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WO2024028628A1 - Blood collection catheter with long-term implantation capability - Google Patents

Blood collection catheter with long-term implantation capability
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Publication number
WO2024028628A1
WO2024028628A1PCT/IB2022/057102IB2022057102WWO2024028628A1WO 2024028628 A1WO2024028628 A1WO 2024028628A1IB 2022057102 WIB2022057102 WIB 2022057102WWO 2024028628 A1WO2024028628 A1WO 2024028628A1
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Prior art keywords
catheter
needle
blood
cap
tube
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PCT/IB2022/057102
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French (fr)
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Omid MODIRAMANI
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Individual
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Individual
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Abstract

Is an intravascular catheter consisting of a hypoallergenic plastic tube section in different sizes that is inserted into a vein. A body that is placed on the surface of the body and has a wing-like part that is fixed on the skin of the entry point. The end of this cover body is fixed by twisting. Inside the flexible tube, there is an elastic layer with a closed head, which prevents the spontaneous exit of blood from this catheter. Inside the flexible tube, there is also a removable needle that helps us enter the vein, and the end of this needle is removed from the end of the body by a plastic structure. The sharp tip of this needle is outside the closed end of the elastic layer and finally exits from the external side of the catheter.

Description

Blood collection catheter with long-term implantation capability
Is an intravascular catheter consisting of a hypoallergenic plastic tube section in different sizes that is inserted into a vein. A body that is placed on the surface of the body and has a wing-like part that is fixed on the skin of the entry point. The end of this cover body is fixed by twisting. Inside the flexible tube, there is an elastic layer with a closed head, which prevents the spontaneous exit of blood from this catheter. Inside the flexible tube, there is also a removable needle that helps us enter the vein, and the end of this needle is removed from the end of the body by a plastic structure. The sharp tip of this needle is outside the closed end of the elastic layer and finally exits from the external side of the catheter. This needle does not remain in the catheter during the time of connecting the catheter to the patient and is removed. And finally, it has a plastic cap for the end of the catheter and a cap for the needle
A61M2025/06, A61M25/10, A61M25/007
Implantable catheter and method of use
US5688237A
An implantable catheter comprises a flexible elongated catheter body having an inflatable balloon positioned near its distal end. At least one distal delivery port is located distal of the balloon and at least one proximal delivery port is located proximal of the balloon. The balloon and the distal and proximal delivery ports are connected in fluid communication with individual lumens. The lumen connected to the balloon is connected to a balloon inflation port at the proximal end of the catheter. The lumens connected to the distal and proximal delivery ports are connected to distal and proximal injection ports. Preferably, the balloon inflation port and the distal and proximal injection ports are all built into an integrated port assembly adapted for implantation under the skin of a medical patient. In use, the distal end of the catheter is inserted and fed into a passageway such as a blood vessel until the balloon and delivery ports lie within a region of interest. The port assembly is then implanted under the patient's skin. Once in place, the balloon can be inflated to occlude the flow of fluid through the passageway, and therapeutic agents can be delivered either distal or proximal of the balloon by injection into the appropriate injection port. It is believed that the catheter is particularly suited to the delivery of hepatocytes and an anticoagulant during a course of cell therapy directed to a patient's liver.
An implantable catheter having an improved check valve
US6783522B2
Disclosed is a check valve for placement near the distal end of a catheter. A continuously smooth outer surface for the catheter with a check valve system assures that there is no propensity for a blood clot to form in cracks on the system's outer surface. The check valve is formed from a low durometer, highly elastic, elastomer cylindrical tube that is shrunk into a cylindrical groove that would typically be located near the catheter's distal end. When pressurized fluid is injected through the catheter, the cylinder that is placed over one or more holes in the cylindrical groove in the catheter is forced to expand radially outward which allows the fluid to be injected into the blood vessel. When the pressure is removed, the elastomer tube retracts to its normal position which position tightly covers the holes thereby preventing any blood from entering the catheter.
Valve assembly
US4846810A
A valve assembly includes an elongated valve body, an elastomeric sheath laterally enclosing the outside surface of the valve body with the sheath being sealed to the valve body at its ends spaced apart in the elongated direction. An inlet channel extends in the elongated direction from one end of the valve body for receiving a fluid from a container, such as a flexible container. An outlet channel is located at the opposite end of the valve body extending in the elongated direction for discharging the fluid received in the inlet channel. At least one port extends outwardly from the inlet channel to the outside surface of the valve body so that the fluid can flow between the outside surface and the elastomeric sheath causing the sheath to expand. The fluid between the outside surface of the valve body and the sheath flows to at least one other port in the valve body directed inwardly to the outlet channel so that the fluid can be discharged. The sheath prevents back flow from the outlet channel into the container.
Subcutaneous delivery device
US4784646A
A subcutaneous delivery device assembly and method are provided. The assembly includes a subcutaneous delivery device comprising a catheter, a self-sealing input port at the first end of the catheter, an internal magnet adjacent to the self-sealing port, and a valve at the second end of the catheter. The assembly further includes a corresponding external locator which is adapted to be magnetically located adjacent to the internal magnet and separator therefrom by a thin layer of human tissue. The assembly can be used to locate and stabilize a syringe needle during injection.
Catheter valve assembly
US5030210A
An improved valve assembly is provided for the distal end of a catheter, and particularly a central venous catheter for controlling fluid passage from the catheter to the blood flow passage in which it is inserted, and flow in the opposite direction. A relatively thin sheath wall covers the distal fluid opening of the catheter, and includes a slit for responding rapidly to pressure differentials on either side of the slit opening to allow fluid passage, as required. In addition, the distal end of the catheter, and the side walls thereof adjacent the end, are covered by a thin sheath which serves to impart a small degree of thickness or "body" to the end of the catheter except at the opening thereof. More importantly, with the arrangement here the integrity of the catheter wall is far less compromised.
Valved catheter
US5261885A
A closed-end catheter having a flat-surfaced valve positioned in a recess about the distal portion of the catheter for preventing retrograde flow of blood therethrough when positioned in a blood vessel of a patient. The valve catheter comprises a flexible material, cylindrical tube having a U-shaped outer wall extending longitudinally about the distal portion thereof. A flat-surfaced valve is positioned in the recess along the U-shaped distal portion and attached to the outer wall. The valve is formed by inserting a flat-surfaced rod in the U-shaped portion of the tube to stretch the outer wall. A flat-surfaced layer of flexible material is applied over the flat-surfaced rod to the stretched outer wall. The flexible material layer is cured and a longitudinal fluid aperture formed therein with the rod remaining in the passage of the U-shaped portion. The rod is then removed and a plug inserted into the passage to close the distal end of the catheter. The stretched outer wall of the U-shaped portion compresses the fluid aperture to a predetermined closed position to prevent fluid leakage therethrough.
This invention is related to the knowledge of medical science in the blood collection basin, which can be placed in place for a long time. Today, syringes are always used for routine and ordered blood draws in the hospital. The invented catheter acts as a long-term way to access the peripheral vessels, and there is no need to traumatize the patient for daily blood draws. Also, the blocking layers of pipes act to significantly reduce the entry of microorganisms. The designed catheter consists of 5 components, the elastic layer (3) is fixed inside the flexible tube (2) and the needle component (4) is placed inside this layer (3) so that the end of this component (4) It protrudes from the end of the main body (2) and is fixed there with a certain structure (with a wider edge and outer sides that are fully described in the claim). This catheter has two caps, one (1) is connected to the flexible tube and the other (5) is connected to the end of the body. Although the main function of this catheter is to draw blood, this catheter can also be used for people who need frequent intravascular injections. In the way that this catheter is installed as an access to the vessels and for each injection we use a needle according to its size. We insert the needle into the catheter and perform vascular injection through it.
Today, the results of blood tests, in addition to diagnosing diseases, also help us estimate the effectiveness of treatment. Therefore, most of the people hospitalized in different departments need to take blood several times a day. These routine blood draws are usually performed by nurses and laboratory officials. On the other hand, a high percentage of hospitalized patients suffer from peripheral edema or peripheral vascular stiffness due to illness, treatment, drugs, and long-term hospitalization. As expected, taking blood from these patients becomes much more difficult, and it is often necessary to insert the needle several times to find suitable vessels. On the other hand, the patients always feel uncomfortable from the multiple blood draws every day and the continuous insertion of the syringe needles into the organs and the resulting bruises and trauma, and they suffer a lot of pain daily in addition to the discomforts caused by the disease. Therefore, I decided to innovate in order to reduce these problems as much as possible and design a catheter that can act as a small impenetrable tunnel into the peripheral vessels and daily blood sampling can always be done from the same place without causing many traumas.
Angioket (peripheral vascular catheter): It is a small flexible catheter that is placed inside the patient's peripheral vessels. This catheter is only used for intravenous injection and fluid therapy. This catheter is used for vascular access before surgeries, in emergency rooms, inpatient departments, etc. Anjucts are usually placed on the veins of the hand and arm. This catheter cannot be used for blood collection because with the fluid therapy and drug therapy that is done through this catheter, the characteristics of the blood fluid around this catheter will change and it will make the response of blood tests difficult, as well as the opening of the end of the catheter. Intravascularization of this catheter causes blood to enter its tubes and the growth of micro-organisms after 48 to 72 hours. Infection, phlebitis, blood vessel rupture, embolism, hematoma, etc. can be among the side effects of injectables.
CVline (Central Venous Catheter): This catheter is used to open the central venous line for long-term hospitalized patients, for long-term fluid transfer, drug therapy, blood sampling, nutritional support, transfusions and products. CV line can remain inside the central vein for a month, and this increases the risk of infection and can cause intravascular embolism. Also, the insertion of this catheter is not recommended except in necessary cases due to its invasive process. (due to the prohibition of unnecessary invasive processes in hospitals)
Permiket and Shaldon: these two catheters are implanted for long-term vascular access for patients who need permanent and long-term access to central vessels (such as dialysis patients). This catheter is placed inside the central vein (jugular, femoral, etc.) and is used for dialysis. This catheter can also be used for blood sampling, which increases the possibility of infection and embolism, due to the access of this catheter to the central vessels. Due to the aggressiveness of the catheterization process, this catheter is not used unless necessary.
Syringe: Today, in the country's hospitals, syringes are used for blood sampling, which, despite its benefits in long-term hospitalizations, can turn blood sampling into a much more painful process than expected and cause numerous scars on the skin and blood vessels, which causes pain and sometimes limits the movement of the organs and will prolong the healing process.
The catheter invented by this side acts as a long-term way to access the peripheral vessels, and for daily blood draws, there is no need to introduce any trauma to the patient. Also, the blocking layers of pipes act to significantly reduce the entry of microorganisms.
Solution of problem
As explained, the insertion of needles and syringes several times a day into the vessels of patients in the wards is associated with pain, trauma and a lot of discomfort for them. Also, the resulting scar and bruise will be painful and uncomfortable this is despite the fact that sometimes in the departments, due to various reasons, the person taking the test is forced to insert the needle into the same place of the vein several times, which will be much more painful than before.
The designed device is a peripheral vascular catheter made of 5 components. The designed catheter consists of 5 components, the elastic layer (3) is fixed inside the flexible tube (2) and the needle component (4) is placed inside this layer (3) so that the end of this component (4) is outside the end of the main body (2) and it is fixed there with a certain structure (with a wider edge and outer edges that are fully described in the claim). This catheter has two caps, one (1) is connected to the flexible tube and the other (5) is connected to the end of the body.
To use this catheter, the nurse/embedding person after finding a healthy, suitable and smooth vein using the usual methods (use of garou, etc.) after periodically disinfecting the catheter insertion site with alcohol, he first removes the tube cap (1) at this time, the tube (2) and the tip of the needle (4) will be clear from the end of the tube. At this time, it is done exactly according to the angioket embedding method. This means that the flexible tube (2) and the needle (4) are directed into the body towards the specified vein, after the van enters the needle (4), we take out the needle a little so that it enters the catheter through the elastic space, then we turn the body forward until the tube is completely inside the body. Then we fix the body completely on the body to make sure the correct functioning of the catheter, we insert the catheter needle (4) into the catheter again and make sure that the blood comes out, then remove the needle (4) completely and remove the cap (5) that was fixed on the plastic end of the needle (4) and connect it to the end of the main body, this also helps to keep the space inside the catheter sterile. After that, whenever there is a need to draw blood from the patient, just open the cap set (5) from the end of the body (2) and insert the needle (syringe or needle and nozzle) according to the size of the catheter from the end of the body into the catheter and up to the end. Send it into the vein and take blood.
The changes made in this catheter have distinguished it from the existing catheter (angiocette) and specialized it for long-term implantation and safer blood collection. This catheter is made of hypoallergenic materials and will be sterilized like all intravascular catheters. The different sizes of this catheter allow us to choose the correct size instead of each size in different cases.
The body fins of this catheter (2) are well fixed on the body with CM or straw adhesives or any of the adhesives available in the sections and it keeps the main body fixed on the body and thus the flexible tube inside the body. The flexible tube and the main body are located continuously and there is no possibility of separating these two components.
Inside this body, there is an elastic structure filled with feathers, one to one and a half centimeters long. This structure is designed to prevent the entry of microorganisms into the space inside the catheter.
Inside the inner space of the flexible tube that is placed inside the vessels, there is an elastic layer (3) that covers the open end of the tube and thus separates the space inside the body from the space inside this catheter. Also, the elastic structure of this layer allows us to pass through it several times without leaving a hole in this layer in order to draw blood. Because after removing the needle from it, the surrounding tissue immediately fills the hole and as a result does not allow the blood to enter the catheter and thus leave the body.
To take blood from this catheter, after removing the cap (5) from the end of the main body (2), which is fixed outside the body, a syringe with the appropriate needle head number can be used or insert the appropriate needle and device from that part and move along the length of the catheter to the end of the needle. The appropriate needle tip should have the same length and diameter as the catheter itself (4). In this case, the needle protrudes approximately half a centimeter from the closed end of the catheter, which is covered by the elastic layer and is located inside the body. This protrusion allows us to access the peripheral vessels without causing re-trauma.
This catheter actually works like an impenetrable tunnel into the blood vessels. For each blood draw, we just need to insert the needle into the space inside the catheter and draw blood from the inside of the blood vessels.
In addition, the above system does not require heparinization due to the absence of blood entering the thin tubes of the catheter and the absence of the possibility of catheter coagulation, which will help in preventing problems in blood tests. The presence of heparin liquid in the tubes of catheters such as Permicet means that we have to throw away some blood to collect blood from people with Permicet from their permicet site, Therefore, as a result of not heparinizing the designed catheter, it means that people with anemia or people who have frequent blood tests will lose less blood.
The elastic layers designed inside this catheter cause far fewer microorganisms to enter and thus reduce the possibility of infection through this catheter. In addition, the elastic property of the layer covering the inner end of the catheter (the end of the thin tube) prevents blood from entering the catheter and thus prevents the creation of a suitable environment for the growth of pathogenic agents.
Advantage effects of invention
This invention prevents needles and syringes from entering the patients' vessels several times a day. Once this catheter is inserted, it will be usable for at least 72 hours.
Less needle insertion means less trauma, bruises and scars on the vessels and tissues of the body.
Reducing patients' anxiety due to reducing the frequency of pain tolerance and improving their quality of life
The elastic structures embedded in this catheter help to control the infection much better than the previous inventions.
Elastic structures also prevent unwanted blood from this catheter.
The insertion of this catheter is much easier than other catheters with the ability to be inserted for a long time and does not require the transfer of the patient to the operating room.
This catheter is disposable
This catheter does not need to be heparinized
Because this catheter is not heparinized, it reduces the possibility of laboratory errors (compared to existing permanent catheters).
In this catheter, unlike existing permanent catheters, there is no need to throw away some blood due to the presence of medicine. This is especially important for people with anemia or people who need frequent blood tests.
In this catheter, due to the lack of blood entering the inner space of the catheter, clots do not form, and as a result, the catheter does not clot until it is removed.
The ability to use needles and nozzles instead of syringes, and to minimize the contact of the blood collector with the patient's blood and create greater safety for the staff.
This catheter can stay in the fixed vein for a longer period of time because due to the absence of liquid etc. in the space inside this catheter, the possibility of micro-organisms entering and growing inside this catheter will be far less than other catheters.
Due to creating only one trauma to the vein, it will heal better and faster. Also, more healthy vessels remain for the patient to perform other possible procedures.
In patients who have inappropriate peripheral vessels or because of edema, it is more difficult to access the peripheral vessels, with the installation of this catheter, the blood collection process will become a simpler process for the treatment team and a much less painful process for the patient.
Although the main function of this catheter is to draw blood, this catheter can also be used for people who need frequent intravenous injections. In the way that this catheter is installed as an access to the vessels and for each injection we use a needle according to its size. We insert the needle into the catheter and perform vascular injection through it.
: This figure shows the overview of the device.
: This figure shows the view of different components of the device separately.
: 2. Flexible catheter, which is a thin tube and is inserted into the vein. The main body of the catheter, which is connected to the end of the flexible tube and has two wing-like structures, is placed on the body. 4. The needle part that is placed inside the elastic cover and helps us to enter the skin and blood vessels. This part will be removed after the catheter is fixed. 5. The end cap is to prevent blood from escaping
: 1. Catheter needle cap to protect the needle and flexible catheter 2. Flexible catheter, which is a thin tube and is inserted into the vein. The main body of the catheter, which is connected to the end of the flexible tube and has two wing-like structures, is placed on the body. 3. Elastic cover with a closed end that is placed inside the flexible tube. 4. The needle part that is placed inside the elastic cover and helps us to enter the skin and blood vessels. This part will be removed after the catheter is fixed. 5. The end cap is to prevent blood from escaping
Examples
To use this catheter, the nurse/implanter after finding a healthy, suitable and smooth vein using the usual methods (using a tourniquet and finding a suitable vein) and after periodically disinfecting the catheter insertion site with alcohol, he first removes the tube cap (1) at this time, the tube (2) and the tip of the needle (4) will be clear from the end of the tube. At this time, it is done exactly according to the angioket embedding method. This means that the flexible tube (2) and the needle (4) are directed into the body towards the specified vein. After the blood enters the needle (4), we take the needle out a little so that it enters the catheter through the elastic space, then we turn the body forward until the tube is completely inside the body. Then we fix the body completely on the body with glue. To make sure the correct functioning of the catheter, we insert the catheter needle (4) into the catheter again and make sure that the blood comes out. Then remove the needle (4) completely and remove the cap (5) that was fixed on the plastic end of the needle (4) and connect it to the end of the main body. This also helps to keep the space inside the catheter sterile. After that, whenever there is a need to draw blood from the client, just open the cap set from the end of the body and send the needle corresponding to the size of the catheter from the end of the body into the catheter and to the end of it into the vein and take blood.
This catheter can also be used for people who need frequent intravenous injections. In the way that this catheter is installed as an access to the vessels and for each injection we use a needle according to its size. We insert the needle into the catheter and perform vascular injection through it.
This invention is related to the field of medical sciences, and as a result, it is industrially related to the medical equipment industry. This invention is used in medical centers, hospitals, in non-patients who need frequent blood tests.

Claims (8)

  1. Is an intravascular catheter consisting of a hypoallergenic plastic tube section in different sizes that is inserted into a vein. A body that is placed on the surface of the body and has a wing-like part that is fixed on the skin of the entry point. The end of this cover body is fixed by twisting. Inside the flexible tube, there is an elastic layer with a closed head, which prevents the spontaneous exit of blood from this catheter. Inside the flexible tube, there is also a removable needle that helps us enter the vein, and the end of this needle is removed from the end of the body by a plastic structure. The sharp tip of this needle is outside the closed end of the elastic layer and finally exits from the external side of the catheter. This needle does not remain in the catheter during the time of connecting the catheter to the patient and is removed. And finally, it has a plastic cap for the end of the catheter and a cap for the needle.
  2. Claim 6) According to claim 1, the needle of this catheter can be removed and it is removed from the inside of the catheter after insertion. The length and diameter of this needle is compatible with the diameter and length of the flexible tube, and only 3-5 mm of the sharp head of the needle comes out of the closed end of the tube. The end of this needle is covered with a plastic structure as follows:
    A thinner part that is placed inside the end part of the main body of the catheter, from the outside of the body.
    A rectangular part that is placed vertically in relation to the thin part. On this part, there is a half circle protruding forward, which is placed between the two protruding parts of the end of the main body and fixes the needle inside the main body.
    An end structure at the end of which the cap is placed.
PCT/IB2022/0571022022-07-302022-07-30Blood collection catheter with long-term implantation capabilityCeasedWO2024028628A1 (en)

Priority Applications (1)

Application NumberPriority DateFiling DateTitle
PCT/IB2022/057102WO2024028628A1 (en)2022-07-302022-07-30Blood collection catheter with long-term implantation capability

Applications Claiming Priority (1)

Application NumberPriority DateFiling DateTitle
PCT/IB2022/057102WO2024028628A1 (en)2022-07-302022-07-30Blood collection catheter with long-term implantation capability

Publications (1)

Publication NumberPublication Date
WO2024028628A1true WO2024028628A1 (en)2024-02-08

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ID=89848584

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PCT/IB2022/057102CeasedWO2024028628A1 (en)2022-07-302022-07-30Blood collection catheter with long-term implantation capability

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Citations (3)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
US20060258957A1 (en)*2005-05-102006-11-16Deleon LuisBlood drawing system
US20180318557A1 (en)*2017-05-042018-11-08Becton, Dickinson And CompanyIntravenous catheter systems and methods
WO2022032242A1 (en)*2020-08-072022-02-10Avia Vascular, LlcBlood collection devices, systems, and methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
US20060258957A1 (en)*2005-05-102006-11-16Deleon LuisBlood drawing system
US20180318557A1 (en)*2017-05-042018-11-08Becton, Dickinson And CompanyIntravenous catheter systems and methods
WO2022032242A1 (en)*2020-08-072022-02-10Avia Vascular, LlcBlood collection devices, systems, and methods

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