WO2017072594A1 - Bloodless percutaneous insertion needle with three control system - Google Patents

Bloodless percutaneous insertion needle with three control system Download PDF

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Publication number
WO2017072594A1
WO2017072594A1 PCT/IB2016/050485 IB2016050485W WO2017072594A1 WO 2017072594 A1 WO2017072594 A1 WO 2017072594A1 IB 2016050485 W IB2016050485 W IB 2016050485W WO 2017072594 A1 WO2017072594 A1 WO 2017072594A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
blood
way stopcock
guide wire
artery
Prior art date
Application number
PCT/IB2016/050485
Other languages
French (fr)
Inventor
Abdollah HABIBI KOUSHA
Norollah HOUSHMAND
Original Assignee
Habibi Kousha Abdollah
Houshmand Norollah
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 Habibi Kousha Abdollah, Houshmand Norollah filed Critical Habibi Kousha Abdollah
Publication of WO2017072594A1 publication Critical patent/WO2017072594A1/en

Links

Classifications

    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/223—Multiway valves

Definitions

  • the Technical field of this invention relates to the medical equipment and a bloodless arterial percutaneous insertion.
  • the needle In order to perform angiography and angioplasty by bloodless arterial percutaneous insertion needle, the needle should be slowly inserted into the artery with the angle of around 15 to 45 degrees.
  • the puncture site is disinfected and local anesthetic is administered by injecting Lidocaine 2% without adrenaline prior to puncture of the artery by a needle.
  • a guide wire is inserted via needle hub upon seeing the blood jet.
  • the Syringe is connected to the distal end of the needle, after visualizing blood in the Syringe and disconnecting Syringe from the distal end of needle and seeing blood jet, we start placing the guide wire. In some cases the blood does not force out of the distal end of needle, thus the guide wire is entered after visualizing blood and checking its color in the hub.
  • the correct placement of guide wire is checked by Fluoroscopy and once the guide wire is properly positioned, the needle is removed over the guide wire. Afterwards, the introducer is passed into the artery over the guide wire; the guide wire and dilator are removed and just the sheath remains in the puncture area.
  • the guide wire is inserted in the pre-determined area only when the blood jet is visualized.
  • the guide wire is entered.
  • the angle of entering needle must increase since the flow of blood jet rises.
  • the blood squirts around the sterilized area which exposes the environment and health care providers at the potential health risks if the blood is contaminated with contagious pathogens.
  • the main objective of using bloodless needle with three control method is to prevent the outflow of blood from the end of the needle, to reduce the risks associated with exposure to blood, and to ensure the proper placement of needle inside the artery before entering the guide wire into the artery.
  • a needle connector assembly comprises a hemostatic segment and a side tube.
  • the hemostatic segment comprises a valve permitting passage of a guide wire therethrough.
  • the hemostatic segment comprises a proximal portion comprises a perimeter ring and a spanning member.
  • the distal portion comprises a bell or rounded configuration.
  • the hemostatic segment Upon insertion of a guide wire, the hemostatic segment generally seals around the guide wire such that blood or other fluids are prevented from entering the area proximal to the hemostatic segment.
  • the side tube comprises a closed distal end and is positioned between the proximal end and the distal end of the needle connector assembly.
  • the side tube is in fluid communication with the passageway of the connector assembly and is adapted to receive blood or other fluids.
  • the connector assembly is adapted for connection with a needle assembly.
  • An insertion apparatus including an object for insertion into a patient; an insertion structure including an annular mounting structure having a mounting structure interior, the mounting structure containing a resilient membrane barrier extending across the mounting structure interior with a resiliently closing membrane valve for passing the object; so that the object can be inserted forwardly through the membrane valve and into a patient and subsequently withdrawn from the patient and rearwardly from the membrane valve, the membrane valve resiliently closes as the object exits the membrane valve and thereby preventing patient bodily fluid from flowing rearwardly out of the insertion structure.
  • the arterial percutaneous insertion needle with three control methods comprises a sharp-tip and narrow needle made of stainless steel or cementite in different sizes (16G - 22G) and different lengths (30 to 90 centimeters).
  • a transparent hub with filtered vent is attached to the end of the needle and is inseparable from the needle.
  • the end of hub comprises a screw (figure 1) through which the hub is screwed to Hemostatic valve (figure 3, needle and hemostatic valve).
  • the hemostatic valve has a transparent white connector approximately 20 cm and a three-way stopcock at its end. ( Figure 2 bloodless needle) the 3-way stopcock of hemostatic valve connects to the pressure connector.
  • the guide wire is entered through the hemostatic valve and the needle into the artery very slowly and as much as required.
  • the valves are tangent to the surrounding area of the guide wire and prevent blood loss from the surrounding sides of the guide wire.
  • the needle is removed.
  • the introducer is advanced over the guide wire and into the artery.
  • the guide wire and dilator are removed and just the sheath remains in the puncture area and the necessary equipments for procedure are passed into the sheath.
  • the needle can be separated from the hemostatic valve by twisting and after the venipuncture, the pacemaker lead is placed in the right chambers of heart which allows the operator to measure the pressure of the right chambers of heart.
  • Fig 1 a general view of needle and side tube
  • Fig 2 a general view of guide wire and introducer
  • This invention is a sharp hollow and narrow needle lusedfor bloodless arterial percutaneous insertion system.
  • the needle can be in different sizes (18-21 G). It comprises a hemostatic valve2and a clear hub 3around four centimeters and a needle with the different length of 35 to 90 mm and different inner diameter of 0.85 to 1.25 mm.
  • the hub is connected to the needle and it is inseparable.
  • the hub is able to be twisted around the hemostatic valve and get opened.
  • There is a transparent side tube 4 with the size of 15-20 cm between the hemostatic valve and the needle hub.
  • the side tube has a three-way stopcock 5.
  • the needle is connected to the pressure connector via the side tube and three-way stopcock of the hemostatic valve.
  • the blood in the hub can be visualized and checked.
  • the patient blood pressure can be checked on the monitor as systolic and diastolic pressure wave. If interested to check the color and intensity of the blood jet; we can open the three-way stopcock toward the needle and close it.
  • the three-way stopcock must be irrigated by heparinized serum after visualizing the blood.
  • One of the most important distinguishing features of this invention is that at this stage of procedure, we can make sure about the accuracy of Arterial artery in which the needle is entered. To do so, the three-way stopcock of needle needs to be connected to the pressure connector and the intensity of blood jet and its color has to be checked.
  • the pressure of the right chambers of heart can be measured, the temporary pacemaker lead can be placed and we can do the venography.

Abstract

A percutaneous insertion needle system comprising a needle (1) having a transparent hub (3); the hug comprises a screw to be attached to a hemostatic valve (3) having a transparent connector (4) with a stopcock valve (5) at its end.

Description

Bloodless Percutaneous Insertion Needle with Three Control System
Description
Field of the Invention:
The Technical field of this invention relates to the medical equipment and a bloodless arterial percutaneous insertion.
Technical Problem:
In order to perform angiography and angioplasty by bloodless arterial percutaneous insertion needle, the needle should be slowly inserted into the artery with the angle of around 15 to 45 degrees. The puncture site is disinfected and local anesthetic is administered by injecting Lidocaine 2% without adrenaline prior to puncture of the artery by a needle. A guide wire is inserted via needle hub upon seeing the blood jet.
If the Syringe is connected to the distal end of the needle, after visualizing blood in the Syringe and disconnecting Syringe from the distal end of needle and seeing blood jet, we start placing the guide wire. In some cases the blood does not force out of the distal end of needle, thus the guide wire is entered after visualizing blood and checking its color in the hub.
Following the insertion of the guide wire through the artery, the correct placement of guide wire is checked by Fluoroscopy and once the guide wire is properly positioned, the needle is removed over the guide wire. Afterwards, the introducer is passed into the artery over the guide wire; the guide wire and dilator are removed and just the sheath remains in the puncture area.
In these methods, the guide wire is inserted in the pre-determined area only when the blood jet is visualized. In cases that the blood does not come out of the distal end of needle, after visualizing blood and its color (deciding either vein or artery) the guide wire is entered. For the obese patients or those suffering from high blood pressure (hypertensive BP>140), the angle of entering needle must increase since the flow of blood jet rises. Sometimes the blood squirts around the sterilized area which exposes the environment and health care providers at the potential health risks if the blood is contaminated with contagious pathogens. The main objective of using bloodless needle with three control method is to prevent the outflow of blood from the end of the needle, to reduce the risks associated with exposure to blood, and to ensure the proper placement of needle inside the artery before entering the guide wire into the artery.
Prior Arts:
Patent Number: US20140107616 Al
A needle connector assembly comprises a hemostatic segment and a side tube. The hemostatic segment comprises a valve permitting passage of a guide wire therethrough. The hemostatic segment comprises a proximal portion comprises a perimeter ring and a spanning member. The distal portion comprises a bell or rounded configuration. Upon insertion of a guide wire, the hemostatic segment generally seals around the guide wire such that blood or other fluids are prevented from entering the area proximal to the hemostatic segment. The side tube comprises a closed distal end and is positioned between the proximal end and the distal end of the needle connector assembly. The side tube is in fluid communication with the passageway of the connector assembly and is adapted to receive blood or other fluids. The connector assembly is adapted for connection with a needle assembly.
Publication Number: 20060200080
An insertion apparatus, including an object for insertion into a patient; an insertion structure including an annular mounting structure having a mounting structure interior, the mounting structure containing a resilient membrane barrier extending across the mounting structure interior with a resiliently closing membrane valve for passing the object; so that the object can be inserted forwardly through the membrane valve and into a patient and subsequently withdrawn from the patient and rearwardly from the membrane valve, the membrane valve resiliently closes as the object exits the membrane valve and thereby preventing patient bodily fluid from flowing rearwardly out of the insertion structure.
Summary of the Invention:
The arterial percutaneous insertion needle with three control methods comprises a sharp-tip and narrow needle made of stainless steel or cementite in different sizes (16G - 22G) and different lengths (30 to 90 centimeters). A transparent hub with filtered vent is attached to the end of the needle and is inseparable from the needle. The end of hub comprises a screw (figure 1) through which the hub is screwed to Hemostatic valve (figure 3, needle and hemostatic valve). The hemostatic valve has a transparent white connector approximately 20 cm and a three-way stopcock at its end. (Figure 2 bloodless needle) the 3-way stopcock of hemostatic valve connects to the pressure connector. In angiography and intervention when the needle is inserted into the patient's artery, the air is emptied via the hub vent; the blood enters the needle hub and the hemostatic valve screwed to the hub prevents the escape of blood jet from the end of the needle. When the blood is seen in the hub, the pressure inside the patient's artery is able to be seen in the form of the systole and diastole pressure wave on the monitor. In case the needle tip comes out of the artery, the pressure wave graph on the monitor is disconnected. Thus, we become aware that the needle is displaced and its tip comes out of the artery and the needle must be entered in the artery again. If interested to see the color and intensity of blood jet, we can open the three way stopcocks in the direction of the needle and close it after visualizing blood.
Afterwards, the guide wire is entered through the hemostatic valve and the needle into the artery very slowly and as much as required. The valves are tangent to the surrounding area of the guide wire and prevent blood loss from the surrounding sides of the guide wire. After checking the guide wire and the accuracy of its insertion in the desired location with fluoroscopy, the needle is removed. Then, the introducer is advanced over the guide wire and into the artery. The guide wire and dilator are removed and just the sheath remains in the puncture area and the necessary equipments for procedure are passed into the sheath. Meanwhile, the needle can be separated from the hemostatic valve by twisting and after the venipuncture, the pacemaker lead is placed in the right chambers of heart which allows the operator to measure the pressure of the right chambers of heart.
After the separation of the hemostatic valve, it is possible to fasten the hemostatic valve to the screwed sheath and use it as an introducer.
Brief Description of the Drawings:
Fig 1: a general view of needle and side tube
Fig 2: a general view of guide wire and introducer
The Detailed Description of the Drawings:
This invention is a sharp hollow and narrow needle lusedfor bloodless arterial percutaneous insertion system. The needle can be in different sizes (18-21 G). It comprises a hemostatic valve2and a clear hub 3around four centimeters and a needle with the different length of 35 to 90 mm and different inner diameter of 0.85 to 1.25 mm. The hub is connected to the needle and it is inseparable. The hub is able to be twisted around the hemostatic valve and get opened. There is a transparent side tube 4 with the size of 15-20 cm between the hemostatic valve and the needle hub. The side tube has a three-way stopcock 5. The needle is connected to the pressure connector via the side tube and three-way stopcock of the hemostatic valve. Therefore, when the needle is entered into the artery, the blood in the hub can be visualized and checked. The patient blood pressure can be checked on the monitor as systolic and diastolic pressure wave. If interested to check the color and intensity of the blood jet; we can open the three-way stopcock toward the needle and close it. The three-way stopcock must be irrigated by heparinized serum after visualizing the blood.
One of the most important distinguishing features of this invention is that at this stage of procedure, we can make sure about the accuracy of Arterial artery in which the needle is entered. To do so, the three-way stopcock of needle needs to be connected to the pressure connector and the intensity of blood jet and its color has to be checked.
In order to work in a sterilized environment and in Catheterization Laboratory (CATH LAB), after local anesthesia is administered by injecting the adequate amount of Lidocaine two percent, first the needle side tube is connected to the pressure connector by the three-way stopcock and then the needle is slowly entered in the pre-determined artery. When the needle is entered into the artery, the blood is able to be seen in the needle hub and Systolic and diastolic pressure wave is able to be checked on the monitor. Then, the guide wire is entered6through the valve very slowly and as much as required. After checking the guide wire in the artery with the fluoroscopy and making sure about the proper placement of guide wires, the needle is removed over the guide wire. After disconnecting the hemostatic valve from the needle and fastening the sheath to the needle, we can use it as an introducer 7or we can use a new introducer, and then the Arterial introducer is advanced over the guide wire and into the artery, the guide wire and dilator are removed while the sheath is left in the puncture area inside the artery. Then the required equipment is passed into it. Meanwhile, we can separate the needle from the hemostatic valve by twisting. In order to do the venipuncture, we can use only the needle to measure the pressures of right chambers of the heart or even place temporary lead pacemaker.
The advantages of Invention:
1. Minimizing or eliminating the possibility of blood jet to the surrounding area during arterial puncture and preventing the transmission of contagious diseases by the blood.
2. Checking both blood and the pressure wave (systole and diastole) at the same time when the needle enters the artery.
3. Controlling the proper placement of needle inside the artery by three factors of observing blood, the systole and diastole wave graphs (the minimum and maximum pressure) at the same time and if necessary visualizing the intensity and color of the blood to compare with the artery and vein blood by the three-way stopcocks
4. Decreasing the working risks and workplace contamination
5. When the needle is separated from the hemostatic valve, the pressure of the right chambers of heart can be measured, the temporary pacemaker lead can be placed and we can do the venography.

Claims

Bloodless Percutaneous Insertion Needle with Three Control System Claims
1. Bloodless Percutaneous Insertion Needle with control systems comprising:
A needle at its distal end a transparent hub with filtered vents is placed; A hemostatic valve to which a screw is connected;
A transparent side tube;
A transparent hub;
Three-way stopcock.
2. The apparatus of claim 1, wherein the Bloodless Percutaneous Insertion Needle
comprises three control systems.
3. The apparatus of claim 1, wherein the transparent hub is located at the distal end of the needle.
4. The apparatus of claim 1 , wherein the filtered vent has a transparent side tube and three- way stopcock is attached to its end.
5. The apparatus of claim 1, wherein the needle has a screw on its top that provides the possibility of its connection to hemostatic valve.
6. The apparatus of claim 1 , wherein the filtered vent attached to the top or side of the
needle hub causes the air to be emptied and prevents the loss of liquid or blood.
7. The apparatus of claim 1, wherein the side tube of hemostatic valve can be connected to the pressure connector and then the pressure monitor via a three-way stopcock.
8. The apparatus of claim 1, wherein the three-way stopcock has a lever which can be
adjusted in different positions by the operator.
9. The apparatus of claim 7, wherein the three-way stopcock can be in a closed mode so that the blood does not exit from any of the outlets.
10. The apparatus of claim 7, wherein the three-way stopcock can be in the position of
connection to pressure monitor.
11. The apparatus of claim 7, wherein the three-way stopcock can be in a position in which the blood comes out of the three-way stopcock so that the operator can visualize it.
12. The apparatus of claim 1, wherein the size of insertion needle can be between 16 to 22 g.
13. The apparatus of claim 1, wherein the length of insertion needle can be between 30 and 90 cm.
14. The apparatus of claim 1, wherein the length of transparent side tube can be between 15 and 25 cm.
15. The method of claim 1, wherein after the needle is inserted inside the artery, the guide wire enters the needle and then the artery from the end side of hemostatic valve.
16. The method of claim 1, wherein after the guide wire passes through the hemostatic valve, the hemostatic available in the valve prevents the loss of blood from the surrounding area.
PCT/IB2016/050485 2015-11-01 2016-01-30 Bloodless percutaneous insertion needle with three control system WO2017072594A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IR139450140003008649 2015-11-01
IR13943008649 2015-11-01

Publications (1)

Publication Number Publication Date
WO2017072594A1 true WO2017072594A1 (en) 2017-05-04

Family

ID=83280616

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2016/050485 WO2017072594A1 (en) 2015-11-01 2016-01-30 Bloodless percutaneous insertion needle with three control system

Country Status (1)

Country Link
WO (1) WO2017072594A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5078688A (en) * 1989-09-22 1992-01-07 Baxter International Inc. Paracentesis catheter system
US5125903A (en) * 1991-08-01 1992-06-30 Medtronic, Inc. Hemostasis valve
US20090234293A1 (en) * 2008-03-14 2009-09-17 Applied Medical Resources Corporation Instrument seal
US20140107616A1 (en) * 2012-10-17 2014-04-17 M. Samy Ahmed Hamboly Bloodless Arterial Percutaneous Insertion System
US20150011977A1 (en) * 2012-03-28 2015-01-08 Terumo Kabushiki Kaisha Puncture device assembly

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5078688A (en) * 1989-09-22 1992-01-07 Baxter International Inc. Paracentesis catheter system
US5125903A (en) * 1991-08-01 1992-06-30 Medtronic, Inc. Hemostasis valve
US20090234293A1 (en) * 2008-03-14 2009-09-17 Applied Medical Resources Corporation Instrument seal
US20150011977A1 (en) * 2012-03-28 2015-01-08 Terumo Kabushiki Kaisha Puncture device assembly
US20140107616A1 (en) * 2012-10-17 2014-04-17 M. Samy Ahmed Hamboly Bloodless Arterial Percutaneous Insertion System

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