WO2020085882A1 - 체내위치확인을 위한 풍선확장조성물 및 시스템 - Google Patents
체내위치확인을 위한 풍선확장조성물 및 시스템 Download PDFInfo
- Publication number
- WO2020085882A1 WO2020085882A1 PCT/KR2019/014289 KR2019014289W WO2020085882A1 WO 2020085882 A1 WO2020085882 A1 WO 2020085882A1 KR 2019014289 W KR2019014289 W KR 2019014289W WO 2020085882 A1 WO2020085882 A1 WO 2020085882A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- catheter
- balloon catheter
- positioning system
- radioactive
- Prior art date
Links
Images
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
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
-
- 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
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
- A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1056—Balloon catheters with special features or adapted for special applications having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- 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
- A61M25/10—Balloon catheters
Definitions
- the present invention relates to a detection technology for confirming the position of a medical device inserted in the body outside the body, and more specifically, a balloon for balloon positioning, which can accurately and safely check the position of the balloon catheter inserted into the body outside the body.
- An expansion composition and a balloon catheter body positioning system including the same.
- Balloon catheters are commonly used to widen narrow or clogged areas of the coronary arteries, esophagus, Eustachian tube, or uureteropelvic junction of kidneys. If the balloon is inflated with a contrast agent and a fluoroscopic image is obtained, the balloon position and expansion process can be confirmed.
- bleeding is the most common cause of preventable death in trauma patients.
- uncompressed trunk bleeding is very fatal and mortality rates range from 18% to 45%.
- the classical method of clamping the external aorta for hemostasis has been used in patients with severe bleeding, but it has a disadvantage that it can be performed only by an experienced doctor in a situation where it is difficult to perform immediately in an emergency and many equipments are well equipped.
- balloon catheters are also used for the temporary closure of large blood vessels with bleeding in patients with truncal hemorrhage.
- good research results have been proposed for a new method of preventing bleeding of large blood vessels in the body by inflating the balloon by inflating the balloon catheter into the blood vessel to control non-compressed interbody bleeding.
- the technique of controlling the bleeding by inflating the balloon in the proximal part of the bleeding lesion has been proven to be superior to the classical method in many studies involving animals and humans.
- ultrasonography cannot show the abdominal aorta in obese or airy patients.
- ultrasound is highly dependent on the experience of the operator performing the ultrasound evaluation, so in an emergency, ultrasound is particularly prone to operator error.
- ultrasound requires checking the REBOA's catheter tip, which can be obscured by debris and air that often appear in most patients.
- the thermal imaging method is another method for confirming the balloon position.
- the infrared imaging device takes 5 to 10 minutes (Barron 2018) to the anatomical target, measures at least 2 points, and then the researchers take additional time to calculate the outcome of the lesion. Has its drawbacks.
- Gamma probes are portable surgical radiation detectors capable of detecting photon radiation such as gamma rays.
- the radiation detection probe system can locate and show the monitoring lymph nodes, identify and show the location of hidden lesions, and evaluate the boundary during surgery.
- various malignant tumors such as breast cancer, melanoma, and colorectal cancer
- surgical treatment of parathyroid disease can provide real-time information necessary for surgeons. Due to these properties demonstrated in many previous studies, the use of gamma probe technology is expanding enormously. However, the application of a gamma probe to confirm the balloon position of the balloon catheter in an endovascular procedure has not been studied.
- the present inventors tried to overcome the shortcomings of the method for determining the location of a balloon catheter using X-rays.
- the balloon expansion composition used to expand the balloon of the balloon catheter included a radioactive isotope as an active ingredient, and the body location of the balloon catheter in vitro
- the present invention was completed by developing a technology capable of confirming.
- an object of the present invention is to provide a balloon expansion composition capable of accurately and safely confirming the balloon position of a balloon catheter inserted into the body by using radioactive isotopes as an active ingredient without using X-rays.
- Another object of the present invention is to expand the balloon of the balloon catheter inserted into the body with a balloon expansion composition containing a radioactive isotope, and a radioisotope sensing device capable of easily detecting the radioisotope contained in the expanded balloon in vitro It is to provide a new catheter positioning system of a balloon catheter with high availability because it has high accuracy of diagnosis, low radiation exposure, safe and easy to move, and does not require expensive equipment.
- the object of the present invention is not limited to the above-mentioned object, and even if not explicitly mentioned, the object of the invention that can be recognized by those skilled in the art from the description of the detailed description of the invention to be described later may also be naturally included. .
- the present invention provides a balloon expansion composition for positioning in the body of a balloon catheter comprising a radioactive isotope as an active ingredient.
- the radioactive isotope is included in an amount of radiation emitted at an intensity of 0.001 cps to 99,999 cps.
- the radioactive isotopes release beta particles and gamma particles.
- the balloon expansion composition consists of any one of a liquid phase, a gas phase, a gel phase, and a solid phase.
- the present invention is a balloon expansion composition for positioning in the body of a balloon catheter comprising a radioactive isotope; A balloon catheter in which the balloon is expanded by the balloon expansion composition while inserted in the body; And a radioactive isotope sensing device that detects the radioactive isotope from the outside of the body.
- the balloon expansion composition includes the radioactive isotope in an amount where radiation is emitted at an intensity of 0.001 cps to 99,999 cps.
- the balloon expansion composition is made of any one of a liquid phase, a gas phase, a gel phase, and a solid phase.
- the radioactive isotope sensing device is a radioactive material detection device.
- the balloon position of the balloon catheter inserted into the body can be checked in real time.
- the balloon position in the body is confirmed within 5 seconds.
- An internal positioning system includes a catheter device having radioactive material and being inserted into the body; It includes; a sensing device that is located outside the body to detect a radioactive material in proximity by the movement of the catheter device.
- the catheter device includes a guide wire provided to be inserted into the body; It may include; a balloon catheter provided to be movable along the guide wire.
- the radioactive material may be fixed to at least one of the guide wire and the balloon catheter.
- the balloon catheter a tube formed with a hollow portion through which the guide wire; It may be provided on the tube, the balloon member is provided to be inflatable.
- the radioactive material may be disposed adjacent to the balloon member.
- the radioactive material may be located inside the balloon member.
- the radioactive material may be fixedly disposed on any one of the inner wall of the balloon member and the tube.
- the balloon member operates in a contracted state and an expanded state in which the outer surface expands from the contracted state to press the inner wall of the blood vessel, and the radioactive material, when the balloon member is in the contracted state and the expanded state, the It may be provided to maintain the same position inside the balloon member.
- the radioactive material may be formed in a solid phase.
- the sensing device includes a probe located at a target site outside the body to detect the radioactive material; It may include; a console unit for receiving the detection signal of the probe and displaying the measurement results.
- the balloon position of the balloon catheter inserted into the body can be accurately and safely confirmed outside the body without using X-rays.
- the balloon of the balloon catheter inserted into the body is expanded with the balloon expansion composition containing the radioactive isotope, and the radioisotope contained in the expanded balloon is easily detected in vitro.
- the diagnosis accuracy is high by using the radioactive isotope detection device that can be used, and the radiation exposure amount is small, so it is safe, easy to move, and high availability because it does not require expensive equipment.
- Figure 1a is a schematic view showing an embodiment of a balloon catheter containing a balloon expansion composition included in the balloon catheter body positioning system according to an embodiment of the present invention
- Figure 1b is a radioisotope included in the balloon expansion composition of the balloon catheter
- Figure 1b is a schematic diagram showing an embodiment of the element sensing device.
- FIGS. 2A and 2B are diagrams of a catheter device according to an embodiment of the present invention.
- 3A, 3B, and 3C are views related to an operation when the catheter device according to an embodiment of the present invention is inserted into the body.
- 4A, 4B, 4C, and 4D are views of a catheter device according to another embodiment of the present invention.
- FIG. 5 is a schematic diagram of the experimental setup (B) picture and phantom (A) of gamma probes in the nuclear medicine imaging room for confirming whether or not the balloon catheter can actually be positioned using the balloon catheter internal positioning system shown above. .
- FIG. 6 is a representative planar image for measuring the distance between the predicted balloon position and the actual balloon position at the lower boundary of the phantom in the areas I (A) and III (B) measured in the experiment set up in FIG. 5.
- FIG. 7 is a graph showing the success and failure frequency of predicting the balloon position in the region I (A) and the region III (B) measured in the experiment set as shown in FIG. 5.
- FIG. 8 is a graph showing the difference in the distance (cm) between the predicted position and the actual position of the experimenter 1 (A) and the experimenter 2 (B) in the experiment set as shown in FIG. 5.
- FIG. 9 is a graph showing the time taken to search for the balloon position measured in the experiment set as shown in FIG. 5 and the average coefficient measured by the gamma probe.
- first and second may be used to describe various components, but the components should not be limited by the terms. The terms are used only for the purpose of distinguishing one component from other components.
- first component may be referred to as a second component without departing from the scope of the present invention, and similarly, the second component may also be referred to as a first component.
- the technical features of the present invention include a radioactive isotope as an active ingredient, and a balloon expansion composition that can accurately and safely confirm the balloon position of the balloon catheter inserted into the body without using X-rays, and the balloon expansion composition.
- a balloon catheter internal positioning system including a radioactive isotope sensing device that can expand the balloon of the balloon catheter inserted into the body and can easily detect the radioisotope contained in the expanded balloon in vitro.
- the present invention since the location of the balloon can be confirmed with a radioactive material detection device in vitro compared to the method using an existing in vitro boundary table, the accuracy of diagnosis can be secured, and the equipment can be compared with the method using an existing X-ray. Since it is easy to move and does not require expensive equipment, it is highly available in emergency bleeding situations, and the method using fluoroscopy increases the radiation exposure of patients and operators depending on the amount of use, but the present invention uses a small amount of radioactive isotopes. Because it is safe.
- the balloon expansion composition for positioning the balloon catheter of the present invention includes a radioactive isotope as an active ingredient.
- the content of radioactive isotopes included in the balloon expansion composition may be included as an amount at which radiation is emitted at an intensity of 0.001 cps to 99.999 cps. If the radioisotope is included below the content at which the radiation is emitted at an intensity of 0.001 cps, the intensity of the radiation is so weak that the radioisotope detection device does not detect the radioisotope contained in the balloon of the balloon catheter inserted in the body.
- the radioisotope included in the balloon expansion composition of the present invention may be any radioisotope that is permitted for medical use by the Ministry of Food and Drug Safety, which may emit beta particles and gamma particles, and as an embodiment 99mTc, 18F, 123I , 131I may be any one or more radioactive isotopes selected from the group consisting of.
- the balloon expansion composition of the present invention may be formed of any one of a liquid phase, a gas phase, and a gel phase.
- the balloon expansion composition When the balloon expansion composition is liquid, it can be formed by including a certain amount of radioactive isotopes in physiological saline, and in the case of gaseous phase, it can be formed by including a certain amount of radioactive isotopes in a gas allowed for medical use. It can be formed by including a certain amount of radioactive isotopes in a medically acceptable gel.
- the radioactive isotope when the radioactive isotope is provided as a solid phase, it can be applied to all medical devices inserted into the body.
- a radioactive isotope provided as a solid phase may be located in the catheter, or may be located in the balloon portion of the balloon catheter.
- the radioactive isotope provided as a solid phase may be located in a separate member inserted into the body.
- the balloon expansion composition may include a radioactive isotope, but is not limited thereto, and the operation of the balloon member in a contracted state and an expanded state may be performed separately, and satisfies this if the radioisotope is located in the catheter device.
- the radioactive isotope may consist of any one of liquid, gaseous, gel, and solid phases.
- the system for positioning a balloon catheter in the present invention includes a balloon expansion composition for checking the position in a balloon catheter body including a radioactive isotope; A balloon catheter in which the balloon is expanded by the balloon expansion composition while inserted in the body; And a radioactive isotope sensing device that detects the radioactive isotope in vitro.
- the balloon catheter 110 included in the system of the present invention may be a catheter of any known configuration as long as it is a catheter equipped with a balloon member 120 at the tip as shown in FIG. 1A. That is, a balloon expansion composition 130 in which a radioactive isotope is contained in a certain amount may be inserted as an expansion composition used by a doctor to insert a balloon catheter 110 into the body for a specific purpose and expand the balloon at the tip. have.
- the radioactive isotope sensing device 150 included in the system of the present invention detects radioactive materials such as alpha rays, beta rays, gamma rays or radioactive isotopes emitted by radioactive isotopes as shown in FIG. 1B. can do.
- the gamma particle detection device 150 may be used.
- the gamma particle detection device 150 may include a gamma probe 160 and a console unit 170 as shown in FIG. 1B.
- the gamma probe 160 is a component that detects emitted gamma particles
- the console unit 170 is a component that displays measurement conditions such as counts and measurement results.
- the radioactive material detection device is not limited thereto.
- PET and SPECT for identifying radioactive materials may be applied, and ionizing boxes, proportional counters, Geiger-Muller counters, scintillation counters, semiconductor detectors, etc. for detecting the signals of radioactive materials may be applied.
- the balloon catheter inserted into the body by the radioactive isotope sensing device 150 having the structure shown in FIG. 1B can be accurately and quickly predicted.
- Figures 2a, 2b is a view of the catheter device according to an embodiment of the present invention
- Figures 3a, 3b, 3c is a view of the operation when the catheter device according to an embodiment of the present invention is inserted into the body
- Figure 4a , 4b, 4c, and 4d are diagrams of a catheter device according to another embodiment of the present invention.
- the catheter device 100 may be provided to be inserted into the body.
- the catheter device 100 having a balloon member is described, but is not limited thereto.
- the catheter device 100 satisfies this if the radioactive material 140 is disposed and can be inserted into the body.
- the catheter device 100 may include a guide wire 102 and a balloon catheter 110.
- the catheter device 100 may be inserted into the body along the blood vessel V.
- the guide wire 102 may be provided to guide the movement of the balloon catheter 110 described later.
- the guide wire 102 may be made of a material having elasticity and flexibility. Guide wire 102 may be inserted so that the tip can reach the target portion in the body.
- the balloon catheter 110 may move along the guide wire 102.
- the balloon catheter 110 has a hollow portion formed therein, and the balloon catheter 110 may be inserted into the body along the guide wire 102 so that the guide wire 102 passes through the hollow portion.
- the balloon catheter 110 may include a tube 115 and a balloon member 120.
- the length may be formed to be connected from the body to the target site.
- the hollow portion described above may be formed in the tube 115.
- the balloon member 120 may be provided on the tube 115.
- the balloon member 120 may be provided to operate in a contracted state (120a) and an expanded state (120b). In the process of moving the balloon catheter 110 in the body, the balloon member 120 may be operated in a contracted state (120a).
- the balloon member 120 of the balloon catheter 110 When the balloon member 120 of the balloon catheter 110 is located at the target site, the balloon member 120 may be operated in the expanded state 120b.
- the balloon member 120 may pressurize the blood vessel V whose bleeding occurred on its outer surface in the expanded state 120b. Through this, the balloon member 120 may prevent or reduce bleeding that occurs in the blood vessel V.
- the catheter device 100 may include radioactive isotopes.
- the balloon expansion composition 130 contains a certain amount of radioactive isotopes.
- the operation of the contraction state 120a and the expansion state 120b of the balloon member 120 is not limited thereto, and is satisfied when a radioactive isotope is located in the catheter device 100. do.
- the radioactive isotope may be referred to as radioactive material 140.
- the radioactive material 140 may be located in the catheter device 100.
- the radioactive material 140 may be fixedly positioned on at least one of the guide wire 102 and the balloon catheter 110.
- the radioactive material 140 is located on the guide wire 102, so that the gamma probe 160 detects the radioactive material 140 to detect the guide wire 102 moving to the target site.
- the radioactive material 140 is located in the catheter device 100, so that the gamma probe 160 detects the radioactive material 140 to detect the balloon catheter 110 moving to the target site.
- the radioactive material 140 is positioned as an example in the balloon catheter 110, but is not limited thereto.
- the radioactive material 140 may be located in the balloon catheter 110.
- the radioactive material 140 may be disposed inside the balloon member 120 of the balloon catheter 110 or adjacent to the balloon member 120. Through this, the balloon member 120 can be detected by the sensing device 150 so that it can be accurately positioned at the target site.
- the position of the radioactive material 140 is not limited, but as shown in FIGS. 2A to 3C, the radioactive material 140 may be located in the tube 115 inside the balloon member 120.
- the radioactive material 140a may be located on the inner wall of the balloon member 120 as shown in FIG. 4A.
- the radioactive material 140b may be located in the tube 115 adjacent to the balloon member 120 as shown in FIG. 4B.
- the radioactive material 140c may be located on the guide wire 102 as shown in FIG. 4C.
- the radioactive material 140d may be located on the inner space formed by the balloon member 120 as shown in FIG. 4D.
- the radioactive material 140 may maintain the same position despite the operation of the contracted state 120a and the expanded state 120b of the balloon member 120 as shown in FIGS. 3B and 3C.
- the radioactive material 140 maintains the same position regardless of the operation of the balloon member 120, so that the catheter device 100 can be finely moved while the balloon member 120 is operating. Through this, it is possible to precisely adjust the position or maintain the position of the catheter device 100.
- the balloon catheter 110 may be configured such that the length of the radioactive material 140 inserted into the blood vessel up to the position detected by the sensing device 150 is checked.
- the tube 115 of the balloon catheter 110 may include a plurality of scales arranged long along the longitudinal direction to check the insertion length.
- the balloon catheter 110 may set the insertion length.
- the insertion length of the balloon catheter 110 may be performed in the same position in the body in the treatment or examination that is repeatedly performed.
- the bleeding site h may be found through examination.
- the sensing probe 160 may be approached to the extracorporeal portion S corresponding to the bleeding portion h.
- the catheter device 100 having the radioactive material 140 may be moved along the blood vessel V.
- the guide wire 102 is first inserted along the blood vessel V.
- the sensing probe 160 is exemplified as approaching the extracorporeal portion S before the guide wire 102 is inserted, but is not limited thereto, and the sensing probe 160 is a balloon after the guide wire 102 is inserted.
- the catheter 110 may be accessed outside the body in correspondence with the insertion process.
- the balloon catheter 110 including the radioactive material 140 is inserted along the guide wire 102.
- the sensing probe 160 may detect the radioactive material 140. That is, during the movement of the balloon catheter 110, the detection probe 160 may detect the radioactive material 140.
- the radioactive material 140 is adjacent to the sensing probe 160, it can be seen that the balloon member 120 of the catheter device 100 has moved to the bleeding area through an alarm or signal from the sensing device 150.
- the gamma particle detection device 150 used in the system of the present invention is much cheaper than the fluoroscopy method, and is smaller in size and portable, so the system of the present invention is moved to the operating room to check the location of the balloon of the aortic occlusion in the operating room. Can also be used to do.
- the gamma probe is very easy to handle, so it does not rely heavily on the skill or experience of the operator, and thus has the advantage of not requiring much training or time to deal with the gamma probe. In the experimental example described below, two surgeons who had 10 years of experience as a surgeon, but had no experience in handling gamma probes, participated.
- a balloon expansion composition was prepared by adding 37 mlq of 99 mTc-pertechnetate into 8 ml of normal saline.
- the gamma probe can guide and confirm the balloon position of the balloon catheter using REBOA in the human vascular phantom, and two surgeons with no experience with the gamma probe The performance of searching the balloon of the balloon catheter was compared to evaluate whether the system of the present invention is easy to use as follows.
- the interior of the Phantom was purchased from Invasive Model LLC (Plymouth, MN, USA).
- This educational simulator (Bilateral Bob Plus, BB-6050) is modeled after the arterial and venous structures of an average-sized adult male, and is designed for practice skills in the installation, insertion and management of catheter, guide wire and balloon catheter. .
- the outer shell of the phantom consists of a 5mm thick skin-colored mat board that is 300mm (W) x 600mm (L) x 300mm (H). When the lid was covered, all sides of the right-angled parallelepiped were blocked except for a small gap approaching both iliac cortical ports at the bottom of the outer shell, as shown in Fig. 5 (A).
- the balloon catheter used by the assistant's system was advanced from any position to the aortic zone I or zone III. Then, the balloon expansion composition prepared in Example 1 was added to inflate the balloon, cover the outer shell of the phantom, and allow the surgeon to enter the laboratory (see FIG. 5 (B)).
- each surgeon entered the nuclear medicine imaging room to find the location of the balloon, set it appropriately for the 99mTc energy, and explored the location of the balloon using the gamma probe of the system of the present invention.
- a beep was heard from the console, and the count was specified high.
- the detector's beeper becomes stronger and the count increases, it means that the position of the gamma probe is close to the balloon containing 99mTc-pertechnetate.
- Each surgeon predicted the inflated position of the balloon and placed the 3mm diameter gamma-ray point light source on the outer shell of the phantom as the predictive point with the highest warning sound and count. And the assistant recorded the count and the time taken. This was defined as 1 time each and repeated 20 times for each surgeon in both aortic zone I and zone III.
- SPECT / CT imaging system Discovery NM / CT 670, GE Healthcare.
- SPECT / CT was filmed every 10 times and a 5 second / 30 degree step-and-shoot protocol was used for a total of 12 views per camera head.
- CT was performed immediately after SPECT acquisition.
- the parameters included a current of 40 mA, a voltage of 140 kV and a 3.75 mm slice reconstructed with a 512 X 512 matrix.
- Continuous variables are expressed as mean ⁇ standard deviation (SD), and categorical variables are expressed as frequency and percentage.
- SD standard deviation
- categorical variables are expressed as frequency and percentage.
- a t-test was used to compare the distance between the two surgeons and the aortic zone, and Fisher's exact test was used to estimate the results. P values less than 0.05 were considered statistically significant, and statistical analysis was performed using SPSS version 21.0 (IBM Corp., Armonk, NY, USA).
- Zone III In order to predict the location of the balloon, a total of 80 times were performed 20 times each in Zone I and Zone III. Two workers failed three times in Zone 1 and four times in Zone 3. The difference from the actual balloon location was 1.40 ⁇ 1.40 cm in zone I and 1.56 ⁇ 1.15 cm in zone III. The difference in distance between the actual balloon site and the predicted distance did not differ significantly between zone I and zone III. However, the time it took to navigate the balloon location was longer in zone I (2.68 ⁇ 1.31 minutes) than in zone III (2.05 ⁇ 1.08 minutes). In addition, the count of balloons measured by the gamma probe was larger than that of Zone III in Zone I.
- Surgeon 1 failed twice in Zone 1 and twice in Zone 3.
- Surgeon 2 failed once in Zone 1 and twice in Zone III ( Figure 8).
- the number of failures did not differ between the two surgeons.
- Surgeon 1 had a larger distance difference predicting balloon position than surgeon 2, but there was no difference between the two surgeons in both region I and region III (FIG. 8).
- Surgeon 1 took more time to navigate the balloon position in both Zone I and Zone III, but the difference was not statistically significant.
- the number of balloons measured by the gamma probe was higher in surgeon 2 than surgeon 1.
- the distance difference between the predicted balloon position and the actual balloon position was 1.40 cm in zone I and 1.56 cm in zone III.
- the time taken to navigate the balloon position using the gamma probe was 2.7 seconds in Zone I and 2.1 seconds in Zone III.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Surgery (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Pulmonology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical & Material Sciences (AREA)
- Child & Adolescent Psychology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Optics & Photonics (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Dispersion Chemistry (AREA)
- Pathology (AREA)
- Robotics (AREA)
- Radiation-Therapy Devices (AREA)
- Apparatus For Radiation Diagnosis (AREA)
Abstract
Description
Claims (20)
- 방사성동위원소를 유효성분으로 포함하는 풍선카테터 체내위치확인용 풍선확장조성물.
- 제 1 항에 있어서,상기 방사성동위원소는 방사선이 0.001cps 내지 99,999cps의 세기로 방출되는 함량으로 포함되는 것을 특징으로 하는 풍선카테터 체내위치확인용 풍선확장조성물.
- 제 1 항에 있어서,상기 방사성동위원소는 베타입자 또는 감마입자를 방출하는 것을 특징으로 하는 풍선카테터 체내위치확인용 풍선확장조성물.
- 제 1 항에 있어서,상기 풍선확장조성물은 액상, 기상, 겔상, 고상 중 어느 하나의 상으로 이루어지는 것을 특징으로 하는 풍선카테터 체내위치확인용 풍선확장조성물.
- 방사성동위원소를 포함하는 풍선카테터 체내위치확인용 풍선확장조성물;체내에 삽입된 상태에서 상기 풍선확장조성물에 의해 풍선이 확장되는 풍선카테터; 및상기 방사성동위원소를 체외에서 감지하는 방사성동위원소 감지장치;를 포함하는 풍선카테터 체내위치확인 시스템.
- 제 5 항에 있어서,상기 풍선확장조성물은 방사선이 0.001cps 내지 99,999cps의 세기로 방출되는 함량으로 상기 방사성동위원소를 포함하는 것을 특징으로 하는 풍선카테터 체내위치확인 시스템.
- 제 5 항에 있어서,상기 풍선확장조성물은 액상, 기상, 겔상, 고상 중 어느 하나의 성으로 이루어지는 것을 특징으로 하는 풍선카테터 체내위치확인 시스템.
- 제 5 항에 있어서,상기 방사성동위원소 감지장치는 감마입자 탐지장치인 것을 특징으로 하는 풍선카테터 체내위치확인 시스템.
- 제 5 항 내지 제 8 항 중 어느 한 항에 있어서,상기 체내에 삽입된 풍선 카테터의 풍선 위치를 실시간으로 확인할 수 있는 것을 특징으로 하는 풍선카테터 체내위치확인 시스템.
- 제 9 항에 있어서,상기 풍선확장조성물이 상기 풍선 카테터의 풍선에 삽입되면체내 풍선위치가 5초 내에 확인 되는 것을 특징으로 하는 풍선카테터 체내위치확인 시스템.
- 방사성물질을 갖고, 체내에 삽입가능하게 마련되는 카테터장치;상기 카테터장치의 이동에 의해 목표부위로 근접하는 상기 방사성물질을 감지하는 감지장치;를 포함하는 체내위치확인 시스템.
- 제 11 항에 있어서,상기 카테터장치는,체내에 삽입가능하게 마련되는 가이드와이어;상기 가이드와이어를 따라 이동가능하게 마련되는 풍선카테터;를 포함하는 체내위치확인 시스템.
- 제 11 항에 있어서,상기 방사성물질은 상기 가이드와이어와 상기 풍선카테터 중 적어도 하나에 고정되게 위치하는 체내위치확인 시스템.
- 제 11 항에 있어서,상기 풍선카테터는,상기 가이드와이어가 지나는 중공부가 형성된 튜브;상기 튜브상에 마련되어, 팽창가능하게 마련되는 풍선부재;를 포함하는 체내위치확인 시스템.
- 제 14 항에 있어서,상기 방사성물질은 상기 풍선부재에 인접하게 배치되는 체내위치확인 시스템.
- 제 14 항에 있어서,상기 방사성물질은 상기 풍선부재의 내부에 위치하는 체내위치확인 시스템.
- 제 16 항에 있어서,상기 방사성물질은 상기 풍선부재의 내벽와 상기 튜브 중 어느 하나에 고정배치되는 체내위치확인 시스템.
- 제 14 항에 있어서,상기 풍선부재는,수축상태와, 상기 수축상태로부터 팽창하여 그 외면이 혈관의 내벽을 가압하는 팽창상태를 동작하고,상기 방사성물질은,상기 풍선부재가 상기 수축상태와 상기 팽창상태일 때, 상기 풍선부재 내부에서 동일한 위치를 유지하도록 마련되는 체내위치확인 시스템.
- 제 11 항에 있어서,상기 방사성물질은 고상으로 형성되는 체내위치확인 시스템.
- 제 11 항에 있어서,상기 감지장치는,체외에서 대상부위에 위치하여, 상기 방사성물질을 감지하는 프로브;상기 프로브의 감지신호를 받아 측정결과를 표시하는 콘솔부;를 포함하는 체내위치확인 시스템.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/288,654 US20220008697A1 (en) | 2018-10-26 | 2019-10-28 | Balloon inflation composition and system for in vivo location confirmation |
GB2107045.3A GB2593359B (en) | 2018-10-26 | 2019-10-28 | Balloon inflation composition and system for in vivo location confirmation |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR10-2018-0129274 | 2018-10-26 | ||
KR20180129274 | 2018-10-26 | ||
US201962880693P | 2019-07-31 | 2019-07-31 | |
US62/880,693 | 2019-07-31 | ||
KR10-2019-0119580 | 2019-09-27 | ||
KR1020190119580A KR20200047321A (ko) | 2018-10-26 | 2019-09-27 | 체내위치확인을 위한 풍선확장조성물 및 시스템 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2020085882A1 true WO2020085882A1 (ko) | 2020-04-30 |
Family
ID=70331633
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/KR2019/014289 WO2020085882A1 (ko) | 2018-10-26 | 2019-10-28 | 체내위치확인을 위한 풍선확장조성물 및 시스템 |
Country Status (2)
Country | Link |
---|---|
US (1) | US20220008697A1 (ko) |
WO (1) | WO2020085882A1 (ko) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5879282A (en) * | 1997-01-21 | 1999-03-09 | Cordis A Johnson And Johnson Company | Catheter having an expandable radioactive source |
KR20000065092A (ko) * | 1996-04-30 | 2000-11-06 | 지. 애플 마크 | 방사능유체를수용하는기구를구비한카테터장치 |
US20030192557A1 (en) * | 1998-05-14 | 2003-10-16 | David Krag | Systems and methods for locating and defining a target location within a human body |
US20040006305A1 (en) * | 2002-07-03 | 2004-01-08 | Stephen Hebert | Balloon catheter having an expandable distal end |
JP2008516722A (ja) * | 2004-10-19 | 2008-05-22 | ナヴォテック メディカル リミテッド | 追跡ガイドを使用するカテーテル端の位置決定 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4096862A (en) * | 1976-05-17 | 1978-06-27 | Deluca Salvatore A | Locating of tubes in the human body |
US5616114A (en) * | 1994-12-08 | 1997-04-01 | Neocardia, Llc. | Intravascular radiotherapy employing a liquid-suspended source |
US5916167A (en) * | 1997-10-10 | 1999-06-29 | Neoprobe Corporation | Surgical probe apparatus and system |
EP3016608B1 (en) * | 2013-07-01 | 2020-05-13 | Faxitron Bioptics, LLC | Gamma probe with hand-piece control of detection parameters |
-
2019
- 2019-10-28 WO PCT/KR2019/014289 patent/WO2020085882A1/ko active Application Filing
- 2019-10-28 US US17/288,654 patent/US20220008697A1/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20000065092A (ko) * | 1996-04-30 | 2000-11-06 | 지. 애플 마크 | 방사능유체를수용하는기구를구비한카테터장치 |
US5879282A (en) * | 1997-01-21 | 1999-03-09 | Cordis A Johnson And Johnson Company | Catheter having an expandable radioactive source |
US20030192557A1 (en) * | 1998-05-14 | 2003-10-16 | David Krag | Systems and methods for locating and defining a target location within a human body |
US20040006305A1 (en) * | 2002-07-03 | 2004-01-08 | Stephen Hebert | Balloon catheter having an expandable distal end |
JP2008516722A (ja) * | 2004-10-19 | 2008-05-22 | ナヴォテック メディカル リミテッド | 追跡ガイドを使用するカテーテル端の位置決定 |
Non-Patent Citations (1)
Title |
---|
PARK, Y. ET AL.: "Gamma probe-guided confirmation of balloon placement in endovascular procedures", JOURNAL OF TRAUMA AND ACUTE CARE SURGERY, vol. 86, no. 6, 1 March 2019 (2019-03-01), pages 994 - 1000 * |
Also Published As
Publication number | Publication date |
---|---|
US20220008697A1 (en) | 2022-01-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP4756425B2 (ja) | Pet装置、及び、その画像再構成方法 | |
US7592600B2 (en) | Diagnosis device for radiographic and nuclear medical examinations | |
Heyd et al. | Radiation exposure to patients and personnel during interventional ERCP at a teaching institution | |
CN101401725B (zh) | 使用混合成像系统治疗患者的装置 | |
WO1994003108A1 (en) | Flexible intraoperative radiation imaging camera | |
KR20050037338A (ko) | 의료용 화상 진단 장치 | |
CN101371161A (zh) | 放射检查中患者皮肤剂量的改进指示 | |
JP2009236793A (ja) | 画像情報作成方法,断層撮影装置の断層画像情報作成方法及び断層撮影装置 | |
WO2016137157A1 (ko) | 의료 영상 장치 및 의료 영상 처리 방법 | |
US6603991B1 (en) | Method and apparatus for dual mode medical imaging system | |
CN107928702A (zh) | 断层扫描辐射防护系统 | |
WO2020085882A1 (ko) | 체내위치확인을 위한 풍선확장조성물 및 시스템 | |
US6984827B2 (en) | Medical system including X-ray CT apparatus and nuclear medicine diagnostic apparatus | |
WO2020085883A1 (ko) | 체내위치확인 시스템 | |
WO2020209568A1 (ko) | 방사선 진단 및 치료 장치의 모션 평가 시스템 및 방법 | |
JP4415707B2 (ja) | 放射線検出装置及び放射線分布監視装置 | |
JP2004313785A (ja) | 断層撮影システム及びx線投影システムの組み合わせ装置 | |
KR20200047321A (ko) | 체내위치확인을 위한 풍선확장조성물 및 시스템 | |
JPH04105641A (ja) | 医用診断システム | |
US5835556A (en) | Process and device for computer tomography transillumination for treatment | |
JP2022000094A (ja) | 医用画像診断システム、医用画像診断方法、入力装置、及び表示装置 | |
Sulieman et al. | Assessment of patient dose and radiogenic risks during endoscopic retrograde cholangiopancreatography | |
Keane et al. | Manual on radiation protection in hospitals and general practice. Vol. 3, X-ray diagnosis | |
Boitsios et al. | Photographs coupled with radiographs in children: perspectives and ethical challenges | |
JP4389645B2 (ja) | 複合型放射線撮像システム |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 19876102 Country of ref document: EP Kind code of ref document: A1 |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
ENP | Entry into the national phase |
Ref document number: 202107045 Country of ref document: GB Kind code of ref document: A Free format text: PCT FILING DATE = 20191028 |
|
122 | Ep: pct application non-entry in european phase |
Ref document number: 19876102 Country of ref document: EP Kind code of ref document: A1 |