CN105852833B - Intravascular pressure measures conduit - Google Patents

Intravascular pressure measures conduit Download PDF

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Publication number
CN105852833B
CN105852833B CN201610236055.1A CN201610236055A CN105852833B CN 105852833 B CN105852833 B CN 105852833B CN 201610236055 A CN201610236055 A CN 201610236055A CN 105852833 B CN105852833 B CN 105852833B
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conduit
pressure
pressure sensor
intravascular
distal cannula
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CN105852833A (en
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宋亮
陈丽丽
郑加祥
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Insight Lifetech Co Ltd
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Shenzhen Insight Lifetech Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/0215Measuring pressure in heart or blood vessels by means inserted into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007Evaluating blood vessel condition, e.g. elasticity, compliance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852Catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876Blood vessel

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Physiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

The invention provides a kind of intravascular pressure measurement conduit, it includes:Distal cannula, it has the guidewire lumen slideably received within single medical guiding wire;Proximal part, it couples with distal cannula;And pressure sensor, it is arranged in proximal part, for measuring endovascular blood pressure and producing blood pressure signal, proximal part has the signal path for transmitting the blood pressure signal from pressure sensor and the connecting conduit for supporting signal path and mobile distal cannula, and pressure sensor is near distal cannula.In intravascular pressure measurement conduit involved in the present invention, can allow doctor that the measurement of intravascular pressure is completed under familiar operating environment, reduce time of measuring, the convenience and operability that reduce operational risk, intravascular pressure measurement is substantially improved.

Description

Intravascular pressure measures conduit
Technical field
The present invention relates to a kind of intravascular pressure measurement conduit.
Background technology
In many cardiovascular diseases such as coronary heart disease, narrow (for example being caused by vascular plaque) of blood vessel can influence blood Normal supply, when blood vessel even causes blocking by further stricturization, then by serious change such as myocardial infarction may be caused. Percutaneous coronary intervention (pci) (PCI) is current relatively effective treatment means.Tradition judges whether to implement PCI (example As angioplasty or support are placed) method be stenosis that doctor estimates coronary artery blood vessel by coronary angiography.However, This traditional determination methods can not well help doctor to make very accurate judgement, and it is possible to can cause doctor Over-treatment.
In recent years, in order to more accurately judge whether patient really needs to implement PCI, assessment stenotic lesion is used The blood flow reserve fraction (Fractional Flow Reverse, abbreviation FFR) that obstruction blood flows through the degree of blood vessel is increasingly obtained To application and popularization.FFR is defined as the ratio of the maximum blood flow and normal maximum blood flow in artery stenosis.In order to calculate Ink vessel transfusing The FFR of given narrow (being possible to place the position of intravascular stent), it is necessary to measure and gather narrow distal side (example respectively Such as, narrow downstream, away from sustainer) and narrow proximal lateral (such as narrow upstream, near sustainer) blood pressure readings. Clinical research shows that narrowness is higher, and FFR values are lower, and whether FFR values can be as useful less than assessed value (such as 0.8) Criterion, be may decide that to whether such patient implements PCI based on standard doctor.The criterion has Effect property has also obtained the confirmation of American-European multiple large-scale clinical study results (such as FAME clinical researches).
At present, as the method for blood pressure in measurement patient's blood vessel, for example, have and use the method for pressure-sensing seal wire.This pressure Power sensing seal wire is internally provided with pressure sensor in seal wire.Before calcification score is carried out, by pressure-sensing seal wire by narrow Narrow distal side and proximal lateral, records distal end blood pressure and near-end blood pressure respectively.Thus, it is possible to calculate narrow FFR values.
The content of the invention
However, for existing pressure-sensing seal wire, due to being required to that pressure sensor is set inside seal wire, therefore The conventional medical guiding wire (such as placing the medical guiding wires such as foley's tube or scaffold tube) that its performance is used with doctor has Notable difference, such usual hardness of pressure-sensing seal wire is bigger, and operation controllability has also declined, for complex lesions region very May not easily pass through.Therefore, doctor is to complex lesions region when intravascular pressure measurement and PCI is carried out, according to seal wire The difference of function, generally requires to change different seal wires, and changing seal wire can increase the complexity and risk of operation.
In addition, for many doctors, in PCI, having get used to using some specific dimensions, having possessed good The seal wire of good pliability and torsion control property etc..Therefore, allowing doctor to reuse other kinds of seal wire carries out PCI, and also having can Can increase time and the difficulty of PCI (seal wire is for example navigated into stenotic lesion).
The present invention is completed in view of the situation of above-mentioned prior art, and its object is to provide one kind the doctor can be easy to make Intravascular pressure suitable for PCI measures conduit.
Therefore, the invention provides a kind of intravascular pressure measurement conduit, it includes:Distal cannula, it has slidably Ground receives the guidewire lumen of single medical guiding wire;Proximal part, it couples with the distal cannula;And pressure sensor, It is arranged in the proximal part, and for measuring endovascular blood pressure and producing blood pressure signal, the proximal part has to be used In the signal path of the blood pressure signal of the transmission from the pressure sensor and for supporting the signal path and moving The connecting conduit of the distal cannula is moved, the pressure sensor is near the distal cannula.
In intravascular pressure measurement conduit involved in the present invention, only distal cannula is limited by medical guiding wire, therefore, doctor Life can rapidly change intravascular pressure measurement conduit, and can the compatible conventional medical guiding wire that doctor uses at present, from And doctor can be allowed to complete the measurement of intravascular pressure under familiar operating environment, reduce time of measuring, reduce operational risk, The convenience and operability of intravascular pressure measurement is substantially improved.Further, since pressure sensor is arranged on into proximal part It is interior, therefore blood pressure measurement conduit cross-sectional area in intravascular can be reduced, so as to reduce the obstruction effect to endovascular blood flow Should, the certainty of measurement thus, it is possible to improve the pressure sensor involved by present embodiment.Further, since pressure sensor is set In proximal part, therefore pressure sensor can also be reduced with intravascular pressure measurement catheter main body (mainly proximal part) The difficulty of the manufacturing process of engagement.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the distal cannula is near with described End lease making is coupled by outer tube.Distal cannula and proximal part are realized coupling thereby, it is possible to pass through outer tube.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the pressure sensor is arranged on The end of the close described distal cannula of the proximal part.In this case, due to setting more to lean on pressure sensor The nearly distal cannula limited by medical guiding wire, therefore, it is possible to the position location of more easily control pressure sensor.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the guidewire lumen is slideably Receive the medical guiding wire with external diameter about 0.2mm to 1mm.Thereby, it is possible to improve intravascular pressure measurement involved in the present invention The applicability of conduit.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the guidewire lumen includes tubular Inner chamber and extend to the outer tube and through the bending inner chamber of the side of the outer tube from the tubular inner chamber.This In the case of, can make medical guiding wire more easily in intravasation pressure measurement conduits guidewire lumen, be conducive to medical leading Movement of the silk in guidewire lumen.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the distal cannula have along The perforate of the length direction of the distal cannula, the perforate allows blood flow to flow into the guidewire lumen.Thereby, it is possible to reduce blood Overpressure measures the use resistance of conduit.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the connection sleeve pipe has to be allowed The pressure sensor measures the opening of blood pressure.Endovascular blood flow is entered thereby, it is possible to facilitate intravascular pressure to measure conduit Row pressure measxurement.
In addition, in intravascular pressure measurement conduit involved in the present invention, alternatively, the signal path is at least part of Be contained in the connecting conduit.Thereby, it is possible to provide protection structure for signal path.
Additionally, in intravascular pressure measurement conduit involved in the present invention, alternatively, in the attached of the pressure sensor Closely, it is additionally provided with the ring-shaped sleeve worked as positioning mark.Thus, by the ring-shaped sleeve as positioning mark, can Efficiently locate the pressure sensor that pressure intravascular pressure measures conduit.
In accordance with the invention it is possible to reduce blood pressure measurement conduit cross-sectional area in intravascular, so as to reduce to endovascular The blocking effect of blood flow, the certainty of measurement thus, it is possible to improve pressure sensor.Further, since pressure sensor is arranged on near-end In part, therefore can also reduce what pressure sensor was engaged with intravascular pressure measurement catheter main body (mainly proximal part) The difficulty of manufacturing process.
Brief description of the drawings
The intravascular pressure that Fig. 1 is showed involved by embodiments of the present invention measures the three-dimensional structure diagram of conduit.
The intravascular pressure measurement conduit that Fig. 2 shows involved by embodiments of the present invention slips over showing for medical guiding wire It is intended to.
The intravascular pressure measurement conduit that Fig. 3 shows involved by embodiments of the present invention is being situated between in patient body The schematic diagram for entering.
The intravascular pressure that Fig. 4 is showed shown in Fig. 1 measures the schematic section of conduit.
Fig. 5 shows the pressure sensor in the intravascular pressure measurement conduit involved by embodiments of the present invention Partial enlarged drawing.
Fig. 6 is that the intravascular pressure involved by embodiments of the present invention measures conduit schematic cross-section in intravascular.
Fig. 7 is section of the intravascular pressure measurement conduit involved by embodiments of the present invention along length of vessel direction Schematic diagram.
Fig. 8 is showed and is used the application method of the intravascular pressure measurement conduit involved by embodiments of the present invention Flow chart.
Symbol description:
1 ... intravascular pressure measures conduit (blood pressure measurement conduit), 2 ... medical guiding wires, 10 ... distal cannulas, 12 ... seal wires Inner chamber, 20 ... proximal parts, 21 ... openings, 22 ... signal paths, 24 ... connecting conduits, 30 ... outer tubes, 40 ... pressure sensors, 50 ... ring-shaped sleeves, 100 ... blood vessels.
Specific embodiment
Hereinafter, refer to the attached drawing, explains the preferred embodiment of the present invention.In the following description, for identical Part assign identical symbol, the repetitive description thereof will be omitted.In addition, accompanying drawing is schematical figure, part chi each other Very little ratio or the shape of part etc. can be with actual differences.
Fig. 1 shows that the intravascular pressure of implementation method involved in the present invention measures the three-dimensional structure diagram of conduit.Fig. 2 is Show that the measurement conduit of the intravascular pressure involved by embodiments of the present invention slips over the schematic diagram of medical guiding wire.Fig. 3 is to show Go out the intravascular pressure involved by embodiments of the present invention and measure conduit 1 in the schematic diagram intervened in patient body. In Fig. 1 to Fig. 3, represent for convenience, the Local map of intravascular pressure measurement conduit 1 and medical guiding wire is illustrate only here, but This is not configured to for intravascular pressure to measure conduit 1 and medical guiding wire 2 is limited to only such length.In addition, in Fig. 2 and Tu In 3, arrow A represents the direction that intravascular pressure measurement conduit 1 is moved in intravascular along medical guiding wire 2.
As shown in figure 1, intravascular pressure measures conduit (hreinafter referred to as " blood pressure measurement conduit ") 1 includes distal cannula 10 and the proximal part 20 that couples with distal cannula 10.In the present embodiment, distal cannula 10 and proximal part 20 can be through Coupled by outer tube 30.Although in addition, showing distal cannula 10 with proximal part 20 via outer tube 30 in the present embodiment Connection, but present embodiment not limited to this.For example, distal cannula 10 can also by welding directly with proximal part 20 Connect, it is also possible to which distal cannula 10 and proximal part 20 is integrally formed and form draw bail.
As shown in Fig. 2 in the blood pressure measurement conduit 1 involved by present embodiment, distal cannula 10 has guidewire lumen 12.The structure with insertion on the length direction of blood pressure measurement conduit 1 of guidewire lumen 12.In the present embodiment, in seal wire Chamber 12 is slideably received within single medical guiding wire 2.That is, medical guiding wire 2 is separated with the distal cannula 10 of blood pressure measurement conduit 1 And independent seal wire in addition, medical guiding wire 2 can pass through guidewire lumen 12.So, by the distal cannula of blood pressure measurement conduit 1 10 through on medical guiding wire 2 when, blood pressure measurement conduit 1 can be relatively moved along medical guiding wire 2.
As shown in figure 3, doctor etc. to patient during PCI is carried out, receive medical by making distal cannula 10 Seal wire 2 is simultaneously slided along medical guiding wire 2 toward the direction of arrow A, makes distal cannula 10 and the near-end coupled with distal cannula 10 Part 20 (mainly including the part of pressure sensor 40 (referring to Fig. 4)) can be sent to (such as vein, dynamic in patient body Arteries and veins) precalculated position.Thereby, it is possible to carry out blood pressure measurement to obtain the blood of the position to the precalculated position (such as lesions position) The reading of stream deposit fraction (FFR), for follow-up PCI provides reference.
Proximal part 20 is with for transmitting the signal path 22 of the blood pressure signal from pressure sensor 40 and being used for The connecting conduit 24 (referring to Fig. 4) of support signal path 22 and mobile distal cannula 10.In the present embodiment, proximal part 20 The constituent material of connecting conduit 24 be not particularly limited, hardness material higher is preferably used, to ensure that doctor controls in intervention Distal cannula 10 can be enable to relatively move and be advanced to along medical guiding wire 2 by the effect of proximal part 20 during treatment In patient's blood vessel, and then pressure sensor 40 is positioned to stenotic lesion.
Here, proximal part 20 is generally harder than distal cannula 10 and with more rigidity, will pass through proximal part 20 Effect can preferably move and advance distal cannula 10.In the present embodiment, the connecting conduit 24 of proximal part 20 can Constituted with by medical stainless steel.In addition, proximal part 20 can also be by the other materials such as structure such as Nitinol, nylon, plastics Into.In addition, representing for convenience, do not showed that in accompanying drawing positioned at the external near-end being connected with external equipment (not shown) of patient The part of part 20.This segment proximal part 20 typically can be as the part of the operation blood pressure measurement such as doctor conduit 1, by behaviour Make the part, the blood vessel further to blood vessel depths propulsion in patient body or from the patient of blood pressure measurement conduit 1 can be made Exit.
In the present embodiment, blood pressure measurement conduit 1 also includes pressure sensor 40.Pressure sensor 40 can be used for surveying Measure endovascular blood pressure and produce blood pressure signal.Pressure sensor 40 can be arranged in proximal part 20.Due to pressure sensing Device 40 is arranged in proximal part 20, therefore, pressure sensor 40 can obtain the protection of proximal part 20, and can with it is near End part 20 forms more firm structure.
In addition, pressure sensor 40 can be fixed in the connecting conduit 24 of proximal part 20.In the present embodiment, press The mode that force snesor 40 is fixed in the connecting conduit 24 of proximal part 20 is not particularly limited, and for example pressure sensor 40 can To be fixed on the connecting conduit 24 of proximal part 20 by modes such as bonding, welding, welding.
In certain embodiments, pressure sensor 40 can with the physical connection of signal path 22 and electrically connect, passed by pressure Blood pressure signal produced by sensor 40 is sent to for example external processing equipment (not shown) via signal path 22.
In addition, in the intravascular pressure measurement conduit 1 of present embodiment, pressure sensor 40 can be arranged on close end Divide 20 end, and the end near distal cannula 10.In this case, due to pressure sensor 40 being closer to By the distal cannula 10 that medical guiding wire 2 is limited, therefore pressure sensor 40 can reach blood with the slip of distal cannula 10 Precalculated position in pipe, while being capable of the position location of more easily control pressure sensor 40.
In addition, in the present embodiment, pressure sensor 40 is arranged in proximal part 20, and near distal cannula 10. In other words, pressure sensor 40 is not arranged in distal cannula 10 (outside of distal cannula 10), and is provided in close end Divide in 20, and near distal cannula 10.In this case, pressure sensor 40 is arranged in proximal part 20, can be with Reduce blood pressure measurement 1 cross-sectional area in intravascular of conduit, so that reduce the blocking effect to endovascular blood flow, thus, it is possible to Improve the certainty of measurement of the pressure sensor 40 involved by present embodiment.
If in general, pressure sensor is arranged on distal cannula, then the cross section of pressure sensor itself Long-pending presence can cause pressure measurement conduits relative to the increase of the cross-sectional area of blood flow, therefore, such technical scheme can be led The reading of pressure sensor is caused to introduce more errors.And in the present invention, close end is arranged on by by pressure sensor 40 Divide in 20 connecting conduit 22, cross-sectional area of the pressure measurement conduits 1 relative to blood flow can be effectively reduced, so as to improve pressure The certainty of measurement of force snesor 40.Additionally, pressure sensor 40 is arranged in the connecting conduit 22 of proximal part 20, it is also possible to Reduce the difficulty of packaging technology between pressure sensor 40 and proximal part 20, improve production efficiency.
As described above, the value (referred to as " FFR values ") of blood flow reserve fraction (FFR) can be used for assessing stenotic lesion obstruction blood Liquid flows through the degree of blood vessel, is whether that doctor etc. provides the decision-making for carrying out PCI.In order to calculate given narrow FFR values, Need to measure respectively and gather narrow distal side (for example, narrow downstream, away from sustainer) and narrow proximal lateral (for example Narrow upstream, near sustainer) blood pressure readings.The blood pressure gradient of stenotic lesion reflects the instruction of narrow seriousness.It is narrow Narrow degree is more serious, and pressure drop is bigger, and FFR values are lower.
In the present embodiment, the signal path 22 of proximal part 20 is communicated to and is for example processed positioned at the external equipment of patient The Medical Devices such as device, display, computer, monitor.Thus, via the signal path 22 of proximal part 20, can be by by pressing The blood pressure signal that force snesor 40 is produced is sent to the external Medical Devices of patient in time.In addition, signal path 22 can also set Put in connecting conduit 24, connecting conduit 24 is coated signal path 22 at least in part, i.e. signal path 22 is at least in part It is contained in connecting conduit 24.Thus, connecting conduit 24 can play support and protection signal path 22.In addition, in some realities Apply in example, signal path 22 can also be configured along the outer surface of proximal part 20.
In addition it is also possible to filler 23 is set between signal path 22 and connecting conduit 24, as shown in Figure 4.Thus, energy It is enough effectively to play support and protection signal path 22.In addition, filler 23 can be dielectric, signal is thereby may be ensured that Electric insulation between path 22 and connecting conduit 24.In the present embodiment, filler 23 is not particularly limited, for example can be with Use medical silica-gel etc..
The intravascular pressure that Fig. 4 is showed shown in Fig. 2 measures the schematic section of conduit.Fig. 5 shows the present invention Implementation method involved by intravascular pressure measurement conduit in pressure sensor partial enlarged drawing.
In the present embodiment, as shown in figure 4, pressure sensor 40 is arranged in proximal part 20.Specifically, pressure Sensor 40 is arranged in the connecting conduit 24 of proximal part 20.In addition, relative with pressure sensor 40 in connecting conduit 24 The position answered is provided with opening 21.Via the opening 21, pressure sensor 40 can be contacted directly with endovascular blood flow, thus Pressure sensor 40 can sense the blood pressure in patient's blood vessel, and produce blood pressure signal correspondingly.
Further, since pressure sensor 40 is arranged in the connecting conduit 24 of proximal part 20, therefore, pressure sensor 40 The protection of the connecting conduit 24 of proximal part 20 can be obtained, thus can also improve the structural stability of pressure sensor 40.
In addition, in the present embodiment, pressure sensor 40 can be capacitance pressure transducer, resistive pressure sensing Device, fibre optic compression sensor etc..In addition, pressure sensor 40 can also be MEMS pressure sensor.For example, pressure sensor 40 Measurement range be for about -50mm Hg to ﹢ 300mm Hg.According to the type of pressure sensor 40, signal path 22 can be conductive Medium such as electric lead.Additionally, in certain embodiments, signal path 22 can also be wireless communication line, infrared communication line Road, optical fiber telecommunications line or ultrasonic communication circuit.
In the present invention, blood pressure measurement conduit 1 and medical guiding wire 2 can enter respectively as single device or exit disease People's is internal.In this case, doctor can independently control blood pressure measurement conduit 1 and medical guiding wire 2.Surveyed by by blood pressure Amount conduit 1 and medical guiding wire 2 can make doctor more easily operate blood pressure measurement conduit 1 and medical as single device Seal wire 2.
In addition, the length of blood pressure measurement conduit 1 and medical guiding wire 2 is not particularly limited, from the viewpoint for being easy to PCI See, for example length is about 160cm to 220cm.In addition, the length of distal cannula 10 is it is not also specifically limited, for example can be about 0.5cm~20cm.In this case, the length due to distal cannula 10 much smaller than medical guiding wire 2, therefore, doctor is waited in profit When operating blood pressure measurement conduit 1 with medical guiding wire 2, the only a part of blood pressure measurement conduit 1 (mainly distal cannula 10) is through doctor With on seal wire 2, therefore, doctor etc. can rapidly change blood pressure measurement conduit 1 using medical guiding wire 2.
In general, during PCI, the operating personnel such as doctor certain position (example first from a patient As at femoral artery) guiding catheter (not shown) is advanced at the coronary artery of such as heart along blood vessel.Here, guiding catheter Diameter be slightly larger than blood pressure measurement conduit 1 and medical guiding wire 2 involved in the present invention.Then, for example, by injecting contrast agent pair The local location radiography, then, for example blood pressure measurement conduit 1 and medical guiding wire 2 are advanced to along the guiding catheter may hair The position of the smaller blood vessel of sick change.Specifically, doctor is medical through this by distal cannula 10 by blood pressure measurement conduit 1 (referring to Fig. 4) on seal wire 2 so that guidewire lumen 12 slips over medical guiding wire 2, and by operating (such as push away and/or draw) patient The connecting conduit 24 (or the operation device (not shown) being connected with connecting conduit 24) of outside proximal part 20 is remote to move End sleeve pipe 10 and proximal part 20, until the pressure sensor 40 being arranged in proximal part 20 is in predetermined position.
In the present embodiment, the size of guidewire lumen 12 is not particularly limited, for example, can receive and slip over about 0.2mm To the medical guiding wire of 1mm overall diameters.In addition, guidewire lumen 12 can also be received and slip over the specific criteria in PCI field The medical guiding wire of size.
As described above, it is necessary to be made by the connecting conduit for operating proximal part 20 24 in interventional procedure is carried out Distal cannula 10 is moved relative to medical guiding wire 2.When moving in intravascular or adjusting distal cannula 10 along medical guiding wire 2, Because the sectional area in intravascular of blood pressure measurement conduit 1 reduces, therefore, it is possible to the 1 pair of influence of measurement of measurement conduit that reduces blood pressure, Improve the certainty of measurement of pressure sensor 40.
In addition, the vicinity of the pressure sensor 40 in proximal part 20, can be provided with the annular casing as positioning mark Pipe 50.Ring-shaped sleeve 50 is included to the opaque material of X-ray.As the ring-shaped sleeve 50 of mark, can be positioned under X-ray The position in intravascular of pressure sensor 40.In the present embodiment, ring-shaped sleeve 50 can be arranged on the company of proximal part 20 The periphery of conduit 24 is connect, such as ring-shaped sleeve 50 can be bonded in the connecting conduit 24 of proximal part 20 for example, by welding etc. On.In certain embodiments, ring-shaped sleeve 50 can also turn into a part for connecting conduit 24.
In addition, in the present embodiment, due to being arranged on the ring-shaped sleeve 50 of pressure sensor 40 comprising impermeable to X-ray Bright material, therefore, when human body by X-ray when being irradiated, the radiopacit of ring-shaped sleeve 50 can be formed and for example become clear Region, by the bright areas, doctor etc. can quickly find corresponding positioning mark.Therefore, in the present embodiment, ring The positioning of the pressure sensor 40 that shape sleeve pipe 50 can also be arranged in proximal part 20 identifies to use.
Further, since pressure sensor 40 is set near the position of ring-shaped sleeve 50, therefore can be by ring-shaped sleeve 50 positioning mark action orients the approximate location of the pressure sensor 40 in proximal part 20.
As described above, in certain embodiments, outer tube 30 can couple distal cannula 10 and proximal part 20.In this feelings Under condition, the outer surface of the outer surface of outer tube 30 preferably with distal cannula 10 and proximal part 20 is continuous, it is possible thereby to make blood The outer surface of pressure measurement conduit 1 forms continuous surface, thus, it is possible to measurement conduit 1 resistance in intravascular that reduces blood pressure.Outward The material of pipe 30 can be polyester, polyamide, nylon, nylon elastomer, polyurethane, polyimides etc..In the present embodiment, Can by outer tube 30, using mode physically or chemically including sweat soldering, laser welding, medical bonding etc. mode by distal end Sleeve pipe 10 couples with proximal part 20.
In other embodiment, outer tube 30 can also turn into a part for the forming process of distal cannula 10.In this way, outer Pipe 30 essentially becomes a part for distal cannula 10.Then, by using modes such as welding by distal cannula 10 and close end Divide 20 closely connections.In addition, the guidewire lumen 12 of distal cannula 10 can melt shaping to be formed by heat.
In the present embodiment, it is also possible between the inner side of the outside of guidewire lumen 12 and outer tube 30 it is gel filled for example Medical silicone gels.
In addition, as shown in figure 4, in distal cannula 10, guidewire lumen 12 can include tubular inner chamber 122 and from tubular Chamber 122 extends to outer tube 30 and through the bending inner chamber 124 of the side of outer tube 30.Here, tubular inner chamber 122 and bending inner chamber 124 connections, therefore ensure that medical guiding wire 2 can enter guidewire lumen 12 or be exited from guidewire lumen 12.
In guidewire lumen 12, bending inner chamber 124 extends to the side of outer tube 30 from tubular inner chamber 122.Correspondingly, outer tube 30 It is formed with and the bending corresponding side opening in inner chamber 124.Specifically, the internal diameter axis of guidewire lumen 12 is from tubular inner chamber 122 Gradually changed to bending inner chamber 124, and bend the internal diameter axis and guidewire lumen 12 of the side of close outer tube 30 of inner chamber 124 The internal diameter axis of tubular inner chamber 122 produces deviation.
By this configuration of guidewire lumen 12, the guidewire lumen 12 that medical guiding wire 2 enters distal cannula 10 is can allow for, So as to be conducive to medical guiding wire 2 to be slided in guidewire lumen 12.In the present embodiment, as noted previously, as being surveyed using blood pressure When the FFR that amount conduit 1 carries out PCI is measured, blood pressure measurement conduit 1 only has distal portions 10 to be limited in medical guiding wire 2 Slide, therefore, doctor etc. can rapidly operate and change the blood pressure measurement conduit 1 involved by present embodiment, thus, it is possible to Improve the procedure efficiency of PCI.
For example, in the present embodiment, showing that guidewire lumen 12 includes tubular inner chamber 122 and continues from tubular inner chamber 122 To outer tube 30 and through the bending inner chamber 124 of the side of outer tube 30.But, guidewire lumen 12 can also only in the shape of distal cannula 10 Into through inner chamber, and without outer tube 30.Now, guidewire lumen 12 is only limited in distal cannula 10, does not extend to outer tube 30。
In the present embodiment, because distal cannula 10 and proximal part 20 are (mainly including the portion of pressure sensor 40 Point) moved along medical guiding wire 2 and be sent to the precalculated position in patient's blood vessel, therefore, doctor is waited in operation present embodiment During involved blood pressure measurement conduit 1 and need not reposition medical guiding wire 2.
Specifically, for example when the pressure sensor 40 on blood pressure measurement conduit 1, to be positioned in narrow distal end (such as narrow Narrow downstream) when, the blood pressure of narrow remote end side is measured first.Then, the position that can adjust medical guiding wire 2 (keeps The position of medical guiding wire 2), by movement (such as advance and/or retract) distal cannula 10 pressure sensor 40 can just arrived Up to narrow proximal lateral, thus, it is possible to read the blood pressure of narrow remote end and narrow width proximal in the case where medical guiding wire 2 is not moved Reading.Therefore, the blood pressure measurement conduit 1 involved by present embodiment can reduce the operation complexity of PCI and save hand The art time.
Fig. 6 is that the intravascular pressure involved by embodiments of the present invention measures conduit schematic cross-section in intravascular. Fig. 7 is schematic section of the blood pressure measurement conduit involved by embodiments of the present invention along length of vessel direction.
In fig. 6 it is shown that the schematic cross-section that blood pressure measurement conduit 1 is moved in blood vessel 100.As shown in fig. 6, in doctor With seal wire 2 in the case of placed completion in patient's blood vessel, blood pressure measurement conduit 1 can be along medical guiding wire 2 in blood vessel Relative movement in 100, so that the convenient given stenosis to the blood vessel 100 for navigating to patient.In addition, Fig. 6 is also shown for blood pressure Measurement conduit 1 is when along the relative movement in blood vessel 100 of medical guiding wire 2 in the approximate location of blood vessel 100.
In fig. 7 it is shown that there is narrow schematic diagram in the blood vessel 100 of patient.As shown in fig. 7, in the blood vessel of blood vessel 100 Patch 110 is formed with inwall.The formation of patch 110 causes the part blood vessel to be presented narrow in the image under X-ray.This In, the blood flow of blood vessel 100 flows to the distal end 100a of blood vessel 100 along blood flow direction D from the near-end 100b of blood vessel 100.
In order to the FFR for carrying out the narrow blood vessel is measured, doctor is waited blood pressure measurement conduit 1 is passed including pressure by operation The proximal part 20 of sensor 40 is placed in the distal side 100a of narrow blood vessel (such as coronary artery) 100 (i.e. under blood flow Trip).Now, pressure sensor 40 is located at the distal side (downstream) at narrow distal side 100a, measures the blood pressure Pd of distal side. Then, by pressure sensor 40 be placed in narrow position (such as stenotic lesion 110) proximal lateral (i.e. the upstream of blood flow, for example Near sustainer) the blood pressure Pp of 100b.FFR values can be with abbreviation as remote pressure relative to proximal pressure ratio, i.e. FFR= Pd/Pp.In the present embodiment, term " downstream " and " upstream " are for the normal direction " D " (referring to Fig. 7) of blood flow 's.
Although the above-mentioned intravascular pressure measurement conduit 1 that describe in detail involved by embodiments of the present invention, this Invention is not limited to above-mentioned implementation method.For example, in certain embodiments, can set multiple along the sidepiece of distal cannula 10 Perforate (not shown).The setting of perforate can reduce the possibility of the blocking in distal cannula 10.For example, working as blood pressure measurement conduit 1 when being moved through artery, and patch 110 of vascular wall etc. is possible to that distal cannula 10 can be entered, and hinders distal cannula 10 along doctor With the relative movement of seal wire 2, perforate is provided with the sidepiece of distal cannula 10 can suppress the counter productive.
Hereinafter, with reference to Fig. 8, the intravascular pressure involved by description embodiments of the present invention measures the user of conduit Method.
Fig. 8 shows the flow of the application method of the intravascular pressure measurement conduit involved by embodiments of the present invention Figure.When using blood pressure measurement conduit 1, first, carry out blood vessel from the privileged site (such as femoral artery, radial artery etc.) of patient and wear After thorn and intervention prepare, medical guiding wire 2 is sent to internal precalculated position (step S10) (referring to Fig. 3).
In above-mentioned steps S10, because vascular puncture and intervention prepare to belong to than more conventional operation technique, therefore specifically Details of operation here is omitted.In certain embodiments, point of puncture can select the stock band lower section about 2cm for patient, And the underface of femoral pulse.Using puncture needle after point of puncture puncture, guide wire is sent into along puncture needle, then exited Puncture needle, arterial sheath is sent into along guide wire, then further takes out guide wire, thus completes femoral artery puncture.
After vascular puncture and intervention preparation is completed, guiding catheter (not shown) can be sent into via arterial sheath, and will lead Guiding tube sends into ad-hoc location, and carries out radiography using contrast agent.For example, for coronary heart disease etc., by injecting contrast agent in hat Shape artery carries out angiography.The guiding catheter that present embodiment is used is not particularly limited, for example, can use Jie Shi (Judkins) coronary catheter etc..
In addition, in step slo, because pressure sensor 40 is arranged in the proximal part 20 of blood pressure measurement conduit 1, because This, when blood pressure measurement conduit 1 is pushed along medical guiding wire 2, reduces the cross-sectional area of blood pressure measurement conduit 1, therefore, it is possible to Reduce blood pressure and measure the push resistance of conduit 1.
Then, blood pressure measurement conduit 1 is configured on medical guiding wire 2 (that is, by medical guiding wire 2 through blood pressure measurement conduit 1 Guidewire lumen 12), and blood pressure measurement conduit 1 is sent at the stenotic lesion of patient's blood vessel 100 along medical guiding wire 2 so that blood Pressure measurement conduit 1 on pressure sensor 40 be positioned at the vicinity in above-mentioned precalculated position (for example, the upstream of stenotic lesion or under Trip) (step S20).Specifically, the proximal part 20 of the blood pressure measurement conduit 1 that doctor etc. can be by operating patient external, To control blood pressure measurement conduit 1 along the feeding position of medical guiding wire 2.In certain embodiments, doctor need not can moved In the case of with seal wire 2, distal cannula 10 is slided along medical guiding wire 2 by operating proximal part 20 and advance distal end to cover Pipe 10.
In step S20, doctor etc. can tentatively be sentenced by estimating the blood vessel image formed by contrast agent under X-ray The stenosis of disconnected patient's blood vessel.Meanwhile, under the auxiliary of X ray image, doctor etc. leads the blood pressure measurement of present embodiment Pipe 1 is sent at the stenotic lesion of patient's blood vessel 100.
Then, the blood pressure Pd in the pre-position downstream is measured using the pressure sensor 40 of blood pressure measurement conduit 1 (i.e. The blood pressure Pd of distal side 100a).Then, by adjusting the position of blood pressure measurement conduit 1, the pressure of blood pressure measurement conduit 1 is passed Sensor 40 moves to the upstream of stenotic lesion, blood pressure Pp (i.e. the blood pressure Pp of proximal lateral the 100b) (steps of measurement stenotic lesion upstream Rapid S30).In certain embodiments, when adjusting the measurement position of blood pressure measurement conduit 1 in step s 30, it may not be necessary to again Position the position of medical guiding wire 2, i.e. can be in the case where keeping the position of medical guiding wire 2 constant, only by operating blood pressure measurement Blood pressure measurement conduit 1 just can be adjusted to conduit 1 upstream of the other positions such as stenotic lesion of stenotic lesion.
Although blood pressure measurement conduit 1 in step s 30 first measures the blood pressure Pd in stenotic lesion downstream, then measures narrow disease Become the blood pressure Pp of upstream.However, present embodiment not limited to this, for example, can also first measure the blood pressure Pp of stenotic lesion upstream, In the blood pressure Pd in measurement stenotic lesion downstream.In this case, the FFR values of the stenotic lesion also can successfully be calculated.
In addition, in step s 30, blood pressure signal (the blood pressure Pd and near-end of distal side as produced by pressure sensor 40 The blood pressure Pp of side) it is output to for example external processing equipment (not shown) via signal path 22.
Finally, by the processing equipment that patient is external, the blood pressure Pd of the distal side and blood pressure Pp of proximal lateral can be calculated Two ratio of measured value (ratio of the downstream blood pressure to upstream blood pressure) Pd/Pp as FFR value, i.e. FFR=Pd/Pp (steps S40).In step s 40, in order to more be precisely calculated above-mentioned FFR values, above-mentioned pressure can be passed in above-mentioned processing equipment Blood pressure signal acquired in sensor 40 carries out Error processing.
Although being illustrated to the present invention above in association with drawings and embodiments, it is not intended to limitation The present invention, it will be appreciated that to those skilled in the art, without departing from the spirit and scope of the present invention, can Deformed and changed with to the present invention, these deformations and change are each fallen within scope of the claimed protection of the invention.

Claims (9)

1. a kind of intravascular pressure measures conduit, it is characterised in that:
Including:
Distal cannula, it has the guidewire lumen slideably received within single medical guiding wire;
Proximal part, it couples with the distal cannula;And
Pressure sensor, it is used to measure endovascular blood pressure and produces blood pressure signal,
The proximal part has signal path, the Yi Jiyong for transmitting the blood pressure signal from the pressure sensor In the connecting conduit for supporting the signal path and the movement distal cannula,
The pressure sensor is close to the distal cannula, and
The pressure sensor is arranged in the connecting conduit of the proximal part.
2. intravascular pressure as claimed in claim 1 measures conduit, it is characterised in that:
The distal cannula couples with the proximal part via outer tube.
3. intravascular pressure as claimed in claim 1 measures conduit, it is characterised in that:
The pressure sensor is arranged on the end of the close described distal cannula of the proximal part.
4. the intravascular pressure as described in any one of claims 1 to 3 measures conduit, it is characterised in that:
The guidewire lumen is slideably received within the medical guiding wire with external diameter about 0.2mm to 1mm.
5. intravascular pressure as claimed in claim 2 measures conduit, it is characterised in that:
The guidewire lumen includes tubular inner chamber and extends to the outer tube and through the outer tube from the tubular inner chamber Side bending inner chamber.
6. the intravascular pressure as described in any one of claims 1 to 3 measures conduit, it is characterised in that:
The distal cannula has the perforate arranged along the length direction of the distal cannula,
The perforate allows blood flow to flow into the guidewire lumen.
7. intravascular pressure as claimed in claim 1 measures conduit, it is characterised in that:
The connecting conduit has the opening for allowing the pressure sensor to measure blood pressure.
8. intravascular pressure as claimed in claim 1 measures conduit, it is characterised in that:
The signal path is at least partially recessed into the connecting conduit.
9. intravascular pressure as claimed in claim 1 measures conduit, it is characterised in that:
In the vicinity of the pressure sensor, the ring-shaped sleeve worked as positioning mark is additionally provided with.
CN201610236055.1A 2016-04-17 2016-04-17 Intravascular pressure measures conduit Active CN105852833B (en)

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CN106361312A (en) * 2016-10-08 2017-02-01 苏州亘科医疗科技有限公司 Guide wire for measuring blood pressure in blood vessel
CN107569223A (en) * 2017-10-21 2018-01-12 深圳北芯生命科技有限公司 Intravascular pressure measurement conduit with developing ring
WO2020158572A1 (en) * 2019-01-30 2020-08-06 日本ゼオン株式会社 Intra-aortic balloon catheter
CN117582192A (en) * 2019-08-02 2024-02-23 深圳北芯生命科技股份有限公司 Pressure measuring catheter
CN113558591B (en) * 2019-12-31 2023-10-31 深圳北芯生命科技股份有限公司 Intravascular pressure measurement system with visualization ring
CN115151293B (en) * 2020-03-30 2024-07-26 日本瑞翁株式会社 Sensor-mounted catheter
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CN112274763A (en) * 2020-11-20 2021-01-29 康迪泰科(北京)医疗科技有限公司 Medical catheter and method of using medical catheter

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