JP2009515582A - Implantable device for securing a sensor to a body lumen - Google Patents

Abstract

  A first dimension of an implant for sensing a parameter in a patient's anatomical vascular network is extended to securely engage the wall of the vascular network in a first longitudinal position. A fixing element; a second fixing element having a shape and dimension that is extended to securely engage the wall of the tube network at a second longitudinal position; and a first fixing element and a second fixing element. Including a coupling element mechanically coupled to each other in a joint-like manner and a sensing element mechanically coupled to the first fixed element located on the opposite side of the coupling element.

Description

  The present invention relates to the field of implantable medical devices, and in particular, to implantable devices for placing sensors in body lumens, eg, in blood vessel lumens.

  It is well known to use sensor devices in anatomical lumens. For example, US Pat. No. 4,485,813 describes a cardiac pacemaker sensor that can be permanently implanted at a specific location within a patient's body. U.S. Pat. Nos. 6,645,143, 6,053,873, 6,442,413, and U.S. Patent Publication No. 2002/0188207 can be permanently implanted in a blood vessel for detection, and the detection results can be telemetryd. A medical monitoring sensor designed to be transmitted to an external monitor via a link is described. The implanted sensing device is used to monitor physiological parameters within the patient's body.

  Forces generated by blood flow and / or heart motion (acting on an embedded sail-shaped sensing device) try to pull the sensing device longitudinally along the blood vessel, or the sensing device may branch blood vessels In order to rotate the detection device when it is embedded in the vicinity of the bifurcation, it is important that the fixing force formed by the detection device and the blood vessel wall is as large as possible. However, when a strong local or radial force is applied to the relatively fragile pulmonary network wall, it can result in perforations or aneurysms. Many intravascular implantation techniques assume that the segment of the vessel intended to be implanted with the sensing device is straight (ie, has no branches). However, the blood vessel segment may be branched. If the vessel segment near the branch is long enough to accommodate the entire length of the sensing device, the sensing device is implanted in the blood vessel regardless of the branch. However, if the length of the blood vessel segment is limited, the sensing device may not be properly embedded within the blood vessel segment unless it is positioned across the bifurcation. In this case, the implanted sensing device may interfere with future access to the vessel branch, eg, becomes unstable due to blood flow flowing across the bifurcation during catheter insertion, and even worse. In particular, it can produce blood clots that can cause embolism. As a result, the length of the sensing device sufficient to be secured to the vessel wall may have to be reduced in order to accommodate the branched vessel. Also, the diameter of many blood vessels is not uniform and is conical, and therefore further attempts have been made to increase the length of the sensing device.

  The right pulmonary artery is often a target for implanting sensors to monitor hemodynamic parameters indicative of heart efficiency or to measure blood glucose levels, but it is bifurcated and not uniform. For example, referring to FIG. 1, an implantable sensing device 10 (which generally includes a fixation element 12 (eg, a stent) and a detection element 14 coupled to the fixation element 12) is placed in the patient's right pulmonary artery RPA. The state of being embedded is shown. As indicated by the arrows, blood flows from the right ventricle RV of the heart through the main pulmonary artery MPA, which branches into the right pulmonary artery RPA and the left pulmonary artery LPA. Thus, when the sensing element 14 is implanted, it can monitor, for example, hemodynamic parameters of blood flowing from the right ventricle RV.

  As seen in FIG. 1, the right pulmonary artery RPA branches into various side branches SBR, all of which are crossed by the sensing device 10 to prevent the above problems from occurring. Absent. However, the segment of the right pulmonary artery RPA in which the sensing device can be implanted (ie, the starting point of the right pulmonary artery RPA and the first side branch SBR (anatomically referred to as “Truncus anterior”) ) Is relatively short (on average 40 mm), the length of the fixing element 12 has to be relatively short in order to accommodate the side branch SBR.

  The stability of the sensing device 10 may be reduced due to the fixing element 12 having to be relatively short. Further, as seen in FIG. 1, the diameter of the right pulmonary artery RPA is substantially reduced in the distal direction (ie, from right to left), thereby allowing the vessel at the proximal end of the fixation element 12 to Engagement is weaker than the engagement of the distal end of the anchoring element 12 to the blood vessel, which further reduces the stability of the sensing device 10.

U.S. Pat. No. 4,485,813 US Pat. No. 6,645,143 US Pat. No. 6,053,873 US Pat. No. 6,442,413 US Patent Application Publication No. 2002/0188207 US Pat. No. 6,764,446 US Pat. No. 7,024,248

  Accordingly, there is a need to provide improved techniques for implanting sensing devices into non-uniform and bifurcated anatomical tubes.

  In accordance with one embodiment of the present invention, an implant is provided for sensing parameters within a patient's anatomical vascular network (eg, vascular network). The implant includes a first anchoring element having a shape and dimension that is extended to securely engage the wall of the tube network in a first longitudinal position; A second anchoring element having a geometric dimension that is extended to engage firmly in a longitudinal position. The anchoring element has any suitable element form (eg, stent or coil). The first longitudinal position and the second longitudinal position can be, for example, within a single anatomical tube or a main anatomical tube and an anatomical tube branch of the main anatomical tube Each inside. In one method, the vascular network has substantially different diameters at the first longitudinal position and the second longitudinal position.

  The implant of the present invention further includes a connecting element that mechanically connects the first fixing element and the second fixing element in an articulated manner. The implant includes a third anchoring element having a geometry that is extended to securely engage the wall of the tube network in a third longitudinal position, and a second anchoring element and a third anchoring element. Another connecting element that is mechanically articulated may optionally be included. Articulating the fixation elements allows the fixation elements to stretch and move relative to each other, thus, for example, connecting the fixation elements to a vessel segment that is misaligned (eg, the primary Anatomical tubes and branches of anatomical tubes) or in non-uniform diameter vessel segments.

  The implant of the present invention further includes a sensing element mechanically coupled to the first fixation element located on the opposite side of the coupling element. Sensing elements include, for example, pressure sensors, accelerometers, position sensors, wall motion sensors, flow sensors, temperature sensors, oxygen sensors, calcium sensors, potassium sensors, glucose sensors, coagulum sensors, electrical activity sensors, pH sensors One or more. In an optionally used embodiment, the implant further includes a transmitter configured to wirelessly transmit information detected by the sensing element to a remote receiver.

  The drawings illustrate the design and utility of embodiments of the present invention, in which similar elements are designated with common reference numerals.

  Reference is now made to FIG. 2 to describe an implantable sensing device 20 configured in accordance with the present invention. The sensing device 20 is shown embedded in the anatomical canal network, specifically in the patient's pulmonary artery network. As mentioned above, blood flows out of the right ventricle RV of the heart H and passes through the main pulmonary artery MPA. The main pulmonary artery MPA branches into a right pulmonary artery RPA and a left pulmonary artery LPA. Blood flowing from the right pulmonary artery RPA further flows into various pulmonary artery branches PBR of the right pulmonary artery RPA.

  The sensing device 20 generally includes a proximal anchoring element 22, a distal anchoring element 24, a coupling element 26 that mechanically couples the proximal anchoring element 22 to the distal anchoring element 24, sensing The sensing element 28 is mechanically coupled to the proximal anchoring element 22 via another coupling element 30 located opposite the coupling element 26 (ie, proximal anchoring). Element 22 is between connecting element 26 and connecting element 30). As shown in FIG. 2, the proximal fixation element 22 is firmly engaged with the wall of the right pulmonary artery RPA at a longitudinal position proximal to the side branch SBR, while the distal The side fixing element 24 is firmly engaged with the wall portion of the side branch SBR.

  Using two anchoring elements 22, 24 effectively increases the force of longitudinally anchoring the sensing device 20 and the vascular wall of the pulmonary artery network, so that the sensing device 20 is in the right pulmonary artery after its implantation. It will be appreciated that the possibility of moving within the RPA is minimized. Further, since the distal fixation element 24 is disposed in the side branch SBR so as to cross the lumen of the right pulmonary artery RPA, the force for fixing the detection device 20 and the blood vessel wall of the pulmonary artery network is applied to the right pulmonary artery RPA. It is also increased in the direction of rotation about the longitudinal axis.

  Advantageously, the coupling element 26 allows the fixation element 22 and the fixation element 24 to be articulated with respect to each other, whereby the proximal fixation element 22 is placed in the right pulmonary artery RPA, In addition, the distal fixation element 24 can be more easily placed in the pulmonary artery branch BR. Further, only the portion of the detection device 20 located in the branch portion between the right pulmonary artery RPA and the side branch SBR is the relatively low profile connecting element 26. As a result, the force applied to the detection device 20 by the blood flowing from the right pulmonary artery RPA into the side branch SBR becomes very small, thereby improving the stability of the detection device 20 in the right pulmonary artery RPA and embolism. (Embolism occurs due to clots formed by obstructed blood flow when the sensing device is unstable). Furthermore, because the connecting element 26 is low profile, future access to the side branch SBR is not significantly hindered, thereby maintaining a state where a catheter can be inserted into the side branch SBR as needed or required.

  The other coupling element 30 may be rigid to maintain the sensing element 28 in place, or may be flexible to allow the sensing element 28 to move within the vessel lumen. In the illustrated embodiment, the other coupling element 30 causes the sensing element 28 to be at a distance between the vessel wall and the center of the vessel lumen, for example, between 0.05 mm and 0.8r (r is the radius of the vessel lumen). maintain. For example, in the case of a blood vessel cavity having a radius of r = 10 mm, the sensing element 28 can be disposed at a distance of 0.05 mm to 8 mm from the blood vessel wall. In another embodiment, the sensing element 28 can be placed against or near the vessel wall or at any other convenient location within the vessel lumen. In these cases, the sensing element 28 may be directly coupled to the proximal fixation element 22.

  As shown in FIG. 2, each of the fixation elements 22, 24 has an expandable stent-like structure that applies an outwardly biasing radial force against the vessel wall. One or more struts connected to each other. In the illustrated embodiment, the elastic struts have a radially open zigzag structure. Alternatively, the elastic struts can have a radially closed zigzag structure, as shown in FIG. In either case, the extended dimensions (specifically the diameter) of the fixation elements 22, 24 are within the respective vessel segment intended to be placed (in this case the right pulmonary artery RPA and the side branch SBR). Are individually selected to provide the required fixation force, so that the expanded diameter of the proximal fixation element 22 is greater than the extended diameter of the distal fixation element 24.

  In the illustrated embodiment, the struts of the fixation elements 22, 24 are constructed of a suitable material that allows the fixation elements 22, 24 to self-extend radially outward even when no compressive force is applied. . For this purpose, the fixing elements 22, 24 can be manufactured from wires, laser cut tubes, or chemically etched tubes, or metal sheets. These tubes or sheets are composed of a suitable biocompatible material, such as a nickel-titanium alloy, stainless steel, titanium, or a cobalt-based alloy, or make the detector radiopaque. To enhance, composed of tantalum, gold, platinum, or platinum iridium. Alternatively, the anchoring elements 22, 24 can be composed of a polymer comprising a shape memory polymer, which can be added with or without a radiopaque material (eg, barium sulfate). Good. The cross-section of the struts can be circular, elliptical, rectangular, or other convenient shape. The strut thickness ranges from 0.05 mm to 0.5 mm. The struts optionally include ridges, barbs, or hooks to prevent the sensing device 20 from moving within the vessel lumen.

  Each of the coupling elements 26, 30 is constructed from a suitable biocompatible material (eg, a nickel-titanium alloy, stainless steel, titanium, or cobalt-based alloy) or is radiopaque of the sensing device. In order to increase the resistance, it is composed of tantalum, gold, platinum, or platinum iridium. Alternatively, the linking elements 26, 30 may be composed of a polymer that includes a shape memory polymer, to which a radiopaque material (eg, barium sulfate) may or may not be added. .

  In the illustrated embodiment, the sensing element 28 is a pressure sensor for monitoring blood pressure in the blood vessel. However, any known sensors can be used, including accelerometers, wall motion sensors, flow sensors, temperature sensors, oxygen sensors, glucose sensors, coagulation sensors, electrical activity sensors, pH sensors. It is not limited to these. In another embodiment, another motion element can be placed in contact with or near the vessel wall or at any other convenient location within the vessel lumen. This operating element may be another sensing element different from sensing element 28 or may be an energy source, for example a battery. For example, insulated wires can be used to electrically connect sensing element 28 to the battery to allow energy transfer from the battery to sensing element 28. A more detailed description of the structure and function of the implantable sensing element is disclosed in US Pat. Nos. 6,764,446 and 7,024,248.

  Referring now to FIG. 4, the detection device 20 is shown embedded in the vascular network with a different configuration. Specifically, the proximal fixation element 22 is firmly engaged with the wall of the right pulmonary artery RPA at a longitudinal position proximal to the side branch SBR, while the distal fixation element 24 is The wall portion of the right pulmonary artery RPA is firmly engaged at a longitudinal position distal to the side branch SBR.

  As described above with respect to FIG. 2, the use of two fixation elements 22, 24 effectively increases the force of longitudinally fixing the sensing device 20 and the vascular wall of the pulmonary artery network, thereby It will be appreciated that the sensing device 20 minimizes the possibility of movement within the right pulmonary artery RPA after its implantation. Furthermore, since the fixation element 22 and the fixation element 24 are articulated with respect to each other, the non-uniform diameter along the right pulmonary artery RPA does not significantly reduce the fixation capability of the sensing device 20. The structure shown in FIG. 4 does not use the side branch SBR as a fixing mechanism, but this structure is adapted to the side branch SBR only by disposing the low profile connecting element 26 at the branch portion. The connecting element 26 may be arranged so as to cross the side branch SBR, or may be arranged so as to be shifted from the side branch SBR without crossing the side branch SBR so as to maintain the full opening of the side branch SBR.

  With reference now to FIG. 5, another implantable sensing device 40 constructed in accordance with the present invention will be described. The sensing device 40 is similar to the sensing device 40 described above, except that the sensing element 28 is connected between the fixed element 22 and the fixed element 24. As can be seen, the sensing element 28 is suspended at the bifurcation in the lumen of the right pulmonary artery RPA. Preferably, the sensing element 28 is placed as far as possible from the bifurcation to minimize blockage of the side branch SBR. Otherwise, the possibility of movement and / or embolism of the sensing element 28 may be increased. An optional coupling element 34 can be mechanically coupled between the securing element 22 and the securing element 24 to further support the securing element and thereby increase the securing force of the sensing device 40.

  With reference now to FIG. 6, another implantable sensing device 50 constructed in accordance with the present invention will be described. The sensing device 50 is similar to the sensing device 20 described above, except that a sensing element 28 is attached to the coupling element 26 between the fixed element 22 and the fixed element 24. As can be seen, the fixation element 22 is firmly engaged with the wall of the right pulmonary artery RPA at a longitudinal position distal to the side branch SBR, while the distal fixation element 24 is side branch. It is firmly engaged with the wall of the SBR. As can be seen, the sensing element 28 is suspended at the bifurcation in the lumen of the right pulmonary artery RPA. Preferably, the sensing element 28 is arranged as far as possible from the bifurcation to minimize blockage of the side branch SBR. Otherwise, the possibility of movement and / or embolism of the sensing element 28 may be increased.

  Although the implantable sensing device 20, 40, 50 has been described as having only two fixed elements and only one sensing element, there are three or more implantable sensing devices constructed in accordance with the present invention. It can have a fixed element, two or more sensing elements. For example, referring to FIG. 7, an implantable sensing device 60 generally includes a proximal fixation element 62, an intermediate fixation element 64, a distal fixation element 66, and a proximal fixation element 62 in an intermediate position. A first coupling element 68 that mechanically couples to the anchoring element 64, a second coupling element 70 that mechanically couples the distal anchoring element 66 to the anchoring element 64 in the intermediate position, and anchoring elements 62, 64, 66 Each includes three sensing elements 72, 74, 76 mechanically coupled via three coupling elements 78, 80, 82. The fixing elements 62, 64, 66, the coupling elements 78, 80, 82, and the sensing elements 72, 74, 76 are configured similarly to the parts having the same names described above, and can have similar functions.

  As shown in FIG. 7, the proximal fixation element 62 is firmly engaged with the wall of the right pulmonary artery RPA at a longitudinal position proximal to the side branch SBR, and the intermediate fixation element 64. Is firmly engaged with the wall of the side branch SBR and the distal fixation element 66 is firmly engaged with the wall of the right pulmonary artery RPA at a longitudinal position distal to the side branch SBR. . Therefore, the use of three fixing elements (one of which is arranged on the side branch SBR) further increases the force for fixing the sensing device 60 and the vessel wall in the pulmonary artery network in the longitudinal and rotational directions. Thus, it will be appreciated that the sensing device 20 further minimizes the possibility of movement within the right pulmonary artery RPA after its implantation. Furthermore, the use of three sensing elements increases the amount and / or type of information detected in the right pulmonary artery RPA.

  Up to this point, the anchoring element has been described as having a stent-like structure, but the anchoring element can be another structure suitable for tightly engaging the wall of an anatomical tube (an anchoring element of the same device). Can have different). For example, referring to FIG. 8, an implantable sensing device 90 is similar to the sensing device 20 shown in FIG. 2, except that the sensing device 90 has a distal locking element 24 of a stent-like structure. , Including two distal anchoring elements 92, 94 in a coiled structure, the anchoring elements 92, 94 being mechanically coupled to the proximal anchoring element 22 via respective coupling elements 96, 98. . Each of the coiled securing elements 92, 94 includes a single wire, which may have the same cross section as the struts of the securing elements 22, 24 previously described with respect to FIG. 2 and be constructed from the same material. . As shown, the fixation element 92 is firmly engaged with the wall of the right pulmonary artery RPA at a position distal to the side branch SBR, and the fixation element 94 is firmly engaged with the wall of the side branch SBR. This provides the same locking advantages as the implantable sensing device 20 of FIG.

  Implantable sensing devices constructed in accordance with the present invention can have a stabilizing element in addition to a fixed element. For example, referring to FIG. 9, the implantable sensing device 100 is similar to the sensing device 20 shown in FIG. 2, except that instead of the distal fixation element 24, a stabilizing element in the form of a flange 102 is provided. It is mechanically connected to the proximal fixation element 22. In the illustrated embodiment, the flange 102 is formed by folding the struts of the securing element 22 in a loop. The flange 102 is pre-formed to extend from the fixing element 22 at a predetermined angle (ie, in a direction transverse or oblique to the longitudinal axis of the fixing element 22) and to contact the wall of the side branch SBR. (For example, by appropriate heat treatment of the nickel-titanium alloy), thereby increasing the force of securing between the sensing device 20 and the pulmonary artery network in both the longitudinal and rotational directions. Preferably, the flange 102 is constructed from a material that is sufficiently rigid to provide the necessary stability to the sensing device 100.

  With reference to FIG. 10, another implantable sensing device 110 is described. The sensing device 110 is similar to the sensing device 100 of FIG. 9 described above, but instead of the proximal fixation element 22, it is rigidly attached to the wall of the right pulmonary artery RPA at a position distal to the side branch SBR. It includes a distal fixation element 24 that is configured to be engaged. Similar to the sensing device 100, the sensing device 110 includes a flange 112, which extends at a predetermined angle from the distal fixation element 24 and contacts the wall of the side branch SBR. 24, and having such a shape, thereby increasing the force of fixing between the sensing device 100 and the pulmonary network in both the longitudinal and rotational directions. The flange 112 is formed by folding the struts of the securing element 24 in a loop and is preferably constructed from a material that is sufficiently rigid to provide the required stability to the sensing device 110.

  With reference to FIG. 11, yet another implantable sensing device 120 will be described. The sensing device 120 is similar to the sensing device 110 described above in FIG. 10 except that it includes a non-preformed flange 122 for extending into the side branch SBR. Rather, the flange 122 is relatively straight so as to remain in the lumen within the right pulmonary artery RPA. In addition, the sensing element 28 is mechanically coupled between the distal fixation element 24 and the flange 122. The flange 122 is not designed to extend into the side branch SBR and thus does not significantly increase the rotational force in the rotational direction about the longitudinal axis of the right pulmonary artery RPA, but the flange 122 does not increase the right pulmonary artery RPA. This prevents the sensing element 28 from bending into the side branch SBR in response to blood flow flowing from the right pulmonary artery RPA into the side branch SBR.

  With reference to FIG. 12, a further implantable sensing device 130 constructed in accordance with the present invention will be described. The sensing device 130 includes a single stationary element 132 to which the previously described sensing element 28 is mechanically coupled. The fixation element 132 is similar to any of the fixation elements 22 and 24 of FIG. 2 described above, but the length of the fixation element 132 is increased so that the fixation element 132 can cross the side branch SBR. ing. For example, the length of the fixing element 132 is 35 mm or more. Increasing the length of the fixation element 132 increases the force of fixation between the sensing device 130 and the wall of the pulmonary artery network. In order to further increase the fixation performance of the fixation element 132, the proximal and distal edges of the fixation element 132 can be curved radially outward as shown in FIG. A gripping force is provided, which reduces the longitudinal movement of the sensing device 130. Alternatively, as shown in FIG. 14, the proximal and distal edges of the fixation element 132 may be curved radially inward. This can increase the elastic spring force of the fixation element 132 so that the edges of the fixation element 132 damage the wall of the right pulmonary artery RPA and in other situations the wall of the right pulmonary artery RPA. The fixing force of the fixing element 132 is increased without worrying about stimulating the part.

  If the anchoring element 132 has a relatively uniform diameter along its length, embedding the anchoring element 132 in a conical vessel creates a spring force that tends to push the sensing device 130 proximally. It is obvious that For this purpose, the anchoring element 132 has a conical shape dimension similar to the conical shape of the blood vessel, as shown in FIG. 15 (for example, a cone angle of 0 to 40 degrees and a length of 10 to 35 mm). Is preformed to have In this case, the anchoring element 132 will fit within the blood vessel such that the larger diameter of the anchoring element 132 will accommodate the larger diameter of the blood vessel and the smaller diameter of the anchoring element 132 will accommodate the smaller diameter of the blood vessel. Placed in. In this way, the tendency of the fixing element 132 that is not loaded to move from the position where the fixing element 132 is to be disposed is weakened. Alternatively, the fixation element 132 is arranged like a mirror image of a blood vessel, as shown in FIG. That is, the large diameter of the fixation element 132 matches the small diameter of the blood vessel, and the small diameter of the fixation element 132 matches the large diameter of the blood vessel. In this case, the shape and structure of the fixation element 132 straightens the blood vessel, so that the blood vessel is no longer conical. Alternatively, as shown in FIG. 17, the distal edge of the fixation element 132 may be curved radially outward to provide a force to grip the vessel wall that reduces the longitudinal movement of the sensing device 130. . It is clear that the principle of these conical fixing elements can be applied to any of the previously described embodiments.

  The previously described sensing device can be delivered and implanted in the patient's pulmonary artery network using any suitable means (eg, delivery catheter). In order to better understand the present invention, a method for delivering the sensing device 20 into the patient's pulmonary artery network will now be described with reference to FIGS. 18A-18D, for example. Delivery system 150 includes a flexible catheter 152 configured to be delivered through a patient's vasculature and a pusher element 154 slidably disposed within the lumen of catheter 152. Sensing device 20, in particular sensing element 28, is removably coupled to the distal end of pusher element 154 using suitable means, such as mechanical interference or electrolysis.

  In the illustrated embodiment, the pusher element 154 can be rotated relative to the catheter 152 so that the sensing device 20 is implanted in the pulmonary artery network at a particular circumferential location. That is, it may be desirable for the sensing element 28 to be located at the top of the vessel wall or the bottom of the vessel wall. It may also be desirable to maintain the direction of rotation of the fixation elements 22, 24 relative to each other. Thus, the connecting element 26 does not cross the vessel cavity but extends along one side of the vessel wall (when crossing, one of the fixation elements 22, 24 is displaced 180 degrees in the direction of rotation). ).

  For this purpose, the radiopaque marker 156 is arranged on the detection device 20 so that the orientation of the detection device 20 can be determined by fluoroscopic imaging. The radiopaque marker 156 is in the form of a material (platinum, gold, tantalum, or commonly used radiopaque material) that is coated on the sensing element 28, as shown. Or may be in the form of wires constructed from these materials, for example wound around one or both of the fixation elements 22, 24. Alternatively, the marker 156 may be in the form of the connecting element 26 itself.

  In the illustrated method, the sensing device 20 is placed in the pulmonary artery network in the shape shown in FIG. 2 (ie, the distal fixation element 24 is placed in the side branch SBR and the proximal fixation element 24 is Delivered to the right pulmonary artery RPA at a longitudinal position proximal to the side branch SBR. As shown in FIG. 18A, the catheter 152 is advanced from the right ventricle RV of the heart and enters the lumen of the right pulmonary artery RPA through the main pulmonary artery MPA. As can be seen, the sensing device 20 is loaded into the delivery catheter 152 such that the distal fixation element 24 is deployed before the proximal fixation element 22.

  As shown in FIG. 18B, the distal end of the catheter 152 is advanced into the side branch SBR (or advanced into the bifurcation in the right pulmonary artery RPA and toward the opening of the side branch SBR). Then the pusher element 154 is advanced in the distal direction to push the distal fixation element 24 out of the catheter 152 into the lumen of the side branch SBR. As discussed above, the distal fixation element 24 is constructed from an elastic material that is self-stretching even when no compressive force is applied. Thus, when the distal fixation element 24 is deployed from the catheter 152, it automatically extends radially outward to make firm contact with the wall of the side branch SBR. Alternatively, if the distal fixation element 24 cannot self-extend, a balloon can be used to stretch the distal fixation element 24 radially to make firm contact with the vessel wall.

  The catheter 152 is then pulled proximally such that the distal end of the catheter 152 is positioned within the right pulmonary artery RPA, as shown in FIG. 18C, and the pusher element 154 is proximally The fixation element 22 is advanced distally to push it out of the catheter 152 and into the lumen of the right pulmonary artery RPA. Within the lumen of the right pulmonary artery RPA, the proximal anchoring element 22 automatically expands radially outward (or radially with the aid of a balloon) and makes firm contact with the wall of the right pulmonary artery RPA. To do. As shown in FIG. 18D, the pusher element 154 is further advanced distally to push the sensing element 28 from the catheter 152 into the lumen of the right pulmonary artery RPA, and then the pusher element 154 is Removed from element 28.

  Similar delivery techniques can be used to form the device shape within the pulmonary network shown in FIGS. 9 and FIG. 10, the detection device is disposed in the pulmonary artery network, with the flange of the detection device in the right pulmonary artery RPA in the proximal direction or the distal direction, and until the flange is disposed in the side branch SBR. Embedded by drawing. This is shown in FIGS. 19A to 19H.

  For example, as shown in FIG. 19A, the sensing device 100 is loaded into the delivery catheter 152 such that the flange 102 is deployed prior to the proximal fixation element 22. As shown in FIG. 19B, the distal end of the catheter 152 is advanced to a position in the right pulmonary artery RPA distal to the side branch SBR, and the pusher element 154 pushes the flange 102 out of the catheter 152. It is advanced distally to make contact with the wall of the right pulmonary artery RPA. As shown in FIG. 19C, the catheter 152 is pulled proximally until the flange 102 is captured in the side branch SBR.

  As a step separate from the steps shown in FIGS. 19B and 19C, as shown in FIG. 19D, the distal end of the catheter 152 is positioned proximal to the side branch SBR in the right pulmonary artery RPA. The pusher element 154 is advanced distally to push the flange 102 out of the catheter 152 and contact the wall of the right pulmonary artery RPA. After this, the catheter 152 is pushed distally until the flange 102 is captured in the side branch SBR.

  In either case, if the flange 102 is placed in the side branch SBR, the pusher element 154 is advanced distally to push the fixation element 22 from the catheter 152 into the lumen of the right pulmonary artery RPA, Within the lumen of the right pulmonary artery RPA, the fixation element 22 automatically expands radially outward as shown in FIG. 19E and makes firm contact with the wall of the right pulmonary artery RPA. The pusher element 154 is further advanced distally to push the sensing element 28 out of the catheter 152 and into the lumen of the right pulmonary artery RPA, as shown in FIG. Removed from element 28.

  A similar method can be used to implant the sensing device 110 shown in FIG. 10 but requires that the distal fixation element 24 be deployed from the catheter 152 before the flange 112. Is different (shown in FIG. 19G for better understanding of the invention). In this case, the catheter 152 is pulled proximally before the sensing element 28 is removed from the pusher element 154, so that the entire sensing device 110, including the extended fixation element 24, is shown in the right pulmonary artery RPA as shown in FIG. As shown, the flange 112 is displaced until it is positioned in the side branch SBR. After the sensing device 110 is properly positioned, the pusher element 154 is removed from the sensing element 28.

  The sensing device 120 shown in FIG. 11 deploys the fixation element 24 in the right pulmonary artery RPA at a location distal to the side branch SBR, and deploys the catheter 152 and the sensor 28 and flange 122 in the right pulmonary artery RPA. By pulling in the proximal direction and removing the pusher element 154 from the sensor element 28, it can be easily implanted in the pulmonary artery network. The sensing device 130 shown in FIG. 12 deploys the fixation element 24 in the right pulmonary artery RPA at the position of the side branch SBR and the catheter 152 in the proximal direction to deploy the sensor 28 in the right pulmonary artery RPA. By pulling and removing the pusher element 154 from the sensor element 28, it can be easily implanted into the pulmonary artery network.

  As discussed above, the distal fixation element 24 is constructed from an elastic material that is self-stretching even when no compressive force is applied. As a result, the distal fixation element 24 automatically expands radially outward when deployed from the catheter 152 and makes firm contact with the wall of the side branch SBR. Alternatively, if the distal anchoring element 24 cannot self-extend, a balloon can be used to stretch the distal anchoring element 24 radially to make firm contact with the vessel wall.

  Although the sensing device has been illustrated and described as being implanted in the right pulmonary artery RPA, the sensing device can be used in other blood vessels of the patient's body, such as the vena cava, pulmonary veins, coronary sinus, aorta, subclavian artery, ileum It should be understood that the artery and carotid artery can also be implanted.

1 is a side view of a state in which a prior art detection device is placed in a pulmonary artery network of a patient. It is a side view of the state which has arrange | positioned the 1st detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 2nd detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 3rd detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 4th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 5th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 6th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 7th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 8th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 9th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 10th detection apparatus according to this invention in the pulmonary artery network. It is a side view of the state which has arrange | positioned the 11th detection apparatus according to this invention in the pulmonary artery network. It is a side view of another embodiment of the fixing element used for the 11th detection apparatus shown in FIG. It is a side view of another embodiment of the fixing element used for the 11th detection apparatus shown in FIG. It is a side view of another embodiment of the fixing element used for the 11th detection apparatus shown in FIG. It is a side view of another embodiment of the fixing element used for the 11th detection apparatus shown in FIG. It is a side view of another embodiment of the fixing element used for the 11th detection apparatus shown in FIG. 1 is a cross-sectional view illustrating one method of embedding a sensing device using an embodiment of the present invention for a better understanding of the present invention. 1 is a cross-sectional view illustrating one method of embedding a sensing device using an embodiment of the present invention for a better understanding of the present invention. 1 is a cross-sectional view illustrating one method of embedding a sensing device using an embodiment of the present invention for a better understanding of the present invention. 1 is a cross-sectional view illustrating one method of embedding a sensing device using an embodiment of the present invention for a better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention. FIG. 6 is a cross-sectional view illustrating another method of embedding a sensing device using an embodiment of the present invention for better understanding of the present invention.

Claims (10)

An implant for sensing a parameter in a patient's anatomical vascular network,
A first securing element having a geometric dimension that is extended to securely engage the wall of the tube network in a first longitudinal position;
A second anchoring element having a geometric dimension that is extended to securely engage the wall of the tube network at a second longitudinal position;
A connecting element that mechanically connects the first fixing element and the second fixing element in an articulated manner;
An implant comprising a sensing element mechanically coupled to the first anchoring element at a position opposite the coupling element.   The implant according to claim 1, wherein the tube network is a vascular network.   The implant according to claim 1 or 2, wherein at least one of the first longitudinal position and the second longitudinal position is in a right pulmonary artery.   The implant according to any one of claims 1 to 3, wherein the tube network has a substantially different diameter at each of the first longitudinal position and the second longitudinal position.   The implant of any one of claims 1-4, wherein the first longitudinal position and the second longitudinal position are within a single anatomical tube.   The first longitudinal position is in a main anatomical tube and the second longitudinal position is in an anatomical branch of the main anatomical tube. The implant according to Item.   The implant according to any one of claims 1 to 6, wherein each of the first fixation element and the second fixation element is selected from the group consisting of a stent and a coil.   The sensing element includes one or more of a pressure sensor, an accelerometer, a wall motion sensor, a flow sensor, a temperature sensor, an oxygen sensor, a glucose sensor, a coagulum sensor, an electrical activity sensor, and a pH sensor. The implant according to any one of 7. And a third securing element having a geometric dimension that is extended to securely engage the wall of the tube network in a third longitudinal position;
The implant according to any one of claims 1 to 8, further comprising another coupling element that mechanically couples the second and third fixation elements in an articulated manner.   The implant of any one of claims 1 to 9, further comprising a transmitter configured to wirelessly transmit information detected by the sensing element to a remote receiver.

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