The present invention relates generally to sensor and guide wire assemblies, in which a sensor element is mounted at the distal end of a guide wire for intravascular measurements of physiological variables in a living body, and particularly to the mounting arrangement of the sensor element, and more particularly to a jacket in which the sensor element is disposed, according to the preamble of the independent claim.
In many medical procedures, various physiological conditions present within a body cavity need to be monitored. These physiological conditions are typically physical in nature—such as pressure, temperature, rate-of-fluid flow, and provide the physician or medical technician with critical information as to the status of a patient's condition.
One device that is widely used to monitor conditions is the blood pressure sensor. A blood pressure sensor senses the magnitude of a patient's blood pressure, and converts it into a representative electrical signal that is transmitted to the exterior of the patient.
For most applications it is required that the sensor is electrically energized. Some means of signal and energy transmission is thus required, and most commonly extremely thin electrical cables, sometimes called microcables, are provided inside a guide wire, which itself is provided in the form of a tube, which often has an outer diameter in the order of 0.35 mm, and oftentimes is made of steel.
In order to increase the bending strength of the tubular guide wire, a core wire is positioned inside the tube. The core wire also helps to improve “pushability” and “torquability” of the guide wire. The mentioned electrical cables are e.g. positioned in the space between the inner lumen wall and the core wire.
Sensor and guide wire assemblies in which a sensor is mounted at the distal end of a guide wire are known. In U.S. patent Re. 35,648, which is assigned to the present assignee, an example of such a sensor and guide wire assembly is disclosed, where a sensor guide comprises a sensor element, an electronic unit, a signal transmitting cable connecting the sensor element to the electronic unit, a flexible tube having the cable and the sensor element disposed therein, a solid metal wire, and a coil attached to the distal end of the solid wire. The sensor element comprises a pressure sensitive device, typically a membrane, with piezoresistive elements connected in a Wheatstone bridge-type of arrangement mounted thereon.
As is disclosed in, for example, U.S. Pat. No. 6,167,763, which also is assigned to the present assignee, the sensor element can be arranged inside a short tube (usually referred to as a sleeve or jacket), which protects the sensor element and comprises an aperture through which the pressure sensitive device is in contact with the ambient medium. The U.S. Pat. No. 6,167,763 further illustrates that a first coil may be attached to the distal end of the jacket and that a similar second coil may be attached to the proximal end of the jacket. The solid metal wire—which, as also mentioned above, in the art usually is referred to as the core wire—extends through the interior of the jacket and may be provided with an enlarged diameter portion adapted for mounting of the sensor element.
U.S. Pat. No. 7,222,539 discloses a jacket, wherein a sensor element and a core wire are provided in separate compartments. Another example of a sensor guide wire comprising a sensor enclosed by a sensor housing is disclosed in WO 2006/037082 A2.
In WO 03094693 A2, a pressure-measuring apparatus is disclosed, the pressure-measuring apparatus comprises a sensor transducer adapted to be incorporated in a catheter.
DE 2420610 A1, discloses a sensor for measuring pressure, the sensor is adapted to be incorporated in a catheter. The sensor is enclosed by a protecting tube.
U.S. Pat. No. 6,019,728 discloses a catheter including a catheter tube to be inserted into a body. A plurality of sensing portions are arranged in the catheter tube. Two pressure communication holes are provided in the wall of the catheter tube to communicate the ambient pressure of the tube into the interior of the tube.
In US 2007088220 A1 an implantable medical device including a physiological sensor is disclosed. The sensor is embedded in a mesh structure of a stent-like structure.
In US 20050187487 A1 and US 20060211946 A1, further examples of catheters provided with sensors are disclosed.
U.S. Pat. No. 6,162,182 discloses a cannula usable to remove blood from a patient during surgery.
Generally, a sensor and guide wire assembly comprises a sensor element in the form of an elongated, essentially rectangular chip with a pressure sensitive member in the form of a membrane provided thereon. The sensor chip is arranged inside a jacket, which besides the sensor chip also accommodates a portion of a core wire and at least one electrical lead connected to the sensor element. A first coil may be attached to the distal end of the jacket, and optionally a second coil may be attached to the proximal end of the jacket. The first and second coils may be attached to the respective end of the jacket, e.g. by gluing, or alternatively soldering.
Although sensor and guide wire assemblies comprising a jacket designed according to the techniques presented by the present assignee in practise have proven to work very well, there are continuously ongoing efforts to improve the performance and functionality of the sensor and guide wire assemblies.
According to the prior art, the jacket is provided with an aperture or window, through which the pressure sensitive part (typically a membrane) of the sensor element is in communication with a surrounding medium, e.g. blood. Now, it has—for the first time—been recognized that the dimensions of the aperture, the sensor element and the interior of the jacket in combination with the particular mounting arrangement of the sensor element are such that air present within the jacket and/or adhering to the surface of the jacket or sensor element has a tendency to be entrapped within the jacket and/or forming an air bubble covering the aperture in the jacket. In other words, the ambient fluid (e.g. blood) does not wet the sensor element and the membrane completely, which affects the signal quality of the device.
An object of the present invention is therefore to provide a sensor and guide wire assembly comprising an improved jacket, with which the above-mentioned wetting problem is eliminated or at least minimized.
By providing a jacket with multiple holes an improved wetting can be achieved, which ensures a more reliable and stable sensor output.
The sensor guide wire for intravascular measurements of at least one physiological, or other, variable in a living body, in accordance with the present invention, comprises a sensor element arranged in a jacket in a sensor region of said sensor guide wire, a core wire extending at least partly along the length of said sensor guide wire, at least one electrical lead connected to said sensor element, wherein said jacket is tubular and provided with a jacket wall, and further comprises a first opening arranged in said jacket wall, said jacket is further provided with proximal and distal end openings, and wherein a core wire is adapted to extend through said jacket via said proximal and distal end openings, and wherein the sensor guide wire has an outer diameter of approximately 0.35 mm, and wherein said jacket further comprises at least a second opening arranged in said jacket wall.
For better understanding of the context in which the present invention is going to be used, a sensor and guide wire assembly 1 of a conventional design is illustrated in
Although not shown in
To solve the problems outlined above, the present inventors suggest a sensor and guide wire comprising a jacket 20 with multiple openings, which allows for complete or at least improved wetting of the sensor element 18 and membrane. In contrast to the previously known jackets, which have only a first opening, through which first opening a membrane senses e.g. the surrounding pressure, and end openings, through which a core wire extends, the jacket 20 comprises further at least a second opening 23.
In
According to a preferred embodiment of the present invention, and as also shown in
In
As shown in
In
According to another embodiment of the present invention, the openings 22, 23, 33, 34 arranged in pairs on opposite sides of the jacket 20 may be slightly displaced in relation to each other along the longitudinal axis 31.
In
It should be noted that previous embodiments are applicable, regarding the number of openings and how they are arranged, in a jacket provided with a mesh-like wall.
The present invention is not limited to the above-described preferred embodiments. Various alternatives, modifications and equivalents may be used. Therefore, the above embodiments should not be taken as limiting the scope of the invention, which is defined by the appending claims.
Number | Date | Country | Kind |
---|---|---|---|
1050717-6 | Jun 2010 | SE | national |
This application is a continuation application of U.S. application Ser. No. 13/806,380, filed on Dec. 21, 2012, which is the National Stage of Application No. PCT/EP2011/060008 filed on Jun. 16, 2011, which is based upon and claims the benefit of priority from U.S. Provisional Application No. 61/359,954, filed on Jun. 30, 2010 and Swedish Application No. 1050717-6, filed on Jun. 30, 2010, the entire contents of all of which are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3521620 | Cook | Jul 1970 | A |
4456013 | De Rossi et al. | Jun 1984 | A |
4712566 | Hok | Dec 1987 | A |
4941473 | Tenerz et al. | Jul 1990 | A |
5018529 | Tenerz et al. | May 1991 | A |
5085223 | Lars et al. | Feb 1992 | A |
5097841 | Moriuchi et al. | Mar 1992 | A |
5125058 | Tenerz et al. | Jun 1992 | A |
5437288 | Schwartz et al. | Aug 1995 | A |
5549109 | Samson et al. | Aug 1996 | A |
RE35648 | Tenerz et al. | Nov 1997 | E |
5993378 | Lemelson | Nov 1999 | A |
6019728 | Iwata et al. | Feb 2000 | A |
6045734 | Luther et al. | Apr 2000 | A |
6162182 | Cole | Dec 2000 | A |
6167763 | Tenerz et al. | Jan 2001 | B1 |
6248083 | Smith et al. | Jun 2001 | B1 |
6295990 | Lewis et al. | Oct 2001 | B1 |
6491712 | O'Connor | Dec 2002 | B1 |
7011636 | Tenerz | Mar 2006 | B2 |
7222539 | Tulkki | May 2007 | B2 |
RE39863 | Smith | Oct 2007 | E |
7724148 | Samuelsson et al. | May 2010 | B2 |
8174395 | Samuelsson et al. | May 2012 | B2 |
8461997 | Samuelsson et al. | Jun 2013 | B2 |
8551022 | Von Malmborg | Oct 2013 | B2 |
9144664 | Jacobsen et al. | Sep 2015 | B2 |
20020013540 | Jacobsen et al. | Jan 2002 | A1 |
20020049392 | Demello | Apr 2002 | A1 |
20020077520 | Segal et al. | Jun 2002 | A1 |
20020173785 | Spear et al. | Nov 2002 | A1 |
20030009208 | Snyder et al. | Jan 2003 | A1 |
20030069522 | Jacobsen et al. | Apr 2003 | A1 |
20050004515 | Hart et al. | Jan 2005 | A1 |
20050038359 | Aimi et al. | Feb 2005 | A1 |
20050043670 | Rosenberg | Feb 2005 | A1 |
20050187487 | Azizkhan et al. | Aug 2005 | A1 |
20050268725 | Tulkki | Dec 2005 | A1 |
20060004346 | Begg | Jan 2006 | A1 |
20060211946 | Mauge et al. | Sep 2006 | A1 |
20070088220 | Stahmann | Apr 2007 | A1 |
20070157588 | Dauber et al. | Jul 2007 | A1 |
20080200770 | Hubinette | Aug 2008 | A1 |
20090020961 | Kameyama et al. | Jan 2009 | A1 |
20090062602 | Rosenberg et al. | Mar 2009 | A1 |
20090177185 | Northrop | Jul 2009 | A1 |
20090192412 | Sela et al. | Jul 2009 | A1 |
20090318798 | Singh et al. | Dec 2009 | A1 |
20100063479 | Merdan et al. | Mar 2010 | A1 |
20100145308 | Layman et al. | Jun 2010 | A1 |
20100152663 | Darr | Jun 2010 | A1 |
20100217304 | Angel et al. | Aug 2010 | A1 |
20100228112 | Von Malmborg | Sep 2010 | A1 |
20100262041 | Von Malmborg | Oct 2010 | A1 |
20110004198 | Hoch | Jan 2011 | A1 |
20110137186 | Limacher et al. | Jun 2011 | A1 |
20110160648 | Hoey | Jun 2011 | A1 |
20110160680 | Cage et al. | Jun 2011 | A1 |
20110213220 | Samuelsson et al. | Sep 2011 | A1 |
20110245808 | Voeller et al. | Oct 2011 | A1 |
20120289808 | Hubinette | Nov 2012 | A1 |
20130102927 | Hilmersson | Apr 2013 | A1 |
20130102928 | Sotos et al. | Apr 2013 | A1 |
20130274618 | Hou et al. | Oct 2013 | A1 |
20130296718 | Ranganathan et al. | Nov 2013 | A1 |
20140058338 | Adams et al. | Feb 2014 | A1 |
20150032011 | Mcgowan et al. | Jan 2015 | A1 |
20160249821 | Boye et al. | Sep 2016 | A1 |
20160262698 | Mahlin | Sep 2016 | A1 |
20190313922 | Ness et al. | Oct 2019 | A1 |
Number | Date | Country |
---|---|---|
24 20 610 | Oct 1975 | DE |
0 387 453 | Sep 1990 | EP |
0 521 595 | May 1999 | EP |
1 340 516 | Sep 2003 | EP |
0 877 574 | Oct 2003 | EP |
1 849 409 | Oct 2007 | EP |
2 085 108 | Aug 2009 | EP |
1 545 680 | Sep 2010 | EP |
63-158064 | Jul 1988 | JP |
05-184666 | Jul 1993 | JP |
07-326770 | Dec 1995 | JP |
H11-508160 | Jul 1999 | JP |
2005-046603 | Feb 2005 | JP |
2009-172385 | Aug 2009 | JP |
2011-529750 | Dec 2011 | JP |
2014-042645 | Mar 2014 | JP |
441725 | Nov 1985 | SE |
453561 | Feb 1988 | SE |
454045 | Mar 1988 | SE |
460396 | Oct 1989 | SE |
469454 | Jul 1993 | SE |
WO-9700641 | Jan 1997 | WO |
WO-0069323 | Nov 2000 | WO |
WO-03094693 | Nov 2003 | WO |
WO-2004011076 | Feb 2004 | WO |
WO-2007050718 | May 2007 | WO |
WO-2009020954 | Feb 2009 | WO |
WO-2009029639 | Mar 2009 | WO |
WO-2009054803 | Apr 2009 | WO |
WO-2009112060 | Sep 2009 | WO |
WO-2011041720 | Apr 2011 | WO |
WO-2011161212 | Dec 2011 | WO |
WO-2012000798 | Jan 2012 | WO |
WO-2014043704 | Mar 2014 | WO |
WO-2014125497 | Aug 2014 | WO |
WO-2016138226 | Sep 2016 | WO |
Entry |
---|
European Office Action, Application No. 18187963.6, dated Nov. 20, 2020, 4 pages. |
International Preliminary Report on Patentability, PCT/US2019/024292, dated Oct. 29, 2020, 8 pages. |
Japanese Office Action and English translation, Application No. JP 2019-237942, dated Oct. 27, 2020, 6 pages. |
Japanese Search Report, Japanese Application No. 2017-545550, dated Sep. 5, 2018, 15 pages. |
USPTO Office Action, U.S. Appl. No. 16/366,112, dated Nov. 2, 2021, 16 pages. |
USPTO Notice of Allowance, U.S. Appl. No. 15/053,308, dated Sep. 17, 2020, 11 pages. |
Kawai, Fusako, Biodegradation of Polyethers (Polyethylene Glycol, Polypropylene Glycol, Polytetramethylene Glycol, and Others,) Biopolymers Online: Biology Chemistry Biotechnology, Applications 9 (2005). Retrieved from <https://onlinelibrary.wiley.com/doi/full/10.1002/3527600035.bpol9012>. (Year: 2005). |
Machine translation of JP H07-326770 A. |
USPTO Office Action, U.S. Appl. No. 15/053,308, dated Mar. 5, 2020, 16 pages. |
U.S. Appl. No. 17/124,864, filed Dec. 17, 2020, Boye et al. |
USPTO Office Action, U.S. Appl. No. 16/366,112, dated Mar. 30, 2021, 29 pages. |
Extended European Search Report, Application No. 20174470.3, dated Jun. 9, 2020, 8 pages. |
European Intention to Grant, Application No. 16 710 367.0, dated Jan. 23, 2020, 6 pages. |
“In”, The American Heritage Dictionary of the English Language, Fifth Edition (2014)Houghton Mifflin Harcourt Publishing Company, pp. 1-3, Retrieved from <https://ahdictionary.co/word/search.html?q-IN> on Mar. 25, 2015. |
“-Like”. 2011. In The American Heritage Dictionary of the English Language, Boston: Houghton Mifflin. <http://search.credoreference.com/content/entry/hmdictenglang/like/0>. |
European Extended Search Report, dated Nov. 19, 2018, 6 pages. |
European Office Action, dated Jul. 20, 2018, 6 pages. |
European Office Action, Application No. 13 723 953.9, dated Jun. 27, 2017, 6 pages. |
International Preliminary Reporton Patentability, PCT/IB2013/000903, dated Nov. 13, 2014, 11 pages. |
International Preliminary Report on Patentability, PCT/US2016/019498, dated Sep. 8, 2017, 11 pages. |
International Search Report and Written Opinion, PCT/US2016/019498, dated Jul. 4, 2016, 17 pages. |
International Search Report and Written Opinion, PCT/US2019/024292, dated Jun. 26, 2019, 11 pages. |
Japanese Office Action and English translation, Application No. 2016-525613, dated Dec. 5, 2017, 6 pages. |
Japanese Office Action and English translation, dated Mar. 21, 2017, 14 pages. |
Machine translation of DE 2420610. |
Notice of Allowance, U.S. Appl. No. 13/804,342, dated Oct. 18, 2018, 14 pages. |
PCT/ISA/206, International Application No. PCT/US2016/019498, 7 pages. |
RADI Medical Systems AB, PressureWire Certus, Brochure, 60680 Rev. 03, Apr. 2008. |
tube.Dictionary.com, Dictionary.com Unabridged, Random House, Inc., http://dictionary.reference.com/browse/tube> (accessed: Sep. 5, 2014). |
USPTO Notice of Allowance, U.S. Appl. No. 13/804,342, dated May 10, 2018, 8 pages. |
USPTO Notice of Allowance, U.S. Appl. No. 13/804,342 dated Sep. 5, 2017, 7 pages. |
USPTO Notice of Allowance, U.S. Appl. No. 15/030,770, dated Jul. 8, 2019, 9 pages. |
USPTO Office Action, U.S. Appl. No. 13/804,342, dated Jan. 16, 2015, 9 pages. |
USPTO Office Action, U.S. Appl. No. 13/804,342, dated Nov. 19, 2015, 12 pages. |
USPTO Office Action, U.S. Appl. No. 13/804,342, dated Apr. 7, 2016, 13 pages. |
USPTO Office Action, U.S. Appl. No. 13/804,342, dated Sep. 12, 2014, 18 pages. |
USPTO Office Action, U.S. Appl. No. 15/030,770, dated Oct. 18, 2018, 14 pages. |
Japanese Office Action, Japanese Application No. 2021-107358, dated Jun. 7, 2022, 14 pages. |
Japanese Search Report, Application No. 2021-107358, dated May 25, 2022, 13 pages. |
Number | Date | Country | |
---|---|---|---|
20190380652 A1 | Dec 2019 | US |
Number | Date | Country | |
---|---|---|---|
61359954 | Jun 2010 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13806380 | US | |
Child | 16551971 | US |