Devices for fixing a sensor in a lumen

Information

  • Patent Grant
  • 9149193
  • Patent Number
    9,149,193
  • Date Filed
    Thursday, July 2, 2009
    15 years ago
  • Date Issued
    Tuesday, October 6, 2015
    8 years ago
Abstract
Apparatus for positioning at least one sensor in a body lumen, the apparatus including a fixation element, a sensor, and a connecting element that connects the sensor to the fixation element, the connecting element extending at least partially into the lumen so that the sensor is located radially inward from a wall of the lumen.
Description
TECHNICAL FIELD

The present invention relates to field of medical devices and more specifically to a device for positioning a sensor in a lumen.


BACKGROUND

The use of sensors in body lumens is well known. For example, U.S. Pat. No. 4,485,813 describes a sensor that can be permanently implanted in a specific location within the human body in an implantable medical device such as a pacemaker. In other applications sensors are implanted alone in a body lumen. U.S. Pat. Nos. 6,645,143, 6,053,873, 6,442,413 and United States Publication Serial No. 2002/0188207 describe medical monitoring sensors designed to be implanted in the vascular system and are capable of sensing and transmitting via a telemetry link to an external monitor.


The implanted sensors are utilized for monitoring physical, chemical or physiological parameters in the body. The aim of such sensors is to accurately monitor the desired parameter.


The position of the sensor within the lumen can influence the accuracy of the measurement. Positioning of a sensor facing a lumen wall can alter the sensing ability. Furthermore, positioning of a sensor pressing against the lumen wall in blood vessels may encourage responses, such as neo-intimal growth, which can influence and/or impact the long and short term accuracy of measurements.


United States Publication Serial No. 2002/0188207 discloses a device and method for anchoring a sensor at the center of the lumen. This concept addresses the issue of tissue growth. However, it is problematic to axially align multiple sensors in the same vicinity of a lumen, since a first sensor would block the further sensor(s) from blood flow through the lumen. Thus, it is desirable, and often functionally necessary, to radially and/or circumferentially off-set the sensors of a multiple sensor arrangement, so that they are not coaxially aligned. On the other hand, it is desirable, and often functionally necessary, to operably connect the individual sensors of a multiple sensor arrangement.


There are several medical procedures that require insertion of catheters or other devices through a body lumen and especially through the vascular system, for example, Swan-Ganz catheter to the pulmonary artery for monitoring hemodynamic parameters. Thus, a sensor implantation device should not prevent accessibility to a desired location within the vascular system.


SUMMARY

One embodiment of the invention is an apparatus for positioning at least one sensor in a body lumen, the body lumen having a wall, the apparatus including a fixation element, a sensor, and a connecting element that connects the sensor to the fixation element. The connecting element extends at least partially into the lumen so that the sensor is located radially inward from the lumen wall. Other and further embodiments and aspects of the invention are disclosed and described herein.





BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the figures, in which:



FIGS. 1A-1D are schematic illustrations of a device having a stent-like configured fixation element according to one an embodiment of the invention.



FIGS. 2A-2B are schematic illustrations of a device having a coiled configured fixation element according to another embodiment of the invention.



FIGS. 3A-3D are schematic illustrations of a device having a wing configured fixation element according to yet another embodiment of the invention.



FIGS. 4A-4C are schematic illustrations of a device having a hook configured fixation element according to still another embodiment of the invention.



FIG. 5 is a schematic illustration of a device having two implants according to a still further embodiment of the invention.





DETAILED DESCRIPTION

The devices disclosed in the following detailed description enable positioning of an implant such as a sensor, a drug reservoir, or other known and/or convenient device within a lumen at a location which is between the inner lumen wall and the lumen center.


In one embodiment, the device includes a fixation part and an implant that is positioned between the lumen wall and the center of the lumen. The implant can be directly connected to the fixation part. The device can further include a connecting element for connecting between the fixation part and the implant and/or for positioning the implant at the desired location. The implant can be a sensor such as, for example, a pressure sensor that is implanted in blood vessels for monitoring blood pressure or any other known and/or convenient device. However, any known and/or convenient sensor can be used, including, but not limited to, a flow sensor, a radiation sensor, a temperature sensor, an electrical impedance sensor, other physical measurement sensor, an optical sensor for monitoring Hemoglobin concentrations and/or glucose, concentrations or any other measurement, or any type of sensor for monitoring chemical species and/or composition, and/or an electrochemical sensor for monitoring various compounds within the bloods, for example, calcium, potassium, sodium and/or any other measurable compound, molecule, atom, and/or ion.


In alternate embodiments, the device can further include a second implant located either in contact with the wall or at the vicinity of the wall or in any other convenient location within a lumen. The second implant can be a second sensor such as, for example, a flow sensor for monitoring flow in the cardiovascular system or an energy source such as a battery or any other known and/or convenient device. The second implant can be connected to the first implant. For example, a first implant which is a sensor can be electrically connected, using an isolated electric wire, to a second implant which is an energy source such as battery for enabling energy transfer from the energy source to the sensor.


In one embodiment, a first implant, which can be a sensor, can be located between the lumen wall and the center of the lumen and a second implant, which can be an energy source, can be located in contact with the lumen wall and electrically connected to the sensor. This configuration enables miniaturizing of the first implant since the energy source is not a part of the sensor.


The insertion of the device into a body lumen can be performed via a catheterization procedure. The device can be mounted on a delivery system, in a compressed configuration so as to enable navigation through the lumen, and delivered through the lumen to the desired deployment site. At the desired deployment site the expandable technique and/or any other known and/or convenient method and/or mechanism.


Other techniques for inserting a device into a lumen, such-as making an incision in the lumen and suturing the device at the desired location can be applied. Additionally, the device can be connected to other implants.


Reference is now made to FIGS. 1A-1D illustrating a device that includes a fixation element having a stent-like configuration according to an embodiment of the invention. The devices shown in the embodiments include a fixation element 100, a connecting element 12 and a sensor 20. For convenience and clarity, the lumen 30 is shown in cross-section.


In the embodiment shown in FIG. 1A, fixation element 100 can be manufactured from a wire, a laser cut tube or a chemical etched tube or sheet made of metal, for example Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate or can be manufactured from any known and/or convenient material using any known and/or convenient method and having any convenient shape. In the embodiment shown in FIG. 1A, the struts 10 cross section can be round, oval, rectangular or any convenient shape. In the embodiment shown in FIG. 1A, the struts are arranged in a zigzag configuration. However in alternate embodiments, the struts can have any convenient configuration. The thickness of struts 10 is in the range of 0.05-0.5 mm. However in alternate embodiments, various other thicknesses can be used. The struts can further include ridges or hooks for preventing migration within the lumen.



FIG. 1A shows fixation element 100 having a radial zigzag configuration that is in contact with the inner side of the lumen wall. The sensor 20 can be connected to a connecting element 12 for connecting sensor 20 to fixation element 100 and for positioning sensor 20 at a desired location distanced from the lumen wall. The sensor 20 can be located between the lumen wall and the center of the lumen. In some embodiments, the sensor can be distanced from the lumen wall between 0.05 mm and 0.8r wherein r is the lumen radius. For example, for a blood vessel having radius of r=10 mm the sensor can be positioned at a distance of 0.05 to 8 mm from the vessel wall.


In some embodiments, connecting element 12 can be made of metal such as Nickel-Titanium alloy, stainless steel, titanium, cobalt-based alloy, or using tantalum, gold, platinum or platinum-iridium for enhanced radio-opacity, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate, and/or composed of any known and/or convenient material and or made in any know and/or convenient shape using any known and/or convenient method.


In some embodiments, connecting element 12 can be rigid so as to maintain sensor 20 at constant position or can be flexible as illustrated in FIG. 1D, so as to enable movement of the sensor within the lumen. In alternate embodiments, sensor 20 can be connected directly to strut 10 of fixation element 100. In selected embodiments, the sensor 20, can be located in a position proximal to the fixation element 100 to reduce neo intima and cell proliferation.


In alternate embodiments, sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. In still further alternate embodiments, the active face of the sensor 20 can be oriented towards the lumen center, the lumen wall or tangential and/or in any other convenient location.


Reference is now made to FIG. 1B, illustrating one configuration of the device having two fixation elements 100 at both sides, proximal and distal to the sensor 20. In the embodiment shown in FIG. 1B, proximal and distal fixation elements 100 can be connected at one or more points and sensor 20 can be connected to fixation element 100 by one connecting element. That is, sensor 20 can be connected to the distal or proximal strut or can be connected to the distal and proximal strut. Sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. The active face of the sensor 20 can be oriented towards the lumen center, the lumen wall or tangential or in any convenient orientation. In some embodiments, connecting element 12 can be rigid so as to maintain sensor 20 at constant position or can be flexible so as to allow movement of sensor 20.


Reference is now made to FIG. 1C, illustrating an alternate configuration of fixation element 100 in which the struts are configured in a closed cell zigzag arrangement. However in some embodiments, any known and/or convenient strut configuration can be used. Furthermore, it will be appreciated that other configurations can be used.


Reference is now made to FIGS. 2A-2B illustrating a device having a coiled fixation element 200 according to an embodiment of the invention. The device can include coiled configured fixation element 200, connecting element 12 and sensor 20. For clarity and convenience the lumen 30 is shown in cross-sectional view.


The coiled fixation element 200 can be manufactured from a wire, a laser cut tube or a chemical etched tube or sheet made of metal, for example Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate or composed of any known and/or convenient material, in any convenient shape and/or using any known and/or convenient method. The fixation element cross-section may be round, oval, rectangular etc. The thickness of strut 10 of coiled fixation element 200 is in the range of 0.05-0.5 mm. Additionally in selected embodiments, the strut can further include ridges or hooks for preventing migration within the lumen.


The coiled fixation element 200 configuration can be radial and can be in contact with the lumen wall. The sensor 20 can be connected to a connecting element 12 for connecting sensor 20 to fixation element 200 and/or for positioning sensor 20 at a desired location distanced from the lumen wall. In alternate embodiments, sensor 20 can be connected directly to coil fixation element 200. In various embodiments, the sensor can be located between the lumen wall and the center of the lumen. In alternate embodiments the sensor can be distanced from the lumen wall between 0.05 mm and 0.8r wherein r is the lumen radius. However in alternate embodiments, the sensor can be located at any convenient distance from the lumen wall. For example, for blood vessel having radius of r=10 mm the sensor can be positioned at a distance of 0.05 to 8 mm of the vessel wall. In selected embodiments, connecting element 12 can be made of metal such as Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or using tantalum, gold, platinum or platinum-iridium for enhanced radio-opacity, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate, or any known and/or convenient material, in any convenient shape and manufactured in any known and/or convenient manner. In selected embodiments, connecting element 12 can be rigid so as to maintain sensor 20 at constant position or can be flexible so as to allow movement of sensor 20.


The sensor 20 may be oriented parallel, perpendicular or at any other angle to the lumen wall. The active face of the sensor 20 can be oriented towards the lumen center, the lumen wall, tangential to the lumen wall or at any other convenient angle within the lumen. In selected embodiments, sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall.


Reference is now made to FIG. 2B, illustrating a device having coiled fixation element 200 at both sides, of sensor 20. In the embodiment shown in FIG. 2B, proximal and distal coiled fixation element 200 can be connected at one or more points. Connecting element 12 can be rigid so as to maintain sensor 20 at constant position or can be flexible so as to allow movement of sensor 20. Additionally, sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. The active face of the sensor 20 can be oriented towards the lumen center, the lumen wall or tangential. Furthermore, sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. As will be apparent to those skilled in the art, other configurations can be used.


Reference is now made to FIGS. 3A-3D, illustrating a device having a wing-configured fixation element. In the embodiments shown in FIGS. 3A-3D, the device includes wing-configured fixation element 300, connecting element 12 and a sensor 20. For convenience and clarity, the lumen 30 is shown in cross-sectional view.


The wing-configured fixation element 300 may be manufactured from a wire, a laser cut tube or a chemical etched tube or sheet made of metal, for example Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or a polymer including a shape memory polymer with or without the addition of radio-opaque material, e.g. barium sulfate, or can be comprised of any known and/or convenient material, can be manufactured using any known and/or convenient shape and can be made using any known and/or convenient method.


The struts 10 of wing configured fixation element 300 may have a round, oval, rectangular etc. cross section. The thickness of struts 10 is in the range of 0.05-0.5 mm. The thickness of the struts may be any convenient thickness. Additionally, the struts can further include ridges or hooks for preventing migration within the lumen.



FIG. 3A is a three dimensional view of the device having wing configured fixation element 300 and FIGS. 3B and 3C illustrate longitudinal and lateral cross sections, respectively.


The sensor 20 may be connected to a connecting element 12 for connecting sensor 20 to fixation element 300 and for positioning sensor 20 at a desired location distanced from the lumen wall. In other embodiment sensor 20 can be connected directly to fixation element 300. The sensor can be located between the lumen wall and the center of the lumen. In one embodiment the sensor can be distanced from the lumen wall between 0.05 mm and 0.6r wherein r is the lumen radius. For example, for a blood vessel having radius of r=10 mm the sensor can be positioned at a distance of 0.05 to 8 mm off the vessel wall. However in alternate embodiments, the sensor can be located at any convenient location within the lumen. Additionally, connecting wire 12 can be made of metal such as Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or using tantalum, gold, platinum or platinum-iridium for enhanced radio-opacity, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate, or any known and/or convenient material, made in any convenient shape using any known and/or convenient manufacturing process.


In alternate embodiments, connecting element 12 can be made of metal such as Nickel-Titanium alloy, stainless steel titanium, a polymer or any known and/or convenient material. The connecting element 12 can be rigid so as to maintain sensor 20 at constant position or can be flexible so as to enable movement of the sensor within the lumen. In alternate embodiments, sensor 20 can be connected directly to fixation element 300.


In the embodiments shown in FIGS. 3A-3C, sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. The active face of the sensor 20 can be oriented towards the lumen center, the lumen wall, tangential to the lumen wall or at any other convenient angle.



FIG. 3D illustrates a lateral cross section of another configuration of the wing fixation element 300. In the configuration shown in FIG. 3D, the sensor is at the same level as the strut. In those embodiments in which the struts 10 are made of superelastic Nickel-Titanium alloy, intermediate levels of expansion can be implemented such that the predetermined distances of the sensor from the vessel wall can be achieved.


Reference is now made to FIGS. 4A-4C, illustrating a device having a hook configured fixation element according to an embodiment of the invention. The device includes hook configured fixation element 400, connecting element 12 and a sensor 20. Cross section of lumen 30, for example a blood vessel, is shown.


Fixation element 400 can be manufactured from a wire, a laser cut or a chemical etched tube or sheet made of metal, for example Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate or of any known and/or convenient material, can be manufactured in any convenient shape using any known and/or convenient method of manufacture. The strut of fixation element 400 cross section can be round, oval, rectangular or have any convenient shape. The thickness of struts is in the range of 0.05-1 mm. The struts can have any convenient thickness and/or dimensions. Additionally, the struts can further include ridges or hooks for anchoring fixation element 400 within the lumen and preventing migration within the lumen.



FIG. 4A shows a device having a hook configured fixation element 400 that is hooked into the lumen wall at least at two points. Hooking can be at the longitudinal axis of the lumen as shown in FIG. 4A or at the transverse axis (not shown).


The sensor 20 can be connected to a connecting wire 12, which is configured so as to distance the sensor from the lumen wall. The connecting wire 12 is connected to the fixation element 400. The sensor can be located between the lumen wall and the center of the lumen. In one embodiment the sensor can be distanced from the lumen wall between 0.05 mm and 0.8r wherein r is the lumen radius. For example, for a blood vessel having radius of r=10 mm the sensor can be positioned at a distance of 0.05 to 8 mm of the vessel wall. However in alternate embodiments, the sensor can be located at any convenient location within the lumen.


Connecting element 12 can be made of metal such as Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or using tantalum, gold, platinum or platinum-iridium for enhanced radio-opacity, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate or any known and/or convenient material, can have any convenient shape and can be manufactured using any convenient manufacturing process. Connecting element 12 can be rigid so as to maintain sensor 20 at constant position or can be flexible as illustrated in FIG. 4B, so as to enable movement of the sensor within the lumen. In other embodiment sensor 20 can be connected directly to fixation element 400.


The sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. The active face of the sensor 20 can be oriented towards the lumen center, the lumen wall, tangential to the lumen wall or at any other convenient angle.


Reference is now made to FIG. 4C, illustrating another configuration of fixation element 400 in which the fixation element 400 is inserted in the lumen similarly to the insertion of a drawing pin. The sensor 20 can be directly connected to fixation element 400 or connected via a connecting wire.


The sensor 20 can be oriented parallel, perpendicular or at any other angle to the lumen wall. The active face of the sensor 20 can be oriented towards the lumen center, the lumen wall, tangential to the lumen wall or any other convenient angle. Additionally, it will be appreciated that other configurations can be used.


Reference is now made to FIG. 5 which is a schematic illustration of a device having two implants according to an embodiment of the invention. The device includes a fixation element 100, a first implant 20, a second implant 22, and a connecting element 12. For convenience and clarity, the lumen, which can be a blood vessel, is shown in cross-section.


It will be appreciated that fixation element 100 can have any other configuration such as, for example, coil, wing, hook and/or any other known and or convenient configuration.


A first implant 20 may be located between the lumen wall and the center of the lumen. First implant 20 can be distanced from the lumen wall between 0.05 mm and 0.8r wherein r is the lumen radius. For example, for a blood vessel having radius of r=10 mm the first implant can be positioned at a distance of 0.05 to 8 mm off the vessel wall. Second implant 22 can be in contact with the lumen wall or distanced from the lumen wall. However in alternate embodiments, the first and second implants can be located at any convenient locations within the lumen and relative to each other.


The first implant 20 and second implant 22 may be connected by connecting element 12. Second implant 22 can be directly connected to fixation element 100 or connected through an additional connecting element.


The connecting element 12 may be made of metal such as Nickel-Titanium alloy, stainless steel titanium, cobalt-based alloy, or using tantalum, gold, platinum or platinum-iridium for enhanced radio-opacity, or a polymer including a shape memory polymer with or without the addition of radio-opaque material e.g. barium sulfate, or of any other known and/or convenient material.


The connecting element 12 may be rigid so as to maintain first implant 20 at constant position or can be flexible so as to enable movement of first implant 20 within the lumen. Connecting element 12 that connects first implant 20 to second implant 22 can be a metallic or a plastic tube that includes an electric wire for enabling electric communication between first and second implants. The connection between first implant 20 and second implant 22 can be achieved using mechanical means, crimp, adhesives, welding or any other convenient mechanism and/or material. In alternate embodiments, the connection between the first implant 20 and second implant 22 can be wireless, wired or made in any other known and/or convenient manner. Furthermore, in embodiments in which the second implant 22 is physically connected with the first implant and/or the fixation element 100, the connection element can support both the first implant and the second implant. Alternately, each implant can have a separate connection element 12 to connect the implant with the fixation element.


In one embodiment first implant 20 can be a sensor such as pressure sensor and second implant 22 can be an energy source such as a battery. The sensor and the battery can be connected by electric wire for enabling energy transfer from the battery to the sensor.


While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular embodiments or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims
  • 1. An implantable vascular pressure sensor for sensing blood pressure within a pulmonary artery, the sensor comprising: a sensor configured to sense blood pressure within the pulmonary artery; anda fixation element configured to secure the sensor to a wall of the pulmonary artery, wherein, when the fixation element is disposed within the pulmonary artery, the sensor is located between the wall of the pulmonary artery and a center of the pulmonary artery, the fixation element including: a first wire loop having a first section fixedly attached to, and extending away from, a first portion of the sensor, the first wire loop having a second section making at least one turn, and the first wire loop having a third section returning to the sensor at, and fixedly attached to, a second portion of the sensor different from the first portion, wherein at least a part of each of the first and third sections of the first wire loop is disposed in a first plane, and at least a part of the second section of the first wire loop is disposed in a second plane that intersects the first plane, the first wire loop comprised entirely of a first wire configured to expand from a collapsed position to an expanded position within the pulmonary artery, wherein, in the expanded position of the first wire loop, an outer periphery of the first wire loop is configured to contact and assert a radial force against the wall at a first location within the pulmonary artery; anda second wire loop having a first section fixedly attached to, and extending away from, a third portion of the sensor different from the first and second portions, the second wire loop having a second section making at least one turn, and the second wire loop having a third section returning to the sensor at, and fixedly attached to, a fourth portion of the sensor different from the first, second, and third portions, wherein at least a part of each of the first and third sections of the second wire loop is disposed in a third plane, and at least a part of the second section of the second wire loop is disposed in a fourth plane that intersects the third plane, the second wire loop comprised entirely of a second wire configured to expand from a collapsed position to an expanded position within the pulmonary artery, wherein, in the expanded position of the second wire loop, an outer periphery of the second wire loop is configured to contact and assert a radial force against the wall at a second location within the pulmonary artery.
  • 2. The pressure sensor of claim 1, wherein the sensor is laterally offset from the outer periphery of the first and second wire loops such that, in the expanded position, the sensor is located radially inward and spaced a distance apart from the wall of the pulmonary artery.
  • 3. The pressure sensor of claim 1, wherein, when the fixation element is disposed within the pulmonary artery, the sensor is located less than approximately 0.8r away from the wall, wherein r represents the artery radius.
  • 4. The pressure sensor of claim 1, wherein the first and second wire loops each comprise a single wire loop.
  • 5. The pressure sensor of claim 1, further comprising a first connecting element connecting the first wire loop to the sensor and a second connecting element connecting the second wire loop to the sensor.
  • 6. The pressure sensor of claim 5, wherein the first and second connecting elements are wires.
  • 7. The pressure sensor of claim 5, wherein the first and second connecting elements are flexible.
  • 8. The pressure sensor of claim 5, wherein the first and second connecting elements are rigid.
  • 9. The pressure sensor of claim 1, wherein an active face of the sensor is adapted to be oriented towards a center of the pulmonary artery.
  • 10. The pressure sensor of claim 9, wherein the active face of the sensor is adapted to be oriented parallel to the wall of the pulmonary artery.
  • 11. The pressure sensor of claim 9, wherein the first and second wire loops are coupled to the sensor on a side opposite the active face.
  • 12. The pressure sensor of claim 9, wherein the active face of the sensor is laterally offset from the outer periphery of the first and second wire loops.
  • 13. The pressure sensor of claim 9, wherein the active face of the sensor is laterally aligned with the outer periphery of the first and second wire loops.
  • 14. The pressure sensor of claim 1, wherein the first and second wire loops are formed at least in part of a metal.
  • 15. The pressure sensor of claim 14, wherein the metal includes a nickel-titanium alloy.
  • 16. The pressure sensor of claim 1, wherein the first and second wire loops are formed at least in part of a polymer.
  • 17. The pressure sensor of claim 1, wherein the sensor includes an energy storage device.
  • 18. An implantable vascular pressure sensor for sensing blood pressure within a pulmonary artery, the sensor comprising: a sensor configured to sense blood pressure within the pulmonary artery; anda fixation element configured to secure the sensor to a wall of the pulmonary artery, wherein, when the fixation element is disposed within the pulmonary artery, the sensor is located between the wall of the pulmonary artery and a center of the pulmonary artery, the fixation element including:a first wire loop having a first section fixedly attached to, and extending away from, a first portion of the sensor, the first wire loop having a second section making at least one turn, and the first wire loop having a third section returning to the sensor at, and fixedly attached to, a second portion of the sensor different from the first portion, wherein at least a part of each of the first and third sections of the first wire loop is disposed in a first plane, and at least a part of the second section of the first wire loop is disposed in a second plane that intersects the first plane, and extending at least in part proximally from the sensor along a longitudinal axis of the pulmonary artery, the first wire loop comprised entirely of a first wire configured to expand from a collapsed position to an expanded position within the pulmonary artery, wherein, in the expanded position of the first wire loop, an outer periphery of the first wire loop is configured to contact and assert a radial force against the wall at a first location within the pulmonary artery proximal to the sensor;a second wire loop having a first section fixedly attached to, and extending away from, a third portion of the sensor different from the first and second portions, the second wire loop having a second section making at least one turn, and the second wire loop having a third section returning to the sensor at, and fixedly attached to, a fourth portion of the sensor different from the first, second, and third portions, wherein at least a part of each of the first and third sections of the second wire loop is disposed in a third plane, and at least a part of the second section of the second wire loop is disposed in a fourth plane that intersects the third plane, and extending at least in part distally from the sensor along the longitudinal axis of the pulmonary artery, the second wire loop comprised entirely of a second wire configured to expand from a collapsed position to an expanded position within the pulmonary artery, wherein, in the expanded position of the second wire loop, an outer periphery of the second wire loop is configured to contact and assert a radial force against the wall at a second location within the pulmonary artery distal to the sensor.
  • 19. An implantable vascular pressure sensor for sensing blood pressure within a pulmonary artery, the sensor comprising: a sensor configured to sense blood pressure within the pulmonary artery; anda fixation element configured to secure the sensor to a wall of the pulmonary artery, wherein, when the fixation element is disposed within the pulmonary artery, the sensor is located between the wall of the pulmonary artery and a center of the pulmonary artery, the fixation element including:a first anchoring member having a first section fixedly attached to, and extending away from, a first portion of the sensor, the first anchoring member having a second section making at least one turn, and the first anchoring member having a third section returning to the sensor at, and fixedly attached to, a second portion of the sensor different from the first portion, wherein at least a part of each of the first and third sections of the first anchoring member is disposed in a first plane, and at least a part of the second section of the first anchoring member is disposed in a second plane that intersects the first plane, the first anchoring member comprising a single wire loop formed entirely of a first wire configured to expand from a collapsed position to an expanded position within the pulmonary artery, wherein, in the expanded position, an outer periphery of the first anchoring member is configured to contact and assert a radial force against the wall at a first location within the pulmonary artery;a second anchoring member having a first section fixedly attached to, and extending away from, a third portion of the sensor different from the first and second portions, the second anchoring member having a second section making at least one turn, and the second anchoring member having a third section returning to the sensor at, and fixedly attached to, a fourth portion of the sensor different from the first, second, and third portions, wherein at least a part of each of the first and third sections of the second anchoring member is disposed in a third plane, and at least a part of the second section of the second anchoring member is disposed in a fourth plane that intersects the third plane, the second anchoring member comprising a single wire loop formed entirely of a second wire configured to expand from a collapsed position to an expanded position within the pulmonary artery, wherein, in the expanded position, an outer periphery of the second anchoring member is configured to contact and assert a radial force against the wall at a second location within the pulmonary artery.
CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 11/034,502, filed on Jan. 12, 2005, which claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Ser. No. 60/536,580, entitled “Device for Fixing a Sensor in a Lumen,” filed on Jan. 13, 2004, each of which are expressly incorporated herein by reference in their entirety.

US Referenced Citations (220)
Number Name Date Kind
3874388 King et al. Apr 1975 A
4391124 Drost et al. Jul 1983 A
4407296 Anderson Oct 1983 A
4485813 Anderson et al. Dec 1984 A
4492107 Sandhu Jan 1985 A
4672976 Kroll Jun 1987 A
4836204 Landymore et al. Jun 1989 A
4846191 Brockway et al. Jul 1989 A
4886065 Collings, Jr. Dec 1989 A
4900303 Lemelson Feb 1990 A
4917089 Sideris Apr 1990 A
4966148 Millar Oct 1990 A
5040538 Mortazavi Aug 1991 A
5218965 Ring Jun 1993 A
5284138 Kujawski Feb 1994 A
5303207 Brady et al. Apr 1994 A
5334217 Das Aug 1994 A
5411551 Winston et al. May 1995 A
5415630 Gory et al. May 1995 A
5451235 Lock et al. Sep 1995 A
5509900 Kirkman Apr 1996 A
5604531 Iddan et al. Feb 1997 A
5634936 Linden et al. Jun 1997 A
5656036 Palmaz Aug 1997 A
5662711 Douglas Sep 1997 A
5704352 Tremblay et al. Jan 1998 A
5725552 Kotula et al. Mar 1998 A
5733249 Katzin et al. Mar 1998 A
5733294 Forber et al. Mar 1998 A
5733313 Barreras, Sr. et al. Mar 1998 A
5772669 Vrba Jun 1998 A
5775331 Raymond et al. Jul 1998 A
5800497 Bakels et al. Sep 1998 A
5824053 Khosravi et al. Oct 1998 A
5833603 Kovacs et al. Nov 1998 A
5855563 Kaplan et al. Jan 1999 A
5860923 Lenker et al. Jan 1999 A
5891154 Loeffler Apr 1999 A
5967980 Ferre et al. Oct 1999 A
5967986 Cimochowski et al. Oct 1999 A
5967989 Cimochowski et al. Oct 1999 A
5995876 Kruse et al. Nov 1999 A
6002969 Machek et al. Dec 1999 A
6015386 Kensey et al. Jan 2000 A
6015387 Schwartz et al. Jan 2000 A
6030413 Lazarus Feb 2000 A
6033366 Brockway et al. Mar 2000 A
6053873 Govari et al. Apr 2000 A
6076016 Feierbach Jun 2000 A
6077227 Miesel et al. Jun 2000 A
6097984 Douglas Aug 2000 A
6106464 Bass et al. Aug 2000 A
6140740 Porat et al. Oct 2000 A
6159156 Van Bockel Dec 2000 A
6179858 Squire et al. Jan 2001 B1
6193745 Fogarty et al. Feb 2001 B1
6214025 Thistle et al. Apr 2001 B1
6231516 Keilman et al. May 2001 B1
6236889 Soykan et al. May 2001 B1
6239724 Doron et al. May 2001 B1
6240312 Alfano et al. May 2001 B1
6246898 Vesely et al. Jun 2001 B1
6277078 Porat et al. Aug 2001 B1
6278790 Davis et al. Aug 2001 B1
6309350 Van Tassel Oct 2001 B1
6328669 Imanishi et al. Dec 2001 B1
6328699 Eigler et al. Dec 2001 B1
6331163 Kaplan Dec 2001 B1
6379308 Brockway et al. Apr 2002 B1
6409674 Brockway et al. Jun 2002 B1
6416474 Penner et al. Jul 2002 B1
6432050 Porat et al. Aug 2002 B1
6442413 Silver Aug 2002 B1
6447522 Gambale et al. Sep 2002 B2
6475170 Doron et al. Nov 2002 B1
6486588 Doron et al. Nov 2002 B2
6527780 Wallace et al. Mar 2003 B1
6543272 Vitek Apr 2003 B1
6585763 Keilman et al. Jul 2003 B1
6592553 Zhang et al. Jul 2003 B2
6628989 Penner et al. Sep 2003 B1
6645143 Van Tassel et al. Nov 2003 B2
6660021 Palmer et al. Dec 2003 B1
6685638 Taylor et al. Feb 2004 B1
6699186 Wolinsky et al. Mar 2004 B1
6702847 DiCarlo Mar 2004 B2
6730108 Van Tassel et al. May 2004 B2
6738671 Christophersom et al. May 2004 B2
6743173 Penner et al. Jun 2004 B2
6746404 Schwartz Jun 2004 B2
6747916 Fleury et al. Jun 2004 B1
6755855 Yurek et al. Jun 2004 B2
6764446 Wolinsky et al. Jul 2004 B2
6783499 Schwartz Aug 2004 B2
6800060 Marshall Oct 2004 B2
6840956 Wolinsky et al. Jan 2005 B1
6855115 Fonseca et al. Feb 2005 B2
6868288 Thompson Mar 2005 B2
6890303 Fitz May 2005 B2
6899729 Cox et al. May 2005 B1
6904308 Frisch et al. Jun 2005 B2
6920347 Simon et al. Jul 2005 B2
6926670 Rich Aug 2005 B2
6934573 Glukhovsky et al. Aug 2005 B1
6950690 Meron et al. Sep 2005 B1
6958034 Iddan Oct 2005 B2
6970742 Mann et al. Nov 2005 B2
6972017 Smith et al. Dec 2005 B2
6984205 Gazdzinski Jan 2006 B2
7001329 Kobayashi et al. Feb 2006 B2
7006858 Silver et al. Feb 2006 B2
7009634 Iddan et al. Mar 2006 B2
7011671 Welch Mar 2006 B2
7024248 Penner et al. Apr 2006 B2
7033322 Silver Apr 2006 B2
7035684 Lee Apr 2006 B2
7039453 Mullick et al. May 2006 B2
7060038 Letort et al. Jun 2006 B2
7064472 Peline et al. Jun 2006 B2
7065409 Mazar Jun 2006 B2
7065709 Ellis et al. Jun 2006 B2
7083822 Brightbill Aug 2006 B2
7116352 Yaron Oct 2006 B2
7118529 Glukhovsky et al. Oct 2006 B2
7118531 Krill Oct 2006 B2
7131986 Sirhan et al. Nov 2006 B2
7160258 Imran et al. Jan 2007 B2
7181261 Silver et al. Feb 2007 B2
7198603 Penner et al. Apr 2007 B2
7211045 Dala-Krishna et al. May 2007 B2
7273457 Penner Sep 2007 B2
7283874 Penner Oct 2007 B2
7308319 Lovett et al. Dec 2007 B2
7338512 McGuckin, Jr. et al. Mar 2008 B2
7347868 Burnett et al. Mar 2008 B2
7392094 Zhang et al. Jun 2008 B2
7437193 Parramon et al. Oct 2008 B2
7452334 Gianchandani et al. Nov 2008 B2
7477946 Tockman et al. Jan 2009 B2
7555351 Zhang et al. Jun 2009 B2
7780694 Palmer et al. Aug 2010 B2
7850708 Pal Dec 2010 B2
7890188 Zhang et al. Feb 2011 B2
9026229 Stalker et al. May 2015 B2
20020077555 Schwartz Jun 2002 A1
20020123672 Christophersom et al. Sep 2002 A1
20020151816 Rich et al. Oct 2002 A1
20020165601 Clerc Nov 2002 A1
20020183628 Reich et al. Dec 2002 A1
20020188207 Richter Dec 2002 A1
20030114897 Von Arx et al. Jun 2003 A1
20030139796 Sequin et al. Jul 2003 A1
20030195606 Davidson et al. Oct 2003 A1
20030200031 de Kok Oct 2003 A1
20040006377 Behm Jan 2004 A1
20040054403 Israel Mar 2004 A1
20040116992 Wardle et al. Jun 2004 A1
20040147969 Mann et al. Jul 2004 A1
20040176672 Silver et al. Sep 2004 A1
20040204744 Penner et al. Oct 2004 A1
20040215228 Simpson et al. Oct 2004 A1
20050080472 Atkinson et al. Apr 2005 A1
20050096702 Denker et al. May 2005 A1
20050115561 Stahmann et al. Jun 2005 A1
20050124875 Kawano et al. Jun 2005 A1
20050136385 Mann et al. Jun 2005 A1
20050149108 Cox Jul 2005 A1
20050149128 Heil, Jr. et al. Jul 2005 A1
20050149155 Scheiner et al. Jul 2005 A1
20050149156 Libbus et al. Jul 2005 A1
20050154321 Wolinsky et al. Jul 2005 A1
20050165456 Mann et al. Jul 2005 A1
20050182387 Webler Aug 2005 A1
20050209678 Henkes et al. Sep 2005 A1
20050245840 Christopherson et al. Nov 2005 A1
20060009818 Von Arx et al. Jan 2006 A1
20060047205 Ludomirsky et al. Mar 2006 A1
20060064133 Von Arx et al. Mar 2006 A1
20060064134 Mazar et al. Mar 2006 A1
20060064142 Chavan et al. Mar 2006 A1
20060064143 Von Arx et al. Mar 2006 A1
20060079740 Silver et al. Apr 2006 A1
20060089627 Burnett et al. Apr 2006 A1
20060089694 Zhang et al. Apr 2006 A1
20060122522 Chavan et al. Jun 2006 A1
20060136004 Cowan et al. Jun 2006 A1
20060142819 Penner et al. Jun 2006 A1
20060149329 Penner Jul 2006 A1
20060149330 Mann et al. Jul 2006 A1
20060178586 Dobak, III Aug 2006 A1
20060206153 Libbus et al. Sep 2006 A1
20060241735 Tockman et al. Oct 2006 A1
20060259085 Zhang et al. Nov 2006 A1
20060287700 White et al. Dec 2006 A1
20060293741 Johnson et al. Dec 2006 A1
20070049833 Tearney et al. Mar 2007 A1
20070060959 Salo et al. Mar 2007 A1
20070129637 Wolinsky et al. Jun 2007 A1
20070156126 Flaherty Jul 2007 A1
20070156205 Larson et al. Jul 2007 A1
20070162090 Penner Jul 2007 A1
20070179583 Goetzinger et al. Aug 2007 A1
20070191904 Libbus et al. Aug 2007 A1
20070208390 Von Arx et al. Sep 2007 A1
20070247565 Sasiaki et al. Oct 2007 A1
20070250126 Maile et al. Oct 2007 A1
20070274565 Penner Nov 2007 A1
20070282413 Tockman et al. Dec 2007 A1
20070282415 Tockman et al. Dec 2007 A1
20080071178 Greenland et al. Mar 2008 A1
20080071248 Delgado et al. Mar 2008 A1
20080071339 Stalker et al. Mar 2008 A1
20080108904 Heil May 2008 A1
20080176271 Silver et al. Jul 2008 A1
20080275350 Liao et al. Nov 2008 A1
20080283066 Delgado et al. Nov 2008 A1
20090054793 Nunez et al. Feb 2009 A1
20090171274 Harlev et al. Jul 2009 A1
20100016840 Stahmann et al. Jan 2010 A1
20100210923 Li et al. Aug 2010 A1
Foreign Referenced Citations (30)
Number Date Country
0897690 Feb 1999 EP
0928598 Aug 2000 EP
1068836 Jan 2001 EP
1488735 Jun 2007 EP
2333044 Jul 1999 GB
H(11)-089942 Apr 1999 JP
2000-507142 Jun 2000 JP
2001-061790 Mar 2001 JP
2006-500991 Jan 2006 JP
WO 8303348 Oct 1983 WO
WO 9934731 Jul 1999 WO
WO 0016686 Mar 2000 WO
WO 0059376 Oct 2000 WO
WO 0167989 Sep 2001 WO
WO 0187137 Nov 2001 WO
WO 2004024034 Mar 2004 WO
WO 2004110263 Dec 2004 WO
WO 2005058202 Jun 2005 WO
WO 2005066849 Jul 2005 WO
WO 2005067817 Jul 2005 WO
WO 2006062725 Jun 2006 WO
WO 2007057739 May 2007 WO
WO 2007062299 May 2007 WO
WO 2007082115 Jul 2007 WO
2008002654 Jan 2008 WO
WO 2008034077 Mar 2008 WO
WO 2008057720 May 2008 WO
WO2008060197 May 2008 WO
WO 2008144191 Nov 2008 WO
2009006610 Jan 2009 WO
Non-Patent Literature Citations (9)
Entry
Holmes et al. “SirolimusEluting Stents vs. Vascular Brachytherapy for InStent Restenosis Within BareMetal Stents” JAMA295 (11): 1264-1273 Mar. 15, 2006.
Lanning & Shandas, “Development and Validation of Implantable Sensors for Monitoring Function of Prosthetic Heart Valves: In Vitro Studies”, Medical & Biological Engineering & Computing, Jul. 2003, vol. 41, issue 4, pp. 416-424.
Sheth et al. “Subacute Thrombosis and Vascular Injury Resulting From Slotted-Tube Nitinol and Stainless Steel Stents in a Rabbit Carotid Artery Model” Circulation 1996, 94: 1733-1740.
Stone et al. “Paclitaxel-Eluting Stents vs.Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents” JAMA 295(11): 1253-1263, Mar. 15, 2006.
Wenaweser et al. “Stent thrombosis following baremetal stent implantation: success of emergency percutaneous coronary intervention and predictors of adverse outcome” European Heart Journal 26: 1180-1187 2005.
Goodall, Eleanor V. et al., “Position-Seletive Activation of Peripheral Nerve Fibers with a Cuff Electrode”, IEEE Transactions on Biomedical Engineering, IEEE Service Center, Piscataway, NJ, US, vol. 43, No. 8, Aug. 1, 1996.
International Search Report and Written Opinion issued in PCT/US2010/020756, mailed Sep. 27, 2010.
Invitation to Pay Fees and Partial Search Report issued in PCT/US2010/020756, mailed May 12, 2010.
Mullins, C.E. et al., “Implantation of Balloon-Expandable Intravascular Grafts by Catheterization in Pulmonary Arteries and Systemic Veins”, Circulation, 1988, vol. 77, pp. 188-199.
Related Publications (1)
Number Date Country
20090270742 A1 Oct 2009 US
Provisional Applications (1)
Number Date Country
60536580 Jan 2004 US
Continuations (1)
Number Date Country
Parent 11034502 Jan 2005 US
Child 12496904 US