Detailed description of the invention
Present invention generally provides a kind of sensor Yarn guide component system for measuring physiological parameter in subject environment.This sensor Yarn guide component system generally includes Yarn guide component, sensor element, the electronic unit that is connected with conductive coating with Yarn guide component.In one aspect, conductive coating covers the part on Yarn guide component surface and is electrically connected to electronic unit.In yet another aspect, the invention provides a kind of sensor Yarn guide component system, its two electrical interfaces had in sensor element are connected to the electrical path of electronic unit with the setting when measuring physiologic variables.
Sensor godet system is used for measuring physiological parameter in position, as the flow velocity etc. of body fluid in pressure, temperature, body cavity, and with a kind of safe, accurately and reliably mode carry out the measurement of monitoring physiological parameters.Sensor Yarn guide component system spendable experimenter environment comprises any physiology chamber of experimenter, as slightly blood vessel, tremulous pulse, vein, heart, organ, tissue and the combination thereof of coronary artery, end.Such as, sensor godet system can be used for the pressure measuring two diverse locations in experimenter's internal medium, and can be used to determine intravascular, Ink vessel transfusing and intraventricular barometric gradient from the pressure measuring value of two position gained.
Sensor element is connected to the far-end of Yarn guide component usually.Sensor Yarn guide component is inserted into the internal medium of experimenter, and is connected to electronic unit to arrange the electrical path for measuring body physiological parameter in experimenter's internal medium.
On the one hand, the sensor element of sensor Yarn guide component is electrically connected to the elongate lead in sensor Yarn guide component, connects as the circuit in electrical path.In one embodiment, elongate lead passes to sensor element through arranging with the electrical input signal sent by electronic unit.In another embodiment, sensor Yarn guide component major part and experimenter's internal medium electric insulation.But at least a part for the outer surface of sensor Yarn guide component is coated with conductive coating.In another embodiment, conductive coating through arranging with the elongate lead in covering sensor Yarn guide component, and serves as electrical ground.
In another embodiment, sensor element is electrically connected with the conductive coating of elongate lead by the first intracellular signaling element.In addition, this sensor element is electrically connected with elongate lead by secondary signal transport element, is then indirectly connected with electronic control unit.Therefore, sensor Yarn guide component is used for reliably measuring one or more physiological parameter, and bending distortion, conduit are whipped or carry out any interference of electrical output signal of sensor elements.
In yet another aspect, elongate lead forms most of body of sensor Yarn guide component, and do not need to be formed any tract or hollow pipe, thus reduce integral thickness and the external diameter of sensor Yarn guide component, and still keep good promotion, pliability and/or turn round control.Sensor Yarn guide component can have the external diameter (such as: from about 0.01 inch to about 0.04 inch, as between 0.020 inch and 0.040 inch) being applicable to putting into any conduit cavity.In one embodiment, sensor Yarn guide component (such as: balloon expandable operation, stenter to implant operation etc.) in operation process can be used as diagnose or treatment conduit in conventional guidewire to guide other apparatuses.
Figure 1A is the schematic diagram of an example of sensor Yarn guide component system.According to one embodiment of present invention, sensor Yarn guide component system comprises sensor Yarn guide component 210, is arranged on sensor element 220 in sensor outer housing 240 and an electronic control unit 230.
Sensor Yarn guide component 210 can comprise far-end 212, near-end 214 and elongate lead 218 usually.Sensor Yarn guide component 210 is connected with electronic control unit 230 by near-end 214 place adapter 232.The sensor outer housing 240 wherein supporting sensor element 220 is placed on proximate distal ends, so that sensor element 220 is for sensing and the physiological parameter in measurement environment.
Such as, adapter 232 can be a kind of metal tube, and its internal diameter (ID) matches with the external diameter (OD) of the near-end 214 of sensor Yarn guide component 210.The side of adapter 232 is open, is convenient to near-end 214 and inserts; And opposite side is closed bottom, pass through to stop near-end 214.Adapter 232 degree of depth can be less than the length of near-end 214.When near-end 214 is inserted in adapter 232, whole length of near-end 214 stop at the bottom of adapter 232, leave some spaces between adapter 232 and the insulated part of sensor Yarn guide component 210 before being inserted into adapter 232.After near-end 214 is inserted into adapter 232, the pressure between near-end 214 and adapter 232 ensure that the elongate lead 218 of sensor Yarn guide component 210 is electrically connected with adapter 232.
Elongate lead 218 constitutes most of body of sensor Yarn guide component 210.Proximally 214 to extend to the elongate lead 218 of far-end 212 very long, human internal environment 270 can be reached, as from insertion position (such as: site of puncture, arm blood vessel, femoral artery etc.) to desired location (such as: coronary artery, heart, organ, tissue, or there is narrow position etc.).Such as, the length of elongate lead 218 can between about 10 centimetres to about 300 centimetres.Elongate lead 218 length can be very long, so that can from the desired location of external arrival experimenter, such as, from the site of puncture of femoral artery to experimenter's cardiovascular.
Elongate lead 218 can form the shape of any expectation, if its be flexible and at environment 270(as blood vessel) innerly provide support structure when pushing.Such as, elongate lead 218 can be the solid heart yearn be made up of conductive material (as rustless steel, conductive metallic material, ferrum, copper, Nitinol etc.).
In one embodiment, elongate lead 218 is made by whole piece conductive material.Therefore, the sensor element 220 being positioned at far-end 212 place is electrically connected with electronic control unit 230 to use this elongate lead 218 to guarantee, electronic control unit 230 is physically connected to the near-end 214 of sensor Yarn guide component 210.In another embodiment, elongate lead 218 is divided into different sections or partly links together, to provide pliability.Such as, elongate lead 218 can be divided into multiple part, and each part has different thickness, thus has different pliabilities.In such an embodiment, elongate lead 218 has at least one or more snippets to be made up of conductive material, and distally 212 links together to near-end 214 in sensor Yarn guide component 210, to provide electric conductivity.
Selectively, sensor Yarn guide component 210 can also comprise one or more wire coil 216 and be positioned at the end cap 215 at far-end 212 place, so that control the motion of sensor Yarn guide component 210 in environment 270 better.As shown in Figure 1A, end cap 215 adopts circular design so that there is better propelling movement property at the tip of sensor Yarn guide component when moving in environment 270.End cap 215 also can form other geometry and carry out improving SNR.
Wire coil 216 and end cap 215 can be made up of radiopaque material, such as, platinum, tungsten, the metal alloy etc. of palladium or electric conductivity, these materials are all opaque under X-ray, thus wire coil 216 can be used as the radiopaque labelling of sensor Yarn guide component 210, and in operation, cryptoscope is used to assist the far-end of sensor Yarn guide component 210 to be in place.In one embodiment, elongate lead 218 can do tapered at its far-end, and is coated with wire coil 216.End cap 215 can be circular or other suitable shape.Wire coil 216 can be coil or spiral or other suitable shape.The total length of wire coil 216 can from about 1 centimetre to about 5 centimetres, such as about 3cm.The thickness of each wire coil can from about 0.025 millimeter to about 0.20 millimeter, such as 0.075 millimeter.
Figure 1B illustrates the profile of sensor seal wire, and this profile is cut open along the 1B-1B ' line of Figure 1A.Due to by insulating barrier 217 around and covering, the outer surface of elongate lead 218 is at least partially usually and ambient dielectric.In addition, the outer surface of elongate lead 218 is coated with conductive coating 251 at least partially.Generally, the outer surface of insulating barrier 217 is coated with conductive coating 251.In one embodiment, the outer surface of sensor Yarn guide component 210 is covered by conductive coating 251 completely.Wire 218 is insulated by insulating barrier 217 and conductive coating 251.
Fig. 1 C illustrates the profile of sensor seal wire, and this profile is cut open along the 1B-1B ' line of Figure 1A.In one embodiment, conductive coating 251A is coated on the regional area of elongate lead 218 outer surface in sensor Yarn guide component 210.In one embodiment, conductive coating 251 is coated in the surface of insulating barrier 217, and this insulating barrier 217 is arranged along the body of elongate lead 218.
Conduction Tu layer 251 through arranging to serve as ground connection, and can comprise the conductive material of thin layer, including (for example) rustless steel, conductive metallic material, ferrum, copper, Nitinol etc.Such as, the thickness of conductive coating 251 can from about 1 micron to about 100 microns.The thickness of conductive coating 251 is not crucial, but it should be enough thick, so that provide conduction in environment 270, as long as sensor Yarn guide component 210 can reach design performance, and conductive coating 251 should be thin as much as possible, to prevent the performance of its disturb sensor Yarn guide component 210.
Insulating barrier 217 can be made up of any insulant, such as, and Parylene and polyimides etc.Such as, the thickness of insulating barrier 217 can from 1 μm to 100 μm.The thickness of insulating barrier 217 is not crucial, but should be enough thick, to provide the insulating properties between conductive coating 251 and elongate lead 218, simultaneously should be thin as much as possible, and to prevent its disturb sensor Yarn guide component as the performance of seal wire function.In addition, as required, one or more additional coatings (such as, hydrophobic coating etc.) (not shown) can be applied to all or part of outer surface of conductive coating 251, to improve function and the performance of sensor Yarn guide component 210.
An embodiment of Fig. 1 D illustrated operation sensor Yarn guide component system, wherein, electronic control unit 230 is connected to physiological monitor 280 by a wire 238, for the physiological parameter measured with monitor in experimenter's environment 270.The far-end 212 of sensor Yarn guide component 210 is connected with electronic control unit 230.Then, electronic control unit 230 is electrically connected with physiological monitor 280.Electronic control unit 230 at least can perform the function of the signal of telecommunication of detecting sensor element 220.According to one embodiment of present invention, experimenter can stand the operative catheter of diagnosis or treatment.
One or more function provided by electronic control unit 230 comprises, but be not limited to: send the signal of telecommunication, Signal Regulation (such as, filter and amplification etc.), Analog-digital Converter (ADC), pick up calibration, with physiological monitor communication, and the combination etc. of these functions.The function that physiological monitor 280 can provide includes, but are not limited to: communication and control the combination etc. of electronic control unit 230, Digital Signal Processing (DSP), data acquisition and storage, data analysis, data display, graphic user interface (GUI) and these functions.
In the example of Fig. 1 D, sensor Yarn guide component 210 can insert in conduit tube component, and this conduit tube component wears mouth from experimenter's femoral artery to enter into experimenter environment 270(such as, blood vessel).In operation, doctor proximally 214 can push sensor Yarn guide component 210, thus makes the far-end 212 of sensor Yarn guide component 210 proceed to the endovascular desired location of experimenter, as position narrow inside coronary artery.Therefore, the far-end 212 of sensor Yarn guide component 210 is surrounded by the blood in environment.The near-end 214 of sensor Yarn guide component 210 is placed on outside subject, and far-end 212 moves to the desired location needing to measure physiologic variables.
In one example in which, sensor Yarn guide component system as herein described can operate in right coronary artery percutaneous transluminal coronary angioplasty (PCTA) operation.At first, such as, the conduit with one or more opening can be used for sensor Yarn guide component (opening by conduit) to be inserted into femoral artery.After conduit is pushed to narrow desired location, far-end can by proceeding to desired location with conduit with the sensor Yarn guide component of sensor element 220, until the far-end of sensor Yarn guide component by right coronary artery upward to descending aorta, as an example, finally enter the little and bending opening of right coronary artery and carry out measurement original position pressure.
First desired location measure pressure, this position be generally in narrow before, pressure record is P herein
1.Then, sensor Yarn guide component proceeds to the second position, it be usually located at narrow after, this position may be exceed the very little distance of primary importance (such as, several centimetres).Original position pressure measured by second position is designated as P
2.In general, blood flow reserve mark (FFR), and can according to formula F FR=P for assessment of the narrow order of severity
2/ P
1calculate.Over the course for the treatment of, sensor Yarn guide component can stay correct position, to be used as guiding tool.Give an example, in an angioplasty procedures, sensor Yarn guide component can be connected to the guiding tool that foley's tube is implanted to serve as balloon dilatation and stenting.Coronary artery hyperemia can be undertaken by (IC) injection or vein (IV) continuous infusion vasodilation in coronary artery.In diagnostic procedure, diagnostic catheter can be placed similarly for injection contrast agent, can withdraw from pressure transducer seal wire after FFR has calculated.
The flow chart of Fig. 2 A graphic technique 100, the method is by using sensor Yarn guide component system described herein for measuring the physiological parameter in subject environment.In a step 102, conduit is arranged on the environment interior (such as, blood vessel, femoral artery etc.) of experimenter.Then, sensor Yarn guide component system is inserted into is placed in the conduit of environmental interior.Such as, the far-end 212 of sensor Yarn guide component 210 can insert in conduit.
Selectively, at step 104, once sensor Yarn guide component is inserted in environment, can calibrate sensor Yarn guide component in physiological parameter.Such as, sensor Yarn guide component 210 can be calibrated by pressure reading, to guarantee that it runs well.In an example, the pressure recorded at insertion position by sensor Yarn guide component 210 can by correcting with consistent with for monitoring the aortic pressure force measuring device measured result of same patient.
In step 106, sensor Yarn guide component can be pushed to desired locations in experimenter's environment.Such as, in medical operating, sensor Yarn guide component 210 is pushed by doctor, and doctor manually promotes sensor Yarn guide component 210 from the catheter insertion site near femoral artery, until it arrives suspect narrow arteria coronaria blood vessel place.
In step 108, sensor Yarn guide component 210 is electrically connected to electronic control unit 230.Such as, the near-end 214 of sensor Yarn guide component 210 can be connected to the adapter 232 of electronic control unit 230 by doctor or medical worker.In certain embodiments, sensor Yarn guide component 210 and electronic control unit 230 integrate, and just connect without the need to carrying out or disconnect between the two.
In step 110, the measurement of physiological parameter is performed by the sensor Yarn guide component 210 being provided with sensor element 220 of desired locations.In one embodiment, any above-mentioned steps can repeat, and order can change, to guarantee the normal operation of sensor Yarn guide component system.In another embodiment, if wish the order of severity assessing stenotic lesion by calculating blood flow reserve mark, doctor can first measure the first pressure P near suspection stenotic lesion place
1, then propelling movement sensor Yarn guide component 210 makes it pass suspection stenotic lesion and sentences measurement second pressure P
2, and according to formula F FR=P
2/ P
1calculate FFR.After doctor completes measurement, sensor Yarn guide component 210 and adapter 232 can be disconnected, to make sensor Yarn guide component 210 can serve as the guiding tool of other medical apparatus and instruments (as foley's tube).In addition, according to the needs measured, at any time can easily pass adapter 232 and sensor Yarn guide component 210 and electronic control unit 230 are carried out being electrically connected or disconnecting.
An embodiment of the flow chart of the illustrative methods 120 of Fig. 2 B illustrated operation sensor Yarn guide component 210.In step 122, electrical input signal is sent to the elongate lead 218 in sensor Yarn guide component 210 from electronic control unit 230.In step 124, electrical input signal is transmitted by elongate lead 218.In step 126, electrical input signal is received by the sensor element 220 in sensor Yarn guide component 210.In step 128, electrical output signal is produced by sensing element 220, and feeds back to electronic control unit 230 by elongate lead 218, is arranged on conductive coating 251 on sensor Yarn guide component 210 outer surface as electrical ground.
Fig. 3 A-3B illustrates the example of the intrasystem circuit of sensor Yarn guide component described according to one or more embodiment of the present invention.In figure 3 a, electric resistance sensor is as sensor element 220.And in figure 3b, capacitance sensor is as sensor element 220.In other application examples, other forms of sensor, such as transducer, also can as sensor element 220.
Electronic control unit 230 can to the sensor element 220 be positioned near far-end 212 provide change in time, with time correlation and/or the exciting power signal irrelevant with the time (such as, in the form of voltage or other forms).As a result, sensor element 220 is suitable for receiving the power signal from electronic control unit, and produce electrical output signal.Electronic control unit 230 can be connected to physiological moniyoting instrument and/or vital sign monitors carries out showing, record and/or monitor the electrical output signal produced by sensor element 220.Human internal environment 270(such as blood vessel, body cavity etc.) in, the proportional relation of pressure amplitude of the general and desired location of the electrical output signal amplitude produced by sensor element 220.
In the example of Fig. 3 A, provide electrical path 300A.Electrical input signal is sent by electronic control unit 230, and the electrical signal path 310A of the extroversion in the elongate lead 218 of sensor Yarn guide component 210, then received by variable resistance 322, variable resistance 322 sends electrical output signal.The electrical output signal that variable resistance 322 exports passes through the signal of telecommunication loop 350 in the elongate lead 218 of sensor Yarn guide component 210, to be sent back to electronic control unit 230 for calculating.
Variable resistance 322 can be arranged in sensor element 220.The resistance value of the variable resistance 322 in sensor element 220 can be the function of the physiological parameter measured desired by sensor element 220.This resistance value may depend on the position of the sensor element 220 be arranged in human internal environment 270.
Therefore, the circuit arrangement shown in Fig. 3 A illustrates the close loop of the variable resistance 322 in sensor element 220, and to produce and to discharge electrical output signal, it is by environment 270 and transmit via signal of telecommunication loop 350, to be detected by electronic control unit 230.
In the example of Fig. 3 B, provide circuit 300B, electrical input signal is sent by electronic control unit 230, the electrical signal path 310B of the extroversion in the elongate lead 218 of sensor Yarn guide component 210, then received by the variable capacitance 328 in sensing element 220, variable capacitance 328 sends electrical output signal again.The electrical output signal that variable capacitance 328 sends by the signal of telecommunication loop 350 in the elongated conductive line 218 of sensing Yarn guide component 210, and is sent back down to electronic control unit 230 for calculating.
Variable capacitance 328 can be arranged in sensor element 220.The resistance value of the variable capacitance 328 in sensor element 220 can be the function of the physiological parameter measured desired by sensor element 220.Electric signal transmission path in Fig. 3 B and the signal of telecommunication transfer path in Fig. 3 A similar.Circuit arrangement in Fig. 3 B can be the close loop of the variable capacitance 328 in sensor element 220, and to produce and to discharge electrical output signal, electrical output signal transmits via signal of telecommunication loop 350, to be detected by electronic control unit 230.
Fig. 3 C illustrates a kind of example circuit arrangement, this circuit arrangement can use at electronic control unit 230, with the signal of telecommunication of processes sensor Yarn guide component 210, wherein electric resistance sensor is used as sensor element 220 and detects and measure physiological parameter in human internal environment 270.As shown in Figure 3A, sensor element can comprise variable resistance 322.
In the example of Fig. 3 C, provide electrical path 300C.Electrical input signal is sent by electronic control unit 230, is transmitted by the electrical signal path 310C of extroversion, and then received by the variable resistance 322 be arranged in sensor element 220, variable resistance 322 sends electrical output signal again.Variable resistance 322 in sensor element 220 is for the formation of the one leg of so-called Wheatstone bridge.Usually, in circuit, wheatstone bridge type electrical arrangement comprises two legs and four resistance.
In electronic control unit 230, at least provide three resistive elements to form the remainder of Wheatstone bridge.In the example of Fig. 3 C, provide resistive element 232,234,236.As a result, variable resistance 322 is used to form one leg together with resistance 236, the another one leg that the variable resistance 232 in itself and Wheatstone bridge and resistance 234 are formed matches.Circuit for signal conditioning 340 collects the signal of telecommunication from paired variable resistance 322 and resistance 236 and the signal of telecommunication from paired variable resistance 232 and resistance 234.Therefore, can filter with the regulating circuit 340 of amplifying signal for detecting the signal of telecommunication in Wheatstone bridge.The output signal of circuit for signal conditioning 340 is processed further by circuit 330.
Although Fig. 3 C provides an example of the electrical path of the signal of telecommunication in treatment and processing electronic control unit 230, this electronic control unit 230 is connected to the electric resistance sensor in sensor Yarn guide component 210, and a lot of effective version can be had between electronic control unit 230 and sensor Yarn guide component 210 to carry out the treatment and processing signal of telecommunication.About other examples arranging dissimilar known sensor element (such as capacitance sensor, transducer etc.) on sensor Yarn guide component 210, those skilled in the art also can use according to same principle.In some cases, also can be adjusted with the electrical path in the electronic control unit 230 of the capacitance sensor be arranged in the sensor element of sensor Yarn guide component or transducer compatibility and element.In the example of Fig. 3 B, when using variable capacitance 328 in sensor element 220, the electrical path in electronic control unit 230 can be adjusted, so that the electrical output signal that sensor element 220 produces can be processed by electronic control unit 230.
Fig. 4 A is the side view of sensor Yarn guide component 210, and this assembly generally can comprise the sensor element 220 be arranged in sensor Yarn guide component 210 far-end 212 place sensor outer housing 240.In one embodiment, sensor element 220 usually comprises and has one or more pressure drag component (such as, variable resistance 322, variable capacitance 328 etc.) one or more small-sized voltage sensitive sensor and/or transducer (such as, sensing chip, silicon-containing film etc.), with the resistive element in electronic control unit 230 (such as, resistance 232,234,236 etc.) cooperatively act on, to form wheatstone bridge type circuit (there are two legs and four resistance).Fig. 3 A-3C illustrates some examples.
Fig. 4 B illustrates the top view of an example of sensing element 400, and this sensing element 400 can be set up in sensor outer housing 240 in Figure 4 A.In one embodiment, sensing element 400 can comprise sensor 420, basic unit 428 and two or more electrical interfaces (such as, the first electrical interface 422 and the second electrical interface 424).Basic unit 428 uses highly-resistant material usually, and can be considered insulant.Sensor 420 can be arranged in basic unit 428, with around insulate.In addition, sensor 420 can be electrically connected to a conductive interface of elongate lead by the first electrical interface 422, can also be electrically connected to another conductive interface of wire 218 by the second electrical interface 424.Or replace sensor 420, sensing element 400 can comprise electric capacity, transducer or be arranged on other elements in insulated substrate 428, to detect and to sense the physiological parameter in human body environment 270.
Therefore, sensor 420 is applicable to receive power signal from electronic control unit 230 by elongate lead 218 and the second conductive interface 424, produces electrical output signal afterwards according to the change of pressure, temperature or other physiological parameters in human body environment 270.The sensor 420 being positioned at sensing element 400 can detect the signal of telecommunication from electronic control unit 230 by the second electrical interface 424 and sense physiological parameter, such as, pressure in body or temperature.Sensor 420 can also send electrical output signal, and the intensity of electrical output signal changes according to the change of the physiological parameter of internal milieu 270.
First electrical interface 422 and the second electrical interface 424 can be made up of metal material (such as, aluminum, copper, gold, nickel etc. and/or metal material lamination), think that sensing element 400 provides better electrical connection.Sensor 420 is arranged on insulation component 428 usually, and insulation component 428 can be made up of insulant, such as silicon.Except the first electrical interface 422 of being connected to sensor 420 and the second electrical interface 424, insulation component 428 is to allow sensing element 400 avoid electrical interference.So for sensing element 400, the electrical interference from environment 270 or sensor Yarn guide component 210 miscellaneous part can be eliminated or minimize.Fig. 4 B diagram has the sensor 420 of two electrical interfaces being connected to it.Be understandable that, sensor 420 can be provided with more electrical interface as required.Will also be appreciated that except electrical interface, sensor 420 can be provided with as required for the non-electric-connecting interface of other objects.
Fig. 5 A illustrates the side sectional view (this section along 5A-5A ' face in Fig. 4 A cut) of sensor Yarn guide component 210 near near-end 212.Sensor Yarn guide component 210 generally includes the sensing element 400 be arranged in sensor outer housing 240, wire coil 216, end cap 215 and elongate lead 218.Sensor outer housing 240 can go out a little opening in its surface engraving, so that sensing element 400 is arranged on wherein, with the pressure of sensing body environment, temperature or any other physiological parameter.The part of sensing element 400 can towards environment 270, and can be covered by protective layer 410 or around, insulate to make sensing element 400 and internal milieu 270.Protective layer 410 can be made up of such as Parylene, silicon or other any insulant, and should prioritizing selection soft material, so just can not affect the operating condition of sensor.
In one embodiment, sensor outer housing 240 can comprise insulation component 242, first conducting element 244 and the second conducting element 246.Insulation component 242 can be made up of any insulant (such as, Tyrone, nylon or other insulant).Sensor outer housing 240 is separated at least that two parts are (such as by insulation component 242, first conducting element and the second conducting element) so that the signal of telecommunication can not directly be delivered to another parts from parts and walk around the sensing element 400 be arranged in sensor housing 240.
In another embodiment, first conducting element 244 and/or the second conducting element 246 can by radiopaque material (such as, platinum, tungsten, the metal alloy of palladium or other electric conductivity) make, to make sensor outer housing 240 also can as the radiopaque position mark of sensing element 400, and auxiliaryly under fluorescent screen accurately to locate in sensing element 400 in vivo environment 270.
In the example of shell 240 as shown, for example, in figure sa, the sensor, the first conducting element 244 can be electrically connected (such as, by the first conductive path 421) to the first electrical interface 422 in sensing element 422.In addition, the second conducting element 246 can be electrically connected (such as, by the second conductive path 423) to the second electrical interface 424 in sensing element 400.First conductive path 421 and the second conductive path 423 can be made up of metal wire, flexible print circuit, conducting resinl or other material etc.
In the fabrication process, can first sensing element 400 be arranged in sensor outer housing 240.Then, the first electrical interface 422 in sensing element 400 and the second electrical interface 424 are connected respectively on the first conducting element 244 and the second conducting element 426.Protective layer 410 can be coated on sensing element 400 to protect sensing element 400; not to be exposed in environment 270 to make it thus with environment electric insulation, maintain sensing element 400 simultaneously and sense and the function of pressure, temperature or other physiological parameters in testing environment 270.
Sensor outer housing 240 can be disposed in far-end 212 place of sensor Yarn guide component 210, to help transmission of electric signals.In one embodiment, one end of sensor outer housing 240 can be connected to wire coil 216 and end cap 215 by the first conducting element 242.One deck conductive coating 251 can also be covered, to form outer conductive coating at the outer surface of wire coil 216, end cap 215, sensor outer housing 240 and elongate lead 218.Wire coil 216 and end cap 215 are made up of conductive metallic material, and the output signal of telecommunication sent from sensor element (such as sensor element 220, sensing element 400 etc.) can be sent to conductive coating 251 by the first electrical interface 422, first conductive path 421, first conducting element 422, wire coil 216 and end cap 215 etc.In one configuration wherein, conical gradual change element 213 can also be arranged in the wire coil 216 between the first conducting element 242 and end cap 215.In an example, the conical gradual change element 213 in wire coil 216 is made up of conductive material, and auxiliary the output signal of telecommunication is sent to conductive coating 251.
In another embodiment, the other end of sensor outer housing 240 is insulated by insulating barrier and conductive coating 251, and such as, insulating barrier 217, its (such as) is coated on the excircle of the second conducting element 244.In addition, the interior section of sensor outer housing 240 is electrically connected to electronic control unit 230 by the second conducting element 244 in sensor outer housing 240, and the second conducting element 244 is connected to the main core of elongate lead 218.
In an example, the connection between elongate lead 218 and the second conducting element 244 of sensor outer housing 240 is formed joint 219 to improve bonding strength.Insulating barrier 217 is applied to the local of the second conducting element 244 of elongate lead 218 and sensor outer housing 240 or whole element.In some cases, the part that not the first conducting element 242, wire coil 216 and end cap 215 are all or element all need to be electrically connected with conductive coating 251.
In the example of Fig. 5 A, sensor outer housing 240 is directly connected with elongate lead 218.Such as, or sensor outer housing 240 also can be connected with elongate lead 218 indirectly, by inserting other structure or element between sensor outer housing 240 and elongate lead 218, such as, with metal-cored polyimide tube, wire coil etc.In this case, the second electrical interface 424 of sensing element 400 is electrically connected by the metal-cored and elongate lead 218 in polyimide tube.
In fig. 5, sensing element 400 is arranged in the opening of sensor outer housing 240, and the space that this open design becomes the sensor 420 in sensing element 400 to contact with the fluid (such as blood, body fluid etc.) in environment 270.The surface of sensor 420 facing fluid can sense the change with physiological parameter in detection bodies environment 270, such as pressure, temperature etc.Some part of sensor Yarn guide component to use packing material (glue, plastic filler etc. of such as medical grade) to carry out filling.Such as, the open space be positioned in the middle of sensor outer housing 240, first conductive path 421 and the second conductive path 423 etc. can be filled.
Fig. 5 B illustrates the profile (this profile is cut open along the 5B-5B ' face in Fig. 5 A) of second certain part of conducting element 246 of sensor outer housing 240 and its inside.Second conducting element 246 of sensor outer housing 240 is insulated with conductive coating 251 by the coating (such as, insulating barrier 217) of thin layer.
Fig. 5 C illustrates the profile (this section is along the 5C-5C ' section on plane in Fig. 5 A) of sensor outer housing 240 another part.As shown in Figure 5 C, sensor outer housing 240 provides support together with the insulation component 242 of its inside for sensing element 400 and fixes.As shown in Figure 5 C, there is the aperture arrangement of the surperficial macro cell facing shell 240 of the sensing element 400 of sensing function.Be understandable that, sensor outer housing 240 can be made up of the shallow pipe with inner chamber, and the backing material of the intracavity that sets within it supports the sensing element 400 arranged near its outer surface.
Fig. 5 D illustrates the profile (this section is along the 5D-5D ' section on plane in Fig. 5 A) of first certain part of conducting element 244 of sensor outer housing 240 and Fig. 5 A.First conducting element 244 of sensor outer housing 240 is electrically connected with conductive coating 251.
Fig. 5 E illustrates the profile (this section along the 5E-5E ' section on plane in Fig. 4 A, near near-end 214 place) of sensor Yarn guide component 210.As shown in fig. 5e, a part for the near-end 214 of sensor Yarn guide component 210 is not applied by insulating barrier 217.Not being connected with the adapter 232 of electronic control unit 230 by the part insulated of elongate lead 218, as shown in Figure 1A.Hydrophobic layer (not shown) can be applied to the part surface of the non-insulated portion of elongate lead 218, adheres on the non-insulated portion of elongate lead 218 with other liquid to prevent the blood from environment 270.
As shown in fig. 5e, in one embodiment, elongate lead 218 is local dents, installs the first conducting ring 261, second conducting ring 264 and dead ring 263 with slot milling.Between the main core and the first conducting ring 261 of elongate lead 218, be coated with insulating layer coating 262 makes both insulate.First conducting ring 261 is electrically connected with conductive coating 251, thus is electrically connected with the first electrical interface 422 of sensing element 400.Second conducting ring 264 is electrically connected with elongate lead 218, thus is electrically connected with the second electrical interface 426 of sensing element 400.
Dead ring 263 assigns between the first conducting ring 261 and the second conducting ring 264, thus makes both insulation.Alternatively, the termination that another one dead ring 265 can be disposed in heart yearn flushes to make the outer surface of whole seal wire.
Fig. 5 F illustrates the profile (this section is along the 5F-5F ' section on plane in Fig. 5 E) of certain part of near-end 214.Insulating barrier 262 makes conducting ring 261 and wire 218 insulate.
Fig. 5 G illustrates the profile (this section is along the 5G-5G ' section on plane in Fig. 5 E) of near-end 214 another part.Wire 218 surrounds by dead ring 263 completely, and the first conducting ring 261 and the second conducting ring 264 are insulated.
Fig. 5 H illustrates the profile (this section is along the 5H-5H ' section on plane in Fig. 5 E) of the another part of near-end 214.Conducting ring 264 is directly connected on conductive core line 218, thus is electrically connected with conductive core line 218.
Fig. 6 A illustrates the profile of another embodiment of sensor Yarn guide component 210.In one embodiment, the first half seal wires 910 be made up of conductive material equally and the second half seal wires 930 are joined together to form a complete seal wire by insulant 920.As shown in Figure 6A, in one embodiment, half seal wire 930 can by the shell of moulding one-tenth sensor.The first half seal wires 910 and the second half seal wires 930 can be made up of conductive material, such as rustless steel, Nitinol and any other suitable metal or metal alloy.
Insulant 920 can be the glue of medical grade, the epoxy resin of medical grade etc.The thickness of insulating barrier 920 can from 1 micron to 100 microns.The thickness of insulating barrier is not crucial, as long as it is enough thick in reliably the first half seal wires 910 and the second half seal wires 930 to be insulated.In an example, the second half seal wires 930 can be electrically connected with the first electrical interface 422 of conductive path 421, conical gradual change element 213, wire coil 216 and sensing element 400, as shown in Figure 4 B.The second half seal wires 930 are electrically connected with conductive path 423 by a metalwork 912.Metalwork 912 can be made up of radiopaque material, and such as, platinum, tungsten, the metal alloy etc. of palladium or electric conductivity, its material is not transparent under X-ray.Therefore, wire coil 216 can as the radiopaque position mark of sensor Yarn guide component 210, and auxiliaryly under fluorescent screen is accurately located by its far-end 212.Sensing element is located with auxiliary by the end that the becket 931 be made up of radiopaque material also can be arranged on the first half seal wires 930.When adapter 232 is connected with sensor Yarn guide component 210, the structure of sensor Yarn guide component near-end can be utilized, the first half seal wires 910 and the second half seal wires 930 are electrically connected with circuit 230.Further, as required, can the whole of sensor Yarn guide component 210 or local one or more extra coating of outer surface (such as, hydrophobic coating etc.) (not shown), to improve function and the performance of sensor Yarn guide component 210.
Fig. 6 C illustrates the profile (this section along the 6C-6C ' section on plane in Fig. 6 A, near far-end 212 place) of sensor Yarn guide component 210.Illustrate an example of embodiment in figure 6 c, without the need to special sensor outer housing, the substitute is the opening 950 jointly formed by the first half seal wires 910 and the second half seal wires 930, sensing element 400 is arranged in this opening.
Insulating barrier 920 can be utilized the first half seal wires 910 and the second half seal wires 930 to be insulated.Sensing element 400 can be arranged on insulating barrier 920.First electrical interface 422 of sensing element 400 can conduct electricity half seal wire 930 by conductive path 421 and second and be electrically connected, and the second electrical interface 424 of sensing element 400 can conduct electricity half seal wire 910 by conductive path 423 and first is electrically connected.Alternatively, as shown in Figure 6 C, radiopaque material 912 can be arranged between conductive path 423 and the first half seal wires 910.Alternatively, as shown in Figure 6 C, the second half seal wires 930 can be electrically connected with conical gradual change element 213 and wire coil 216.
Fig. 6 D to illustrate in far-end 212 and Fig. 6 C the profile (this profile is along the 6D-6D ' section on plane in Fig. 6 C) of the part of the second half seal wires 930.In figure 6d, the second half seal wires 930 are complete circles.As shown in the example in Fig. 6 D, radiopaque ring 931 is for sealing the second half seal wires 930.In some cases, do not use radiopaque ring 931, so only there are the second half seal wires 930 along the plane of 6D-6D '.
Fig. 6 E illustrates the profile (this section is along the 6E-6E ' section on plane in Fig. 6 C) of far-end 212 another part.As illustrated in fig. 6e, the second half seal wires 930 along the shape in 6E-6E ' plane close to semicircle, and together with insulating barrier 920, sensing element 400 to be provided support and fixation.As illustrated in fig. 6e, the surface of sensing element 400 tool sensing function is upwards towards the aperture arrangement between the first half seal wires 910 and the second half seal wires 930.Alternatively, layer protective layer (not shown) can be covered, to be protected from environment 270 by sensing element 400 at the end face of sensing element 400.
Fig. 6 F illustrates far-end 212 and is arranged on the profile (this section is along the 6F-6F ' section on plane in Fig. 6 C) of local of radiopaque material 912 of the first half seal wire 910 ends.Insulating barrier 920 makes the first half seal wire 910(and radiopaque material 912 be electrically connected) and the second half seal wires 930 insulate.The thickness of insulating barrier 920 can from 1 micron to 100 microns.The thickness of insulating barrier 920 is not crucial, as long as it is enough thick in reliably to make two and half seal wire insulation.
Fig. 6 G illustrates the profile (this section is along the 6G-6G ' section on plane in Fig. 6 C) of the local of far-end 212 and the second half seal wires 930.Insulating barrier 920 makes the first half seal wires 910 and the second half seal wires 930 insulate.The thickness of insulating barrier 920 can from 1 micron to 100 microns.The thickness of insulating barrier 920 is not crucial, as long as it is enough thick in reliably to make the first half seal wires 910 and the second half seal wires 930 insulate.
Fig. 6 H illustrates the side cut away view (this section along the 6H-6H ' section on plane in Fig. 6 A, near near-end 214 place) of sensor Yarn guide component 210.As shown in figure 6h, the first half seal wires 910 and the second half seal wires 930 moulding, conducting ring 940,942 and dead ring 941 can be inserted in the part near sensor Yarn guide component 210 near-end and install, the first half seal wires 910 can be connected with adapter 232 (as shown in Figure 1) with the second half seal wires 930, and finally be connected with electronic control unit 230.Conducting ring 940,942 can be made up of conductive material, such as rustless steel, Nitinol etc.
Fig. 6 I illustrates the profile (this section is along the 6I-6I ' section on plane in Fig. 6 H) of a part of near-end 214.Fig. 6 J illustrates the profile (this section is along the 6J-6J ' section on plane in Fig. 6 H) of a part of near-end 214.Fig. 6 K illustrates the profile (this section cuts along the 6K-6K ' section in Fig. 6 H) of another part of near-end 214.
As shown in fig. 6i, insulating barrier 950 can be formed at the outer surface of the part of the second half seal wires 930 of sensor Yarn guide component 210 proximal end.Conductive metal ring 942 can be utilized, to be electrically connected with the first half seal wires 910 in the proximal end of sensor Yarn guide component 210.Can by the combined effect of insulating barrier 950 and insulating barrier 920, make way for the second half seal wires 930 of sensor Yarn guide component 210 same position and the first half seal wires 910 along 6I-6I ' plane mutually insulated in Fig. 6 A.
As shown in fig. 6k, insulating barrier 951 can be formed on the outer surface being positioned at sensor Yarn guide component 210 near-end another location and being in the part of the first half seal wires 910.Conductive metal ring 940 can be utilized to be electrically connected with the second half seal wires 930 at sensor Yarn guide component near proximal ends.Can by the combined effect of insulating barrier 950 and insulating barrier 920, make way for the first half seal wires 910 of sensor Yarn guide component 210 same position and the second half seal wires 930 along 6K-6K ' plane mutually insulated in Fig. 6 A.Utilize dead ring 941 by the first half seal wires 910 and the second half seal wires 930 completely around, make it along 6J-6J ' the plane mutually insulated in Fig. 6 A.
Fig. 7 shows the schematic diagram of a kind of method sensor Yarn guide component 210 and guiding catheter 800 are combined according to an embodiment of the invention.In general catheterization procedure (such as, angioplasty), for diagnosis or therapeutic purposes, the femoral artery of guiding catheter 800 from patient can be inserted, until its far-end arrives the desired locations in heart.Then sensor Yarn guide component 210 is inserted in guiding catheter 800, and pushed forward is until it arrives the position of expection in patient's blood vessel (such as, environment 270), carries out diagnosing or treating.
From foregoing, can find out, the invention provides a sensor Yarn guide component system, system that employs solid heart yearn, but not lumen tube.In addition, this sensor Yarn guide component system can be used for one or more physiologic variables accurately measured in organism, as pressure and temperature etc.Further, this sensor Yarn guide component system can also be used as seal wire, core seal wire as real in routine.Compared with the traditional sensing Yarn guide component for measuring Ink vessel transfusing physiological parameter, the sensor Yarn guide component system mentioned by the present invention at least has the following advantages: the first, with the linear formula work of solid core, proximally arrives all conducting of far-end neither containing inner chamber; The second, it easily can manufacture as conventional guidewire; 3rd, easily can arrive suspicious narrow lesion locations; 4th, the measurement or any at arteria coronaria blood vessel or other blood vessels or endoceliac blood pressure measurement of physiological parameter can be completed without the need to additional programs.
Foregoing is the part in embodiment of the present invention, is not departing under elemental range prerequisite, and still can propose other and further embodiment of the present invention, its scope is determined by claims.