• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:

    公开号:SE1050717A1
    申请号:SE1050717
    申请日:2010-06-30
    公开日:2011-12-31
    发明作者:Mats Hilmersson
    申请人:St Jude Medical Systems Ab；
    IPC主号:
    专利说明:

    15 20 25 30 35 40 45 50 2 medium. US 6, 167, 763 further show that a first coil may be attached to the distal end of the capsule and that a similar second coil may be attached to the proximal end of the capsule. The solid metal wire - which, as also mentioned above, in the field is usually called core wire - extends through the interior of the capsule and may have an enlarged diameter part adapted to mount the sensor element.
    U.S. Pat. 7,222,539 discloses a capsule in which a sensor element and a core wire are arranged in separate compartments. Another example of a sensor guidewire comprising a sensor enclosed by a sensor housing is shown in WO 2006/037082 A2.
    Generally, a sensor and guidewire device comprises a sensor element in the form of an elongate, substantially rectangular chip with a pressure sensitive part in the form of a membrane arranged thereon. The sensor chip is arranged inside a capsule, which in addition to the sensor chip also houses a part of a core wire and at least one electrical cable connected to the sensor element. A first coil may be attached to the distal end of the capsule and optionally a second coil may be attached to the proximal end of the capsule. The first and second spirals may be attached to the respective ends of the capsule, e.g. using lirn or alternatively soldering.
    Although sensor and guidewire devices comprising a capsule designed according to the techniques presented by the present applicant have been found to work well in practice, continuous efforts are being made to improve the performance and functionality of the sensor and guidewire devices.
    According to prior art, the capsule is provided with an opening or a window through which the pressure-sensitive part (typically a membrane) of the sensor element communicates with a surrounding medium, e.g. Blood. Now it has been discovered - for the first time - that the dimensions of the opening, the sensor element and the interior of the capsule in combination with the special mounting device for the sensor element are such that air present in the capsule and / or adhered to the surface of the capsule or sensor element tends to enclose in the capsule and / or form an air bubble covering the opening in the capsule. M.a.o. does not completely wet the surrounding fluid (eg blood) the sensor element and the membrane, which affects the signal quality of the device.
    An object of the present invention is therefore to provide a sensor and guidewire device comprising an improved capsule, with which the above-mentioned wetting problems are eliminated or at least minimized.
    Summary of the Invention The above objects are achieved by the present invention according to the independent claim.
    Preferred embodiments are set out in the dependent claims.
    Consequently, by providing a capsule with multiple holes, improved wetting can be achieved, which ensures a more reliable and stable sensor output. The sensor guidewire for intravascular measurements for at least one physiological, or other, variable in a living body, in accordance with the present invention, comprises a sensor element disposed in a capsule in a sensor area of said sensor guidewire, wherein said capsule is tubular and provided with a capsule wall, and further comprises a first opening arranged in said capsule wall, and the capsule further comprises at least a second opening arranged in said capsule wall.
    Brief Description of the accompanying Drawings Fig. 1 schematically illustrates the general design of a sensor and guidewire device according to the prior art.
    Fig. 2 shows a part of the sensor and guidewire device for Fig. 1, and illustrates how air can be trapped in a capsule and form a bubble on the surface of the capsule according to the prior art.
    Fig. 3 illustrates a capsule according to a first embodiment of the present invention.
    Fig. 4a illustrates a sensor guidewire and a capsule according to a second embodiment of the present invention.
    Fig. 4b illustrates the capsule according to the second embodiment, also shown in fi g. 4a, of the present invention.
    Fig. 5 shows a capsule according to a third embodiment of the present invention.
    Fig. 6 shows a capsule according to a fourth embodiment of the present invention.
    Fig. 7a shows a sensor guidewire and capsule according to a fifth embodiment of the present invention.
    Fig. 7b shows the capsule from above according to the fifth embodiment, also shown in Fig. 7a, of the present invention.
    Fig. 8 shows a capsule according to a sixth embodiment of the present invention.
    Fig. 9 shows a capsule according to a seventh embodiment of the present invention.
    Detailed Description of Preferred Embodiments of the Invention For a better understanding of the context in which the present invention is to be used, a sensor and guidewire device 1 of conventional design is shown in Figs. The sensor guide 1 comprises a hollow tube 2, a core wire 3, a first coil 4, a second coil 5, a capsule or sleeve 6, a hemispherical tip 7, a sensor element or chip 8 and one or more electrical cables 9. The proximal the end of the first coil 4 is attached to the distal end of the hollow tube 2 while the distal end of the first coil 4 is attached to the proximal end of the capsule 6. The proximal end of the hollow tube 4 the second coil 5 is connected to the distal end of the capsule 6 and the hemispherical tip 7 is attached to the distal end of the second coil 5. The core wire 3 is at least partially arranged inside the hollow tube 2 so that the distal part of the core wire 3 extends out of the hollow tube 2 and into the second coil 5. The sensor element 8 is mounted on the core wire 3 at the position of the capsule 6, is connected by the electrical cables 9 to an electronic unit (not shown in fi g. 1). The sensor element 8 comprises a pressure-sensitive device in the form of a membrane 10, which through an opening 11 in the capsule 6 communicates with a medium, such as blood, which surrounds at least the distal end of the sensor guide 1. At the proximal end of the sensor guide 1 is each electrical cable is connected to a conductive element 12 and the conductive elements 12 are insulated from each other by means of insulating elements 13 to thereby form a male contact for the sensor guide 1.
    Even though it does not appear in ñg. 1, the sensor element 8 further comprises an electrical circuit, which in a Wheatstone-type bridge is connected to one or more piezoresistive elements arranged on the membrane 10. As is well known in the art, a certain pressure exerted on the membrane 10 from the surrounding medium will correspond to a some extent of the membrane 10 and thereby a special resistance of the piezoresistive element mounted thereon and, in turn, a special output from the sensor element 8.
    Fig. 2 shows the capsule part of the sensor guide 1 in fi g. 1, and illustrates how air 14 can be trapped in the capsule 6 or form a bubble 15 covering the opening 11 in the capsule 6. Clearly, the air bubble 15, which covers the opening 11, will create an undefined intermediate medium which prevents direct liquid contact between the surrounding medium ( typically blood) and the pressure sensitive membrane 10 and it is also clear that if the air bubble 15, or parts thereof, disappears, the output from the sensor element 8 will be affected. Air 14 enclosed in the capsule 6 exerts pressure on the sensor element 8 and can induce voltage in the diaphragm or in the sensor element 8, the output of which can change if the air 14 disappears out of the capsule 6 during use of the sensor guide 1. The above explanation of how air can affect the measurements is only intended to be a proposal, but it is clear that all uncontrolled factors must be eliminated in order to achieve a sensor and guide wire that is as reliable as possible. Here it can be mentioned that the standard outer diameter of a sensor guide is only 0.35 mm (0.014 inch), while an opening in a capsule can have a diameter of about 0.25 mm.
    To solve the above problems, the present inventors propose a sensor and guide wire comprising a capsule 20 with multiple openings, which enable total or at least improved wetting of the sensor element 18 and the membrane. In contrast to previously known capsules which only have a first opening through which first opening a membrane senses e.g. the ambient pressure, and end openings through which a core wire extends, the capsule 20 further comprises at least a second opening 23.
    I fi g. 3 schematically shows a first embodiment of a capsule 20 for a sensor and guidewire device, for intravascular measurements for at least one physiological, or other, variable in a living body. The capsule 20 is tubular and provided with a capsule wall 21 and comprises a first opening 22 arranged in said capsule wall 21. Through this first opening 22, or at least through the first opening 22, the sensor element 18 ( not shown in Figure 3) adapted to sense one or fl your physiological, or other, variables. The capsule 20 further comprises at least one second opening 23 arranged in the capsule wall 21. The second opening 23 allows trapped air in the capsule 20 to come out of the capsule 20, or even prevents trapped air from forming. A second opening 23 also provides a better liquid communication, which prevents an air bubble from forming over the previously mentioned opening in the capsule 20. According to this preferred embodiment, the second opening 23 is arranged on the opposite side of the tubular capsule 20 relative to said first opening 22. Furthermore, the capsule 20 is hollow and may be provided with proximal and distal end openings 29, 30.
    According to a preferred embodiment of the present invention, and as also shown in fi g. 3, the capsule 20 has a longitudinal axis 3, and the capsule wall 2 1 extends substantially parallel to said longitudinal axis 31.
    The capsule 20 may have a circular or square or an oval cross-section in a plane perpendicular to said longitudinal axis line 3 1.
    I fi g. 4a shows a sensor guidewire 24 and a capsule 20 according to a second embodiment of the present invention. The sensor guidewire 24 comprises a hollow tube 25, a core wire 26 and at least a second coil 27, a sensor element 18 arranged in the capsule 20 in a sensor area for said sensor guidewire 24, a hemispherical tip 28, and one or two electrical cables (not shown). In this embodiment, the capsule 20 is provided with a number of elongate openings 22, 23, 33, 34, 35, 36, 37 (23, 34, 37 not shown in Figure 4a] distributed over the capsule wall 21 around the entire capsule 20, which allows air enclosed in the capsule 20 to get out of there.
    Fig. 4b also shows the capsule 20 according to the second embodiment of the present invention. The capsule 20 has a first opening 22 and a second opening 23 arranged on the opposite side of the capsule 20 in relation to the first opening 22. In addition, the capsule 20 is provided with five further openings named 33, 34, 35, 36 and 37. Accordingly according to the In the second embodiment of the present invention, the capsule 20 is provided with seven openings 22, 23, 33, 34, 35, 36, 37 distributed over the capsule wall 21 around the capsule 20.
    I fi g. 5, the capsule 20 according to a third embodiment of the present invention is shown. The capsule has a first 22, a second 23 and a third opening 33.
    The capsule 20 has a circular cross-section in a plane perpendicular to the longitudinal axis 31 and the openings 22, 23, 33 are arranged evenly distributed around the said capsule wall 21.
    Fig. 6 shows the capsule 20 according to a fourth embodiment of the present invention. According to this embodiment, the capsule 20 has a first 22 and a second 23 opening and is further provided with proximal and distal end openings 29, 30.
    Furthermore, the capsule 20 is provided with a further number of elongate openings 33, 34, 35, 36, the openings 33, 3, 35, 36 having different sizes in relation to each other.
    Fig. 7a shows the sensor guidewire 24 and the capsule 20 according to a fifth preferred embodiment of the present invention. The capsule 20 is provided with proximal and distal end openings 29, 30 and a core wire 26 extending through said capsule 20 via the proximal and distal end openings 29, 30. Furthermore, the capsule 20 is provided with a first 22, a second 23, a third 33 and a fourth 34 opening, which openings are arranged in pairs on opposite sides of the capsule 20. According to this preferred embodiment, the openings 22, 23, 33, 34 are asymmetrical. The first and fourth openings 22, 34 (not shown in Figure 7a) arranged on a first side 38 of the capsule 20 are wider in a proximal part than in a distal part of the openings 22, 34. While the second and third openings 23 , 33, arranged on a second side 39, opposite the first side of the capsule 20, is wider in a proximal part than in a distal part of the openings 22, 23. An advantage is that the openings for the two pairs are wider in different parts ( distal or proximal) at different sides, is that it is not possible to arrange the capsule 20 in the wrong direction when the capsule 20 and sensor guidewire 24 are assembled. Thus, the openings at e.g. the first side 38 can be arranged in the same way regardless of which of the end openings 29, 30 of the capsule 20 is arranged e.g. distal. Another advantage of this embodiment is that the liquid used to rinse the sensor guidewire comprising the capsule 20 before insertion of the sensor guidewire, to a greater extent stays inside the capsule 20 when rinsed straight through the capsule 20.
    Fig. 7b illustrates the capsule 20 from above according to the fifth embodiment of the present invention. Fig. 7b illustrates that the two pairs of openings 22, 23, 33, 34 are arranged on opposite sides 38, 39 of the capsule 20.
    According to another embodiment of the present invention, the openings, 22, 23, 33, 34 arranged in pairs on opposite sides of the capsule 20 may be slightly offset relative to each other along the longitudinal axis 31.
    I fi g. 8, the capsule 20 is illustrated in accordance with a sixth embodiment of the present invention. According to this embodiment, the capsule wall 21 is net-shaped and thus provided with a number of openings evenly distributed over said capsule wall 21.
    Fig. 9 shows the capsule 20 according to a seventh embodiment of the present invention. In this embodiment the capsule wall 21 is reticulated and further the capsule 20 is provided with a first 22 and a second opening 23. The second opening 23 is arranged on the opposite side of the tubular capsule 20 in relation to said first opening 22. The capsule 20 is hollow and may be provided with proximal and distal end openings 29, 30.
    It should be noted that the previous embodiments are all useful, in terms of the number of openings and how they are arranged, in a capsule provided with a net-like wall.
    The present invention is not limited to the embodiments described above.
    Various alternatives, modifications and equivalents can be used. Therefore, the above embodiments should not be construed as limiting the scope of the invention, as defined by the appended claims.
    权利要求:
    Claims (13)
    [1]
    Sensor guidewire (24) for intravascular measurements of at least one physiological, or other, variable in a living body, comprising: - a sensor element (18) arranged in a capsule (20) in a sensor area of said Sensor guidewire (24), - a core wire (26) extending at least partially along the length of the sensor guidewire (24), - at least one electrical cable connected to the sensor element (18), said capsule (20) being tubular and provided with a capsule wall (21), and further comprising a first opening (22) arranged in said capsule wall (21), said capsule (20) being further provided with proximal and distal end openings (29, 30), a core wire (26) being adapted to extend through said capsule (20) via said proximal and distal end openings (29, 30), and wherein the sensor guidewire (24) has an outer diameter of the order of 0.35 mm, characterized in that said capsule (20) further comprises at least one second opening (23) arranged in the capsule wall (21) .
    [2]
    The sensor guidewire (24) of claim 1, wherein said second opening (23) is disposed on the opposite side of the capsule (20) relative to said first opening (22.)
    [3]
    A sensor guidewire (24) according to any one of claims 1-2, wherein said capsule (20) has a longitudinal axis (3 1) and said capsule wall (2 1) extends substantially parallel to said longitudinal axis (31).
    [4]
    The sensor guidewire (24) of claim 3, wherein said capsule (20) has a circular, square or oval cross-section in a plane perpendicular to said longitudinal axis (31).
    [5]
    A sensor guidewire (24) according to any one of claims 1-4, wherein said capsule (20) is hollow.
    [6]
    A sensor guidewire (24) according to any one of claims 1-5, wherein said capsule (20) is provided with a number of openings (22, 23, 33, 34, 35, 36, 37). 10 15 20 25
    [7]
    A sensor guidewire (24) according to claim 6, wherein said openings (22, 23, 33, 34, 35, 36, 37) are arranged evenly distributed over said capsule wall (21).
    [8]
    A sensor guidewire (24) according to any one of claims 6-7, wherein said capsule wall (2 1) is mesh-like.
    [9]
    A sensor guidewire (24) according to any one of claims 6-8, wherein said apertures (22, 23, 33, 34, 35, 36, 37) have different sizes relative to each other.
    [10]
    A sensor guidewire (24) according to any one of claims 1-9, wherein at least said second opening (23) is asymmetrical.
    [11]
    A sensor guidewire (24) according to any one of claims 1 to 10, wherein at least said second opening (23) is elongate relative to said capsule (20).
    [12]
    The sensor guidewire (24) of claim 10, wherein at least said second opening (23) is wider in a proximal portion than in a distal portion of said opening (23).
    [13]
    The sensor guidewire (24) of claim 10, wherein at least said second opening (23) is wider in a distal portion than in a proximal portion of said opening (23).
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    SE1050717A|SE535022C2|2010-06-30|2010-06-30|Sensor guide wire comprising a multi-hole sensor capsule|SE1050717A| SE535022C2|2010-06-30|2010-06-30|Sensor guide wire comprising a multi-hole sensor capsule|
    US13/806,380| US10426404B2|2010-06-30|2011-06-16|Sensor jacket|
    PCT/EP2011/060008| WO2012000798A1|2010-06-30|2011-06-16|Sensor jacket|
    EP11738407.3A| EP2587990B1|2010-06-30|2011-06-16|Sensor jacket|
    EP18187963.6A| EP3417772B1|2010-06-30|2011-06-16|Sensor jacket|
    US16/551,971| US20190380652A1|2010-06-30|2019-08-27|Sensor jacket|
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