Implanted medical device and wireless sensor attachment

Abstract

An embodiment of the present disclosure relates to an implantable medical device configured to be implanted in a heart with a fixation mechanism that reduces or eliminates transmission interference of a sensor signal. The implantable medical device may include a sensor configured to sense a physiological parameter of the heart and a housing including a transmitter and an antenna. A fixation device formed by one or more wound wires includes an engagement component disposed around at least a portion of the housing, a first frame component, and a second frame component. The first frame component, the second frame component, or the first frame component and the second frame component include a first end separated from a second end to form a discontinuous loop and are formed from a conductive material.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 63 / 237,878, filed Aug. 27, 2021, which is hereby incorporated by reference in its entirety for all purposes.

[0002] The present disclosure generally relates to devices, systems, and methods that include a sensing unit and a securing device for the sensing unit. More particularly, the devices, systems, and methods are directed to an implantable sensing unit for measuring one or more cardiac physiological parameters and a securing device that reduces the potential for transmission interference of signals transmitted between the implantable sensing unit.

Background Art

[0003] Sensors may be implanted within a patient to acquire data. In some cases, the sensors may be disposed or coupled to implantable medical devices.

Summary of the Invention

[0004] According to one example (Example 1), an implantable medical device configured to be implanted into the heart and reducing or eliminating the possibility of signal transmission interference includes a sensor configured to sense physiological parameters of the heart, a housing including a transmitter and an antenna, the sensor being connected to the housing, and the transmitter and the antenna being configured to transmit the sensed physiological parameters of the heart, a fixing device formed by one or more wires, an engaging component disposed around at least a part of the housing, a first frame component configured to engage a first wall defining a first heart chamber of the heart, and a second frame component configured to engage a second wall defining a second heart chamber of the heart, the fixing device including the engaging component, the first frame component, and the second frame component, and the first frame component, the second frame component, or both the first frame component and the second frame component having a first end separated from a second end to form a discontinuous loop and being formed of a conductive material.

[0005] According to one example (Example 2), in the implantable medical device of Example 1, the discontinuous loop is disposed around the sensor at a position where the antenna of the sensor is located.

[0006] According to one example (Example 3), in the implantable medical device of Example 1, at least a part of the conductive material is covered with a non-conductive material.

[0007] According to one example (Example 4), in the implantable medical device of any one of Examples 1 to 3, the first end, the second end, or both the first end and the second end are laminated in a non-conductive material.

[0008] According to one example (Example 5), in the implantable medical device of any one of Examples 3 or 4, the non-conductive material is a film.

[0009] According to one example (Example 6), in any one of the implantable medical devices of Examples 1 to 5, the sensed physiological parameters include pressure measurements from at least one cardiac chamber of the heart.

[0010] According to one example (Example 7), in any one of the implantable medical devices of Examples 1 to 6, the engaging component includes a ring and the sensor defines a groove in cross-section.

[0011] According to one example (Example 8), in any one of the implantable medical devices of Examples 1 to 7, one or more wires of the conductive material form one or more contact mechanisms in each of the first frame component and the second frame component.

[0012] According to one example (Example 9), a fixation device configured to be implanted within the heart that reduces or eliminates the possibility of signal transmission interference includes an engaging component configured to be disposed around at least a portion of the housing of an implantable sensor for the heart, a first frame component configured to engage a first wall defining a first cardiac chamber of the heart, and a second frame component configured to engage a second wall defining a second cardiac chamber of the heart. The first frame component, the second frame component, or the first and second frame components include a first end separated from a second end to form a discontinuous loop and are formed from a conductive material.

[0013] According to one example (Example 10), in the fixation device of Example 9, at least a portion of the conductive material is covered with a non-conductive material.

[0014] According to one example (Example 11), in either one of the fixation devices of Example 9 or Example 10, the first end, the second end, or the first and second ends have a non-conductive material laminated thereon.

[0015] According to one example (Example 12), in any one of the fixing devices of Example 10 or Example 11, the non-conductive material is a film.

[0016] According to one example (Example 13), in any one of the fixing devices of Examples 9 - 12, the sensed physiological parameter includes a pressure measurement value from at least one cardiac chamber of the heart.

[0017] According to one example (Example 14), in any one of the fixing devices of Examples 9 - 13, the engaging component has a reduced cross-section that fits into a groove within the sensor.

[0018] According to one example (Example 15), a method of manufacturing an implantable medical device that reduces or eliminates the potential for signal transmission interference, the method comprising receiving a housing that includes a transmitter, an antenna, and a sensor coupled to the housing, wherein the transmitter and the antenna are configured to transmit sensed physiological parameters of the heart, and disposing at least a portion of the engaging component of the fixing device around the housing, the fixing device comprising a first frame component configured to engage a first wall that defines a first cardiac chamber of the heart and a second frame component configured to engage a second wall that defines a second cardiac chamber of the heart, wherein disposing includes providing a first end formed from a conductive material that is separated from a second end to form a discontinuous loop, the first frame component, the second frame component, or both the first frame component and the second frame component.

[0019] According to one example (Example 16), in the method of Example 15, at least a portion of the conductive material is covered with a non-conductive material.

[0020] According to one example (Example 17), in the method of Example 15, the fixing device is formed from one or more wires.

[0021] According to one example (Example 18), an implantable medical device configured to be implanted into the heart and reduce or eliminate the possibility of signal transmission interference, comprising: a sensor configured to sense physiological parameters of the heart; a housing comprising a transmitter and an antenna, the sensor being coupled to the housing, and the transmitter and the antenna being configured to transmit the sensed physiological parameters of the heart; a fixing device comprising an engaging component containing a conductive material and disposed around at least a part of the housing, the engaging component having a first end and a second end separated by a slit extending along the length of the engaging component that radially separates a circumferential loop surrounding a part of the housing; a first frame component configured to engage a first wall defining a first heart chamber of the heart; and a second frame component configured to engage a second wall defining a second heart chamber of the heart.

[0022] According to one example (Example 19), in the implantable medical device of Example 18, the conductive material is a laser-cut tube having slits that make it discontinuous.

[0023] According to one example (Example 20), in the implantable medical device of Example 18, the engaging component includes a proximal portion, an intermediate portion, and a distal portion, the slit is disposed in the intermediate portion, and the proximal portion and the distal portion extend beyond the first frame component and the second frame component, respectively.

[0024] According to another example (Example 21), a method of monitoring physiological parameters of a body using the implantable medical device of Example 18 includes monitoring, using the sensor, physiological parameters in a first heart chamber of the heart, and monitoring, using the sensor, physiological parameters in a second heart chamber of the heart.

[0025] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any of the concepts of the invention provided otherwise by the present disclosure. Although multiple examples are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description which illustrates and describes exemplary examples. Accordingly, the drawings and the detailed description are to be regarded as being essentially non-limiting and essentially exemplary in nature.

Brief Description of the Drawings

[0026] The accompanying drawings are included to provide a further understanding of the present disclosure, are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description of the specification serve to explain the principles of the present disclosure.

[0027]

Figure 1

[0028]

Figure 2A

Figure 2B

[0029]

Figure 3

[0030]

Figure 4

[0031]

Figure 5

Modes for Carrying Out the Invention

[0032] Definitions and Terms The present disclosure is not intended to be read restrictively. For example, the terms used in this application should be read broadly in the context of the meaning that one of ordinary skill in the art would ascribe to such terms.

[0033] With respect to the term of inaccuracy, the terms “about” and “approximately” may be used interchangeably to refer to a measurement that includes the recited measurement value and also any measurement value that is reasonably close to the recited measurement value. A measurement value that is reasonably close to the recited measurement value deviates from the recited measurement value by a reasonably small amount, as would be understood and readily grasped by one of ordinary skill in the relevant art. Such deviations can occur, for example, due to measurement errors, differences in measurement and / or manufacturing equipment calibration, human error in measurement reading and / or setting, minor adjustments made to optimize performance and / or structural parameters in consideration of measurement differences related to other components, particular implementation scenarios, inaccurate adjustment and / or operation of an object by a person or machine, and the like. If it is determined that one of ordinary skill in the relevant art cannot readily grasp the value of such a reasonably small difference, the terms “about” and “approximately” may be understood to mean plus or minus 10% of the recited value. Description of Various Embodiments

[0034] One of ordinary skill in the art will readily understand that the various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. Also, note that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to show the various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0035] Various aspects of the present disclosure are directed to placing an implantable medical device including an implantable sensing unit and a fixation device within a patient. The implantable medical devices discussed herein can minimize the risk of embolization, minimize the risk of generating loose thrombi, and / or minimize the risk of allowing loose tissue growth, all of which can lead to stroke or other clinical sequelae.

[0036] In some cases, the implantable sensing unit may be placed with and / or coupled to the fixation device. The implantable sensing unit, which may be a wireless pressure sensor, can titrate medical treatment to monitor heart failure and prevent heart failure hospitalization. In some cases, the sensing unit may be placed within the atrial septum of the heart and can access one or both of the left atrial pressure and the right atrial pressure. Further, to avoid overgrowth of tissue on the sensor surface (which can disrupt pressure readings), the sensing units discussed herein may protrude across the septum. As described herein, the fixation device attached to the sensing unit reduces the potential for transmission interference of signals transmitted between the implantable sensing unit.

[0037] FIG. 1 is an exemplary implantable medical device 100 for sensing blood pressure, according to one embodiment. This figure is merely an example and is not intended to unduly limit the claims. Those skilled in the art will recognize many variations, alternatives, and modifications.

[0038] The implantable medical device 100 is shown in a state of being implanted within a patient's heart H. The medical device 100 is shown in a state of being disposed between the patient's left atrium and right atrium. In some cases, the medical device 100 may be used to sense physiological parameters of the heart H and / or measure blood pressure or pressure within the heart H. For example, the medical device 100 may sense the pressure in one or more heart chambers of the heart H, such as sensing the pressure in the left atrium LA and the right atrium RA, and / or may regulate the blood flow in one or more heart chambers of the heart H, for example, between the left atrium LA and the right atrium RA. In one embodiment, the medical device 100 includes a first frame component 110 disposed on a first side of the septum (e.g., within the right atrium RA), a second frame component 120 disposed on a second side of the septum (e.g., within the left atrium LA), and an engagement component 130 extending through the septum. A needle can be used to form an opening in the septum. According to one embodiment, the first frame component 110, the second frame component 120, and the engagement component 130 may sometimes be collectively referred to herein as a fixation device. In some cases, the engagement component 130 includes a conical or cylindrical cross-section.

[0039] In some cases, the first frame component 110 and the second frame component 120 can be formed of a single continuous wire or two separate wires. Additionally or alternatively, the first frame component 110 and the second frame component 120 and / or the engagement component 130 can be formed of and / or include a shape memory conductive material. For example, nitinol (NiTi) may be used as the material for the first frame component 110 and the second frame component 120 and / or the engagement component 130 (and any of the frame components and / or engagement components discussed herein). However, without limitation, other materials such as stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other suitable biocompatible material, and combinations thereof, can be used as the material for the first frame component 110 and the second frame component 120 and / or the engagement component 130. Since the first frame component 110 and the second frame component 120 and / or the engagement component 130 can be formed of a conductive material, the first frame component 110 and the second frame component 120 and / or the engagement component 130 have the potential to interfere with signals transmitted between them and the sensing unit 150. According to one embodiment, the first frame component 110 and the second frame component 120 and / or the engagement component 130 can be configured to reduce or eliminate the potential for signal transmission and / or signal reception by the medical device 100, as will be described in more detail below.

[0040] Sheath 140 and restraint lines and / or release lines (not shown) may be used to facilitate deployment of the medical device 100. For example, the first side of the medical device 100 including the first frame component 110 may be released after the sheath 140 is advanced through the septum into the LA, and the second side of the medical device 100 including the second frame component 120 may be released on the RA side of the septum. The engagement component 130 is disposed within the opening. According to an embodiment, the engagement component 130 may be incorporated into and / or coupled to one or both of the first frame component 110 and / or the second frame component 120. The first frame component 110, the second frame component 120, and / or the engagement component 130 may be compressed within the sheath 140 during delivery of the medical device 100 to a desired treatment region within the patient and then expanded during deployment of the medical device 100. In other cases, the implantable medical device 100 may be implanted at different locations within the heart or different locations within the patient (e.g., digestive system, vasculature, brain).

[0041] In some cases, the engagement component 130 is configured to engage and / or couple to the sensing unit 150. The engagement component 130 may, in some cases, extend beyond each of the first frame component 110 and the second frame component 120 and / or between the first frame component 110 and the second frame component 120 to facilitate positioning of the sensing unit 150. According to an embodiment, the sensing unit 150 includes one or more electrical components 160 for sensing one or more physiological parameters within the heart H, such as the pressure in the left atrium LA and / or the right atrium RA. Exemplary electrical components 160 include, but are not limited to, one or more sensors, a processing unit for processing sensor measurements from the one or more sensors, a memory for storing the one or more sensor measurements and / or for storing one or more processed signals, a transmitter / receiver, and / or an antenna for transmitting the one or more sensor measurements to another device and / or for receiving one or more signals from another device. To reduce the likelihood of signal interference of the one or more signals transmitted and / or received by the electrical component 160, the first frame component 110, the second frame component 120, and / or the engagement component 130 can form a discontinuous loop around the sensing unit 150 and / or the antenna, as will be described in more detail below.

[0042] FIG. 2A is a side view of an exemplary sensing unit 200, and FIG. 2B is an axial view of the sensing unit 200 shown in FIG. 2A according to at least one embodiment. These figures are merely examples and should not unduly limit the claims. Those skilled in the art will recognize many variations, alternatives, and modifications.

[0043] The sensing unit 200 may be the same as or similar to the sensing unit 150 described above in connection with FIG. 1. For example, the sensing unit 200 may be configured to sense one or more physiological parameters within the heart H, such as the pressures in the left atrium LA and / or the right atrium RA. According to an embodiment, the sensing unit 200 may be coupled to one or more frame components (e.g., the first and second frame components 110, 120, 302, 304, 404, 406) and / or engagement components (e.g., the engagement components 130, 212, 306, 408) and may be disposed within the heart H, such as within the atrial septum. As described above in connection with FIG. 1, one or more frame components and / or one engagement component coupled to the sensing unit 200 can fix the sensing unit 200 at a position within the heart H (e.g., the atrial septum).

[0044] According to an embodiment, the sensing unit 200 includes a sensor housing 202. In some examples, the engagement component 212 may be configured to engage the sensor housing 202 to couple one or more of the first frame component 110 and the second frame component 120 to the sensor housing 202. In some cases, the engagement component 212 includes a ring or groove cross-section. For example, in some examples, the engagement component 212 includes a reduced cross-section that fits into a groove of the sensor.

[0045] In some cases, the sensor housing 202 can be formed from a non-conductive material, such as glass or ceramic. Additionally, or alternatively, the sensor housing 202 can be formed from a biocompatible material and / or can be coated with a biocompatible material. For example, the sensor housing 202 can be coated with a fluoropolymer such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In some examples, the sensor housing 202 can be formed from and / or can include, but is not limited to, one or more of the following materials: polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer, or combinations thereof. In some examples, a bioabsorbable material or bioabsorbable material, such as a bioabsorbable polymer or bioabsorbable polymer, may be used. In some examples, the sensor housing 202 can include Dacron, polyolefin, carboxymethyl cellulose fabric, polyurethane, or other woven, non-woven, or film elastomers.

[0046] According to an embodiment, the sensing element 204 is disposed at both ends of one or more sensing units 200. The sensing element 204 can be configured to sense one or more physiological parameters within the heart H, such as the pressure within the left atrium LA and / or the right atrium RA.

[0047] In some cases, the physiological parameters sensed by the sensing element 204 are transmitted to one or more electrical components 206 disposed within the sensor housing 202. Exemplary electrical components 206 include, but are not limited to, a processing unit, a memory, a power source, a transmitter, and / or a receiver. In some cases, the processing unit is configured to process one or more sensed physiological parameters from the sensing element 204 (e.g., convert analog sensor measurements to digital signals, reduce noise, and / or perform other signal processing on the sensor measurements). The memory can be configured to store one or more sensed physiological parameters from the sensing element 204 and / or the signals processed by the processing unit. The transmitter can be configured to wirelessly transmit one or more sensor measurements from the sensing element 204 to another device via the antenna 208. The receiver can be configured to receive signals from another device. Also, the power source can be configured to supply power to one or more of the sensing element 204 and / or the electrical components 206.

[0048] In some embodiments, the sensing unit 200 includes a notch 210. Although the illustrated embodiment shows one notch 210, in some cases, the sensing unit 200 includes two or more notches 210. The notch(s) 210 can be a depression and / or a cutout of the sensor housing 202. In some examples, the notch(s) 210 facilitate connecting an engagement component 212 and / or one or more frame components to the sensing unit 200. For example, the notch(s) 210 can reduce the possibility that the engagement component 212 and / or one or more frame components translate towards one side or the other side of the sensing unit 200.

[0049] The sensing unit 200 is configured to wirelessly transmit one or more sensed physiological parameters from the sensing unit 200 to another device and / or wirelessly receive one or more signals from another device. Therefore, it is important to reduce signal interference. Conventional frame components often form a continuous conductive loop around the sensing unit (including the antenna), which may often interfere with the signal. However, one or more of the frame components and / or engagement components disclosed herein are designed to reduce the potential for signal interference, as will be described in more detail below.

[0050] According to certain embodiments, the engagement component 212 is coupled to the sensing unit 200. In some cases, the engagement component 212 is coupled to and / or formed by the first frame component 110 and the second frame component 120. In some cases, the engagement component 212 can at least partially surround the sensor housing 202, such as the notch 210.

[0051] According to some embodiments, the engagement component 212 can be formed from and / or include a shape memory conductive material. For example, NiTi may be used as the material for the engagement component 212 (and any of the frames discussed herein), but is not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other suitable biocompatible material, and combinations thereof, can be used as the material for the engagement component 212. The superelastic properties and flexibility of NiTi can improve the vascular shape followability of the engagement component 212. Further, NiTi can be shape set to a desired shape. That is, NiTi can be shape set such that when the engagement component 212 is not constrained, such as when the engagement component 212 is deployed from a delivery system, the frame has a tendency to self-expand to the desired shape.

[0052] Since the engaging component 212 can be formed from a conductive material, the engaging component 212 may interfere with the signals transmitted between the sensing unit 200. To reduce the possibility of signal interference, the engaging component 212 can include a slit 214. In some cases, the slit 214 may be referred to herein as a gap, a discontinuity, and / or the like. In some cases, the slit 214 extends along the entire length 216 of the engaging component 212. For example, the engaging component 212 can include a first end 218 separated from a second end 220 by a space 214 such as the slit 214. In some cases, the space 214 may be air and / or filled with a dielectric such as glass, plastic, etc. Additionally, or alternatively, the engaging component 212 can be coated with a non-conductive material such as a fluoropolymer such as PTFE polymer or ePTFE polymer.

[0053] FIG. 3 is a perspective view of an exemplary fixing device 300 according to at least one embodiment. This figure is merely an example and does not unduly limit the scope of the claims. Those skilled in the art will recognize many variations, alternatives, and modifications.

[0054] According to an embodiment, the fixing device 300 can be coupled to the sensing units 150, 200 to position the sensing units 150, 200 within the heart H, for example, within the atrial septum of the heart H.

[0055] According to an embodiment, the fixing device 300 includes a first frame component 302, a second frame component 304, and an engagement component 306. The first frame component 302 and the second frame component 304 can each have the same or similar characteristics as the first frame component 110 and the second frame component 120, respectively. For example, the first frame component 302 may be disposed on the first side of the atrial septum, and the second frame component 304 may be disposed on the second side of the atrial septum to fix the fixing device 300 and the sensing units 150, 200 within the heart H. As another example, the first frame component 302 and the second frame component 304 can be formed of a single continuous wire or two separate wires. Additionally or alternatively, the engagement component 306 can have the same or similar characteristics as the engagement component 212 described above in relation to FIG. 2. In some cases, the fixing device 300 may be formed from a laser-cut tube.

[0056] According to an embodiment, each of the first frame component 302 and the second frame component 304 can include one or more contact mechanisms 308 that extend radially from the engagement component 306. In some examples, the contact mechanisms 308 have an oval shape as shown. However, this is merely an example and is not intended to be limiting. It is also contemplated that the contact mechanisms 308 can have other non-oval shapes. In an embodiment, the contact mechanisms 308 form a frame for the first frame component 302 and the second frame component 304, which are used to fix the anchor component 300 within the heart H. In some cases, the contact mechanisms 308 and / or the engagement component 306 can be formed from NiTi or another shape memory material.

[0057] According to an embodiment, the contact mechanism 308 can be covered with a membrane 310. The membrane 310 can be disposed across the contact mechanism 308 of the first frame component 302 and the contact mechanism 308 of the second frame component 304. As shown, the membrane 310 extends over regions 312 of the first frame component 302 and the second frame component 304 that do not include the contact mechanism 308 forming the first frame component 302 and the second frame component 304. In some cases, the membrane 310 can be formed from a non-conductive biocompatible material such as a fluoropolymer such as a PTFE polymer or an ePTFE polymer.

[0058] In some cases, as shown, the contact mechanism 308 is connected to the engagement component 306 via the material used to form the contact mechanism 308. Alternatively, the contact mechanism 308 is connected to the engagement component 306 via the membrane 310.

[0059] According to an embodiment, the engagement component 306 includes a slit 314 such that the engagement portion 306 forms a continuous conductor surrounding the sensing units 150, 200. In some cases, the slit 314 can have the same or similar characteristics as the slit 214 described above in connection with FIG. 2. For example, the slit 314 can extend along the entire length 316 of the fixing device 300. Additionally or alternatively, air and / or a dielectric such as glass or plastic can be between the slits 314. Additionally or alternatively, the engagement component 306 can be coated with a non-conductive material such as a fluoropolymer such as a PTFE polymer or an ePTFE polymer. As described above, the slit 314 can reduce the possibility that the fixing device 300 interferes with the signals transmitted between the sensing units 150, 200. As described above, the fixing device 300 can be a laser-cut tube, and the slit 314 can be the cut portion of the laser-cut tube. The slit 314 of the laser-cut tube can make the fixing device 300 discontinuous.

[0060] In some embodiments, the engagement portion 306 includes a proximal portion 318, an intermediate portion 320, and / or a distal portion 322. The proximal portion 318 can be connected to the intermediate portion 320 by one or more struts 324. Additionally or alternatively, the intermediate portion 320 can be connected to the distal portion 322 by one or more struts 324. In some embodiments, the struts 324 connect the portions 318, 320, 322 and also space the portions 318, 320, 322 apart from each other. As shown, the struts 324 can include a gap 326 therebetween. The proximal portion 318 and the distal portion 322 may extend beyond the first frame component 302 and the second frame component 304. In some cases, the slit 314 extends along the length of the engagement component 306 and radially separates a circumferential loop that surrounds a portion of the housing of the sensing unit (e.g., where the antenna is located).

[0061] In at least some embodiments, one or more slits 314 connect with one or more gaps 326 so as to prevent the securing device 300 from forming a continuous conductor around the sensing unit (e.g., sensing units 150, 200). For example, as shown, slit 314A connects to gap 326A. Gap 326A then connects to slit 314B. The slit then connects to gap 326B, and gap 326B connects to slit 314C. Since the slits 314 and the one or more gaps 326 do not form a continuous conductor around the sensing unit, the securing device 300 is less likely to interfere with transmissions sent from and received by the sensing unit. The intermediate portion 320 may be circumferentially continuous around the sensing unit except for the one or more slits 314.

[0062] According to an embodiment, the engagement component 306 includes one or more bosses 328 that extend radially inwards from the proximal portion 318 and / or radially inwards from the distal portion 322. In some cases, the bosses 328 can facilitate centering and / or coupling of the securing device 300 to the sensing unit.

[0063] Figure 4 is a perspective view of another exemplary fixation device 400 according to at least one embodiment. This figure is merely an example and does not unduly limit the claims. Those skilled in the art will recognize many variations, alternatives, and modifications.

[0064] According to one embodiment, the fixation device 400 can be coupled to a sensing unit 402 for positioning the sensing unit 402 within the heart H, for example, within the atrial septum of the heart H. In one embodiment, the sensing unit 402 can have the same or similar characteristics as the sensing units 150, 200 described above.

[0065] According to one embodiment, the fixation device 400 includes a first frame component 404, a second frame component 406, and an engagement component 408. The first frame component 404 and the second frame component 406 can each have the same or similar characteristics as the first frame components 110, 302 and / or the second frame components 120, 304. For example, the first frame component 404 may be disposed on a first side of the atrial septum, and the second frame component 406 may be disposed on a second side of the atrial septum to fix the fixation device 400 and the sensing unit 402 within the heart H. As another example, the first frame component 404 and the second frame component 406 can be formed of a single continuous wire or two separate wires. Additionally, or alternatively, the engagement component 408 can have the same or similar characteristics as the engagement components 212, 306.

[0066] According to one embodiment, each of the first frame component 404 and the second frame component 406 can include one or more contact mechanisms 410 that extend radially from the engagement component 408. In some examples, the contact mechanism 410 has a star shape as shown. However, this is merely an example and is not intended to be limiting. It is also contemplated that the contact mechanism 410 can have other non-star shapes. In one embodiment, the contact mechanism 410 forms a frame for the first frame component 404 and the second frame component 406, and they are used to fix the fixation device 400 within the heart H. In some cases, the contact mechanism 410 and / or the engagement component 408 can be formed from NiTi or another shape memory material.

[0067] According to one embodiment, the contact mechanism 410 can be covered with a membrane 412. The membrane 412 can be disposed across the contact mechanism 410 of the first frame component 404 and the contact mechanism 410 of the second frame component 406. As shown, the membrane 412 extends over the regions 414 of the first frame component 404 and the second frame component 406 that do not include the contact mechanism 410 forming the first frame component 404 and the second frame component 406. In some cases, the membrane 412 can be formed from a non-conductive biocompatible material such as a fluoropolymer such as PTFE polymer or ePTFE polymer.

[0068] According to one embodiment, the engagement component 408 and the contact mechanism 410 can be formed from one or more wires 416. For example, the first frame component 404 can be formed using wire 416A, the second frame component 406 can be formed using wire 416B, and / or the engagement component 408 can be formed using wire 416C. In some embodiments, the wires 416A, 416B, 416C are separate wires or the same wire.

[0069] In one embodiment, each of the wires 416A, 416B used to form the first frame component 404 and the second frame component 406 includes a discontinuity 418, and thus, neither of the wires 416A, 416B for the first frame component 404 and the second frame component 406 continuously surrounds the sensing unit 402. Additionally, or alternatively, the wire 416C used to form the engagement component 408 does not form a continuous loop around the sensing unit 402. For example, the ends 420 of the wire 416C are not connected and thus do not form a continuous conductor around the sensing unit 402. Since none of the wires 416A, 416B, 416C form a continuous conductor around the sensing unit 402, the wires 416A, 416B, 416C are less likely to interfere with transmissions sent from and received by the sensing unit 402. In some cases, the wires 416A, 416B, 416C do not form an electrically conductive loop, either individually or collectively, around the sensing unit 402.

[0070] In one embodiment, for example, to reduce the possibility that different portions of one or more wires 416 contact each other to form a continuous conductor around the sensing unit 402, one or more wires 416 may be coated (e.g., laminated) with a non-conductive material that extends along the entire length of the one or more wires 416 or a portion of the length of the one or more wires 416. Additionally, or alternatively, to reduce the possibility that one or more wires 416 form a continuous conductor around the sensing unit 402, a sleeve and / or jacket may be disposed over the entire length of the one or more wires 416 or a portion of the length of the one or more wires 416. In one embodiment, the non-conductive material is a fluoropolymer such as a PTFE polymer or an ePTFE polymer. In some cases, an oxide layer of the one or more wires 416 may form the non-conductive material. Additionally, or alternatively, the end 422 of the first frame component 404 and / or the end 424 of the second frame component 406 may be coated (e.g., laminated) with a non-conductive material such as a fluoropolymer to reduce the possibility that the wires 416A, 416B form a continuous conductor around the sensing unit 402.

[0071] According to one embodiment, the end 420 can curve over the end of the sensing unit 402 to facilitate centering and / or connecting the fixing device 400 to the sensing unit 402.

[0072] FIG. 5 is a side view of an exemplary sensing unit 200 and fixing device according to at least one embodiment. This figure is merely an example and does not unduly limit the scope of the claims. Those skilled in the art will recognize many variations, alternatives, and modifications.

[0073] According to one embodiment, the fixation device 400 can be coupled to the sensing unit 402 for positioning the sensing unit 402 within the heart H, for example, within the atrial septum of the heart H. In one embodiment, the sensing unit 402 can have the same or similar characteristics as the sensing units 150, 200 described above.

[0074] According to one embodiment, the fixation device 400 includes a first frame component 404, a second frame component 406, and an engagement component 408. The first frame component 404 and the second frame component 406 can each have the same or similar characteristics as the first frame components 110, 302 and / or the second frame components 120, 304. For example, the first frame component 404 may be disposed on a first side of the atrial septum, and the second frame component 406 may be disposed on a second side of the atrial septum to fix the fixation device 400 and the sensing unit 402 within the heart H. As another example, the first frame component 404 and the second frame component 406 can be formed of a single continuous wire or two separate wires. Additionally or alternatively, the engagement component 408 can have the same or similar characteristics as the engagement components 212, 306.

[0075] In some cases, the first frame component 110 and the second frame component 120 can be formed of a single continuous wire or two separate wires. As shown in FIG. 5, the engagement component 408 may be formed of one or more wires. The engagement component 408 may be disposed around the sensing unit 200 (optionally, around the section of the sensing unit 200 where the antenna is located). The engagement component 408 may include a discontinuity 418 such that neither the wires of the first frame component 404 nor the wires of the second frame component 406 continuously surround the sensing unit 402.

[0076] The invention of the present application has been described above both generally and with respect to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the present disclosure. Accordingly, the embodiments are intended to cover modifications and variations of the present invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

**Claim 1** An implantable medical device configured to be implanted within the heart that reduces or eliminates the potential for signal transmission interference, a sensor configured to sense physiological parameters of the heart, a housing comprising a transmitter and an antenna, wherein the sensor is coupled to the housing and the transmitter and the antenna are configured to transmit the sensed physiological parameters of the heart, a fixation device formed by one or more wires, an engagement component disposed around at least a portion of the housing, a first frame component configured to engage a first wall defining a first heart chamber of the heart, a second frame component configured to engage a second wall defining a second heart chamber of the heart, and the engagement component has a first end and a second end separated by a slit extending along a length of the engagement component that radially separates a circumferential loop surrounding the portion of the housing, the first frame component, the second frame component, or the first frame component and the second frame component comprise a first end separated from the second end to form a discontinuous loop and are formed of a conductive material, the fixation device; An implantable medical device comprising. **Claim 2** The implantable medical device according to claim 1, wherein the discontinuous loop is disposed around the sensor at a location where the antenna of the sensor is located. **Claim 3** The implantable medical device according to claim 1, wherein at least a portion of the conductive material is covered with a non-conductive material. **Claim 4** The implantable medical device according to any one of claims 1 to 3, wherein the first end, the second end, or the first end and the second end are laminated in a non-conductive material. **Claim 5** The implantable medical device according to claim 3, wherein the non-conductive material is a film. **Claim 6** The implantable medical device according to any one of claims 1 to 3, wherein the sensed physiological parameters include pressure measurements from at least one heart chamber of the heart. **Claim 7** The implantable medical device according to any one of claims 1 to 3, wherein the engagement component includes a ring and the sensor defines a groove in cross-section. **Claim 8** The one or more wires of the conductive material form one or more contact mechanisms in each of the first frame component and the second frame component, the implantable medical device according to any one of claims 1 to 3.

9. A fixation device configured to be implanted in the heart that reduces or eliminates the possibility of signal transmission interference, An engagement component configured to be disposed around at least a portion of the housing of the implantable sensor for the heart, A first frame component configured to engage a first wall defining a first heart chamber of the heart, A second frame component configured to engage a second wall defining a second heart chamber of the heart, comprising one or more wound wires forming the same, The engagement component has a first end and a second end separated by a slit extending along the length of the engagement component that radially separates a circumferential loop surrounding the portion of the housing, The first frame component, the second frame component, or the first frame component and the second frame component include a first end separated from the second end to form a discontinuous loop and are formed of a conductive material, a fixation device.

10. At least a portion of the conductive material is covered with a non-conductive material, the fixation device according to claim 9.

11. The first end, the second end, or the first end and the second end are laminated in a non-conductive material, the fixation device according to claim 9 or 10.

12. The non-conductive material is a film, the fixation device according to claim 10.

13. The physiological parameter sensed by the implantable sensor includes a pressure measurement value from at least one heart chamber of the heart, the fixation device according to claim 9 or 10.

14. The engagement component has a reduced cross-section that fits into a groove in the sensor, the fixation device according to claim 9 or 10.

15. A method of manufacturing an implantable medical device that reduces or eliminates the possibility of signal transmission interference, When providing the housing comprising a transmitter, an antenna, and a sensor coupled to the housing, the transmitter and the antenna are configured to transmit sensed physiological parameters of the heart, Placing an engagement component of a fixing device around at least a part of the housing, wherein the fixing device A first frame component configured to engage a first wall defining a first cardiac chamber of the heart; A second frame component configured to engage a second wall defining a second cardiac chamber of the heart, and The engagement component has a first end and a second end separated by a slit extending along the length of the engagement component that radially separates a circumferential loop surrounding the part of the housing, The method includes arranging the first frame component, the second frame component, or the first frame component and the second frame component to include a first end separated from the second end and formed of a conductive material to form a discontinuous loop. **Claim 16** The method according to claim 15, wherein at least a part of the conductive material is covered with a non-conductive material. **Claim 17** The method according to claim 15, wherein the fixing device is formed of one or more wires. **Claim 18** An implantable medical device configured to be implanted within the heart to reduce or eliminate the possibility of signal transmission interference, A sensor configured to sense physiological parameters of the heart; A housing including a transmitter and an antenna, wherein the sensor is coupled to the housing, and the transmitter and the antenna are configured to transmit the sensed physiological parameters of the heart; A fixing device, An engagement component including a conductive material and disposed around at least a part of the housing, the engagement component having a first end and a second end separated by a slit extending along the length of the engagement component that radially separates a circumferential loop surrounding the part of the housing; A first frame component configured to engage a first wall defining a first cardiac chamber of the heart; A second frame component configured to engage a second wall defining a second cardiac chamber of the heart, and An implantable medical device comprising the above. **Claim 19** The implantable medical device according to claim 18, wherein the conductive material is a laser-cut tube having a slit that makes it discontinuous.

20. The engagement component includes a proximal portion, an intermediate portion, and a distal portion, the slit is disposed in the intermediate portion, and the proximal portion and the distal portion extend beyond the first frame component and the second frame component, respectively, of the implantable medical device according to claim 18.

21. A method of monitoring a physiological parameter of a body using the implantable medical device according to claim 18, the method comprising monitoring the physiological parameter in the first heart chamber of the heart using the sensor and monitoring the physiological parameter in the second heart chamber of the heart using the sensor.

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