CN110270004A - HVPG foley's tube and preparation method thereof - Google Patents
HVPG foley's tube and preparation method thereof Download PDFInfo
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- CN110270004A CN110270004A CN201910676535.3A CN201910676535A CN110270004A CN 110270004 A CN110270004 A CN 110270004A CN 201910676535 A CN201910676535 A CN 201910676535A CN 110270004 A CN110270004 A CN 110270004A
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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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- 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
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- 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
- A61M2025/0001—Catheters; Hollow probes for pressure measurement
- A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Manufacturing & Machinery (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a kind of HVPG foley's tubes comprising: tube body one, is double lumen tube, and the proximal end of the tube body one is equipped with connector one；Tube body two is single lumen catheter, and the proximal end of the tube body two is equipped with connector two, and the distal end of the tube body two is connected to and in communication with by the proximal, side wall of a three-way piece and the tube body one；Wherein, sacculus is arranged on the distal end side wall of the tube body one, the sacculus is connected to the tube body one；The position at both ends of the tube body one in the sacculus is respectively equipped with developing mark；The head end of the tube body one is radially equipped with several side openings.The invention also discloses the production methods of the foley's tube.The available more accurate monitoring result of HVPG foley's tube of the invention may also help in doctor and preferably position under X-ray to HVPG foley's tube, and can reach diseased region better by tortuous blood vessel.
Description
Technical Field
The invention relates to an HVPG balloon catheter used in interventional operation, which is used for monitoring Hepatic Vein Pressure Gradient (HVPG), mainly used for solving the problems of difficult balloon catheter positioning, poor monitoring accuracy and poor passing performance when the hepatic vein pressure gradient is monitored, and can better meet the clinical use requirement.
Background
Portal hypertension is an important factor affecting the clinical prognosis of patients with liver cirrhosis, and the severity of portal hypertension determines the occurrence and development of complications of liver cirrhosis (such as bleeding due to esophageal and gastric varices rupture, hydrops in abdominal cavity, hepatorenal syndrome and the like). The number of patients with liver diseases in China is reported to exceed 4 hundred million, and the number of the patients with liver diseases in China is the country with the highest global liver disease burden, wherein about 1.06 million patients with positive hepatitis B surface antigens or positive hepatitis C antibodies, about 6000 million patients with alcoholic liver diseases and about 2 million patients with non-alcoholic fatty liver diseases are reported. Although the incidence of infectious liver disease is reduced compared with the prior art, the number of nonalcoholic fatty liver patients is steadily increasing, and is expected to exceed 3.1 hundred million by 2030. Viral hepatitis, alcoholic hepatitis, and non-alcoholic steatohepatitis all have the risk of progressing to cirrhosis. Therefore, the situation of the liver cirrhosis disease in future in China is severe, but the epidemiological investigation data related to the liver cirrhosis portal hypertension with multiple centers and large sample size is still lacking in China at present. Esophageal and gastric variceal bleeding is the most important complication of portal hypertension of cirrhosis, and the incidence rate of the bleeding is up to 55.6%.
Hepatic venous wedge pressure (WHVP) represents hepatic sinus pressure, which may be indirectly reflected in portal hypertension due to sinus causes. While the Hepatic Venous Pressure Gradient (HVPG), which is the difference between WHVP and the hepatic venous free pressure (FHVP), reflects the pressure difference between the portal vein and the vena cava of the abdominal cavity, compared to WHVP, HVPG eliminates the effect of intra-abdominal pressure on the measurement results and can better reflect portal venous pressure. The normal value of HVPG ranges from 3 to 5mmHg (1mmHg ═ 0.133kPa), and when HVPG >5mmHg, it suggests the presence of portal hypertension of cirrhosis.
In the early stage, a straight catheter is used for measuring HVPG (high pressure drainage catheter), namely, a Seldinger intubation method is adopted, the catheter is firstly inserted into a hepatic venule branch through a jugular vein or femoral vein, pressure measurement is carried out to obtain WHVP, then the catheter is withdrawn to a hepatic vein close to an opening of a inferior vena cava (generally 1-2 cm away from the inferior vena cava) and pressure measurement is carried out to obtain FHVVP, and the HVPG is obtained by subtracting the two. This method requires adjustment of the catheter position, and is complicated to operate and has poor repeatability.
When measuring the WHVP, the catheter does not need to be embedded into a hepatic venule branch, only needs to be placed at a larger hepatic vein branch, measures the pressure when the balloon is full to block venous blood backflow, and represents the WHVP by the pressure measuring device, and the measured pressure when the balloon is not full is the FHVPG. Compared with a straight catheter, the balloon catheter is simple, rapid and good in repeatability, and meanwhile, the deviation of WHVP caused by different measurement positions due to the adoption of the straight catheter for pressure measurement is avoided.
However, the balloon catheter is mainly used for taking out thrombus and embolus in blood vessels and temporarily blocking blood flow of the blood vessels, and the problems of difficult positioning, poor monitoring accuracy and poor passing performance of the balloon catheter exist when the balloon catheter is used for measuring HVPG.
Disclosure of Invention
The invention provides an HVPG balloon catheter and a manufacturing method thereof, wherein the HVPG balloon catheter is used for measuring HVPG, and can solve the problems of difficult positioning, poor monitoring accuracy and poor passing performance of the balloon catheter in the measuring process.
The technical scheme of the invention is as follows:
an HVPG balloon catheter, comprising:
the first tube body is a double-cavity tube and is made of one or more materials selected from PCTG, PA, PC and PVC, and a first connecting piece is arranged at the proximal end of the first tube body;
the second tube body is a single-cavity tube and is made of one or more materials selected from PCTG, PA, PC and PVC, a second connecting piece is arranged at the proximal end of the second tube body, and the distal end of the second tube body is connected and communicated with the proximal side wall of the first tube body through a three-way piece; wherein,
the far-end side wall of the first pipe body is sleeved with a balloon, and the balloon is communicated with the first pipe body;
developing marks are respectively arranged at the positions of the first tube body at the two ends of the balloon;
and a plurality of side holes are formed in the head end of the first pipe body in the radial direction.
In a preferred embodiment, the side holes of the head end of the first pipe body are two and are uniformly arranged along the periphery of the first pipe body.
The HVPG balloon catheter is provided with the side holes at the head end uniformly, so that the uniform distribution of the physiological saline is facilitated, and the feedback result is objective and accurate.
For the HVPG balloon catheter, the material of the first connecting piece and the second connecting piece is selected from one or more of high polymer materials such as PCTG, PA, PC, PVC and the like.
For the HVPG balloon catheter, the material of the tee joint part is selected from one or more of high polymer materials such as PEBA, PU, PVC and the like.
For the HVPG balloon catheter, the balloon is a compliance balloon, and the material is selected from one or more of TPU, silica gel, latex and other high polymer materials.
For the HVPG balloon catheter, the material of the development mark is selected from one or more of X radiopaque metal materials such as platinum iridium alloy, platinum tungsten alloy, platinum, tungsten and the like.
In a preferred embodiment, the development mark is a development ring. In particular a full ring or a ring consisting of a plurality of points or sheets. The distance between the developing rings at the two ends of the saccule is 1 cm-3 cm.
In a preferred embodiment, the developing mark is made of platinum-iridium alloy, so that the developing mark has better X-ray impermeability than 302 stainless steel, can be seen clearly, is positioned more accurately, and realizes a high-brightness developing effect.
In a preferred embodiment, the material of the first tube (double lumen tube) is Pebax7233, compared with PVC material, Pebax7233 has both hardness and elasticity requirements, and perfect balance between hardness and elasticity of the double lumen tube is achieved, so that better maneuverability can be achieved, and the HVPG balloon catheter can reach a target position easily.
In one embodiment, a connection side hole is formed in the proximal end of the first tube, and the second tube and the tee piece are bonded at the connection side hole of the first tube through an adhesive.
The manufacturing method of the HVPG balloon catheter comprises the following steps:
the first connecting piece is bonded with the first pipe body through an adhesive; the second connecting piece is bonded with the second pipe body through an adhesive; the two operations are not in sequence;
a connection side hole is formed in the near end of the first tube body, and the second tube body and the three-way piece are bonded at the connection side hole of the first tube body through an adhesive;
the far end of the first tube body is provided with a communicating side hole, two ends of the communicating side hole of the first tube body are pressed and held by developing mark pressing and holding equipment, the pressing and holding distance of the two developing marks is 1 cm-3 cm, a balloon tube is sleeved outside the communicating side hole of the first tube body, and after the balloon tube is axially stretched by 1.5-3 times, two ends of the balloon tube are fixed by using a heat-shrinkable tube;
two use LCP silk winding in development mark department the sacculus pipe uses the adhesive to fix after twining the LCP silk cuts off the unnecessary sacculus pipe part in both ends, is in at last the head end of body one is beaten the side opening.
In some embodiments, the adhesive is 1-CN011 glue.
In some embodiments, the balloon tube is a TPU balloon tube. The developing mark pressing and holding device is a developing ring pressing and holding machine.
The manufacturing method of the HVPG balloon catheter comprises the following steps:
the first connecting piece is bonded with the first pipe body through an adhesive; the second connecting piece is bonded with the second pipe body through an adhesive; the two operations are not in sequence;
a connection side hole is formed in the near end of the first tube body, and the second tube body and the three-way piece are bonded at the connection side hole of the first tube body through an adhesive;
a communicating side hole is formed in the far end of the tube body I, a balloon tube is sleeved outside the communicating side hole of the tube body I, and after the balloon tube is axially stretched by 1.5-3 times, two ends of the balloon tube are fixed by using a heat-shrinkable tube; two ends of the balloon tube are pressed and held by a developing mark pressing and holding device, the pressing and holding distance between the two developing marks is 1 cm-3 cm, the developing marks are fixed by using an adhesive, redundant balloon tube parts at two ends are cut off, and finally the head end of the tube body I is provided with the side hole.
In some embodiments, the adhesive is loctite 3311 glue.
In some embodiments, the balloon tube is a silicone balloon tube.
The manufacturing method of the HVPG balloon catheter comprises the following steps:
the first connecting piece is bonded with the first pipe body through an adhesive; the second connecting piece is bonded with the second pipe body through an adhesive; the two operations are not in sequence;
a connection side hole is formed in the near end of the first tube body, and the second tube body and the three-way piece are bonded at the connection side hole of the first tube body through an adhesive;
a communication side hole is formed in the far end of the first tube body, and two developing marks are fixed at two ends of the communication side hole by developing mark pressing and holding equipment or adhesives; the sacculus pipe is established to the peripheral cover outside the intercommunication side opening of body one, axial stretch sacculus pipe 1.5 ~ 3 times after, use the pyrocondensation pipe fixed the both ends of sacculus pipe use the tungsten filament winding in two development ring departments the sacculus pipe uses the adhesive to fix after the winding is good the tungsten filament cuts off the unnecessary sacculus pipe part in both ends, is in at last the head end of body one is beaten the side opening.
In some embodiments, the adhesive is loctite 4011 glue.
In some embodiments, the balloon tube is a latex balloon tube.
Compared with the prior art, the invention has the following beneficial effects:
1. according to the HVPG balloon catheter and the manufacturing method thereof, the plurality of side holes (preferably two side holes) are formed in the head end of the first pipe fitting, so that the physiological saline is uniformly distributed, the feedback result is more objective and accurate, and the more accurate monitoring result can be obtained;
2. according to the HVPG balloon catheter and the manufacturing method thereof, a doctor can be helped to better position the HVPG balloon catheter under X-rays by arranging a plurality of developing marks (preferably platinum-iridium alloy developing rings);
3. according to the HVPG balloon catheter and the manufacturing method thereof, the material of the first pipe fitting is selected, and Pebax7233 is more preferable, so that the perfect balance of hardness and elasticity is realized, and the HVPG balloon catheter can better pass through a tortuous blood vessel and reach a lesion part.
Of course, it is not necessary for any product in which the invention is practiced to achieve all of the above-described advantages at the same time.
Drawings
FIG. 1 is a diagram of a balloon catheter product according to an embodiment of the invention;
fig. 2 is a schematic view of a balloon catheter for HVPG monitoring according to an embodiment of the invention.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art. The invention is further described below with reference to specific embodiments.
Example 1
Referring to fig. 1, the HVPG balloon catheter of this embodiment mainly consists of a connector, a tube, a tee, a visualization mark, and a balloon, and the head end of the HVPG balloon catheter has a side hole (see fig. 1). In particular, the amount of the solvent to be used,
an HVPG balloon catheter product comprising: a first connecting piece 11, a second connecting piece 12, a first tube body 13, a second tube body 14, a three-way piece 15, a developing mark 16, a balloon 17 and a side hole 18, wherein,
the near end of the first pipe body 13 is provided with a first connecting piece 11;
the near end of the second pipe body 14 is provided with a second connecting piece 12, and the far end of the second pipe body 14 is connected and communicated with the near end side wall of the first pipe body 13 through a tee piece 15; wherein,
the side wall of the far end of the first pipe body 13 is sleeved with a saccule 17, and the saccule 17 is communicated with the first pipe body 13;
the positions of the first tube body 13 at the two ends of the saccule 17 are respectively provided with a developing mark 16;
a plurality of side holes 18 are radially arranged at the head end of the first pipe body 13.
In particular, the amount of the solvent to be used,
(1) the materials of the first connecting piece 11 and the second connecting piece 12 are mainly selected from high polymer materials such as PCTG, PA, PC, PVC and the like;
(2) the first pipe body 13 is a double-cavity pipe and is made of polymer materials such as PEBA, PU, PVC and the like;
(3) the second pipe body 14 is a single-cavity pipe and is made of polymer materials such as PEBA, PU, PVC and the like;
(4) the material of the tee piece 15 is mainly selected from high polymer materials such as PEBA, PU, PVC and the like;
(5) the material of the development mark 16 is mainly selected from a platinum-iridium alloy, a platinum-tungsten alloy, platinum, tungsten and other X radiopaque metal materials;
(6) the balloon 17 is a compliance balloon, and the main material is selected from one or more of TPU, silica gel, latex and other high polymer materials;
(7) the head end of the first pipe body 13 is provided with a plurality of side holes 18 along the radial direction, in fig. 1, two side holes 18 are arranged, and the two side holes 18 are uniformly arranged along the radial direction.
In the present embodiment, it is preferred that,
the material of the first tube body 13 is Pebax7233, so that the perfect balance of hardness and elasticity of the double-lumen tube can be achieved, and the HVPG balloon catheter can better pass through a tortuous blood vessel and reach a lesion part;
the development mark 16 is a platinum-iridium alloy development ring. The far-end developing material adopts platinum-iridium alloy, has better X-ray impermeability than 302 stainless steel, and can be seen more clearly and positioned more accurately.
In addition, the HVPG balloon catheter of this embodiment is favorable to normal saline evenly distributed at the side hole 18 that the head end of body 13 set up, and then makes the result of feedback more objective accurate.
Referring to fig. 2, the HVPG balloon catheter of the present embodiment measures HVPG (hepatic venous pressure gradient) on the principle: a pressure extension tube on a disposable invasive pressure sensor (a pressure sensor in the figure) is connected with an HVPG sacculus catheter, an interface cable joint of the pressure sensor is connected with an invasive pressure meter, and a pressure extension tube at the other end is connected with anticoagulation saline. By injecting anticoagulated saline into the HVPG balloon catheter, the anticoagulated saline is taken as a medium, and a pressure signal is transmitted to a sensor without distortion and is finally displayed by an invasive pressure gauge.
The method of monitoring using the HVPG balloon catheter of this example was as follows:
(1) preparation before pressure measurement
The pressure sensor is connected with an invasive pressure measuring instrument, air in the connecting pipe is fully exhausted by anticoagulated saline, the transducer and the connecting tee joint thereof are fixed at the level of the right atrium (the level of the axillary midline) of a person to be measured, and the rotating tee joint is communicated with the atmosphere to perform zero calibration. For those without a tee at the side of the transducer, the tail end of the catheter can be fixed at the right atrium level for zero calibration at the same time, and the position is kept from moving in the whole pressure measurement process; if the movement occurs, the zero calibration is required again. The integrity of the compliant balloon catheter used for manometry was checked.
(2) Puncture procedure
The right internal jugular vein is typically selected for puncture via the internal jugular vein, subclavian vein, elbow vein or femoral vein. Sterilizing by a conventional method, laying an aseptic hole towel, performing local anesthesia, successfully puncturing, then placing a catheter sheath, and introducing the catheter into the inferior vena cava through the right atrium by using a guide wire. Introducing a contrast catheter (such as a multifunctional catheter, a single-bend catheter or a Cobra catheter) into a hepatic vein, firstly carrying out hepatic vein contrast examination, confirming that the vein is unobstructed and has no stenosis, and no obvious vein-vein collateral shunt is seen at the periphery, and selecting the hepatic vein as a pressure measuring blood vessel (otherwise, other hepatic veins must be replaced). And introducing the guide wire, withdrawing the catheter and introducing the balloon catheter to the hepatic vein inlet through the guide wire. And withdrawing the guide wire, injecting anticoagulant saline after blood is pumped back to drain the blood and the contrast agent in the balloon catheter, connecting the balloon catheter and the pressure converter connecting pipe, and paying attention to avoid generating bubbles.
(3) Measuring FHVP
Selecting the balloon catheter to a hepatic vein under fluoroscopy, waiting for at least 20s (the time for a part of patients to reach stable reading is longer) at a position 2-4 cm away from a inferior vena cava, and reading FHVP after the displayed pressure value is stable.
(4) Measurement of WHVP
The balloon is inflated with contrast or air to block sufficiently hepatic venous flow (fig. 2), waiting at least 40s, and after the indicated pressure value stabilizes, the WHVP is read. Keeping the balloon in an expanded state, ordering the patient to hold his breath, slowly injecting 5mL of contrast agent through the balloon catheter for hepatic vein angiography examination, and confirming that no contrast agent flows backwards or vein-vein collateral flow is shunted.
(5) Repeated measurement of FHVP
And (5) pumping out the contrast agent or air in the saccule, repeating the step (3), and measuring FHVP for the 2 nd time. The difference between the two FHVP measurements should not exceed 1mmHg, otherwise, the 3 rd measurement should be performed, and the two measurements with the difference within 1mmHg among the 3 results should be taken.
(6) Repeated measurement of WHVP
And (5) repeating the step (4) and measuring the 2 nd WHVP. The difference between the two WHVP measurements should not exceed 2mmHg, otherwise the 3 rd measurement should be performed, and the two measurements with the difference within 1mmHg among the 3 results should be taken.
(7) Computing HVPG
The HVPG should be averaged over the two measurements, calculated according to the formula HVPG ═ WHVP-FHVP.
Before the balloon 17 of the HVPG balloon catheter of this embodiment is inflated, anticoagulant saline is injected into the interface of the first connecting member 11, and the side hole 18 measures the hepatic vein free pressure (FHVP); after the balloon 17 is filled, anticoagulant saline is injected into the interface of the first connecting piece 11, hepatic vein wedging pressure (WHVP) is measured at the side hole 18, and Hepatic Vein Pressure Gradient (HVPG) is obtained by subtracting hepatic vein free pressure (FHVP) from hepatic vein wedging pressure (WHVP).
Example 2
Referring to fig. 1, the present embodiment provides a method for manufacturing an HVPG balloon catheter as follows:
the first connecting piece 11 is bonded with the first pipe body 13 through 1-CN011 glue; the second connecting piece 12 is bonded with the second pipe body 14 through 1-CN011 glue;
the near end of the first pipe body 13 is provided with a side hole for connecting the second pipe body 14 with the three-way piece 15, and the second pipe body 14 and the three-way piece 15 are bonded at the side hole at the near end of the first pipe body 13 through 1-CN011 glue;
the far end of the first tube body 13 is further provided with a side hole for communicating the balloon 17, two ends of the side hole at the far end of the first tube body 13 are pressed and held by two platinum-iridium alloy developing rings through a developing ring pressing and holding machine, the pressing and holding distance of the developing rings is 1 cm-3 cm, the position of the side hole at the far end of the first tube body 13 is sleeved with a TPU balloon tube, the two ends of the TPU balloon tube are fixed by using a heat shrink tube after the TPU balloon tube is axially stretched by 1.5-3 times, LCP wires are wound on the TPU balloon tube at the two developing rings, the LCP wires are fixed by using 1-CN011 glue after the TPU balloon tube is wound, redundant TPU balloon tube parts at the two ends are cut off, and finally two side holes 18 are drilled at.
Example 3
This example provides another method of making an HVPG balloon catheter as follows:
the first connecting piece 11 is bonded with the first pipe body 13 through the loctite 3311 glue; the second connecting piece 12 is bonded with the second pipe body 14 through the loctite 3311 glue;
the near end of the first pipe body 13 is provided with a side hole for connecting the second pipe body 14 with the three-way piece 15, and the second pipe body 14 and the three-way piece 15 are bonded at the side hole at the near end of the first pipe body 13 through le Tai 3311 glue;
the far end of the first tube body 13 is further provided with a side hole for communicating the balloon 17, a silica gel balloon tube is sleeved at the side hole at the far end of the first tube body 13, after the silica gel balloon tube is axially stretched by 1.5-3 times, two ends of the silica gel balloon tube are fixed by using a heat-shrinkable tube, two platinum-iridium alloy developing rings are pressed and held by a developing ring pressing and holding machine, the pressing and holding distance of the developing rings is 1-3 cm, the platinum-iridium alloy developing rings are fixed by using Tai 3311 glue, redundant parts of the silica gel balloon tube at two ends are cut off, and finally, two side holes 18 are drilled at the head end of the first tube body 13.
Example 4
This example provides yet another method of making an HVPG balloon catheter as follows:
the first connecting piece 11 is bonded with the first pipe body 13 through the Lontai 4011 glue; the second connecting piece 12 is bonded with the second pipe body 14 through the Letai 4011 glue;
the near end of the first pipe body 13 is provided with a side hole for connecting the second pipe body 14 with the three-way piece 15, and the second pipe body 14 and the three-way piece 15 are bonded at the side hole at the near end of the first pipe body 13 through the lotai 4011 glue;
the far end of the first pipe body 13 is further provided with a side hole for communicating the balloon 17, two developing rings are fixed at two ends of the side hole by using a developing ring holding press or glue, the latex balloon tube is sleeved at the side hole at the far end of the first pipe body 13, after the latex balloon tube is axially stretched by 1.5-3 times, two ends of the latex balloon tube are fixed by using a heat-shrinkable tube, the latex balloon tube is wound by using tungsten wires at the two developing rings, the tungsten wires are fixed by using Letai 4011 glue after winding, redundant latex balloon tube parts at two ends are cut off, and finally two side holes 18 are drilled at the end of the first pipe body 13.
When the balloon catheter is used for HVPG test, a more accurate monitoring result can be obtained, a doctor can be helped to better position the balloon catheter under X-rays, and the balloon catheter can better reach a lesion part through a tortuous blood vessel.
In particular, the HVPG balloon catheter is structurally arranged, so that the measured hepatic vein free pressure (FHVP) is measured when the balloon is decompressed, the measurement result is more accurate, and the clinical requirement is better met. Other measurement methods and devices in the prior art measure the Free Hepatic Vein Pressure (FHVP) when the balloon is inflated, which is distal to the measurement point, but still affects the change in blood flow, resulting in inaccurate measurement results.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention. The invention is limited only by the claims and their full scope and equivalents.
Claims (16)
1. An HVPG balloon catheter, comprising:
the first tube body is a double-cavity tube and is made of one or more materials selected from PCTG, PA, PC and PVC, and a first connecting piece is arranged at the proximal end of the first tube body;
the second tube body is a single-cavity tube and is made of one or more materials selected from PCTG, PA, PC and PVC, a second connecting piece is arranged at the proximal end of the second tube body, and the distal end of the second tube body is connected and communicated with the proximal side wall of the first tube body through a three-way piece; wherein,
the far-end side wall of the first pipe body is sleeved with a balloon, and the balloon is communicated with the first pipe body;
developing marks are respectively arranged at the positions of the first tube body at the two ends of the balloon;
and a plurality of side holes are formed in the head end of the first pipe body in the radial direction.
2. The HVPG balloon catheter of claim 1, wherein the side holes of the head end of the first tube are two and are uniformly disposed along the circumference of the first tube.
3. The HVPG balloon catheter of claim 1, wherein the material of the first connecting piece and the second connecting piece is selected from one or more of PCTG, PA, PC, PVC.
4. The HVPG balloon catheter of claim 1, wherein the tee is made of a material selected from one or more of PEBA, PU, PVC.
5. The HVPG balloon catheter of claim 1, wherein, the balloon is a compliant balloon, and the material is selected from one or more of TPU, silica gel, and latex.
6. The HVPG balloon catheter of claim 1, wherein the material of the visualization marker is an X radiopaque metallic material selected from one or more of platinum iridium alloy, platinum tungsten alloy, platinum gold, and tungsten.
7. The HVPG balloon catheter of claim 1, wherein the visualization mark is a visualization ring.
8. The HVPG balloon catheter of claim 7, wherein the distance between the visualization rings at both ends of the balloon is 1cm to 3 cm.
9. The HVPG balloon catheter of claim 1, wherein the material of the first tube is Pebax 7233.
10. The HVPG balloon catheter of claim 1, wherein the proximal end of the first tube defines a connection side hole, and the second tube and the tee are bonded at the connection side hole of the first tube by an adhesive.
11. A method for making an HVPG balloon catheter according to any of claims 1-10, characterized by comprising the steps of:
the first connecting piece is bonded with the first pipe body through an adhesive; the second connecting piece is bonded with the second pipe body through an adhesive; the two operations are not in sequence;
a connection side hole is formed in the near end of the first tube body, and the second tube body and the three-way piece are bonded at the connection side hole of the first tube body through an adhesive;
the far end of the first tube body is provided with a communicating side hole, two ends of the communicating side hole of the first tube body are pressed and held by developing mark pressing and holding equipment, the pressing and holding distance of the two developing marks is 1 cm-3 cm, a balloon tube is sleeved outside the communicating side hole of the first tube body, and after the balloon tube is axially stretched by 1.5-3 times, two ends of the balloon tube are fixed by using a heat-shrinkable tube;
two use LCP silk winding in development mark department the sacculus pipe uses the adhesive to fix after twining the LCP silk cuts off the unnecessary sacculus pipe part in both ends, is in at last the head end of body one is beaten the side opening.
12. The method of making an HVPG balloon catheter of claim 11, wherein the adhesive is 1-CN011 glue.
13. A method for making an HVPG balloon catheter according to any of claims 1-10, characterized by comprising the steps of:
the first connecting piece is bonded with the first pipe body through an adhesive; the second connecting piece is bonded with the second pipe body through an adhesive; the two operations are not in sequence;
a connection side hole is formed in the near end of the first tube body, and the second tube body and the three-way piece are bonded at the connection side hole of the first tube body through an adhesive;
a communicating side hole is formed in the far end of the tube body I, a balloon tube is sleeved outside the communicating side hole of the tube body I, and after the balloon tube is axially stretched by 1.5-3 times, two ends of the balloon tube are fixed by using a heat-shrinkable tube; two ends of the balloon tube are pressed and held by a developing mark pressing and holding device, the pressing and holding distance between the two developing marks is 1 cm-3 cm, the developing marks are fixed by using an adhesive, redundant balloon tube parts at two ends are cut off, and finally the head end of the tube body I is provided with the side hole.
14. The method of making an HVPG balloon catheter according to claim 13, wherein the adhesive is loctite 3311 glue.
15. A method for making an HVPG balloon catheter according to any of claims 1-10, characterized by comprising the steps of:
the first connecting piece is bonded with the first pipe body through an adhesive; the second connecting piece is bonded with the second pipe body through an adhesive; the two operations are not in sequence;
a connection side hole is formed in the near end of the first tube body, and the second tube body and the three-way piece are bonded at the connection side hole of the first tube body through an adhesive;
a communication side hole is formed in the far end of the first tube body, and two developing marks are fixed at two ends of the communication side hole by developing mark pressing and holding equipment or adhesives; the sacculus pipe is established to the peripheral cover outside the intercommunication side opening of body one, axial stretch sacculus pipe 1.5 ~ 3 times after, use the pyrocondensation pipe fixed the both ends of sacculus pipe use the tungsten filament winding in two development ring departments the sacculus pipe uses the adhesive to fix after the winding is good the tungsten filament cuts off the unnecessary sacculus pipe part in both ends, is in at last the head end of body one is beaten the side opening.
16. The method of making an HVPG balloon catheter according to claim 15, wherein the adhesive is loctite 4011 glue.
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| CN201910676535.3A CN110270004A (en) | 2019-07-25 | 2019-07-25 | HVPG foley's tube and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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