconvenient to advance the catheter without hydrodilatation, one of the catheter-related complications of spinal and epidural anesthesia, and it has been abandoned. Vascular, nerve, and tissue damage may occur during the advancement of the catheter by hydrodissection. Even if the existing hard catheters are hydrodissected in the regional anesthesia approach to the patient with a tendency to bleeding, tissue injury, especially vascular injury, and bleeding, may still occur, although the rate is low. Vascular injury by the catheter can cause very troublesome situations. In the state of the art, a normal catheter with a pointed tip is used. However, this spike can cause damage to small vessels. In addition, due to the pointed tip, there may be problems in the progression of the substance to be given by the catheter for regional numbness into the region. Catheter-related bleeding in the spinal or epidural regions requires surgery in the bleeding area. In the interfascial block method, which has just started to be used in regional and local anesthesia, it is aimed to block the nerve fibers passing through the fascia between the two muscles by giving a local anesthetic and spreading the fluid or local anesthetic along the plan or gap. In this method, since the nerve fibers are not localized in one place and are widely distributed throughout the fascia, it is very important that the injected fluid is homogeneous and widely distributed or spread over a large area. Nerve block catheters used in peripheral nerve blocks are also used in interphase plan blocks. However, adverse conditions, complications, injuries, or inadequacies related to the use of these catheters have been reported. In order to prevent these negativities, it is necessary to improve nerve block catheters and make their use more widespread, which is the demand of patients and the market.

As a result, the existence of the need for a J-tip nerve block catheter or fasial plan block catheter, which eliminates the disadvantages of the current art, and the inadequacy of the existing solutions made it necessary to make a development in the relevant technical field.

Brief Description of the Invention

The present invention relates to a J-tip nerve block catheter for epidural, spinal, plan or fasial plane block regional anesthesia, which meets the above-mentioned requirements, eliminates all disadvantages, and brings some additional advantages.

Based on the state of the art, the object of the invention is to provide the elimination of vascular rupture and similar complications by means of the J-shaped blunt tip of the block catheter developed.

The object of the invention is to ensure that the drug acts quickly and spreads in all directions in the region thanks to the mutual holes on the sides of the J-shaped tip of the block catheter.

Another object of the invention is to provide outward expansion, that is, hydrodissection, thanks to the liquid coming out of the holes at the beginning and end of the J-shaped tip.

Another object of the invention is to ensure that the catheter passes through this cavity and that the anesthetic fluid is delivered to the area expanded through the same holes, thanks to the hydrodissection of the fluid in the holes in the catheter and the creation of a cavity with water in the area.

Another object of the invention is to prevent the catheter from stretching and straightening while entering and leaving the needle, and thus to prevent ruptures that may occur in the catheter, thanks to the lack of holes in the region that will move in the part that forms the back part of the J-shaped tip where the catheter moves while entering and leaving the needle.

Another object of the invention is to increase the spread of local anesthesia through the opening at the catheter tip.

Another object of the invention is to ensure that the block catheter placed near the nerve to be blocked can be placed near it without touching the nerve or positioned around it by hydrodissection, thanks to the fact that it has a J-shaped tip.

The structural and characteristic features and all the advantages of the invention will be understood more clearly by means of the figures and the detailed description with reference to these figures given below and therefore, the evaluation should be made by taking these figures and the detailed description into consideration.

Brief Description of the Figures

In order to best understand the structure of the present invention and its advantages with additional elements, it should be evaluated together with the figures described below.

Figure- 1 is the schematic overview of the block catheter.

List of the Reference Numbers

10. Block catheter

11. Distal region

12. Back region

13. Main body

14. Hole

15. Fluid inlet hole

Detailed Description of the Invention In this detailed description, the catheter for epidural and spinal anesthesia or epidural, spinal J-tip nerve block or fasial plan block catheter (10) of the invention is described only as an example for a better understanding of the subject matter and without limitation.

The block catheter (10) subject to the invention is characterized in that its tip is J-shaped, shaped in a blunt and curving form, in which the anesthesia needle moves in order to prevent vascular ruptures. During the use of the block catheter (10), liquid is first given in the holes (14) at the J-tip (hydrodissection) and a gap with water is formed in the region. The catheter

(10) passes through this space and anesthesia fluid is delivered to the area expanded through the same holes (14). The number of holes (14) is one or more on the sides of the J-tip. In this way, it is ensured that the drug acts quickly in all directions in the region and spreads.

In the current nerve block catheters used today, there is an opening for the local anesthetic outlet starting from the catheter tip with an interval of 1-3 cm, and the openings in this case limit the local anesthetic spread or cause its insufficiency.

The J-shaped tip of the block catheter (10) of the invention shown in Figure 1 is divided into three different regions. The distal region (11) of the J-shaped tip of the block catheter (10) at the tip of the needle outlet, preferably 1-10 mm in length, comprises at least 1 preferably 1-5 holes (14) positioned on the outer part, at least 1 preferably 1-3 sides. The convex and preferably 1-20 mm long back region (12), which moves as the needle enters and exits and forms the back part (curved part) of the J-shaped tip, does not contain a hole (14) to prevent rupture of the block catheter (10) since it will stretch and straighten when the needle enters and exits. The main body (13), which is located in the continuation of the back region (12), and which is preferably 10-50 mm in length, comprises at least 1 cm, preferably 1-3 cm spaced apart on the outside, and at least 1, preferably 1-4, side hole (14). The aforementioned holes (14) are located only in the distal region (11) and the main body (13), and their diameters are preferably 0.1-10 mm. There is an opening at the lowest part of said block catheter (10), preferably at intervals of 0.5-1 cm, preferably 5 cm and 7 cm. Thus, it increases the spread of local anesthetic. There is a fluid inlet hole (15), preferably 0.2-2 mm in diameter, at the bottom of said block catheter (10) to allow fluid to enter. The distal region

(11) and the axes of the main body (13) are parallel to each other, and the liquid comes out of the holes (14) they contain and expands outwards, that is, it makes hydrodissection. The block catheter (10) progresses from the hydrodissection area without damaging the surrounding tissue. The hydrodissection process becomes easier or possible due to the fact that the tip of the block catheter (10) is pointed, that is, piercing or damaging, and is not located in the vein, that is, due to the J-shaped form. At the same time, the J-tip block catheter (10) placed near the nerve to be blocked can be placed close to the nerve without touching it or positioned around it by hydrodissection.

Claims

1. A catheter for epidural and spinal anesthesia or epidural, spinal nerve, or fasial plan block catheter (10), characterized in that it comprises the following: a J-shaped tip, shaped in a blunt and curved form, through which the anesthetic needle moves to prevent vessel rupture; hole (14) positioned on the outer side of the J-shaped tip, through which the fluid exits and expands outwards, i.e., hydrodissection, in order for the block catheter (10) to advance without damaging the surrounding tissue.

2. The block catheter (10) according to Claim 1, characterized in that it comprises a convex portion forming the back part (curved part) of the J-shaped tip which moves in and out of the needle and back region (12), preferably with a length of 1-20 mm.

3. The block catheter (10) according to Claim 1, characterized in that the tip comprises a distal region (11) positioned at the end where the needle exits and having at least one hole (14) on the outside thereof.

4. The block catheter (10) according to Claim 1, characterized in that it comprises a main body (13) positioned in the continuation of the back part (12) and having at least one hole (14) on the outer part.

5. The block catheter (10) according to Claim 1, characterized in that it comprises a liquid inlet hole (15) positioned at the bottom for entering the liquid and increasing the local anesthetic spread.