Cranial shunt system and method for treating hydrocephalus

Abstract

A cranial shunt system includes at least one housing. A fluid channel is fixed with the at least one housing. The fluid channel extends between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing. The fluid channel defines a fluid pathway between the proximal fluid port and the distal fluid port. A valve assembly is fixed inside the at least one housing and operatively connected to the fluid channel between the proximal fluid port and the distal fluid port along the fluid pathway. A pressure sensor is disposed along the fluid channel between the proximal fluid port and the distal fluid port. The pressure sensor includes a sensing portion exposed to a pressure of the CSF along the fluid pathway, and a conductor extending from the pressure sensor into the at least one housing.

Description

PCT PATENT APPLICATION Inventors: Michael NagyJeffrey Neuwirth Alessandra Rivera Hidalgo Kyle CodaRobert ShulerTyler WankeSuyash BhattAdithya Subramanian Docket No.: 53560-00022TITLE CRANIAL SHUNT SYSTEM AND METHOD FOR TREATING HYDROCEPHALUSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No.63 / 773,073 filed March 17, 2025, entitled “SPLIT-HOUSING SHUNT SYSTEM AND METHOD FOR TREATING HYDROCEPHALUS”, the disclosure of which is incorporated by reference in its entirety herein.TECHNICAL FIELD

[0002] The present teachings relate to methods, systems, and components thereof for treating hydrocephalus, and more particularly to a split-housing cerebrospinal-fluid shunt method and system for treating hydrocephalus.BACKGROUND

[0003] Cerebrospinal Fluid (“CSF”) is a fluid surrounding the human brain that serves as a mechanical shock absorber and drains residual particles away from the brain. Structures in the brain produce CSF, and other structures drain it into the venous system. Overproducing and / or under draining CSF may cause a buildup of CSF in the head and spine, a condition known as hydrocephalus. Hydrocephalus can significantly increase pressure inside the cranium, leading to severe headaches, skull deformation, cognitive impairment, brain damage, or death. Shunts have traditionally been used to convey excess CSF to other parts of the human body. A t pical shunt (e.g., a ventriculoperitoneal shunt) includes a proximal catheter inserted into the brain’s ventricles via a hole in the cranium, and a valve that opens when intracranial pressure (“ICP”) increases beyond a threshold to allow CSF to flow into a distal catheter attached to the valve.However, most conventional cranial shunts fail within the first three years of implantation. A cranial shunt failure can put a patient at risk of death or permanent cognitive injury and usually requires revision surgery. Many cranial shunt failures are attributed to obstruction of the fluid line due to CSF over drainage, triggered by ICP spikes corresponding to sudden posture changes, coughing, straining, shouting, etc.

[0004] Thus, it is desirable to have a system that shunts CSF from the cranium to another part of the body while preventing shunt failure due to over drainage or underdrainage.SUMMARY

[0005] The following presents a summary of this disclosure to provide a basic understanding of some aspects. This summary is intended to neither identi fy key or critical elements nor define any limitations of embodiments or claims. Furthermore, this summary may provide a simplified overview of some aspects that may be described in greater detail in other portions of this disclosure. This summary' is intended to include various combinations of described aspects.

[0006] In accordance with an embodiment, a cranial shunt system includes at least one housing. A fluid channel is fixed with the at least one housing. The fluid channel extends between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing. The fluid channel defines a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port. A valve assembly is fixed inside the at least one housing and operatively connected to the fluid channel between the proximal fluid port and the distal fluid port along the fluid pathway. A pressure sensor is disposed along the fluid channel between the proximal fluid port and the distal fluid port. The pressure sensor includes a sensing portion exposed to a pressure of the CSF along the fluid pathway, and a conductor extending from the pressure sensor into the at least one housing.

[0007] In accordance with another embodiment, a cranial shunt system includes a housing having at least one wall defining an interior and an opening to the interior. A fluid channel is fixed with the housing. The fluid channel extends between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing. The fluid channel defines a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port. An electronic component is disposed in the interior of the housing. A cover is extended across the opening. An antenna is supported on the cover, outside of the housing, at a side of the opening opposite the electronic component.

[0008] In accordance with another embodiment, a cranial shunt system includes a housing. A fluid channel is fixed with the housing. The fluid channel includes a proximal fluid port thatconveys cerebrospinal fluid (CSF) toward the housing and a distal fluid port that conveys the CSF away from the housing, defining a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port in a first direction. An electronic component is disposed within the housing, including at least one of a valve operatively connected to the fluid channel along the fluid pathway, a pressure sensor exposed to a pressure of the CSF along the fluid pathway, or a battery. A circuit board assembly is disposed within the housing and operatively connected to the electronic component. The circuit board assembly includes a first board, a second board, and an interconnect coupling the first board and the second board. The interconnect is flexible relative to the first board and the second board. At least one of the first board and the second board overlaps the electronic component in a second direction orthogonal to the first direction.

[0009] The present disclosure relates to a cranial shunt system. In various embodiments, the cranial shunt system comprises at least one housing. A fluid channel is fixed with the at least one housing. The fluid channel extends between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing. The fluid channel defines a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port. A valve assembly is fixed inside the at least one housing and is operatively connected to the fluid channel between the proximal fluid port and the distal fluid port along the fluid pathway. A pressure sensor is disposed along the fluid channel between the proximal fluid port and the distal fluid port. The pressure sensor includes a sensing portion exposed to a pressure of the CSF along the fluid pathway, and a conductor extending from the pressure sensor into the at least one housing.

[0010] In certain embodiments, the fluid channel includes a wall that defines the fluid pathway and an opening to the fluid pathway. The pressure sensor is positioned in the opening and welded, brazed, or adhered to the wall such that the sensing portion defines the fluid pathway with the wall. By positioning the pressure sensor within the opening and securing it to the wall through welding, brazing, or adhesion, the sensing portion is integrated into the fluid pathway boundary defined by the wall, thereby enabling direct exposure to the CSF pressure within the fluid channel.

[0011] In some embodiments, the cranial shunt system further comprises a circuit board assembly disposed within the at least one housing and operatively connected to the valve assembly. The conductor extends from a side of the pressure sensor opposite the sensing portion at the fluid pathway, and directly to the circuit board assembly within the at least one housing. This arrangement enables a direct electrical connection between the pressure sensorand the circuit board assembly while maintaining the sensing portion in fluid communication with the CSF along the fluid pathway.

[0012] In various embodiments, the at least one housing defines an opening. The pressure sensor is fixed with the at least one housing or the fluid channel at the opening. A connection portion of the pressure sensor opposite the sensing portion defines or is disposed within an interior of the at least one housing. The conductor extends from the connection portion. In this manner, the sensing portion faces the fluid pathway to measure CSF pressure, while the connection portion and conductor are positioned within or define the interior of the housing, facilitating electrical connectivity with other components housed therein.

[0013] In certain embodiments, the at least one housing is formed from a metallic material. The metallic material defines an opening. The cranial shunt system further comprises an antenna positioned outside the at least one housing, at a side of the opening opposite the valve assembly or the pressure sensor. In one arrangement, a ceramic layer is fixed with the metallic material. The ceramic layer extends across and closes the opening, and supports the antenna outside the at least one housing. In another arrangement, a glass layer is fixed with the at least one housing. The glass layer extends across and covers a side of the antenna opposite the opening, retaining the antenna with the at least one housing. These arrangements allow the antenna to be positioned outside the metallic housing for effective wireless communication while maintaining the structural integrity and hermeticity of the housing through the ceramic layer or glass layer closure.

[0014] In some embodiments, the valve assembly or the pressure sensor are fixed directly to the fluid channel. The fluid channel includes a flange fixed directly to the at least one housing such that the pressure sensor or the valve assembly are fixed with the at least one housing through the fluid channel. This indirect fixation through the flange of the fluid channel provides a secure structural connection between the internal components and the housing while maintaining the fluid integrity of the fluid pathway.

[0015] In various embodiments, the fluid channel extends along a side of the at least one housing, across an entire length of the at least one housing in a first direction along the fluid pathway. The fluid channel occupies a same position as each of the valve assembly and the pressure sensor in a second direction orthogonal to the first direction. By extending the fluid channel along the full length of the housing in the first direction and aligning it with the valve assembly and pressure sensor in the second orthogonal direction, the system achieves a compact and streamlined profile suitable for implantation.

[0016] In certain embodiments, the cranial shunt system further comprises a circuit board in the at least one housing, operatively connected to the valve assembly and the pressure sensor, and a battery in the at least one housing, operatively connected to the circuit board. The at least one housing includes a first housing and a second housing. The valve assembly is disposed within the first housing, and the battery and the circuit board are disposed within the second housing. This multi-housing configuration separates the valve assembly from the battery and circuit board, allowing each housing to be sized and configured independently according to the components it contains.

[0017] In some embodiments, the cranial shunt system further comprises a flexible connector joining the first housing with the second housing. The first housing and the second housing each include a bottom surface that faces a cranium of a patient. The flexible connector is less rigid than the bottom surface of the first housing and the second housing. The flexible connector permits relative movement between the first housing and the second housing, enabling the system to conform to the curvature and contours of the patient's cranium while the bottom surfaces of the respective housings maintain structural rigidity for supporting the internal components.

[0018] In various embodiments, the cranial shunt system further comprises an overmold that encapsulates exterior portions of the at least one housing and the fluid channel as a unitary body fixing the fluid channel with the housing. The overmold fixes the fluid channel with the at least one housing, providing a unified external structure that protects and secures the assembled components, and creates a smooth, biocompatible exterior surface suitable for implantation.

[0019] In certain embodiments, the pressure sensor is a first pressure sensor. The valve assembly is operatively connected to the fluid pathway via a valve port. The cranial shunt system further comprises a second pressure sensor exposed to the pressure of the CSF along the fluid pathway at a side of the valve port opposite the first pressure sensor. The provision of first and second pressure sensors on opposite sides of the valve port enables measurement of CSF pressure both upstream and downstream of the valve assembly, allowing determination of a pressure differential across the valve.

[0020] In accordance with another aspect of the present disclosure, a cranial shunt system comprises a housing having at least one w all defining an interior and an opening to the interior. A fluid channel is fixed with the housing. The fluid channel extends between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing. The fluid channel defines a fluid pathway of CSF flowbetween the proximal fluid port and the distal fluid port. An electronic component is disposed in the interior of the housing. A cover is extended across the opening. An antenna is supported on the cover, outside of the housing, at a side of the opening opposite the electronic component.

[0021] In some embodiments, the at least one wall is formed from a metallic material. The cover includes a first layer formed from a ceramic material extending across the opening, and a second layer formed from a glass material extending across the first layer, at a side of the first layer opposite the electronic component. The ceramic first layer and the glass second layer together provide a hermetic seal across the opening while enabling wireless signal transmission through the non-metallic cover materials.

[0022] In various embodiments, the first layer extends across and closes the opening. The second layer covers a side of the antenna opposite the opening, retaining the antenna with the first layer. The first layer includes a conductor extended through the ceramic material, forming an electric circuit connection between the antenna and the electronic component in the interior. In this configuration, the ceramic first layer serves as both a structural closure for the opening and a feedthrough substrate carrying the conductor that electrically connects the externally positioned antenna with the electronic component disposed in the interior of the housing.

[0023] In certain embodiments, the fluid pathway extends in a first direction. The antenna occupies a same position as the electronic component in a second direction orthogonal to the first direction. The electronic component includes at least one of a battery, a circuit board assembly, a valve assembly operatively connected to the fluid channel along the fluid pathway, and a pressure sensor exposed to a pressure of the CSF along the fluid pathway. By aligning the antenna and the electronic component in the second direction orthogonal to the first direction of fluid flow, the system maintains a low-profile configuration along the axis perpendicular to the cranial surface.

[0024] In some embodiments, the second direction is orthogonal to a cranium. The alignment of the antenna and the electronic component in a direction orthogonal to the cranium positions these components in a stacked arrangement relative to the cranial surface, minimizing the footprint of the system along the surface of the cranium.

[0025] In accordance with yet another aspect of the present disclosure, a cranial shunt system comprises a housing. A fluid channel is fixed with the housing. The fluid channel includes a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing and a distal fluid port that conveys the CSF away from the housing, defining a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port in a first direction. An electronic component is disposed within the housing, including at least one of a valve operativelyconnected to the fluid channel along the fluid pathway, a pressure sensor exposed to a pressure of the CSF along the fluid pathway, or a battery’. A circuit board assembly is disposed within the housing and operatively connected to the electronic component. The circuit board assembly includes a first board, a second board, and an interconnect coupling the first board and the second board. The interconnect is flexible relative to the first board and the second board. At least one of the first board and the second board overlaps the electronic component in a second direction orthogonal to the first direction.

[0026] In certain embodiments, the electronic component is interposed between and separates the first board and the second board in the second direction. This arrangement positions the electronic component between the two boards in a stacked configuration, with each board on an opposite side of the electronic component along the second direction, enabling electrical connections to the electronic component from both boards while efficiently utilizing the interior volume of the housing.

[0027] In some embodiments, the housing includes a bottom and a wall extended away from the bottom along a perimeter of the bottom such that the bottom and the wall define an interior of the housing containing the electronic component. The first board is disposed between the bottom and the electronic component in the second direction. The wall defines a cutout from an edge opposite the bottom such that the interconnect in an unfolded condition extends from the first board in the interior, through the wall at the cutout. The cutout in the wall facilitates routing of the flexible interconnect from the interior of the housing, allowing the circuit board assembly^ to be folded into the housing during assembly while maintaining the flexibility needed to accommodate the electronic component between the boards.

[0028] In various embodiments, the electronic component is a coin cell battery. The first board and the second board are folded toward each other across the interconnect in the housing. The first board or the second board defines a curved edge that maintains constant offset from the coin cell battery. The curved edge conforms to the cylindrical geometry of the coin cell battery, maintaining a consistent spacing between the board and the battery' perimeter, thereby- maximizing the available board area within the housing while avoiding interference with the coin cell battery.DESCRIPTION OF THE DRAWINGS

[0029] The present teachings may be better understood by reference to the following detailed description taken in connection with the following illustrations, wherein:

[0030] FIG. 1 is a block diagram of an example cranial shunt system for treating hydrocephalus according to an embodiment.

[0031] FIG. 2 is a block diagram of a cranial shunt system for treating hydrocephalus according to another embodiment.

[0032] FIG. 3 is a block diagram of a cranial shunt system for treating hydrocephalus according to another embodiment.

[0033] FIG. 4 is a block diagram of a valve assembly of a cranial shunt system according to another embodiment.

[0034] FIG. 5 is a block diagram of a cranial shunt system for treating hydrocephalus according to another embodiment.

[0035] FIG. 6A is a perspective view of the cranial shunt system of FIG. 5 showing a proximal catheter extending through a burr hole in a skull surface.

[0036] FIG. 6B is a cross-sectional view of the proximal catheter of the cranial shunt system of FIG. 5 showing a dual-lumen construction.

[0037] FIG. 7A is a perspective view of a cranial shunt system according to another embodiment, showing a pressure sensor capsule tethered to a valve assembly body.

[0038] FIG. 7B is an exploded perspective view of the cranial shunt system of FIG. 7A.

[0039] FIG. 8 is a process flow diagram of a method for determining a possible blockage event in a cranial shunt system.

[0040] FIG. 9 is a diagram of example communication architecture of a cranial shunt system according to another embodiment.

[0041] FIG. 10 is a diagram of example communication architecture of a cranial shunt system according to another embodiment.

[0042] FIG. 11 is a perspective view of a cranial shunt system according to another embodiment.

[0043] FIG. 12 is a top view of a cranial shunt system.

[0044] FIG. 13 is a perspective view of a cranial shunt system according to another embodiment.

[0045] FIG. 14 is a perspective view of the cranial shunt system of FIG. 13 with portions of a housing illustrated as transparent, revealing internal components of the housing.

[0046] FIG. 15 is a perspective view of the cranial shunt system of FIG. 13 including a base with electronic components mounted on the base.

[0047] FIG. 16 is a back perspective view of the cranial shunt system of FIG. 15 including an electronics assembly with circuit boards mounted on the base.

[0048] FIG. 17 is a front perspective view of the cranial shunt system of FIG. 16.

[0049] FIG. 18 is a perspective view of the cranial shunt system of FIGS. 16 and 17 including installation of a battery within the electronics assembly.

[0050] FIG. 19 is a perspective view of the cranial shunt system of FIG. 18 including installation of a charging antenna within the electronics assembly.

[0051] FIG. 20 is a perspective view of the cranial shunt system of FIG. 19 including placement of a cover over the electronics assembly.

[0052] FIG. 21 is a perspective view of the cranial shunt system of FIG. 20 including attachment of a valve to the base.

[0053] FIG. 22 is a top view of the cranial shunt system of FIG. 21 including installation of a sensor assembly.

[0054] FIG. 23 is a perspective view of the cranial shunt system of FIG. 22 including formation of a header around the valve and fluid ports.

[0055] FIG. 24 is a top view' of a cranial shunt system according to another embodiment, including a base.

[0056] FIG. 25 is a side view of the cranial shunt system of FIG. 24.

[0057] FIG. 26 is a top view of the cranial shunt system of FIG. 24, including installation of a circuit board above the base, forming an electronics assembly.

[0058] FIG. 27 is a side view of the cranial shunt system of FIG. 26.

[0059] FIG. 28 is a top view of the cranial shunt system of FIG. 26. including installation of a battery within the electronics assembly.

[0060] FIG. 29 is a side view of the cranial shunt system of FIG. 28.

[0061] FIG. 30 is a top view of the cranial shunt system of FIG. 28, including installation of a charging antenna.

[0062] FIG. 31 is a side view of the cranial shunt system of FIG. 30.

[0063] FIG. 32 is a top view of the cranial shunt system of FIG. 30, including coating and filling of the electronics assembly.

[0064] FIG. 33 is a side view of the cranial shunt system of FIG. 32.

[0065] FIG. 34 is a top view of the cranial shunt system of FIG. 32, including placement of a cover over the electronics assembly.

[0066] FIG. 35 is a side view of the cranial shunt system of FIG. 34.

[0067] FIG. 36 is a top view of the cranial shunt system of FIG. 34, including attachment of a valve and a sensor assembly.

[0068] FIG. 37 is a side view of the cranial shunt system of FIG. 36.

[0069] FIG. 38 is a top view of the cranial shunt system of FIG. 36, including formation of strain relief and coating around the sensor assembly and the valve.

[0070] FIG. 39 is a side view of the cranial shunt system of FIG. 38.

[0071] FIG. 40 is a top view of the cranial shunt system of FIG. 38, including installation of an end cap.

[0072] FIG. 41 is a side view of the cranial shunt system of FIG. 40.

[0073] FIG. 42 is a top view of the cranial shunt system of FIG. 40, including installation of fluid ports.

[0074] FIG. 43 is a side view of the cranial shunt system of FIG. 42.

[0075] FIG. 44 is a front view of a cranial shunt system according to another embodiment, including an electronics enclosure.

[0076] FIG. 45 is a side view of the cranial shunt system of FIG. 44 including the electronics enclosure.

[0077] FIG. 46 is a top view of the cranial shunt system of FIG. 44 including the electronics enclosure.

[0078] FIG. 47 is a front view of the cranial shunt system of FIG. 44 including installation of a feedthrough within a side opening of the electronics enclosure.

[0079] FIG. 48 is a side view of the cranial shunt system of FIG. 47.

[0080] FIG. 49 is a top view of the cranial shunt system of FIG. 47.

[0081] FIG. 50 is a front view of the cranial shunt system of FIG. 47, including installation of a window within atop opening of the electronics enclosure.

[0082] FIG. 51 is a side view of the cranial shunt system of FIG. 50.

[0083] FIG. 52 is a top view of the cranial shunt system of FIG. 50.

[0084] FIG. 53 is a top view of the cranial shunt system of FIG. 44 including a circuit board assembly.

[0085] FIG. 54 is a side view of the cranial shunt system of FIG. 53 including installation of an antenna onto the circuit board assembly.

[0086] FIG. 55 is a longitudinal side view of the cranial shunt system of FIG. 53, including the antenna installed on the circuit board assembly.

[0087] FIG. 56 is a front view of the cranial shunt system of FIG. 55.

[0088] FIG. 57 is a lateral side view of the cranial shunt system of FIG. 55.

[0089] FIG. 58 is a front view of the cranial shunt system of FIG. 55, including insertion of the circuit board assembly into the electronics enclosure.

[0090] FIG. 59 is a side view of the cranial shunt system of FIG. 58.

[0091] FIG. 60 is a side view of the cranial shunt system of FIG. 58, including soldering the circuit board assembly within the electronics enclosure.

[0092] FIG. 61 is a side view of the cranial shunt system of FIG. 60, including electrical connection of a batter}' to the circuit board assembly.

[0093] FIG. 62 is a side view of the cranial shunt system of FIG. 61, including installation of the battery within the electronics enclosure.

[0094] FIG. 63 is a side view of the cranial shunt system of FIG. 62, including coating of an electronics assembly within the electronics enclosure using a potting compound.

[0095] FIG. 64 is a side view of the cranial shunt system of FIG. 63, including attachment of a plate to the electronics enclosure.

[0096] FIG. 65 is a side view of the cranial shunt system of FIG. 44 including a valve enclosure.

[0097] FIG. 66 is a top view of the cranial shunt system of FIG. 65.

[0098] FIG. 67 is a top view of the cranial shunt system of FIG. 65, including installation of a tube within the valve enclosure.

[0099] FIG. 68 is a top view of the cranial shunt system of FIG. 65 including the tube joined to the valve enclosure.

[0100] FIG. 69 is a side view of the cranial shunt system of FIG. 68.

[0101] FIG. 70 is a side view of the cranial shunt system of FIG. 44 including a sensor assembly with a sensor capsule and a sensor cable.

[0102] FIG. 71 is a side perspective view of the cranial shunt system of FIG. 44, including insertion of the sensor cable through the tube.

[0103] FIG. 72 is a side view of the cranial shunt system of FIG. 71.

[0104] FIG. 73 is a top view of the cranial shunt system of FIG. 44 including a valve assembly installed within the valve enclosure.

[0105] FIG. 74 is a side view of the cranial shunt system of FIG. 73.

[0106] FIG. 75 is a top view of the cranial shunt system of FIG. 74, including potting of an interior of the valve enclosure.

[0107] FIG. 76 is a side view of the cranial shunt system of FIG. 75.

[0108] FIG. 77 is a side view of the cranial shunt system of FIG. 76, including electrical connection between the valve enclosure and the electronics enclosure.

[0109] FIG. 78 is a partially assembled view of the cranial shunt system of FIG. 77, including a bottom view of the valve enclosure and a front view of the electronics enclosure.

[0110] FIG. 79 is a side view of the cranial shunt system of FIG. 78, including attachment of the valve enclosure to the electronics enclosure.

[0111] FIG. 80 is atop view of the cranial shunt system of FIG. 79 including attachment of the valve enclosure to the electronics enclosure.

[0112] FIG. 81 is an exploded side view of the cranial shunt system of FIG. 80 including fluid channel structures assembled with a valve assembly.

[0113] FIG. 82 is a side view of the cranial shunt system of FIG. 81 including attachment of the fluid channel structures to the electronics enclosure.

[0114] FIG. 83 is a perspective view of a cranial shunt system according to another embodiment, arranged along a catheter pathway.

[0115] FIG. 84 is a perspective view of the cranial shunt system of FIG. 83 and a cranial shunt system according to another embodiment.

[0116] FIG. 85 is a perspective view of the cranial shunt system of FIG. 83 including a fluid channel with a pressure sensor.

[0117] FIG. 86 is a perspective view of the cranial shunt system of FIG. 83 including the fluid channel and a valve enclosure.

[0118] FIG. 87 is a perspective view of the cranial shunt system of FIG. 83 including the valve enclosure attached to the fluid channel in a closed configuration, with the housing positioned over the valve enclosure.

[0119] FIG. 88 is a perspective view of the cranial shunt system of FIG. 83 including the fluid channel fixed with a pressure sensor.

[0120] FIG. 89 is a perspective view of the cranial shunt system of FIG. 83 with a battery positioned within the housing adjacent to the valve enclosure and the pressure sensor.

[0121] FIG. 90 is a top perspective view of the cranial shunt system of FIG. 83 including a circuit board assembly.

[0122] FIG. 91 is a top perspective view of the cranial shunt system of FIG. 83 including the circuit board assembly assembled with the valve assembly and the pressure sensor.

[0123] FIG. 92 is a bottom perspective view of the cranial shunt system of FIG. 91.

[0124] FIG. 93 is an exploded perspective view of the cranial shunt system of FIG. 83 including the housing, the valve enclosure, a cover, the pressure sensor, the fluid channel, and the valve assembly.

[0125] FIG. 94 is a perspective view of the cranial shunt system of FIG. 93 in an assembled configuration.

[0126] FIG. 95 is a top view of the cranial shunt system of FIG. 94.

[0127] FIG. 96 is a perspective view of the cranial shunt system of FIG. 83 including a first layer of a cover with connections to an antenna.

[0128] FIG. 97 is a perspective view of the cranial shunt system of FIG. 83 including a second layer of a cover positioned above the antenna.

[0129] FIG. 98 is a perspective view of the cranial shunt system of FIG. 83 including an overmold applied over exterior portions.

[0130] FIG. 99 is a side view of a cranial shunt system according to another embodiment including a first housing and a second housing coupled by a flexible connector.

[0131] FIG. 100 is a perspective view of a cranial shunt system according to another embodiment.

[0132] FIG. 101 is a top view of the cranial shunt system of FIG. 100 and a cranial shunt system according to another embodiment.

[0133] FIG. 102 is a side view of the cranial shunt system of FIG. 100 and the cranial shunt system introduced in FIG. 101.

[0134] FIG. 103 is a side view of the cranial shunt system of FIG. 100 and the cranial shunt system introduced in FIG. 101.

[0135] FIG. 104 is a side perspective view of a cranial shunt system according to another embodiment.

[0136] FIG. 105 is atop perspective view of the cranial shunt system of FIG. 104.

[0137] FIG. 106 is a top perspective view of the cranial shunt system of FIG. 104 with a lid removed from a housing.

[0138] FIG. 107 is a top perspective view of a cranial shunt system according to another embodiment, including a circuit board assembly shown in a flat configuration.

[0139] FIG. 108 is a top perspective view of the cranial shunt system of FIG. 107 including the circuit board assembly in a partially folded configuration.

[0140] FIG. 109 is a side perspective view of the cranial shunt system of FIG. 107 including the circuit board assembly in a folded configuration.

[0141] FIG. 110 is a front perspective view of the cranial shunt system of FIG. 107 including an electronics assembly.

[0142] FIG. Ill is a top perspective view of the cranial shunt system of FIG. 107 including the electronics assembly positioned within a housing in the flat configuration.

[0143] FIG. 112 is a front perspective view of the cranial shunt system of FIG. 107 including the electronics assembly in the folded configuration w ithin the housing.

[0144] FIG. 113 is a top perspective view of a cranial shunt system according to another embodiment.

[0145] FIG. 114 is a side perspective view of the cranial shunt system of FIG. 113 with a fluid channel illustrated as transparent.

[0146] FIG. 115 is a top perspective view7of the cranial shunt system of FIG. 113 with a lid removed from a housing, revealing internal components.

[0147] FIG. 116 is a top perspective view of a cranial shunt system according to another embodiment.

[0148] FIG. 117 is an exploded view7of the cranial shunt system of FIG. 116.

[0149] FIG. 118 is a top perspective view of a cranial shunt system according to another embodiment.

[0150] FIG. 119 is a side perspective view of a cranial shunt system according to another embodiment.

[0151] FIG. 120 is a partial, enlarged, side perspective view of the cranial shunt system of FIG. 119 with a fluid channel illustrated as transparent.

[0152] FIG. 121 is a top view of the cranial shunt system of FIG. 119 including a circuit board assembly.

[0153] FIG. 122 is a top perspective view7of a cranial shunt system according to another embodiment.

[0154] FIG. 123 is a side view of the cranial shunt system of FIG. 122.

[0155] FIG. 124 is atop perspective view of the cranial shunt system of FIG. 122 including a circuit board.

[0156] FIG. 125 is atop view of the cranial shunt systems of FIGS. 100, 101, 116, 118, 119, and 122, and a cranial shunt system according to another embodiment.

[0157] FIG. 126 is a side view of the cranial shunt systems of FIG. 125.DETAILED DESCRIPTION

[0158] The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.

[0159] Reference will now be made in detail to embodiments of the present teachings, examples of which are illustrated in the accompanying drawings. It is to be understood that other embodiments may be utilized, and structural and functional changes may be made withoutdeparting from the scope of the present teachings. Moreover, features of the embodiments may be combined, switched, or altered without departing from the scope of the present teachings, e.g., features of each disclosed embodiment may be combined, switched, or replaced with features of the other disclosed embodiments. In this disclosure, numerous specific details provide a thorough understanding of the subject disclosure. It should be understood that aspects of this disclosure may be practiced with other embodiments not necessarily including all aspects described herein, etc. As such, the following description is presented by way of illustration and does not limit the various alternatives and modifications that may be made to the illustrated embodiments and still be within the spirit and scope of the present teachings.

[0160] As used herein, the words "example" and “exemplary ’' mean an instance, or illustration. The words “example” or “exemplary” do not indicate a key or preferred aspect or embodiment. The word “or” is intended to be inclusive rather than exclusive, unless context suggests otherwise. As an example, the phrase “A employs B or C,” includes any inclusive permutation (e.g., A employs B; A employs C; or A employs both B and C). As another matter, the articles “a” and “an” are generally intended to mean “one or more” unless context suggest otherwise.

[0161] Throughout this disclosure, ‘proximal’ means towards the brain, ‘distal’ away from the brain. In an embodiment, a proximal catheter drains CSF from the ventricle and a distal catheter empties the CSF into an abdominal peritoneum of a patient. However, other configurations, such as drainage from the subarachnoid space, or discharge into the right atrium or pleural sac, are also possible based on the present teachings. The present disclosure is not limited to the location of discharge. What is described herein is exemplary' and any appropriate location of discharge within or even outside of the body may be utilized without departing from the present teachings.

[0162] "Logic," synonymous with "circuit" as used herein, includes but is not limited to hardware, firmware, software and / or combinations of each to perform a function(s) or an action(s). For example, based on a desired application or needs, logic may include a software controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device and / or controller apparatus. Logic may also be fully embodied as software.

[0163] "Software", as used herein, includes but is not limited to one or more computer readable and / or executable instructions that cause a computer, logic, or other electronic device to perform functions, actions, and / or behave in a desired manner. The instructions may be embodied in various forms such as routines, algorithms, modules or programs includingseparate applications or code from dynamically linked libraries. Software may also be implemented in various forms such as a stand-alone program, a function call, a servlet, an app, instructions stored in a memory, part of an operating system or other type of executable instructions. It will be appreciated by one of ordinary skill in the art that the form of software is dependent on, for example, requirements of a desired application, the environment it runs on, and / or the desires of a designer / programmer or the like.SYSTEM OVERVIEW

[0164] It should be understood that the description and drawings herein are merely illustrative and that various modifications and changes can be made in the structures disclosed without departing from the present disclosure. Referring now to the drawings, wherein like numerals refer to like parts throughout the several views. FIG. 1 depicts an example cranial shunt system 100 for treating hydrocephalus. The cranial shunt system 100 includes a shunt 106, at least one external device 140 communicatively coupled to the shunt 106 via a communications network 160, at least one atmospheric sensor 146, and the at least one external device 140 communicatively coupled to the communications network 160. In FIG. 1, the shunt 106 includes a valve assembly 110, a valve 130, a proximal catheter 170, a distal catheter 172, an inlet 130a, an outlet 130b, and an electronics assembly 115. The electronics assembly 115 in FIG. 1 contains at least one sensor apparatus 132, a controller apparatus 120, a power supply 134, and a communications device 165. The valve assembly 110 may be in a housing that is modular where the valve assembly 110 may be attached to the electronics assembly 115 and detached from the electronics assembly 115. The electronics assembly 115 may be removed from the patient without removing the valve assembly 110 or the catheter 170 / 172.

[0165] Continuing to refer to FIG. 1, the electronics assembly 115 may include the controller apparatus 120, and the sensor apparatus 132 operatively connected to the controller apparatus 120. The sensor apparatus 132 contains at least one sensor, with FIG. 1 depicting a first sensor 132a and a second sensor 132b. The controller apparatus 120 may include a microcontroller, where the microcontroller sends or receives data from the sensor apparatus 132 to control the operation of the valve assembly 110 or the valve 130. The controller apparatus 120 may also be a processor 122 or a storage device 124. The processor 122 may embody any suitable processing device or set of processing devices such as, but not limited to: a microprocessor, a microcontroller-based platform, a suitable integrated circuit, one or more field programmable gate arrays (FPGAs), and / or one or more application-specific integrated circuits (ASICs). The storage device 124 may be volatile memory (e g., RAM, which can include non-volatile RAM,magnetic RAM, ferroelectric RAM, and any other suitable forms); non-volatile memory (e.g., disk memory, FLASH memory, EPROMs, EEPROMs, non-volatile solid-state memory, etc.), unalterable memory (e.g., EPROMs), read-only memory, etc.). In embodiments of the present disclosure, the storage device 124 may include volatile memory and non-volatile memory. The storage device 124 may also embody a computer readable medium on which one or more sets of instructions are embedded. The instructions may embody one or more of the methods or logics as described herein. In a particular embodiment, the instructions may reside completely or partially within any one or more of the storage device 124, the computer readable medium, or within the processor 122 during execution of the instructions.

[0166] Continuing to refer to FIG. 1, a software application (“App"’) 150 may reside on the external device 140. The external device 140 may’ be a smartphone 144 owned by the patient or the treating physician. The App 150 may include a computer program or software including a set of instructions. The instructions may embody one or more of the methods or logic as described herein. The App 150 may be configured to receive or send data to the valve assembly 110, the valve 130, the controller apparatus 120 thereof and / or the electronics assembly 115 via the external device 140.

[0167] In an embodiment, the data may include atmospheric data, for example, an ambient pressure value or temperature, and the like. In such embodiments, it is contemplated that the App 150 may receive the data via a barometer or temperature sensor residing in the external device 140. It is also contemplated that the App 150 may be communicatively coupled to another app, a website, or an external server to receive atmospheric data. In some embodiments, the App 150 is publicly available so that anyone may download it on to their respective external device 140 for use with the system.

[0168] The sensor apparatus 132 may include environmental sensors (e.g.. temperature sensors, humidity sensors, pressure sensors, accelerometers, light sensors, etc ). In an embodiment, the sensor apparatus 132 may include a pressure sensor 132a, as the first sensor 132a, configured to provide ICP (e.g., absolute ICP) of the patient in real time. For example, the pressure sensor 132a may be disposed in the end of a rigid tube extending through a burr hole below the shunt to measure ICP in the subarachnoid space just below the dura, or somewhat deeper, inside the brain’s parenchyma. It is also contemplated that pressure sensor 132 may be disposed in a capsule tethered to the shunt, or be disposed at an end of a lumen, for example, in a catheter with a dual lumen structure, i.e., a first lumen for conveying / draining CSF, and a second lumen for communicating pressure to the pressure sensor via a fluid column. In these embodiments, the pressure sensor 132a may' be configured to measure and provide ICPat a location outside of a fluid channel for convey ing / draining CSF. Separating the ICP measurement point from the fluid channel may facilitate detection of potential obstructions of the fluid channel. If the valve assembly 110 or the fluid channel is obstructed the valve assembly 110 may be replaced, the electronics assembly 115 may remain inside the brain when the valve assembly 110 is removed. As shown in FIG. 1 the sensor apparatus 132 is within the electronics assembly 115, but in an alternative embodiment, the sensor apparatus 132 may be within the valve assembly 110 housing.

[0169] In some embodiments, the electronics assembly 115 may include the communications device 165, one or more controllers 120 / 122 / 124 for standards-based networks (e.g., 2G, 3G, 4G. 4G LTE, 5G, 6G, GSM, UMTS, LTE, CDMA, WiMAX, etc.), satellite communication networks, and / or wireless local area networks (e.g., Wi-Fi®, Wireless Gigabit, etc.), etc. In some examples, the communication device 165 may include controllers for personal area networks (e.g., ZigBee® (“IEEE 802.15.4”), Near Field Communication (“NFC”), etc.) to communicatively couple the valve assembly 110 to the external devices 140. In some embodiments, the communications device 165 may include a Bluetooth device (e.g., antenna and transceiver), or facilitate Wi-Fi-based communication such as via frequencies defined by the IEEE 802.11 standards, short-range wireless frequencies such as Bluetooth®, or any suitable wired or wireless communications protocol that facilitates communication between the valve assembly 110 and the external devices 140. In some embodiments, the communications device 165 may include a RFID antenna to wirelessly communicate with the external devices 140. It is also contemplated that the components of the valve assembly 110 may wirelessly communicate with each other via RFID technology.

[0170] In some embodiments, the sensor apparatus 132 may also include a tilt sensor 132b, as the second sensor 132b. configured to provide an angle of orientation relative to gravity. In some embodiments, the pressure sensor 132a may include a low-drift, media compatible pressure sensor configured to measure absolute ICP, and the tilt sensor 132b may include a 3-axis chip accelerometer configured to measure the implant patient’s posture relative to gravity'. The low-drift media compatible pressure sensor 132a may also be encapsulated in a high durability' and biocompatible material such as Titanium.

[0171] The valve 130 may include the inlet 130a operatively^ coupled to the proximal catheter 170 (e.g., a first catheter), and the outlet 130b operatively coupled to the distal catheter 172 (e.g., a second catheter). The proximal catheter 170 may be configured to convey cerebrospinal fluid (CSF) to the inlet 130a, and the distal catheter 172 may be configured to convey the CSF to another portion of the patient’s body, e.g., into the abdominal peritoneum thereof. The valve130 may be configured to reside on top of the implanted patient’s skull, for example, under the scalp. Operatively, the valve 130 is configured to allow or block the flow of CSF from the inlet 130a to the outlet 130b based on instructions from the controller apparatus 120, e.g., to open or close the valve assembly 110 based on ICP data. In some embodiments, the valve 130 may be an electromechanical latching valve based on shape memory alloy technology to provide silent switching, small size, and low power. In some embodiments, the sensors 132. power supply 134 and controller apparatus 120 may form part of the valve 130. It is also contemplated that each of the sensors 132, valve 130, and controller apparatus 120 may embody separate elements or form part of one or more subassemblies.

[0172] Referring to FIG. 1, the power supply 134 may be operatively connected to each of the valve 130, the sensors 132, the controller apparatus 120, and the communications device 165 to supply power thereto. The power supply 134 may embody a battery (e.g., a rechargeable high-density lithium cell). Wireless charging and power management circuitry may be included in the electronics assembly 115 to ensure a safe, reliable recharge from an external charger device.

[0173] As noted above, one or more external devices 140 may be communicatively coupled with the valve assembly 110 and the electronics assembly 115. The external device 140 may embody, for example, a smartphone 144, a tablet, or a notebook, or a wearable device 142 worn by the user (e.g., a smartwatch or other suitable device including a processor, a sensor, and a transceiver (e.g., a BLE transceiver circuit) for receiving or sending data to the valve assembly 110 and the electronics assembly 115. For example, the wearable device 142 may embody a necklace, a bracelet, a clip, a ring, a pin, a clip, a belt buckle (or attachment therefor), or a puckshaped device (e.g., that may be stored in the user’s pocket), each including a processor, a sensor, and a transceiver. In some embodiments, the external device 140 may embody a host device (e.g., a clinic device) hosting a clinic App that is used by clinicians (certified medical specialists e.g., doctors and nurses). The clinic App may generally communicate with the wearable, with the shunt, or with a cloud server to exchange data with the other devices. The clinic App may act as a portal to the cloud database. It may allow clinicians to access a given patient’s historical data. It may filter said data using thresholds and parameters set by the clinician, or default thresholds and parameters. It may graphically display the data and perform statistical analysis of it, for example averages, standard deviations, variance analysis. It may identify longitudinal trends in the patient's data, for example long-term changes in daily ICP over time. It may include search capability allowing the clinician to use search criteria to filter, correlate and display data. For example, a clinician may want to find average ICP duringnightime versus daytime, or may wish to see the patient's average “valve open’" time per day per month and time to restore normal ICP for each ‘valve open’ event for the past 3 years. The clinical App may allow correlation of data with external events that are either reported by the patient, patient caregivers, clinicians, the patient’s electronic medical record, or the Smartshunt system itself. External events may include any of the ‘event data' parameters listed elsewhere in this application, and may further include data from other sources such as the patient’s medical record. The clinical App may contain learning algorithms or artificial intelligence algorithms that may predict future physiological outcomes based on past outcomes and may recommend or implement systems setings changes based on these. Clinical software may perform automated data analysis and look for correlations between ICP, drainage events, time of day. and patient-recorded events. It may allow the physician to change device settings remotely, for example valve open ICP threshold, valve close ICP threshold, time of ICP averaging window, valve ‘safe state’ in case of power loss (open or closed). The clinic App may be configured to recommend setings and treatment based on accepted medical guidelines and on the individual patient’s physiological status and / or measurements including data available through Medicaid database (or foreign equivalent databases or any other medical database available) to predict resting ICP of patient using sex, age, weight, and height of patient as cofactors. The clinic App may alert clinicians to Smartshunt system health conditions that may require atention, for example suspected shunt obstruction, low batery, batery end-of-lifetime, suspected system malfunction, inability to contact wearable, internal system faults, etc. The clinic App may connect to a larger database of SmartShunt patients who under the care of other clinicians. The larger database may anonymize patient data to comply with Protected Health Information standards such as HIPAA and the EU General Data Protection Regulation. The clinic App may use data from the larger database to allow clinicians to see how their patients compare to the larger hydrocephalus population, as well as how other physicians are using the system (adjusting setings, etc.) and their outcomes. The clinic App may provide similar search and correlation functions to the larger database as to the database from the clinicians’ own patients.

[0174] Referring to FIG. 1, one or more atmospheric sensors 146 may be coupled to or embedded within each external device 140 to measure local atmospheric conditions, e.g., atmospheric pressure, temperature, and the like. For this purpose, each external device 140 may include a barometer or a temperature sensor (e.g., that measures the battery or CPU temperatures of the external device).

[0175] A software application (“app”) 150 may reside on the external device 140, for example, on the patient’s or another person’s smartphone 144. The App 150 may include a computer program or software including a set of instructions. The instructions may embody one or more of the methods or logic as described herein. The App 150 may be configured to receive or send data to the valve assembly 110 (e.g., to the controller apparatus 120 thereof) and / or the electronics assembly 115 via the external device 140. In an embodiment, the data may include atmospheric data, for example, an ambient pressure value or temperature, and the like. In such embodiments, it is contemplated that the App 150 may receive the data via a barometer or temperature sensor residing in the external device 140. It is also contemplated that the App 150 may be communicatively coupled to another app, a website, or an external server to receive atmospheric data. In some embodiments, the App 150 is publicly available so that anyone may download it on to their respective external device 140 for use with the system.

[0176] In some embodiments, a shunt system user may have more than one wearable device 142 configured to provide atmospheric data to the valve assembly 110, for example, a first wearable device 142 to communicate with the valve assembly 110 while a second wearable device 142 is charging.

[0177] In some embodiments, the controller apparatus 120 (e.g., firmware thereof) may include logic to listen for and communicate with the wearable device 142, for example, to receive atmospheric data therefrom every 3 to about 12 seconds, or about ever}’ 8 seconds, for example. In this manner, the controller apparatus 120 may include logic to determine a gauge ICP (e.g., gauge average ICP value) based on the atmospheric pressure (obtained via the external device 140) and an absolute ICP value (e.g., absolute average) received from the sensors 132. The controller apparatus 120 may determine the gauge ICP based on additional data, for example, tilt angle data (provided by the tilt sensor 132b) to account for fluid column weight offsets based on the patient’s posture. In an embodiment, the implant may stay in a low-power sleep mode for a present interval and wake itself up using an internal timer circuit. It may then listen for the ambient pressure data from the w earable as described above.

[0178] It is contemplated that communication between a user’s wearable device 142 and the valve assembly 110 may be lost, for example, due to a communication network outage, or because the wearable device 142 is not charged or has been lost or damaged by the patient. In such embodiments, the controller apparatus 120 may listen for the external device 140, but not receive a reading (e.g., atmospheric data) therefrom. For this purpose, the user may utilize the App 150 on another external device 140 (e.g., a smartphone 144) to provide atmospheric data to the valve assembly 110 (e g., to the controller apparatus 120 thereof). In this manner, theApp 150 (downloaded on the smartphone 144) may serve as a backup to provide atmospheric data to the controller apparatus 120 when the controller apparatus 120 is unable to receive atmospheric data from the user’s wearable device 142. In this manner, the App 150 may provide atmospheric data to the controller apparatus 120 after it has failed to receive it from the wearable device 142, for example, at about 30 to 90 seconds, or about 60 seconds after failing to communicate with the wearable device 142. In some embodiments, the controller apparatus 120 may communicate with the App 150 to receive atmospheric data therefrom after a certain number of attempts to reach the user’s wearable device 142, for example, after 10 or 100 attempts or more. In some embodiments, the system 100 may be setup such that the App 150 is configured to transmit atmospheric data to the valve assembly 110 at an interval that is less than the system's search time, i.e.. the time to search for the wearable device 142. For instance, the system may be configured to search for the wearable device 142 to receive atmospheric data therefrom every’ 10 seconds, while the App 150 is configured to transmit atmospheric data to the system every’ second.

[0179] In some embodiments, the App 150 may feature a user interface or an input device 152 to enable the App 150 to send atmospheric data to the valve assembly 110, for example, a slider, a toggle button, a voice activated command, etc. In some embodiments, the App 150 may be downloaded via any smartphone (e.g., Android or Apple® devices), thereby providing the user a variety of options to provide atmospheric data to the system. In an embodiment, the display will simply state that the ambient pressure is currently being broadcast and may state the frequency of broadcasting. It may display the ambient pressure. In embodiments where the clinical App 150 carries out 2-way communications with the valve assembly 110, the display may include acknowledgements from the valve assembly 110 that the ambient pressure data was received.

[0180] In some embodiments, the patient’s wearable device 142 or other external device 140 (e.g., smartphone 144) may alert the user that their wearable device 142 has not successfully transmitted ambient data to the valve assembly 110 within a preset time limit, for example, via an audible or visible warning or alarm. This may prompt the patient to ask a family member, friend, or another person (e.g., a person on a plane or bus, a person at work or school etc.) to download the App 150 onto that person’s external device 140 (e.g. smartphone 144) to transmit atmospheric data to the user’s valve assembly 110 as a temporary’ backup option, until the patient finds their wearable device 142, or until it is again communicatively coupled with the valve assembly 110. This aspect of the present disclosure may be beneficial for situations, where the implant patient is expected to experience pressure changes, for example, a pressurereading before a plane descends and then a subsequent reading while on the plane at a higher altitude. Members of a patient's family, friends, caregivers, school, workplace, may be instructed to have the clinical App 150 available in case the patient requires it due to a lost or damaged wearable. Entities that routinely expose the public to significant ambient pressure changes, such as airlines, reception staff at tall buildings, amusement parks, etc., may also be instructed to have the clinical App 1 0 available. In further embodiments, one of the one or more external devices 140 includes a dedicated beacon device including a battery, a pressure sensor, and a wireless transceiver, the dedicated beacon device being configured to transmit ambient pressure data to the shunt 106 as a backup to a wearable device when the wearable device is unavailable. In further embodiments, one of the one or more external devices 140 may include a patient portal device including a locked computing device with a pre-installed application configured to serve as an authorized backup to a wearable device for transmitting ambient pressure data to the shunt 106, while other third-party devices are not authorized to transmit such data.

[0181] In some embodiments, the App 150 may reside on the user's wearable device 142 and the same App 150 may be used for each external device 140 (e.g., their wearable device 142 or their smartphone 144). In some embodiments, the App 150 may be unique to the patient’s valve assembly 110, for example, by only enabling communication between the App 150 and the valve assembly 110 based on authentication, e.g., the user's credentials, serial number, etc. It is also contemplated that the App 150 may include a unique, embedded token specific to the implant patient. The App 150 may be configured to be highly simplified such that no pairing is needed.

[0182] In addition to transmitting atmospheric data to the valve assembly 110 and electronics assembly 115. the App 150 may be operable to log data (e.g.. symptoms the user is experiencing) that is stored in memory, e.g., any suitable example of a storage device or memory disclosed herein.

[0183] In an embodiment, the shunt firmware may be setup so that if the shunt does not contact its designated wearable during a reading after a set number of tries, the shunt looks for a cell phone App for e.g., 60 seconds. Other optional features: a) The application on the smartphone may be configured to operate as a beacon that periodically transmits ambient pressure data at intervals several times shorter than the shunt searching interval, for example, every second if the shunt search time is 10 seconds; b) Any cell phone App can w ork w ith any shunt; c) The cell phone user has to activate a pressure beacon. In some embodiments, the communication may be unidirectional from the external device to the shunt. In this manner, thevalve assembly receives the most recent ambient pressure data without requiring device pairing, thereby reducing data transfer overhead; d) In such embodiments, the smartphone application may serve as a backup to the wearable device, for example, in situations where the patient's wearable device is lost or damaged. The patient may utilize the application on the patient's smartphone or on another person's external device to transmit ambient pressure data to the valve assembly. The patient can use their cell phone App or anyone else’s to get ambient pressure to their shunt; e) For example, in a scenario where an implant patient loses the wearable device prior to boarding an aircraft, it may be advantageous to provide ambient pressure data to the valve assembly before the aircraft ascends to cruising altitude, where ambient pressure may decrease by approximately 100 mmHg (e.g., within 2-5% thereof) relative to ground level. In this instance, a caregiver may utilize the application on the caregiver's smartphone as a temporary substitute for the wearable device. If the caregiver does not have the application installed, another individual in proximity to the patient may download the application onto the individual's external device to transmit ambient pressure data to the valve assembly, because the application is configured to transmit ambient pressure data and to communicate with any compatible valve assembly; and f) In an alternative embodiment, the patient may be provided with a smartphone application that is functionally equivalent to the application residing on the patient's wearable device. Such an application may be specific to the patient's valve assembly, configured to pair only with a patient-specific valve assembly, and may include display, data logging, and other functions of the patient-specific wearable device. In some embodiments, the application may include a locating feature configured to scan the environment for the wearable device using proximity-detection technologies (e.g., Bluetooth-based tracking or GPS-based location services).

[0184] A simplified "Beacon Mode" alternative to the beacon mode described above may utilize dedicated devices for beacon functionality, including: (1) a patient application residing on a dedicated patient portal device (e.g., a locked computing device, such as a smartphone or tablet, with a pre-installed application), and / or (2) a charger device configured to transmit ambient pressure data to the valve assembly. When a wearable device is lost at or near the patient's residence, the patient or a caregiver may return to the residence and activate the beacon mode from the patient portal device or the charger device. When a w earable device is lost w hi le the patient is aw ay from the patient's residence, the patient or caregiver may utilize the portable patient portal device or charger device as a backup. In some embodiments, the patient may be instructed to carry the patient portal device and charger device during travel, for example, in carry-on luggage during air travel. The beacon mode is configured to serve as a temporaryalternative to the wearable device, for example, while the patient awaits delivery of a replacement wearable device from the manufacturer. In an alternative embodiment, a dedicated beacon device may be provided to the patient as a backup. The dedicated beacon device may include a battery, a pressure sensor, and a Bluetooth chipset, and may be stored by the patient for use when the primary' wearable device is unavailable. The patient need not carry' the dedicated beacon device at all times, but may retrieve it when needed while awaiting receipt of a replacement wearable device. In some embodiments, the simplified beacon mode may utilize a locked device, such as a dedicated smartphone, wearable, or charger having the beacon mode pre-installed, in contrast to other beacon modes in which the application may be downloaded onto a plurality of third-party' external devices.

[0185] The system will record and store a continuous data log. It will include timestamped readings of ICP, valve state, posture, temperature, and many other parameters. In addition, the wearable data log is also timestamped. In an embodiment, the wearable combines its data with that from the shunt into a single log while at the same time maintaining the original and unaltered data. Wearable data could include ambient pressure, temperature, patient location (from GPS for example), and patient altitude. Wearable could also include patient inputs such as when they' experience headaches or other symptoms (logged by' pushbutton, text, phone app, or speech). Other patient inputs could include medications. The data log may incorporate other body sensors, e.g., EEG, ECG. temperature, Apple Watch functions, sleep I wake times, blood pressure, glucose, diet and eating times, exercise times and types, walking / jogging, patient’s mood, etc.

[0186] Referring now to FIG. 2, another example system 200 for treating hydrocephalus is shown. The system 200 includes a shunt 206 with a valve assembly 210, a proximal catheter 270, and a distal catheter 272, and one or more external devices 240 communicatively coupled to the valve assembly 210 via a communications network 260.

[0187] To facilitate communication, the valve assembly 210 may include a communications device 265 for sending and receiving data from the external devices 240. In some examples, the communications device 265 may include one or more controllers for standards-based networks (e g., 2G, 3G, 4G, 4G LTE, 5G, 6G GSM, UMTS, LTE, CDMA, WiMAX, etc ), satellite communication networks, and / or wireless local area networks (e.g., Wi-Fi®, Wireless Gigabit, etc.), etc. In some examples, the communication device 265 may include controllers for personal area networks (e.g., ZigBee® (“IEEE 802.15.4’’), Near Field Communication (“NFC”), etc.) to communicatively couple the valve assembly 210 to the external device 240. In some embodiments, the communications device 265 may include a Bluetooth device (e.g.,antenna or transceiver), or facilitate Wi-Fi-based communication such as via frequencies defined by the IEEE 802.11 standards, short-range wireless frequencies such as Bluetooth®, or any suitable wired or wireless communications protocol that facilitates communication between the valve assembly 210 and the external device 240. In some embodiments, the communications device 265 may include an antenna to wirelessly communicate with the external device 240. It is also contemplated that the components of the valve assembly 210 may wirelessly communicate with each other.

[0188] The valve assembly 210 may include a controller apparatus 220, a valve 230, and one or more sensors 232 (e.g., a pressure sensor, tilt angle sensor, etc.) operatively connected to the controller apparatus 220. The controller apparatus 220 may include a microcontroller that can send or receive data from the one or more sensors 232 to control an operation of the valve 230. The controller apparatus 220 may include a processor 222 and a storage device 224. The processor 222 may embody any suitable processing device or set of processing devices such as, but not limited to: a microprocessor, a microcontroller-based platform, a suitable integrated circuit, one or more field programmable gate arrays (FPGAs), and / or one or more applicationspecific integrated circuits (ASICs). The storage device 224 may be volatile memory (e.g., RAM, which can include non-volatile RAM, magnetic RAM, ferroelectric RAM, and any other suitable forms); non-volatile memory (e.g., disk memory, FLASH memory', EPROMs, EEPROMs, non-volatile solid-state memory, etc.), unalterable memory (e.g., EPROMs), readonly memory, etc.). In some examples, the storage device 224 includes multiple kinds of memory, particularly volatile memory and non-volatile memory. The storage device 224 may also embody a computer readable media on which one or more sets of instructions are embedded. The instructions may embody one or more of the methods or logic as described herein. In a particular embodiment, the instructions may reside completely, or at least partially, within any one or more of the storage device 224, the computer readable medium, and / or within the processor 222 during execution of the instructions.

[0189] The valve 230 may include an inlet 230a operatively coupled to the proximal catheter 270 (e.g., a first catheter), and an outlet 230b operatively coupled to the distal catheter 272 (e.g., a second catheter). The proximal catheter 270 may be configured to convey cerebrospinal fluid (CSF) to the inlet 230a, and the distal catheter 272 may be configured to convey the CSF to another portion of the implant patient’s body, e.g., into the abdominal peritoneum thereof. Operatively, the valve 230 is configured to allow or block the flow of CSF from the inlet 230a to the outlet 230b based on instructions from the controller apparatus 220, e.g., to open or close the valve assembly based on ICP data derived from the sensors 232, for example, based on adetected, absolute ICP, a tilt angle of the patient relative to gravity, and atmospheric pressure (e.g., retrieved via the sensors 232 or via atmospheric sensors in the external devices 240). In some embodiments, the controller apparatus 220 may control the valve 230 based on event data derived from the external devices 240, for example, to open or close the valve 230 based on the event data and the system data. In some embodiments, the valve 230 may include a throttling valve configured to adjust a flow rate of CSF flowing from the inlet 230a to the outlet 230b, e.g., in addition to or in lieu of opening or closing the valve 230.

[0190] The external devices 240 may embody, for example, a smartphone 244, a tablet, or a notebook, or a wearable device 242 worn by the user (e.g., a smartwatch or other suitable device including a processor, a sensor, and a transceiver (e.g., aBLE transceiver circuit)) for receiving or sending data to the valve assembly 210. For example, the wearable device 242 may embody a necklace, a bracelet, a clip, a ring, a pin, a clip, a belt buckle (or attachment therefor), a wristwatch, a smartphone, or a coin- or puck-shaped device (e.g., that may be stored in the user’s pocket), each including a processor, a sensor, and a transceiver.

[0191] A software application (“app”) 250 may reside on some or all of the external devices 240, for example, on the patient’s smartphone 244 or wearable device 242. In some embodiments, at least one of the external devices 240 may include a user interface or input device 252 operable to log event data. As used herein, event data is intended to refer to data associated with an event that may affect, be affected by. or be related to the patient’s hydrocephalus. For example event data may include data associated with events the patient suffers or incurs such as headaches, dizziness, light-headedness, nausea, weight, electrocardiogram data, posture, swimming or diving, exercise, exertion, eating, sleeping, bowel movements, urination, medication changes, tobacco / alcohol / controlled substance use, strokes or seizures, pupil dilation, menstrual cycle, travel / move to new location, fatigue level, work / school schedule, home / life events (death in family, divorce, etc.), childbirth, medical or dental procedures, accidents, psychological stress, blood pressure (arterial, venous, or pulmonary artery), glucose level, hydration (including water intake), ambient pressure, ambient temperature, neural dysfunction (e.g. speech, hearing, vision or motor skill abnormalities), psychological conditions (e.g. anxiety, mood swings, etc.), head or other injuries, dementia symptoms, other medical conditions, states, or symptoms, etc. In embodiments, the event data may be utilized to correlate the events to ICP or make predictions concerning patient outcomes based on the data, e.g.. via machine learning. In embodiments, the event data may be used by the neuroscience industry as a whole to discover new correlations and / or make predictions regarding hydrocephalitics. For example, it may be discovered that opening the valve relievesheadaches for a specific patient, or a subset of patients, or that a patient or subset of patients may exhibit lightheadedness, despite corrective measures in place, for example, a shunt with a valve assembly including logic to prevent this. The system records ICP, valve state, & patient posture before, during and after a headache is recorded by a patient. Artificial intelligence or a physician detect trends regarding cause of headache and cause of cessation of headache.

[0192] In embodiments, the event data, ICP, atmospheric data, or other data (e.g., made available from the valve assembly or external device) (collectively referred to as "operating data”) may be sent to a remote server including a processor 247 communicatively coupled with a shunt, an external device, host device, or app. The processor may embody any suitable processing device or set of processing devices disclosed herein.

[0193] The processor may receive the operating data and include logic to make insights or predictions regarding patient outcomes or shunt performance, e.g., for a specific patient, a subset of patients, a shunt manufacturer, or for the neurosciences industry as a whole. In embodiments, the remote server may receive the operating data to train and build a predictive model (e.g., via unsupervised machine learning) for making predictions concerning patient outcomes or shunt performance, e.g., via artificial intelligence. For example, the processor may make predictions (e.g., concerning battery life, CSF flow rates, potential catheter blockages, and the like) based on the operating data. In some embodiments, the processor may utilize the operating data to make predictions regarding shunt performance (e g., in the future, e.g.. after 2, 3, 4. or 10 years, for example). The processor may also utilize the operating data may to make predictions regarding a specific patient’s CSF flow rates or ICP in the future or after time has passed since the system was first operational. For example, the processor make predictions that the CSF flow rate or ICP for a particular patient may change in the future, for example, based on operating data including the patient’s age, height, weight, a projected growth (e.g., a projected increase in height or weight during adolescence) or any other suitable information specific to the patient (e.g., the patient’s race or ethnicity). In some embodiments, the operating data may be supplemented with patient data, for example, data from the patient’s medical records (e.g.. available CT scans).

[0194] In an embodiment, the input device may be communicatively coupled to a global positioning system (GPS) device configured to determine a location of the implant patient during the event. The external device may be combined with other devices, such as the wearable used for ambient pressure and data communications described in the reference applications. The external device 240 may be a dedicated device or may be an App on a 3rdparty device such as a smartphone or tablet. The external device 240 may include a userinterface such as pushbutton, touchscreen, voice input or gesture input. The user interface may further include a means for the user to input additional information about the logged event, for example severity of symptoms (e.g., scale 1-10), type of food eaten, etc. The user interface may include an automated interface to one or more custom or 3rdparty activity logging apps as are known in the art, for example food log, exercise log, or location tracking apps. In this configuration the user interface would automatically retrieve timestamped data from the activity logging apps. The external device 240 may be configured to timestamp the user input and add it to a datalog created by the system. The correlation of logged events with data logged by the system (pressure measurements, valve state, posture, etc.) may be carried out by dedicated software located in one of the devices or in a remote processor I server. The correlation of logged events and measured parameters may be used as input to machine learning or artificial intelligence algorithms.

[0195] The input device 252 may form part of the external device 240 (e.g., a button or rotatable dial on the housing or enclosure of the external device), or a feature of a graphic user interface thereof. The input device 252 may be accessible via the App 250 associated with the external device 240. Examples of the input device 252 may include, but are not limited to, an alphanumeric input device (e.g., a keyboard), a pointing device, a physical button or a touch screen button, an audio input device (e.g., a microphone, a voice response system, etc.), a cursor control device, a touchpad, a video capture device (e.g., a still camera, a video camera), a touchscreen, a text button, a dropdown button, a text box, a slider, a toggle button, haptic or gesticulate inputs, and / or any combinations thereof. In some embodiments, it is contemplated that the input device 252 may be operable to define the severity rating associated with the event, for example, on a scale from 1-10. In some embodiments, the input device 252 may include one or more inputs for defining a severity rating for one or more symptoms, for example, a first input for indicating the severity of a headache, and another input for indicating the severity of lightheadedness.

[0196] The event data captured via the input device 252 may be supplemented with other event data, for example, the date and time of the medical event, the atmospheric conditions including temperature and atmospheric pressure (e.g., provided via sensors 232 or the external device 240), or the tilt angle, e.g., the tilt angle of the patient’s head or thorax relative to gravity. In some embodiments, the event data may include or be supplemented by a voice recording of the user, for example, the implant patient speaking into a microphone on their external device 240 to describe the event or symptoms. In some embodiments, the external device 240 may transcribe the implant patient’s voice recording into text, e.g., via a voice to text feature.

[0197] In some embodiments, the input device 252 may be communicatively coupled to a global positioning system (GPS) device configured to determine a location of the implant patient during the medical event. The patient’s location may then be added to the event data.

[0198] The event data may be transmitted to other external devices or a host device 246 communicatively coupled with the external devices 240 via the communications network 260. The host device 246 may embody a smartphone, a table, a notebook, or any other suitable example of a external device described herein. The host device 246 may belong to a clinician who could review the event data associated with the medical event, in conjunction with system data retrieved from the valve assembly 210, for example, the ICP, tilt angle, etc. Clinicians may include any licensed medical professional, such as doctors, nurses, nurse practitioners, physicians’ assistants, etc. Specifically, neurosurgeons, neurologists and their staff members may include the Smartshunt’s clinician user base.

[0199] Referring now to FIG. 3, another example system 300 for treating hydrocephalus is shown. The system 300 includes a shunt 306 with a valve assembly 310, a proximal catheter 370, a distal catheter 372, and one or more external devices 340 communicatively coupled to the valve assembly 310 via a communications network 360.

[0200] To facilitate communication, the valve assembly 310 may include a communications device 365 for sending and receiving data from the external devices 340. In some examples, the communications device 365 may include one or more controllers for standards-based networks (e.g.. 2G, 3G, 4G. 4G LTE, 5G, 6G. GSM, UMTS, LTE. CDMA, WiMAX, etc ), satellite communication networks, and / or wireless local area networks (e.g., Wi-Fi®, Wireless Gigabit, etc.), etc. In some examples, the communication device 365 may include controllers for personal area networks (e.g., ZigBee® (“IEEE 802.15.4’'), Near Field Communication (“NFC”), etc.) to communicatively couple the valve assembly 310 to the external device 340. In some embodiments, the communications device 365 may include a Bluetooth device (e.g., antenna or transceiver), or facilitate Wi-Fi-based communication such as via frequencies defined by the IEEE 802.11 standards, short-range wireless frequencies such as Bluetooth®, RFID, or any suitable wired or wireless communications protocol that facilitates communication between the valve assembly 310 and the external device 340. It is also contemplated that the components of the valve assembly 310 may wirelessly communicate with each other via RFID technology7.

[0201] The valve assembly 310 may include a controller apparatus 320, a valve 330, and one or more sensors 332 (e.g., a pressure sensor, tilt angle sensor, etc.) operatively connected to the controller apparatus 320. The controller apparatus 320 may embody a microcontroller that cansend or receive data from the one or more sensors 332 to control an operation of the valve 330. The controller apparatus 320 may include a processor 322 and a storage device 324. The processor 322 may embody any suitable processing device or set of processing devices such as, but not limited to: a microprocessor, a microcontroller-based platform, a suitable integrated circuit, one or more field programmable gate arrays (FPGAs), and / or one or more applicationspecific integrated circuits (ASICs). The storage device 324 may be volatile memory (e.g., RAM, which can include non-volatile RAM, magnetic RAM, ferroelectric RAM, and any other suitable forms); non-volatile memory (e.g., disk memory, FLASH memory, EPROMs, EEPROMs, non-volatile solid-state memory, etc.), unalterable memory' (e.g., EPROMs), readonly memory', etc.). In some examples, the storage device 324 includes multiple kinds of memory, particularly volatile memory and non-volatile memory. The storage device 324 may also embody a computer readable media on which one or more sets of instructions are embedded. The instructions may embody one or more of the methods or logic as described herein. In a particular embodiment, the instructions may reside completely, or at least partially, within any one or more of the storage device 324, the computer readable medium, and / or within the processor 322 during execution of the instructions.

[0202] The valve 330 may include an inlet 330a operatively coupled to the proximal catheter 370 (e.g., a first catheter), and an outlet 330b operatively coupled to the distal catheter 372 (e.g., a second catheter). The proximal catheter 370 may be configured to convey cerebrospinal fluid (CSF) to the inlet 330a. and the distal catheter 372 may be configured to convey the CSF to another portion of the implant patient’s body, e g., into the abdominal peritoneum thereof. Operatively, the valve 330 is configured to allow or block the flow of CSF from the inlet 330a to the outlet 330b based on instructions from the controller apparatus 320, e g., to open or close the valve assembly based on ICP data derived from the sensors 332, for example, ICP data derived from an absolute ICP, a tilt angle of the patient (e.g., the patient’s thorax or a catheter relative to gravity), or atmospheric pressure (e.g., retrieved via the sensors 332 or via the external devices 340).

[0203] The external device 340 may embody a smartphone 344, a tablet, a notebook, or a wearable device 342 worn by the user (e.g., a smartwatch or other suitable device including a processor, a sensor, and a transceiver (e.g., a BLE transceiver circuit)) for receiving or sending data to the valve assembly 310. For example, the wearable device 342 may embody a necklace, a bracelet, a clip, a ring, a pin, a clip, a belt buckle (or attachment therefor), or a puck-shaped device (e.g., that may be stored in the user’s pocket), each including a processor, a sensor, anda transceiver. In some embodiments, the external device 340 may include a host device 346 (e.g., a clinic device) hosting clinic app.

[0204] A software application ('‘app’’) 350 may reside on some or all of the external devices 340, for example, on the user’s smartphone 344 or wearable device 342. In some embodiments, at least one of the external devices 340 may include a user interface or input device 352. The input device 352 may form part of the external device 340 (e.g., a button or rotatable dial on the housing or enclosure of the external device), or a feature of a graphic user interface thereof. In addition or alternatively, the input device 352 may be accessible via the App 350 associated with the external device 340. Examples of an input device 352 may include, but are not limited to, an alphanumeric input device (e.g., a keyboard), a pointing device, a physical button or a touch screen button, an audio input device (e.g.. a microphone, a voice response system, etc.), a cursor control device, a touchpad, a video capture device (e.g., a still camera, a video camera), a touchscreen, a text button, a dropdown button, a text box, a slider, a toggle button, and / or any combinations thereof.

[0205] In some embodiments, it is contemplated that the input device 352 may be operable to actuate a disable or swimming mode (i.e., an override mode), to inform the controller apparatus 320 that the user will soon be exposed to significant, transient atmospheric pressure changes, for example, when diving into water, which adds about 74 mmHg of ambient pressure for every meter underwater. The controller apparatus 320 may receive this communication from the user via input device 352. At the next data communication between valve assembly 310 and external device 340 (for example the timed pressure reading and data exchange between valve assembly 310 and an external wearable device described herein), the external device 340 may send a “Swim Mode"’ signal to the valve assembly 310. The valve assembly 310 may react to the Swim Mode signal by altering its Timed reading’ algorithm until a “Cancel Swim Mode” signal is received from the user via external device 340. In one embodiment, the altered algorithm may simply suspend timed readings until the “Cancel Swim Mode” signal is received; in this embodiment it may place the valve in its designated safe state (open or closed as determined by physician setting, with default closed). In another embodiment, the altered algorithm may take the timed ICP reading as described elsewhere, but when computing the average ICP from samples taken throughout the measurement time window, it may ignore all samples that are greater than a certain threshold, for example 15 mmHg, above the ambient reading provided by the external device 340. The reading rejection threshold may be a value adjustable in the device settings by the physician. Typical values may be between 5 and 20mmHg. The input device 352 may also be operable to deactivate the disable or swimming mode, for example, when the user has finished swimming.

[0206] In some embodiments, it is contemplated that the input device 352 may also be operable to activate a mode to find their wearable device 340, for example, to activate an audible alarm or beacon to direct the patient to more readily locate a missing wearable device 342. In some embodiments, the external device 340 may communicate (via a notification) that the wearable device 342 is missing or disconnected, and this notification may be sent to other external devices 340 or the host device 346 (e.g., operated by the patient’s physician). Technologies to implement wearable device 352 tracking include Bluetooth, Wi-Fi, the Global Positioning System, and the cellular Network. Examples of commercial devices that implement this feature include the ‘Find My iPhone’ App by Apple and the ‘Tile’ device by Life360.

[0207] Referring now to FIG. 4, another example system 400 for treating hydrocephalus is shown. The system 400 includes a valve assembly 410 with a controller apparatus 420, a valve 430, a power supply 434, and one or more sensors 432 (e.g., a pressure sensor, tilt angle sensor, etc.) operatively connected to the controller apparatus 420. The controller apparatus 420 may embody a microcontroller that can send or receive data from the one or more sensors 432 to control an operation of the valve 430. The controller apparatus 420 may include a processor 422 and a storage device 424. The processor 422 may embody any suitable processing device or set of processing devices such as, but not limited to: a microprocessor, a microcontrollerbased platform, a suitable integrated circuit, one or more field programmable gate arrays (FPGAs), and / or one or more application-specific integrated circuits (ASICs). The storage device 424 may be volatile memory (e.g., RAM, which can include non-volatile RAM, magnetic RAM, ferroelectric RAM, and any other suitable forms); non-volatile memory (e.g., disk memory, FLASH memory, EPROMs, EEPROMs, non-volatile solid-state memory, etc.), unalterable memory (e.g., EPROMs), read-only memory, etc.). In some examples, the storage 424 includes multiple kinds of memory', particularly volatile memory and non-volatile memory. The storage device 424 may also embody a computer readable media on which one or more sets of instructions are embedded. The instructions may embody one or more of the methods or logic as described herein. In a particular embodiment, the instructions may reside completely, or at least partially, within any one or more of the storage device 424, the computer readable medium, and / or within the processor 422 during execution of the instructions.

[0208] The valve 430 is configured to connect to a distal catheter and a proximal catheter (not shown) to control the flow of cerebrospinal fluid (CSF) passing therethrough, for example, based on instructions from the controller apparatus 420, e.g., to open or close the valveassembly based on ICP data derived from the sensors 432, for example, ICP data derived from an absolute ICP, a tilt angle of the patient (e.g., the thorax or a catheter) relative to gravity, or atmospheric pressure (e.g., retrieved via the sensors 432 or via external devices communicatively coupled with the valve assembly 410).

[0209] The power supply 434 may be operatively connected to each of the valve 430, the sensors 432, and the controller apparatus 420 to supply power thereto. The power supply 434 may embody a battery (e.g., a rechargeable high- density lithium coin cell). Wireless charging and power management circuitry 435 may be included in the shunt 410 to ensure a safe, reliable recharge from an external charger device. In some embodiments, the valve assembly 410 may include a full “shutdown mode” that may be actuated to fully electrically disconnect the power supply 434 from the rest of the device during sterilization, shipment, or storage. In some embodiments, the valve assembly 410 may receive a wireless signal from an external device 240 to initiate shutdown. The system may place the valve 430 in a predetermined state just prior to shutdown, for example in the open state prior to sterilization (to facilitate gas diffusion throughout the fluid channel). The valve 430 shutdown state may be selectable by wireless software communication from the external device 240. The full shutdown command may require a security feature to limit shutdown capability to authorized personnel, for example factory or repair personnel. The security feature could be, for example, a password, an unusual input key sequence (“key dance”), or another means known in the art. In some embodiments, the shunt 410 may resume its normal operational state by holding a wireless charger (e.g.. LTC 4124 made available by Analog Devices) near the shunt power source 434 to wake up the valve assembly 410 and resume the shunt’s normal operational state.

[0210] Referring to FIGS. 5-6B, another example system 500 for treating hydrocephalus is shown. The system 500 includes a shunt 506 with a valve assembly 510, a proximal catheter 570, and a distal catheter 572. The valve assembly 510 includes a controller apparatus 520, a valve 530, and one or more sensors 532 operatively connected to the controller apparatus 520. The controller apparatus 520 may include a microcontroller that can send or receive data from the one or more sensors 532 to control an operation of the valve 530. The controller apparatus 520 may include a processor 522 and a storage device 524. The processor 522 may embody any suitable processing device or set of processing devices such as, but not limited to: a microprocessor, a microcontroller-based platform, a suitable integrated circuit, one or more field programmable gate arrays (FPGAs). and / or one or more application-specific integrated circuits (ASICs). The storage device 524 may be volatile memory (e.g., RAM, which can include non-volatile RAM, magnetic RAM, ferroelectric RAM, and any other suitable forms);non-volatile memory (e.g., disk memory, FLASH memory, EPROMs, EEPROMs, non-volatile solid-state memory’, etc.), unalterable memory (e.g., EPROMs), read-only memory, etc.). In some examples, the storage device 524 includes multiple kinds of memory7, particularly volatile memory and non-volatile memory. The storage device 524 may also embody a computer readable media on which one or more sets of instructions are embedded. The instructions may embody one or more of the methods or logic as described herein. In a particular embodiment, the mstructions may reside completely, or at least partrally, within any one or more of the storage device 524, the computer readable medium, and / or within the processor 522 during execution of the instructions.

[0211] The valve 530 may include an inlet 530a operatively coupled to the proximal catheter 570 (e.g., a first catheter), and an outlet 530b operatively coupled to the distal catheter 572 (e.g., a second catheter). The valve 530 is configured to allow or block the flow of CSF from the inlet 530a to the outlet 530b based on instructions from the controller apparatus 520, e.g., to open or close the valve assembly based on ICP data derived from the sensors 532, wherein the data may include an absolute ICP, a tilt angle (e.g., the implant patient’s thorax relative to gravity, an angle of a catheter relative to gravity), and atmospheric pressure (e.g., retrieved via the sensors 532 or via one or more external devices 540 (e.g., a smartphone or wearable device) communicatively coupled to the valve assembly 510.

[0212] The proximal catheter 570 may be configured to convey cerebrospinal fluid (CSF) to the inlet 530a of the valve 530, and the distal catheter 572 may be configured to convey the CSF from the outlet 530b thereof to another portion of the implant patient’s body, e.g., into the abdominal peritoneum thereof.

[0213] The sensors 532 may include a pressure sensor 532a configured to measure intracranial pressure (ICP) in a subarachnoid space within the cranium, or within parenchyma of a patient's brain. The sensors 532 may also include a tilt sensor 532b configured to detect an angle of orientation of the implant patient’s thorax relative to gravity, or another component of the system (e.g., the distal catheter) relative to gravity to determine whether the implant patient is in an upright position. In this manner, the pressure sensor 532a and the tilt sensor 532b may be respectively coupled to the controller apparatus 520 to transmit the ICP and tilt angle readings to the microcontroller, whereupon the controller apparatus 520 may include logic to determine an ICP based on the readings. In an embodiment, the pressure sensor 532a may be configured to measure ICP at a location outside the fluid channels defined by the first and second catheters.

[0214] Referring to FIG. 6B, in some embodiments, the first catheter 570 may include a first lumen 570a and a second lumen 570b. The first lumen 570a (also referred to herein as a“draining lumen"’) may define a fluid channel to drain CSF, and the second lumen 570b (also referred to herein as a “sensing lumen”) may define a fluid column to communicate ICP to a pressure sensor 532a, for example, an absolute ICP. The pressure sensor 532a may be disposed inside a shunt housing 511 for example, as part of the valve 530, or alternatively may embody a separate component in the housing 511 or be disposed at an end of the second lumen 570b proximate the housing 511.

[0215] In an alternative embodiment shown in FIGS. 7A and 7B, a system 700 includes the pressure sensor 532a may be housed in a capsule 702 having sensor ports 704. The capsule 702 may connect to a valve assembly body 710 via a flexible electrical or optical cable 712. In alternative embodiments, the pressure sensor may be housed in a rigid rod (not shown) that extends downward from the valve assembly body 710. The valve assembly body 710 may rest subcutaneously on top of the patient’s skull surface, and the capsule 702 may feed through a burr hole drilled into the skull and reside at least partially in the subarachnoid space or within the brain parenchyma. In an embodiment, the pressure sensor capsule may penetrate 5-10 mm below the brain’s surface. The pressure sensor 532a may be cylindrical and may be mounted coaxially inside cylindrical capsule 702. The sensitive surface of sensor 532a (not show n) may point downwards along the cylindrical axis. The capsule 702 may have a solid bottom to preclude the brain parenchyma pushing against the sensitive surface and creating a false pressure reading. The capsule 702 may have at least one of the sensor ports 704 on the side of the cylinder, near the sensitive surface, to allow cerebrospinal fluid to enter and contact the sensitive surface. The sensor ports 704 may be sized to allow fluid passage but keep brain matter from invaginating, clogging, or otherwise entering the capsule. The sensor ports 704 and capsule surface may be made of materials, and provided with geometries, sizes, coatings, surface features, or surface roughness or smoothness to inhibit fibrosis, inflammation, scarring, or other forms of biofouling. In the depicted embodiment, the proximal catheter has a drain channel 570a as part of a single lumen.

[0216] In an embodiment, the downw ard (proximal) side of the capsule may be slightly cone-shaped, coming to a rounded point, similar to an upside-down traffic cone allowing for easier pushing into the parenchyma by spreading the tissue as it goes downward. There may also be features on the capsule that facilitate pushing with a stylet or other rigid tool. For example, a small blind hole on the distal side of the capsule that accepts a stylet for pushing but allow s removal of the stylet after the capsule is in place.

[0217] Referring to FIGS. 6A, 6B, and 7A the controller apparatus 520 may include logic to determine a possible blockage event in at least one of the first and second lumens 570a, 570b,or at the sensor ports 704 in FIG. 7A. More specifically, with reference to the system 500 of FIGS. 5-6B and the method depicted in FIG. 8, the controller apparatus 520 may start the algorithm at a time when the valve is in the closed position (step 817). The controller apparatus 520 may receive a tilt angle reading from the tilt sensor 532b (step 804) to determine if the implant patient is in an upright position (step 808). If the implant patient is upright, then the controller apparatus 520 (at step 810) may open the valve 530 and monitor ICP (step 812) based on pressure readings from the pressure sensor 532a.

[0218] The controller apparatus 520 may monitor the ICP readings for a short period (e.g., between about .5 and 3 seconds in step 812) while the valve 530 is open to prevent over draining CSF. If the controller apparatus 520 receives pressure readings indicative of a large ICP drop due to fluid column weight (with the implant patient upright), then the controller apparatus 520 may determine that there is no blockage. The pressure drop may be nominally related to the torso size of the patient and can be between about 2 and 75 mmHg, or between about 5 and 50 mmHg, for example. The expected upright pressure drop for a given patient may be adjustable via an external device 540.

[0219] If the controller apparatus 520 receives pressure readings indicative of little or no ICP drop, then it may send an alert, alarm warning or message (step 814) to the implant patient via one or more of the external devices 540 communicatively coupled with the valve assembly 510, or to a host device (e.g., operated by the manufacturer of the system, or the implant patient’s physician). The message may indicate possible shunt obstruction or valve malfunction, and may advise the patient to contact their physician, or may refer the patient to a 3rdparly service or the manufacturer, who may take appropriate diagnostic or remediate action. In some embodiments, the controller apparatus 520 may postpone (step 816) a blockage check for another time, for example, at a time between about 10 hours and 24 hours after the check. This may be prompted by the controller apparatus 520 receiving tilt angle readings indicating that the implant patient is not in an upright position (at step 808), whereupon the controller apparatus 520 may reschedule the blockage check for a subsequent time. In some embodiments, blockage checks may be implemented automatically during a routine timed schedule, for example, at times the implant patient is most likely to be in an upright position, e.g., at 3 pm every day. In some embodiments, each check may be spaced out by at least 24 hours to avoid the possibility' of over draining CSF. In some embodiments, a user may manually initiate a self-test wirelessly via external device 540. The blockage check may be performed based on a change or lack of change in absolute ICP reading when the valve opens; it therefore may not require obtaining an ambient pressure reading from an external device 540. In someembodiments, it is contemplated that the blockage check may be performed to detect blockage in the distal catheter, for example, for embodiments where the system utilizes a single lumen proximal catheter to drain CSF, and wherein the pressure sensor 532a is disposed within the valve assembly 510 (e.g., within the valve 530 thereof). In general, the blockage check may indicate one of several failure modes: drain channel obstruction (catheters 570 or 572, fluid channel or valve); sense channel obstruction (for dual lumen architecture); sensor port 704 obstruction or sensor biofouling (for capsule version in FIG. 7A); sensor failure; valve 530 stuck in closed position; controller apparatus 520 failure; proximal catheter 570 (either lumen for dual lumen embodiment) detached from a valve port 720 of the valve assembly body 710.

[0220] The self-test algorithm of FIG. 8 also serves to exercise the valve 530 and prevent the valve 530 from mechanically sticking in the closed position after extended periods of inactivity. Valve exercise may be performed as part of the self-test or as a separate operation without measurement. In this manner, valve exercise may be initiated automatically based on a timer that tracks time since a last valve position change, or it may be manually initiated by a user via an external device 540.

[0221] In some embodiments, the self-test algorithm may be carried out in any patient posture, although the measured change in ICP between valve open and valve closed may be most pronounced in the upright position. The results of these self-tests may accordingly be communicated to the patient or physician via the external devices 540, logged, and input into machine learning algorithms to improve device performance. In this regard, the frequency of tests may be limited to conserve battery power.

[0222] For example, an algorithm may monitor longitudinal self-test data and observe the ICP rate of change dP / dt when the valve 530 is opened. A decrease in dP / dt over successive tests may indicate a gradual increase in fluid resistance due to buildup of obstructive material. In such embodiments, the system may issue an early warning or alert to the user in response.

[0223] In an embodiment, dual-lumen disconnect sensing may be accomplished by calculating ICP of the ventricle based on the fluid column of the sensing catheter within the Dual-lumen design. If the pressure sensor measures a sudden sustained decrease in pressure (before calculation), it could be due to the lack of the fluid column because the proximal catheter has detached. The tilt sensor may be used to filter out the scenario where pressure changes due to a change in a patient’s position.

[0224] In an embodiment, the system may prevent or determine valve sticking when configured with two ICP sensors. A first ICP sensor on one side of valve and a second ICP sensor on the other side of the valve. The system may determine if the valve is open bymeasuring that ICP on both sides of the valve. If the valve is open, the pressure measured by the first ICP sensor and the pressure measured by the second ICP sensor should be functionally the same within the measurement error range of ICP sensors. This protocol may be initiated if the valve has been closed for a set amount of time.

[0225] FIG. 9 depicts an example communication architecture of a cranial shunt system 900, where an implant 902 communicates wirelessly with one or more nearby external devices 904, such as awearable device 910, agateway device 912, and a smartphone 914 executing a patient application 920. In an embodiment, the wearable device 910, the gateway device 912, and the smartphone 914 communicate with the implant 902 using short-range wireless communication such as Bluetooth®, and the wearable device 910 additionally communicates with the gateway device 912 and the smartphone 914, relaying data between devices, including the implant 902. The patient application 920 also communicates with the wearable device 910, exchanging operating data and user inputs. In embodiments, a charger 922 communicates with one or more of the implant 902, the w earable device 910, the gateway device 912, or the smartphone 914, supporting charging, configuration, and data exchange. The gateway device 912 further communicates with a remote server 930, including a SmartShunt database 932, via a communications network 924 including Wi-Fi or cellular connectivity. Authorized clinicians may review7patient data associated with the cranial shunt system 900 through a portal application 934 operating on a portal device 940 that accesses the SmartShunt database 932 via the communications network 924. In this manner, the devices of the cranial shunt system 900 communicate with each other, providing information to patients and clinicians and enabling control of the implant 902.

[0226] FIG. 10 depicts a cranial shunt system 1000 according to another embodiment, including a valve assembly in a housing 1002 a pressure sensor 1010. the assembly being connected to a proximal catheter 1012 and a distal catheter 1014. The valve assembly in the housing 1002 communicates with a wearable device 1020, which may be worn on a w istband and may include a watch or other w earable electronic device. The wearable device 1020 communicates with an external device 1022 executing a patient application 1024. which exchanges operating data with a remote SmartShunt database 1030. Clinicians may review patient data associated with the cranial shunt system 1000 through a physician portal 1032 that accesses the SmartShunt database 1030 from a remote server. In embodiments, a charger 1034 may be positioned near the implant site and recharges the valve assembly in the housing 1002.

[0227] FIG. 11 depicts a cranial shunt system 1100 according to an embodiment. The cranial shunt system 1100 includes a housing 1102 containing a valve assembly that regulates CSFflow through the cranial shunt system 1100 between fluid ports 1104. The housing 1102 extends elongated in a longitudinal direction as compared to a lateral direction or a vertical direction of the housing 1102, and elongated in the lateral direction as compared to the vertical direction. With this construction, the housing 1102 may lay against a cranium with minimal vertical impact on the patient.

[0228] Fluid ports 1104 extend from a lateral side of the housing 1102 and connect to respective catheters that convey CSF to and from the valve assembly in the housing 1102. In the embodiment shown in FIG. 11, the fluid ports 1104 initially extend laterally from the housing 1102 and bend and extend generally along the longitudinal direction of the housing 1102. A tether 1110 extends from a longitudinal end of the housing 1102 at approximately a lateral center of the housing and terminates at a capsule 1112 that houses a pressure sensor 1114. The capsule 1112 extends in the longitudinal direction from the housing 1102 and may flex during placement within the cranium.

[0229] FIG. 12 depicts a cranial shunt system 1200 according to another embodiment. The cranial shunt system 1200 includes a housing 1202 containing a valve assembly that regulates CSF flow through the cranial shunt system 1200 between fluid ports 1204. The housing 1202 extends elongated in a longitudinal direction as compared to a lateral direction or a vertical direction of the housing 1202, and elongated in the lateral direction as compared to the vertical direction. With this construction, the housing 1202 may lay against a cranium with minimal vertical impact on the patient.

[0230] In the embodiment shown in FIG. 12, the fluid ports 1204 extend from opposite longitudinal sides of the housing 1202 and connect to respective catheters that convey CSF to and from the valve assembly in the housing 1202. The fluid ports 1204 extend generally in the longitudinal direction away from the housing 1202. A tether 1210 extends from a longitudinal end of the housing 1202 at approximately a lateral center of the housing and terminates at a capsule 1212 that houses a pressure sensor. The capsule 1212 extends in the longitudinal direction from the housing 1202 and may flex during placement within the cranium of the patient.

[0231] FIG. 13 depicts a cranial shunt system 1300 according to another embodiment. The cranial shunt system 1300 includes a housing 1302 containing a valve assembly 1304 that regulates CSF flow through the cranial shunt system 1300 between fluid ports 1312. In the embodiment shown in FIG. 13, the housing 1302 includes an enlarged bulb portion 1310 at a side of the housing 1302 opposite the fluid ports 1312 in the longitudinal direction, whichcontains internal electronic components of the cranial shunt system 1300, including a battery', a circuit board, and a charging antenna.

[0232] The fluid ports 1312 extend from opposite lateral sides of the housing 1302 and connect to respective catheters that convey CSF to and from the valve assembly 1304 in the housing 1302. The fluid ports 1312 extend generally laterally from the housing 1302 and are connected internally to the valve assembly 1304. A tether 1314 extends from one of the lateral sides of the housing 1302 and terminates at a capsule 1320 that houses a pressure sensor 1322. The capsule 1320 extends outward from the housing 1302 and may flex during placement within the cranium of the patient.

[0233] FIG. 14 depicts the cranial shunt system 1300 of FIG. 13 with portions of the housing 1302 illustrated as transparent, revealing internal components of the housing 1302. In the embodiment shown, the housing 1302 includes a cover 1324 and a base 1330 supporting internal electronic components of the cranial shunt system 1300. The cover 1324 and the base 1330 may be formed from a ceramic material such as alumina, zirconia, or sapphire. The electronic components may include a battery 1332. a charging antenna 1334, and a circuit board 1340 disposed within the housing 1302. The housing 1302 may further include a header 1342 that supports a valve 1344 included in the valve assembly 1304, and supports the fluid ports 1312 that connect to catheters. A sensor assembly 1352 extends from the housing 1302 and includes sensor wires 1354 extending to the capsule 1320.

[0234] FIG. 15 depicts the base 1330 of the cranial shunt system 1300 with electronic components mounted on the base 1330. In the embodiment shown, the base 1330 includes connection locations for the battery' 1332, the sensor assembly 1352 including the pressure sensor 1322, and the valve 1344, along w ith electronic components supporting operation of the cranial shunt system 1300. The base 1330 may support standoffs 1364 that position the battery 1332 relative to other electronic components.

[0235] FIG. 16 depicts a back perspective view of an electronics assembly 1370 with circuit boards 1372 mounted on the base 1330. Three circuit boards 1372 extend vertically from the base 1330 and may support electronic components on one or both sides, reducing the overall footprint of the electronics assembly 1370. The circuit boards 1372 may be electrically connected to the base 1330 through soldered connections, board to board connectors, or other electrical interfaces. In embodiments, components may be placed on both sides of one or more of the circuit boards 1372, reducing board size.

[0236] FIG. 17 depicts a front perspective view of the electronics assembly 1370 shown in FIG. 16 with the circuit boards 1372 mounted on the base 1330. In embodiments, a communication chip 1374 may be positioned on one of the circuit boards 1372.

[0237] FIG. 18 depicts installation of the battery 1332 within the electronics assembly 1370. In the embodiment shown, the battery 1332 is positioned between two of the vertically oriented circuit boards 1372 in a lateral direction of the cranial shunt system 1300, including the base 1330. The battery 1332 is also positioned adjacent to a third circuit board 1372 positioned along a longitudinal centerline of the housing 1302 opposite the valve 1344.

[0238] FIG. 19 depicts installation of the charging antenna 1334 within the electronics assembly 1370. In the embodiment shown, the charging antenna 1334 is positioned above the battery 1332 and includes a spiral conductive coil that enables inductive charging. In embodiments, a shield 1380 formed from a conductive material may be positioned beneath the antenna 1334, and a spacer or standoff may be provided between the antenna 1334 and the battery 1332, w hich may reduce potential electromagnetic interference.

[0239] FIG. 20 depicts placement of the cover 1324 over the electronics assembly 1370. In the embodiment shown, the cover 1324 is positioned above and over the charging antenna 1334 and cooperates with the base 1330 to enclose the other electronic components disposed within the housing 1302. The cover 1324 and the base 1330 together define a hermetically sealed electronics enclosure that protects the internal electronic components from exposure to bodily fluids and environmental contaminants while permitting wireless communication and inductive charging through the cover 1324.

[0240] FIG. 21 depicts attachment of the valve 1344 to an exterior portion of the housing 1302 outside the hermetically sealed electronics enclosure formed by the cover 1324 and the base 1330. In the embodiment shown, the valve 1344 electrically interfaces with the electronics assembly 1370 through feedthroughs 1384 extending through the base 1330.

[0241] FIG. 22 depicts installation of the sensor assembly 1352. In the embodiment shown, the sensor wires 1354 extend from the housing 1302 and are electrically connected to the electronics assembly 1370 through feedthroughs 1390 in the base 1330, with the sensor wires 1354 terminating at the capsule 1320.

[0242] FIG. 23 depicts formation of the header 1342 around the valve 1344 and the fluid ports 1312. In embodiments, the header 1342 may include a silicone overmold that encapsulates portions of the housing 1302, the valve 1344, and the fluid ports 1312. The silicone overmold may form a rounded external surface that avoids sharp edges and reduces the likelihood of irritation or damage to surrounding soft tissue.

[0243] FIGS. 24-43 depict a cranial shunt system 2400 according to another embodiment. FIGS. 24 and 25 depict assembly of a floor plate circuit of the cranial shunt system 2400. In the embodiment shown, a base 2402 serves as both a structural floor plate and an electrical substrate. The base 2402 may be formed from a biocompatible ceramic material including alumina, zirconia, sapphire, or glass. Circuit traces and pads are patterned onto a circuit region 2404 of the base 2402, the circuit region 2404 including routing layers disposed on a top surface and one or more internal routing layers. The circuit region 2404 supports electronic components 2410 mounted to the base 2402 and includes sensor pads 2412 that connect to sensors and connector pins 2414 that route signals between the base 2402 and the electronic components 2410. After placement of the electronic components 2410, underfill may be disposed beneath the electronic components 2410 and a coating may be applied while masking the connector pins 2414.

[0244] FIGS. 26 and 27 depict installation of a circuit board 2420 above the base 2402, forming an electronics assembly 2430. The circuit board 2420 is a thin rigid circuit board electrically and mechanically connected to the base 2402 using connector pins 2414 extending between the boards. The circuit board 2420 includes traces and electronic components disposed on both sides of the board that reduce overall circuit footprint. In embodiments, additional connector pins 2414 or spacers 2432 may be included that increase mechanical stability. In embodiments, the circuit board 2420 may include flexible extensions 2434 extending downward that provide additional circuit area. A communication module 2440 may be mounted on the circuit board 2420, and antenna pads 2442 on the circuit board 2420 connect to a charging antenna 2444.

[0245] FIGS. 28 and 29 depict installation of a battery 2450 within the electronics assembly 2430. In the embodiment shown, the battery 2450 is positioned on the base 2402 and electrically connected to battery pads 2452 of the electronics assembly 2430 through leads 2454. The battery 2450 is positioned within the electronics assembly 2430 with spacing between the battery 2450 and an antenna associated with the communication module 2440, the spacing reducing electromagnetic interference between the battery 2450 and the antenna.

[0246] FIGS. 30 and 31 depict installation of the charging antenna 2444. In the embodiment shown, the charging antenna 2444 includes a coil 2460 connected to the antenna pads 2442 on the circuit board 2420 through leads 2462. After electrical connection, the antenna 2444 is positioned above the electronics assembly 2430 and battery 2450. In embodiments, a shield such as a copper foil sheet may be positioned between the battery 2450 and the chargingantenna 2444. In embodiments, the charging antenna 2444 may include a ferrite element disposed within a center portion of the coil.

[0247] FIGS. 32 and 33 depict coating and filling of the electronics assembly 2430. In the embodiment shown, the electronics assembly 2430 including the base 2402, the circuit board 2420, and the electronic components 2410 is masked and coated with a coating applied over exposed electronics surfaces. In embodiments, filler 2470 may be disposed around electronic components 2410, the filler 2470 stabilizing the components and protecting the electronics assembly 2430 from environmental exposure.

[0248] FIGS. 34 and 35 depict placement of a cover 2472 over the electronics assembly 2430. The cover 2472 is a five sided structure lacking a bottom surface and positioned over the electronics assembly 2430 disposed on the base 2402. The cover 2472 may be fabricated from the same material as the base 2402 and may be sealed to the base 2402 using a low temperature joining process including laser welding or brazing. In embodiments, holes may be formed in the cover 2472 through which potting material may be introduced after the cover 2472 is attached, the holes subsequently sealed with solder plugs.

[0249] FIGS. 36 and 37 depict attachment of a valve 2480 and a sensor assembly 2482. Sensor wires 2484 are electrically connected to the sensor pads 2412 on the base 2402, and the sensor wires 2484 extend from the base 2402 to a sensor capsule 2490. In embodiments, a housing of the cranial shunt system 2400 encloses the base 2402 and associated electronics, and the sensor wires 2484 pass through the housing to the sensor capsule 2490. The valve 2480 may be attached to the cranial shunt system 2400 using a flip chip solder interface. In embodiments, the valve 2480 may include pins or solder pads that attach using solder balls.

[0250] FIGS. 38 and 39 depict formation of strain relief and coating around the sensor assembly 2482 and the valve 2480. In the embodiment shown, adhesive 2494 such as epoxy is applied around the sensor wires 2484 that provides strain relief. In embodiments, selected regions of the electronics assembly 2430 are masked and coated with a coating applied over the sensor connection region and portions of the valve interface.

[0251] FIGS. 40 and 41 depict installation of an end cap 2500. The end cap 2500 may be attached to an end portion of the cranial shunt system 2400 covering a potted region 2502. In embodiments, the potted region 2502 may remain exposed without the end cap 2500. The end cap 2500 may be formed from a biocompatible material including ceramic or PEEK and may include sloped surfaces that conform to surrounding anatomy.

[0252] FIGS. 42 and 43 depict installation of fluid ports 2504 that interface with the valve 2480. In embodiments, the fluid ports 2504 may be formed as two separate components or asa single component including an internal wall dividing fluid pathways. The fluid ports 2504 may be formed from biocompatible materials including PEEK or titanium and may include a D shaped cross section that conforms to an exterior surface of the cranial shunt system 2400. Openings in the fluid ports 2504 align with valve ports of the valve 2480, and the fluid ports 2504 may be secured using adhesive bonding or ultraviolet welding.

[0253] FIGS. 44-82 depict a cranial shunt system 4400 according to another embodiment. FIGS. 44-46 depict an electronics enclosure 4402 of the cranial shunt system 4400. In the embodiment shown, the electronics enclosure 4402 is formed from a biocompatible metal such as machined titanium and defines an internal cavity 4404 that receives an electronics assembly. The electronics enclosure 4402 includes a top opening 4410, a side opening 4412, and an open bottom 4414 providing access to the internal cavity 4404. The top opening 4410 receives a window element. The side opening 4412 receives a feedthrough providing electrical connections between electronics disposed within the electronics enclosure 4402 and external device components. In an embodiment, the electronics enclosure 4402 has approximate external dimensions of about 23 mm by 16 mm by 8 mm (e g., within 2-10% thereof).

[0254] FIGS. 47-49 depict installation of a feedthrough 4420 within the side opening 4412 of the electronics enclosure 4402. In the embodiment shown, the feedthrough 4420 includes a body 4422 supporting a plurality of pins 4424 extending through the feedthrough 4420. In embodiments, the feedthrough 4420 includes six pins 4424, including three pins that electrically connect to a valve assembly and three pins that electrically connect to a sensor assembly. The feedthrough 4420 is joined to the electronics enclosure 4402 along a perimeter interface forming a hermetic seal between the feedthrough 4420 and the electronics enclosure 4402.

[0255] FIGS. 50-52 depict installation of a window 4430 within the top opening 4410 of the electronics enclosure 4402. The window 4430 may be formed from a ceramic or glass material including alumina, sapphire, fused silica, or other RF -transparent material. The window 4430 is positioned within the top opening 4410 and joined to the electronics enclosure 4402 along a perimeter interface forming a hermetically sealed window structure.

[0256] FIG. 53 depicts a circuit board assembly 4432 that is installed within the electronics enclosure 4402. In the embodiment shown, the circuit board assembly 4432 includes a circuit region 4434 and four side portions 4440 that fold relative to the circuit region 4434. The circuit board assembly 4432 is a flex-rigid PCB having a large circuit region 4434 and fold-down tabs forming the side portions 4440. In an embodiment, the circuit board assembly 4432 includes six conductive layers and supports electronic components mounted on one or both sides of thecircuit region 4434. In an embodiment, a rigid PCB configuration occupies about 420 mm2, while the circuit board assembly 4432 occupies about 572 mm2, representing an increase in circuit area enabled by the foldable side portions 4440. The circuit region 4434 may be expanded in one or more directions to increase available circuit area. Prior to installation, the circuit board assembly 4432 may be assembled, electrically tested, and coated with a coating.

[0257] FIG. 54 depicts installation of an antenna 4444 onto the circuit board assembly 4432, and FIGS. 55-57 depict the antenna 4444 installed on the circuit board assembly 4432. As shown in FIGS. 54-57, the antenna 4444 is mounted on a surface 4450 of the circuit region 4434 and electrically connected to antenna pads 4452 disposed on the circuit board assembly 4432. In embodiments, the antenna 4444 is secured to the circuit board assembly 4432 using solder connections or adhesive and may be coated with a coating.

[0258] FIGS. 58 and 59 depict insertion of the circuit board assembly 4432 into the electronics enclosure 4402. FIG. 60 depicts soldering the circuit board assembly 4432. In the depicted embodiment, the side portions 4440 of the circuit board assembly 4432 are folded relative to the circuit region 4434 forming an electronics assembly 4454 within the electronics enclosure 4402. The folded circuit board assembly 4432 is inserted into the internal cavity 4404 of the electronics enclosure 4402, and openings 4460 formed in the side portions 4440 are aligned with the pins 4424 of the feedthrough 4420.

[0259] FIG. 61 depicts electrical connection of the circuit board assembly 4432 to feedthrough pins 4424. In the depicted embodiment, the pins 4424 extending through the openings 4460 in the circuit board assembly 4432 are soldered to pads 4462 of the circuit board assembly 4432 using a soldering tool 4464, establishing electrical connections between internal electronics and external device components of the cranial shunt system 4400. While FIG. 61 depicts a particular soldering tool 4464, other soldering tools or soldering techniques may be used to form the solder connections.

[0260] FIG. 62 depicts installation of a battery 4470 within the electronics enclosure 4402. In the depicted embodiment, leads 4472 of the battery 4470 are soldered to corresponding pads 4474 of the circuit board assembly 4432. The battery 4470 is positioned within the internal cavity 4404 of the electronics enclosure 4402, with the leads 4472 arranged within the cavity 4404 to accommodate placement of the battery 4470 within the electronics enclosure 4402.

[0261] FIG. 63 depicts coating of the electronics assembly 4454 disposed within the electronics enclosure 4402 using a potting compound 4480. In the depicted embodiment, the electronics assembly 4454 including the circuit board assembly 4432, the battery 4470, and other electronic components in the electronics enclosure 4402 may be tested wirelessly throughthe window 4430 to verify operation of electronic circuitry and wireless communication functionality before or after application of the potting compound 4480. The potting compound 4480 may be applied to electronic components disposed within the electronics enclosure 4402, including each component of the electronics assembly 4454.

[0262] FIG. 64 depicts attachment of a plate 4482 to the electronics enclosure 4402. In the embodiment shown, the plate 4482 is formed from titanium and positioned over the open bottom 4414 of the electronics enclosure 4402. The plate 4482 is joined to the electronics enclosure 4402 using a laser welding process forming a hermetic enclosure containing the electronics assembly 4454. In the depicted embodiment, the welding process maintains internal temperatures below approximately 50°C (e.g., one to two degrees higher or lower) during joining of the plate 4482 to the electronics enclosure 4402. after which the electronics enclosure 4402 forms a hermetically sealed enclosure around the electronics assembly 4454.

[0263] FIGS. 65 and 66 depict a valve enclosure 4484 that houses a valve assembly 4490 (see FIG. 73) of the cranial shunt system 4400. In the embodiment shown, the valve enclosure 4484 is formed from a biocompatible metal such as titanium and includes an open side 4492, side openings 4494, and a front opening 4500. The open side 4492 permits insertion of the valve assembly 4490, while the side openings 4494 are positioned to receive valve ports of the valve assembly 4490. The front opening 4500 receives a tube component as described below.

[0264] FIG. 67 depicts installation of a tube 4502 within the valve enclosure 4484, and FIGS.68 and 69 depict the tube 4502 joined to the valve enclosure 4484. In the embodiment shown, the tube 4502 is inserted into the front opening 4500 formed in the valve enclosure 4484 and joined to the valve enclosure 4484, forming a passage through which a sensor cable extends into the valve enclosure 4484. In the depicted embodiment, the tube 4502 is formed from titanium.

[0265] FIG. 70 depicts a sensor assembly 4504 including a sensor capsule 4510 and a sensor cable 4512. In the depicted embodiment, the sensor capsule 4510 is attached to the sensor cable 4512, and the sensor cable 4512 includes ajacket 4514 and aplurality of lead wires 4520 that connect to the feedthrough pins 4424 of the electronics enclosure 4402. The sensor capsule 4510 may be secured to the sensor cable 4512 using adhesive, and portions of the sensor cable 4512 may be coated or potted using a coating material such as epoxy. The lead wires 4520 extend from the sensor cable 4512 as flying leads. In embodiments, the sensor assembly 4504 is tested and calibrated prior to installation, including calibration of electrical balance resistors associated with the sensor assembly 4504.

[0266] FIGS. 71 and 72 depict insertion of the sensor cable 4512 through the tube 4502 of the valve enclosure 4484. In the embodiment shown, the sensor cable 4512 is threaded through the tube 4502 so that the sensor capsule 4510 remains external to the valve enclosure 4484 while the lead wires 4520 extend into the interior of the valve enclosure 4484.

[0267] FIGS. 73 and 74 depict the valve assembly 4490 installed within the valve enclosure 4484. In the embodiment shown, the valve assembly 4490 is inserted through the open side 4492 of the valve enclosure 4484, and valve ports 4522 of the valve assembly 4490 are aligned with the side openings 4494 formed in the valve enclosure 4484. In the depicted embodiment, the valve assembly 4490 includes a circuit portion 4524 with solder openings that provide electrical connection. The valve ports 4522 may fit within the side openings 4494 and may include sealing elements such as gaskets or O-rings disposed around the valve port interfaces.

[0268] FIGS. 75 and 76 depict potting of the interior of the valve enclosure 4484. In the embodiment shown, a potting compound 4530 is introduced into the valve enclosure 4484 filling an internal volume of the valve enclosure 4484 while electrical connection regions of the valve assembly 4490 remain exposed.

[0269] FIGS. 77 and 78 depict electrical connection between the valve enclosure 4484 and the electronics enclosure 4402. In the embodiment shown, the valve enclosure 4484 is positioned relative to the electronics enclosure 4402 with the valve enclosure 4484 rotated approximately 90 degrees relative to the electronics enclosure 4402 (e.g., within 5-10 degrees thereof). The circuit portion 4524 of the valve assembly 4490 is positioned over the feedthrough pins 4424, and the lead wires 4520 of the sensor assembly 4504 and the circuit portion 4524 of the valve assembly 4490 are soldered to corresponding feedthrough pins 4424.

[0270] FIGS. 79 and 80 depict attachment of the valve enclosure 4484 to the electronics enclosure 4402. In the embodiment shown, wires associated with the sensor assembly 4504 and the circuit portion 4524 of the valve assembly 4490 are folded within the assembly, and the valve enclosure 4484 is joined to the electronics enclosure 4402 using a welding process. In the depicted embodiment, the valve enclosure 4484 is joined to the electronics enclosure 4402 using laser welding, although other joining techniques may be used in various embodiments. In this manner, the electronics enclosure 4402 and the valve enclosure 4484 together define at least one housing of the cranial shunt system 4400. The housing defined by the electronics enclosure 4402 and the valve enclosure 4484 encloses the electronics assembly 4454 and the valve assembly 4490, and provides structural support for additional components of the cranial shunt system 4400, including fluid channel structures and a sensor assembly, as described below.

[0271] FIG. 81 depicts an exploded view of fluid channel structures 4532 assembled with the valve assembly 4490. In the depicted embodiment, the fluid channel structures 4532 include passages 4534 that convey CSF between the valve assembly 4490 and catheter connections. The fluid channel structures 4532 may include hose barbs 4540 that attach to catheter tubing. In embodiments, the hose barbs 4540 are separate components attached to the fluid channel structures 4532, while in other embodiments the hose barbs 4540 are formed integrally with the fluid channel structures 4532. The fluid channel structures 4532 may include a surface 4542 positioned adjacent to an exterior wall of the electronics enclosure 4402, and openings 4544 formed in the surface 4542 align with valve ports 4522 of the valve assembly 4490. The fluid channel structures 4532 may be formed from biocompatible materials including metal or polymer materials, and passages 4534 may include smooth surfaces and rounded transitions.

[0272] FIG. 82 depicts attachment of the fluid channel structures 4532 to the electronics enclosure 4402 of the cranial shunt system 4400. In the embodiment shown, the openings 4544 in the fluid channel structures 4532 are aligned with the valve ports 4522 of the valve assembly 4490, and the fluid channel structures 4532 are attached to the electronics enclosure 4402 using adhesive bonding or welding. In embodiments, the fluid channel structures 4532 may be formed as a single component or as multiple components joined to the electronics enclosure 4402.

[0273] After assembly of the cranial shunt system 4400, selected regions including the fluid channel structures 4532 and the sensor capsule 4510 may be masked while coatings are applied to portions of the electronics enclosure 4402. The cranial shunt system 4400 may then undergo final testing including verification of electronic operation, wireless communication, valve operation, and pressure sensing functional ity.

[0274] FIG. 83 depicts a cranial shunt system 8300 arranged along a catheter pathway 8302. In the depicted embodiment, the cranial shunt system 8300 includes a housing 8304 positioned along a fluid path between a proximal catheter segment 8310 and a distal catheter segment 8312. The housing 8304 contains components of the cranial shunt system 8300 including a valve assembly and electronics that control and monitor operation of the shunt system. A sensor structure 8314 is disposed along the catheter pathway 8302 adjacent to the housing 8304 and measures a physiological parameter associated with CSF, such as pressure. The sensor structure 8314 may be positioned external to the housing 8304 and connected to electronics within the housing 8304 through one or more conductors extending along the catheter pathway 8302. The configuration depicted in FIG. 83 illustrates an arrangement in which sensing components are positioned in line along the catheter pathway 8302 adjacent to the housing 8304.

[0275] FIG. 84 depicts a comparison between the cranial shunt system 8300 and a cranial shunt system 8400 according to another embodiment. The cranial shunt system 8400 includes a housing 8402 arranged along a catheter pathway between fluid ports 8404. 8410, which may convey CSF during treatment of hydrocephalus. In the depicted embodiment, internal components of the cranial shunt system 8400 are visible through the housing 8402, and the cranial shunt system 8400 is in fluid communication with a sensing assembly through a lumen 8412 separate from the fluid ports 8404, 8410. The cranial shunt system 8400 further includes a housing profile that is more rounded relative to the housing 8304 of the cranial shunt system 8300.

[0276] As shown in FIG. 84. the cranial shunt system 8300 has an overall length of approximately 36.88 mm, a housing width of approximately 22.23 mm, and a housing height of approximately 7.20 mm while the cranial shunt system 8400 has an overall length of approximately 40.50 mm, a housing width of approximately 24.00 mm, and a housing height of approximately 10.00 mm (all within 5-10% thereof). The comparison shown in FIG. 84 illustrates alternative packaging arrangements of components of the cranial shunt systems 8300, 8400 that may be used to achieve different device profiles and internal component layouts.

[0277] FIG. 85 depicts the cranial shunt system 8300 in further detail, including a fluid channel 8500 configured for being fixed with a pressure sensor 8502 (see FIG. 88). The fluid channel 8500 is configured to be fixed with the housing 8304. In the depicted embodiment, the fluid channel 8500 extends between a proximal fluid port 8504 and a distal fluid port 8510, defining a fluid pathway of CSF How between the proximal fluid port 8504 and the distal fluid port 8510, through which CSF may pass during operation of the cranial shunt system 8300. The proximal fluid port 8504 is configured to convey CSF toward the housing 8304, and the distal fluid port 8510 is configured to convey CSF away from the housing 8304. The pressure sensor 8502 is disposed along the fluid channel 8500 between the proximal fluid port 8504 and the distal fluid port 8510, and measures a pressure of fluid within the fluid channel 8500. In the depicted embodiment, the pressure sensor 8502 is integrated with the fluid channel 8500 such that the pressure sensor 8502 is positioned in line with the fluid pathway defined by the fluid channel 8500. Positioning the pressure sensor 8502 in line with the fluid pathway along the fluid channel 8500 may enable direct measurement of CSF pressure within the flow path, which may reduce or eliminate the need for a separate sensing lumen or tethered capsule configured to extend from the housing 8304.

[0278] FIG. 86 depicts the fluid channel 8500 fixed with a valve enclosure 8512. In the depicted embodiment, the valve enclosure 8512 is positioned adjacent to the fluid channel 8500 and houses a valve assembly that regulates fluid flow through the fluid channel 8500. The valve enclosure 8512 may be formed from a metal material such as titanium and may include a thinwalled structure that receives the valve assembly and associated actuator components for regulation of fluid flow through the fluid channel 8500. The valve enclosure 8512 interfaces with the fluid channel 8500 such that the valve assembly disposed within the valve enclosure 8512 is in fluid communication with the fluid pathway defined by the fluid channel 8500.

[0279] FIG. 87 depicts the valve enclosure 8512 attached to the fluid channel 8500 in a closed configuration. In the depicted embodiment, a plate 8514 is joined to the valve enclosure 8512 to close an opening of the valve enclosure 8512. The housing 8304 is configured to be positioned over the valve enclosure 8512 and configured to receive the electronic components of the cranial shunt system 8300, including a circuit board assembly and a battery . Conductors 8520 extend from within the valve enclosure 8512 and pass through the plate 8514, providing electrical connections between the valve assembly disposed within the valve enclosure 8512 and electronic components configured to be disposed within the housing 8304. The conductors 8520 are configured to transmit electrical power and information across the hermetically sealed valve enclosure 8512 and through the plate 8514 into an interior of the housing 8304. In embodiments, the plate 8514 is joined to the valve enclosure 8512 using a welding process to form a sealed enclosure.

[0280] FIG. 88 depicts the fluid channel 8500 with the pressure sensor 8502 installed in the fluid channel 8500. In the depicted embodiment, the fluid channel 8500 includes a wall 8522 that defines the fluid pathway and the pressure sensor 8502 is positioned in an opening 8524 to the fluid pathway, formed in the wall 8522 of the fluid channel 8500 adjacent to the valve enclosure 8512. The pressure sensor 8502 is fixed with the fluid channel 8500 at the opening 8524. The pressure sensor 8502 is fitted within the opening 8524 and joined to the fluid channel 8500, including by welding, brazing, or adhering the pressure sensor 8502 to the wall 8522, such that the pressure sensor 8502 is fixed directly to the fluid channel 8500 and a sensing portion 8530 of the pressure sensor 8502 defines the fluid pathway with the wall 8522, and is exposed to pressure of CSF along the fluid pathway within the fluid channel 8500.

[0281] By positioning the pressure sensor 8502 in the opening 8524 such that the sensing portion 8530 defines the fluid pathway with the wall 8522, the sensing portion 8530 is flush with or forms part of the fluid pathway boundary, which may reduce dead volume and enable the sensing portion 8530 to measure CSF pressure directly within the flow path. A connectionportion 8532 of the pressure sensor 8502 opposite the sensing portion 8530 is configured to be disposed within an interior of the housing 8304. In this manner, the sensing portion 8530 faces the fluid pathway while the connection portion 8532 is configured to face the interior of the housing 8304, which may protect electrical connections at the connection portion 8532 from exposure to CSF and simplify conductor routing between the pressure sensor 8502 and the circuit board assembly 8544 configured to be disposed within the housing 8304.

[0282] Leads 8534 extend from the pressure sensor 8502 away from the fluid channel 8500, from a side of the pressure sensor 8502 opposite the sensing portion 8530 at the fluid pathway, and more specifically from the connection portion 8532 of the pressure sensor 8502. The leads 8534 transmit electrical power to the pressure sensor 8502 and information from the pressure sensor 8502 to other components of the cranial shunt system 8300. In this regard, the leads 8534 define a conductor configured to extend from the pressure sensor 8502 into the housing 8304, enabling electronic components configured to be disposed within the housing 8304 to receive pressure data from the pressure sensor 8502 without requiring external wiring or additional feedthroughs.

[0283] FIG. 89 depicts the cranial shunt system 8300 with a battery 8540 configured to be positioned within the housing 8304 adjacent to the valve enclosure 8512 and the pressure sensor 8502. In the depicted embodiment, the battery 8540 is a coin cell battery configured to be arranged within the housing 8304 alongside the valve enclosure 8512 and proximate the fluid channel 8500, providing electrical power for components of the cranial shunt system 8300. Conductors are configured to extend between the battery 8540, electronic components configured to be disposed within the housing 8304, and the pressure sensor 8502, transmitting electrical power and information between the components of the cranial shunt system 8300. The arrangement depicted in FIG. 89 illustrates a relatively compact configuration of the cranial shunt system 8300 in which the battery 8540, the valve enclosure 8512, and the pressure sensor 8502 are configured to be positioned in close proximity within the housing 8304 along the fluid channel 8500.

[0284] FIG. 90 depicts a circuit board assembly 8544 included in the cranial shunt system 8300. In the depicted embodiment, the circuit board assembly 8544 includes a plurality of two board portions 8550 connected by an interconnect portion 8552, forming a rigid-flex circuit structure. The board portions 8550 include a first board and a second board, and the interconnect portion 8552 defines an interconnect coupling the first board and the second board. The interconnect is flexible relative to the first board and the second board, such that the first board and the second board are rigid while the interconnect is flexible, permitting the first boardand the second board to be folded toward each other across the interconnect. The board portions 8550 support electronic components associated with operation of the cranial shunt system 8300, and the interconnect portion 8552 provides electrical connections between the board portions 8550 while permitting the circuit board assembly 8544 to conform to packaging constraints of the cranial shunt system 8300. While in the depicted embodiment the circuit board assembly 8544 includes two board portions 8550, alternative embodiments of the cranial shunt system 8300 may include more or fewer board portions operatively connected through interconnect portions, such as the interconnect portion 8552 without departing from the scope of the present disclosure.

[0285] FIGS. 91 and 92 depict the circuit board assembly 8544 assembled with the cranial shunt system 8300. In the depicted embodiment, the circuit board assembly 8544 includes the board portions 8550 configured to be positioned within the housing 8304, at a side of the valve enclosure 8512 opposite the fluid channel 8500, and electrically connected to components of the cranial shunt system 8300, including the pressure sensor 8502 and the battery 8540. The circuit board assembly 8544 is configured to be disposed within the housing 8304 and operatively connected to an electronic component configured to be disposed within the housing 8304. The electronic component includes at least one of a valve operatively connected to the fluid channel 8500 along the fluid pathway, such as a valve assembly disposed within the valve enclosure 8512, a pressure sensor exposed to a pressure of the CSF along the fluid pathway, such as the pressure sensor 8502, or a battery, such as the battery 8540.

[0286] The circuit board assembly 8544 is operatively connected to a valve assembly disposed within the valve enclosure 8512 through the conductors 8520 extending from within the valve enclosure 8512 and configured to extend into the housing 8304. Connections 8560 are configured to extend between the circuit board assembly 8544. the pressure sensor 8502, and the battery 8540, transmitting electrical power and information between the components. More specifically, the circuit board assembly 8544 includes a flex connection 8562 extending from one of the board portions 8550 to the pressure sensor 8502, the flex connection 8562 transmitting electrical power and information between the circuit board assembly 8544 and the pressure sensor 8502. In this regard, the conductor extends from the side of the pressure sensor 8502 opposite the sensing portion 8530 directly to the circuit board assembly 8544 configured to be disposed within the housing 8304, providing a short, direct signal path between the pressure sensor 8502 and the circuit board assembly 8544 that avoids routing conductors across the fluid pathway.

[0287] FIGS. 93-95 depict components and an assembled configuration of the cranial shunt system 8300. FIG. 93 depicts an exploded view including the housing 8304, the valve enclosure 8512, a cover 8564, the pressure sensor 8502, the fluid channel 8500, and the valve enclosure 8512 housing a valve assembly fixed directly to the fluid channel 8500. The valve enclosure 8512 is configured to be fixed inside the housing 8304 and operatively connected to the fluid channel 8500 between the proximal fluid port 8504 and the distal fluid port 8510 along the fluid pathway. In the depicted embodiment, the valve enclosure 8512 is coupled to the fluid channel 8500 such that fluid passing through the fluid channel 8500 is regulated by a valve assembly disposed within the valve enclosure 8512, and the pressure sensor 8502 is positioned to measure pressure of CSF within the fluid channel 8500.

[0288] The fluid channel 8500 includes a flange 8570 fixed directly to the housing 8304 such that the valve enclosure 8512 and the pressure sensor 8502 are fixed with the housing 8304 through the fluid channel 8500. In this manner, because the valve enclosure 8512 and the pressure sensor 8502 are each fixed directly to the fluid channel 8500, and the fluid channel 8500 is in turn fixed directly to the housing 8304 via the flange 8570, the valve enclosure 8512 and the pressure sensor 8502 are structurally supported by the housing 8304 through the fluid channel 8500 without requiring separate fixation between the valve enclosure 8512 or the pressure sensor 8502 and the housing 8304. This arrangement may simplify assembly by enabling the valve enclosure 8512 and the pressure sensor 8502 to be pre-assembled with the fluid channel 8500 before the fluid channel 8500 is fixed to the housing 8304 via the flange 8570. Fixing the valve enclosure 8512 inside the housing 8304 and fixing the fluid channel 8500 with the housing 8304 may reduce the overall implant footprint and simplify surgical placement by integrating fluid regulation and pressure sensing components within a single housing structure.

[0289] The housing 8304 and cover 8564 together define an enclosure that contains electronic components associated with operation of the cranial shunt system 8300, including the circuit board assembly 8544 and the battery 8540. The housing 8304 includes at least one wall 8572 defining an interior of the housing 8304 and an opening 8574 to the interior. Each of the circuit board assembly 8544, the battery 8540, and the valve enclosure 8512 defines an electronic component disposed in the interior of the housing 8304. The cover 8564 is extended across the opening 8574, enclosing the interior of the housing 8304.

[0290] The valve enclosure 8512 is disposed within the housing 8304 and houses a valve assembly. In embodiments, the housing 8304 is formed from a metallic material, such as titanium, and the cover 8564 is formed from ceramic. The metallic material of the housing 8304defines the opening 8574. The opening 8574 is defined at a side of the housing 8304 opposite the valve enclosure 8512 and the pressure sensor 8502, such that the opening 8574 faces away from the fluid channel 8500. The cover 8564 may reduce interference with electromagnetic fields associated with wireless charging or wireless communication of the cranial shunt system 8300. By positioning the cover 8564 across the opening 8574 in the metallic material of the housing 8304, the cover 8564 provides a non-metallic boundary at the opening 8574 that enables electromagnetic energy to pass between an antenna 8584 and the electronic components in the interior, while the wall 8572 of the housing 8304 structurally encloses and protects the electronic components from the surrounding tissue environment.

[0291] FIG. 94 depicts a perspective view of the cranial shunt system 8300 in an assembled configuration. In the depicted embodiment, the housing 8304 is positioned over the valve enclosure 8512 and the fluid channel 8500, with the valve enclosure 8512 disposed along the fluid channel 8500, and the pressure sensor 8502 disposed along the fluid channel 8500. The fluid ports 8504, 8510 extend from opposite ends of the fluid channel 8500, connecting with catheter segments of the cranial shunt system 8300.

[0292] FIG. 95 depicts a top view- of the cranial shunt system 8300. In the depicted embodiment, the housing 8304 extends over the valve enclosure 8512 along a side of the fluid channel 8500, and the valve enclosure 8512 is positioned along the fluid channel 8500 between the fluid ports 8504, 8510. The fluid channel 8500 extends along a side of the housing 8304, across an entire length of the housing 8304 in a first direction along the fluid pathway. In the depicted embodiment, the fluid channel 8500 occupies a same position as each of the valve enclosure 8512 and the pressure sensor 8502 in a second direction orthogonal to the first direction, such that the valve enclosure 8512, the pressure sensor 8502, and the fluid channel 8500 are aligned in the second direction.

[0293] This arrangement enables the valve enclosure 8512 and the pressure sensor 8502 to each interface with the fluid pathway defined by the fluid channel 8500 without requiring lateral offsets or separate fluid connections in the first direction, and positions the fluid channel 8500 as a structural spine extending along the entire length of the housing 8304 that supports the valve enclosure 8512 and the pressure sensor 8502 in a low-profile configuration. The top view illustrates the relative arrangement of the housing 8304, the valve enclosure 8512, the fluid channel 8500, and the pressure sensor 8502 within the cranial shunt system 8300.

[0294] FIGS. 96 and 97 depict layers of the cover 8564 of the cranial shunt system 8300. In this regard. FIG. 96 depicts a first layer 8580 of the cover 8564 including connections 8582 that transmit energy between the antenna 8584 and electronic components disposed within thehousing 8304. The first layer 8580 may be formed from a ceramic material. The first layer 8580 defines a ceramic layer fixed with the metallic material of the housing 8304, where the ceramic layer extends across and closes the opening defined by the metallic material, and supports the antenna 8584 outside the housing 8304. The first layer 8580 includes a conductor 8590 extended through the ceramic material, the connections 8582 forming an electric circuit connection between the antenna 8584 and the electronic component in the interior of the housing 8304. By extending the conductor 8590 through the ceramic material of the first layer 8580, the first layer 8580 enables electrical communication between the antenna 8584 and the electronic component in the interior while maintaining the hermetic seal at the opening 8574, eliminating the need for a separate feedthrough at the opening 8574.

[0295] In embodiments, the first layer 8580 is positioned flush with, directly on top of, or adjacent to an end of the housing 8304. The first layer 8580 positions the antenna 8584 outside the housing 8304, at a side of the opening 8574 opposite the valve enclosure 8512 and the pressure sensor 8502. In this manner, the first layer 8580 supports the antenna 8584 on the cover 8564, outside of the housing 8304, at a side of the opening 8574 opposite the electronic component disposed in the interior of the housing 8304. By forming the first layer 8580 from a ceramic material that extends across and closes the opening 8574, the first layer 8580 may provide a hermetic boundary at the opening 8574 while remaining substantially transparent to radio frequency energy’, enabling wireless communication and inductive charging through the first layer 8580.

[0296] FIG. 97 depicts a second layer 8592 of the cover 8564 positioned above the antenna 8584. The second layer 8592 extends across the first layer 8580, at a side of the first layer 8580 opposite the electronic component disposed in the interior of the housing 8304. The second layer 8592 defines a glass layer fixed with the housing 8304, where the glass layer extends across and covers a side of the antenna 8584 opposite the opening 8574, retaining the antenna 8584 with the first layer 8580. In the depicted embodiment, the antenna 8584 is disposed between the first layer 8580 and the second layer 8592 such that the antenna 8584 is sandwiched between the first layer 8580 and the second layer 8592.

[0297] The first layer 8580 and the second layer 8592 together form the cover 8564, with the antenna 8584 positioned outside the housing 8304 and behind the second layer 8592. This configuration may reduce interference between the antenna 8584 and the housing 8304 during wireless charging or wireless communication. In addition, by covering the side of the antenna 8584 opposite the opening, the glass layer may mechanically retain and protect the antenna 8584 against displacement, while remaining substantially transparent to radio frequencyenergy. The combined two-layer cover structure, in which the first layer 8580 formed from the ceramic material provides a hermetically sealed. RF-transparent boundary’ at the opening 8574 and the second layer 8592 formed from the glass material mechanically retains and protects the antenna 8584, may enable the cover 8564 to simultaneously seal the interior of the housing 8304, support the antenna 8584 outside the housing 8304, and maintain wireless communication and charging performance.

[0298] With reference to FIG. 95, in the depicted embodiment, the fluid pathway defined by the fluid channel 8500 extends in a first direction. The antenna 8584 occupies a same position as the electronic component in a second direction orthogonal to the first direction, such that the antenna 8584 and the electronic component are aligned in the second direction. The second direction is orthogonal to a cranium of the patient when the cranial shunt system 8300 is implanted, such that the antenna 8584 faces outward from the cranium while the electronic component is positioned between the antenna 8584 and the cranium in the second direction. In this regard, the electronic component includes at least one of a battery, such as the battery 8540, a circuit board assembly, such as the circuit board assembly 8544, a valve assembly operatively connected to the fluid channel 8500 along the fluid pathway, such as the valve assembly in the valve enclosure 8512, and a pressure sensor exposed to a pressure of the CSF along the fluid pathway, such as the pressure sensor 8502.

[0299] Aligning the antenna 8584 with the electronic component in the second direction orthogonal to the cranium may maximize the effective area of the antenna 8584 relative to the electronic component disposed beneath it, enable direct electromagnetic coupling between the antenna 8584 and the electronic component without lateral offset, and ensure the antenna 8584 faces outward from the cranium to maximize wireless communication and charging performance with external devices positioned outside the patient's head. Additionally, stacking the antenna 8584 and the electronic component in the second direction orthogonal to the cranium may minimize the lateral footprint of the cranial shunt system 8300 on the cranial surface.

[0300] FIG. 98 depicts the cranial shunt system 8300 including an overmold 8594 applied over exterior portions of the cranial shunt system 8300. In the depicted embodiment, the overmold 8594 encapsulates exterior portions of the housing 8304, the fluid channel 8500, the valve enclosure 8512, the cover 8564, and adjacent structures of the cranial shunt system 8300 as a unitary body, providing a smooth exterior profile. The overmold 8594 may be formed from silicone or another biocompatible elastomer. The overmold 8594 reduces or eliminates sharp exterior edges of the cranial shunt system 8300, forming rounded transitions along exteriorsurfaces of the cranial shunt system 8300. In addition, the overmold 8594 fixes the fluid channel 8500 with the housing 8304 by encapsulating exterior portions of both the housing 8304 and the fluid channel 8500 within the overmold 8594. In this manner, the overmold 8594 provides a secondary fixation mechanism that secures the fluid channel 8500 to the housing 8304, reduces relative movement between the fluid channel 8500 and the housing 8304, and consolidates the cranial shunt system 8300 into a single handleable unit that may simplify surgical placement of the cranial shunt system 8300.

[0301] In embodiments, the overmold 8594 defines exterior edges having a minimum radius of curvature. Based on the overall dimensions of the cranial shunt system 8300, the minimum radius of curvature may be on the order of approximately 1 mm to 3 mm (e.g., within 5-10% thereof), although other radii may be used in different configurations. The rounded exterior surfaces formed by the overmold 8594 may reduce localized pressure concentrations on surrounding tissue when the cranial shunt system 8300 is implanted.

[0302] FIG. 99 depicts a cranial shunt system 9900 according to another embodiment. In the depicted embodiment, the cranial shunt system 9900 includes at least one housing including a first housing 9902 and a second housing 9904 joined by a flexible connector 9910. The flexible connector 9910 permits relative movement between the first housing 9902 and the second housing 9904, allowing the cranial shunt system 9900 to conform to a curvature of a patient's cranium when implanted.

[0303] In the depicted embodiment, the first housing 9902 is positioned along a fluid pathway and supports a fluid channel 9912 extending between fluid ports 9914, 9920, with a valve assembly 9922 disposed within the first housing 9902 and disposed along the fluid channel 9912 that regulates flow of CSF. A pressure sensor is positioned along the fluid channel 9912 adjacent to the first housing 9902 and measures pressure of CSF within the fluid channel 9912. The second housing 9904 is positioned adjacent to the first housing 9902 and contains electronic components disposed within the second housing 9904 associated with operation of the cranial shunt system 9900, including a circuit board and a battery.

[0304] The battery is operatively connected to the circuit board, and the circuit board is operatively connected to the valve assembly 9922 and the pressure sensor, and the circuit board communicates with the pressure sensor and the valve assembly 9922. Separating the valve assembly 9922 into the first housing 9902 and the battery and the circuit board into the second housing 9904 may reduce the individual footprint of each housing, distribute implant mass more evenly across the patient's cranium, and enable independent replacement of the valve assembly 9922 or the electronic components without disturbing the other housing.

[0305] In the depicted embodiment, the first housing 9902 and the second housing 9904 each include a bottom surface 9934 that faces a cranium of the patient when the cranial shunt system 9900 is implanted. The flexible connector 9910 is less rigid than the bottom surface 9934 of the first housing 9902 and the second housing 9904, such that the bottom surfaces 9934 of the first housing 9902 and the second housing 9904 maintain structural integrity and protect internal components of the cranial shunt system 9900 while the flexible connector 9910 flexes to accommodate the curvature of the patient's cranium. This differential rigidity between the flexible connector 9910 and the bottom surfaces 9934 of the first housing 9902 and the second housing 9904 may enable the cranial shunt system 9900 to conform to the patient's cranium without imposing concentrated stresses on the skull surface, while each housing individually resists deformation that could damage the valve assembly 9922, the battery, the circuit board, or other internal components.

[0306] FIG. 100 depicts a cranial shunt system 10000 according to another embodiment. In the depicted embodiment, the cranial shunt system 10000 includes a housing 10002 arranged along a catheter pathway between a proximal catheter segment 10004 and a distal catheter segment 10010. The housing 10002 contains components of the cranial shunt system 10000 including a valve assembly 10024 and electronic components that control and monitor operation of the shunt system. In the depicted embodiment, the housing 10002 includes an upper portion 10012 formed from a ceramic material and a lower portion 10014 formed from a metallic material, such as titanium, defining an internal enclosure for electronic components. An antenna may be disposed within or beneath the upper portion 10012 of the housing 10002, enabling wireless communication and inductive charging of the cranial shunt system 10000. The housing 10002 is integrated with a fluid channel 10022 extending between the proximal catheter segment 10004 and the distal catheter segment 10010, with the valve assembly’ 10024 disposed along the fluid channel 10022 in the lower portion 10014 that regulates flow of CSF through the cranial shunt system 10000.

[0307] FIGS. 101-103 depict comparisons between the cranial shunt system 10000 of FIG.100 and a cranial shunt system 10100 according to another embodiment. In the depicted embodiments, the cranial shunt system 10100 includes a housing 10102 arranged along a catheter pathway between a proximal catheter segment 10104 and a distal catheter segment 10110, with a sensor port 10112 extending from the housing 10102. The sensor port 10112 receives or connects with a pressure sensor disposed within the brain of the patient, allowing pressure measurements to be obtained from within brain tissue while the cranial shunt system 10100 regulates CSF flowthrough the catheter pathway.

[0308] FIG. 102 depicts side views of the cranial shunt systems 10000, 10100 illustrating relative external profiles of the respective housings 10002, 10102 and the positions of the catheter interfaces along the fluid pathway. In the depicted embodiment, the cranial shunt system 10100 includes the sensor port 10112 extending from the housing 10102 that connects with the pressure sensor.

[0309] FIG. 103 depicts a further side view comparison between the cranial shunt system 10000 and the cranial shunt system 101 0, with the cranial shunt system 10000 positioned in front of the cranial shunt system 10100 in the depicted view. The view illustrates relative external profiles of the housings 10002, 10102 and the presence of the sensor port 10112 extending from the housing 10102.

[0310] FIGS. 104-106 depict a cranial shunt system 10400 according to another embodiment. FIG. 104 depicts a side perspective view of the cranial shunt system 10400. In the depicted embodiment, the cranial shunt system 10400 includes a housing 10402 arranged along a fluid channel 10404 extending between a proximal catheter segment 10410 and a distal catheter segment 10412.

[0311] FIG. 105 depicts a top perspective view of the cranial shunt system 10400. In the depicted embodiment, the housing 10402 extends along the fluid channel 10404 and contains internal components of the cranial shunt system 10400 while the fluid channel 10404 provides a CSF pathway between the proximal catheter segment 10410 and the distal catheter segment 10412.

[0312] FIG. 106 depicts atop perspective view of the cranial shunt system 10400 including a battery 10414, a valve assembly 10420, and a pressure sensor 10422 disposed within the housing 10402. The housing 10402 includes a bottom 10430, a wall 10432 extended away from the bottom 10430 along a perimeter of the bottom 10430 such that the bottom 10430 and the wall 10432 define an interior of the housing 10402 containing the battery 10414, the valve assembly 10420, and the pressure sensor 10422.

[0313] The wall 10432 defines a cutout 10434 extending from an edge 10440 of the wall 10432 opposite the bottom 10430, toward and to the bottom 10430, such that a flexible printed circuit board may lay flat through the cutout 10434 during assembly. With this construction, a circuit board assembly may be laid into the housing 10402 along the bottom 10430 of the housing 10402, with the valve assembly 10420 then placed on top of the circuit board assembly in a manufacturing process. The arrangement shown in FIG. 106 illustrates an embodiment in which the battery 10414, the valve assembly 10420, and the pressure sensor 10422 are packaged within the housing 10402 and adjacent to the fluid channel 10404.

[0314] As shown in FIGS. 104 and 105, the cranial shunt system 10400 includes a lid 10442 that closes the interior of the housing 10402, covering the battery 10414, the valve assembly 10420, and the pressure sensor 10422. The lid 10442 is complementary to the cutout 10434 and extends along the wall 10432 at the edge 10440, including along the cutout 10434, closing the housing 10402.

[0315] FIGS. 107-112 depict a cranial shunt system 10700 according to another embodiment. FIGS. 107-109 depict assembly of electronic components of the cranial shunt system 10700. FIG. 107 depicts a circuit board assembly 10702 in a flat configuration prior to assembly. In the depicted embodiment, the circuit board assembly 10702 includes board portions 10704 connected by interconnect portions 10710. The board portions 10704 include a first board 10712 and a second board 10714, and the interconnect portions 10710 define an interconnect coupling the first board 10712 and the second board 10714. The interconnect is flexible relative to the first board 10712 and the second board 10714, permitting the first board 10712 and the second board 10714 to be folded toward each other across the interconnect.

[0316] With reference to FIG. 111. the circuit board assembly 10702 is shown together with a battery 10720 and a pressure sensor 10722, which are electrically connected to the circuit board assembly 10702 during assembly of the cranial shunt system 10700. Each of the battery 10720 and the pressure sensor 10722 defines an electronic component disposed within a housing 10724 of the cranial shunt system 10700, and the circuit board assembly 10702 is disposed within the housing 10724 and operatively connected to the electronic component. A fluid channel 10734 fixed with the housing 10724 defines a fluid path wax' of CSF flow in a first direction.

[0317] FIG. 108 depicts an intermediate assembly configuration of the components shown in FIG. 107. In the depicted embodiment, one of the board portions 10704 is folded relative to another board portion 10704 and the battery 10720, while another board portion 10704 is folded inward between upper and lower board portions 10704. The pressure sensor 10722 is also partially folded inw ard relative to the circuit board assembly 10702.

[0318] FIG. 109 depicts the components in a further assembled configuration in which the board portions 10704, the interconnect portions 10710, the battery 10720, and the pressure sensor 10722 are folded inward to form a compact electronics assembly. The assembled electronics assembly is sized for placement within the housing 10724 of the cranial shunt system 10700.

[0319] FIGS. 110-112 depict installation of the electronics assembly within the cranial shunt system 10700. FIG. 110 depicts a top perspective view of an electronics assembly 10730including a folded circuit board assembly having the board portions 10704 connected by the interconnect portions 10710, together with the battery 10720 and the pressure sensor 10722 arranged in a compact configuration.

[0320] FIG. I ll depicts the electronics assembly 10730 positioned within the housing 10724 together with other components of the cranial shunt system 10700 in an unfolded configuration. In the depicted embodiment, the electronics assembly 10730 is arranged relative to the battery 10720 and a valve assembly 10732 disposed along the fluid channel 10734.

[0321] FIG. 112 depicts the electronics assembly 10730 in a folded configuration within the housing 10724. The housing 10724 includes a bottom 10740 and a wall 10742 extended away from the bottom 10740 along a perimeter of the bottom 10740 such that the bottom 10740 and the wall 10742 define an interior of the housing 10724 containing the electronic component. In the depicted embodiment, portions of the circuit board assembly are folded over the battery 10720 and the valve assembly 10732, positioning the electronics assembly 10730 within the housing 10724 of the cranial shunt system 10700. In the folded configuration, at least one of the first board 10712 and the second board 10714 overlaps the electronic component in a second direction orthogonal to the first direction, such that the first board 10712 or the second board 10714 is positioned above the battery 10720 or the valve assembly 10732 in the second direction.

[0322] The electronic component, such as the battery 10720. is interposed between and separates the first board 10712 and the second board 10714 in the second direction, such that the first board 10712 is disposed between the bottom 10740 and the electronic component in the second direction, and the second board 10714 is positioned above the electronic component in the second direction. This arrangement enables each of the first board 10712 and the second board 10714 to be positioned on opposite sides of the electronic component, utilizing both the space above and below the electronic component for circuit area and maximizing total circuit area within the housing 10724 footprint. By folding the first board 10712 and the second board 10714 across the interconnect such that at least one board overlaps the electronic component in the second direction, the circuit board assembly 10702 may occupy a larger total circuit area than a single rigid board of comparable footprint while fitting within the housing 10724, and may utilize vertical space within the housing 10724 above the electronic component that would otherwise be unused, enabling a more compact overall implant configuration.

[0323] In the depicted embodiment, the wall 10742 of the housing 10724 defines a cutout 10744 from an edge opposite the bottom 10740 such that the interconnect in an unfolded condition extends from the first board 10712 in the interior, through the wall 10742 at the cutout10744. During assembly, the circuit board assembly 10702 may be arranged in the unfolded condition with the interconnect extending outward through the cutout 10744 in the wall 10742, and the first board 10712 positioned in the interior between the bottom 10740 and the electronic component. The circuit board assembly 10702 may then be folded such that the second board 10714 passes over the edge of the wall 10742 at the cutout 10744 and overlaps the electronic component in the second direction.

[0324] This arrangement may simplify assembly of the cranial shunt system 10700 by enabling the circuit board assembly 10702 to be inserted into the housing 10724 in the unfolded condition with the interconnect passing through the cutout, and then folded into the final configuration without requiring the entire circuit board assembly 10702 to fit through the opening of the housing 10724 in the folded state. Additionally, the first board 10712 being disposed between the bottom 10740 of the housing 10724 and the electronic component may provide a protective layer between the bottom surface of the housing 10724, which faces the cranium, and the electronic component.

[0325] FIGS. 113-115 depict a cranial shunt system 11300 according to another embodiment. FIG. 113 depicts a perspective view of the cranial shunt system 11300 including a housing 11302 and a fluid channel 11304 extending between a proximal catheter segment 11310 and a distal catheter segment 11312. In the depicted embodiment, the fluid channel 11304 extends along the housing 11302 and turns around a comer before continuing toward the distal catheter segment 11312.

[0326] FIG. 114 depicts the cranial shunt system 11300 with the fluid channel 11304 removed. In the depicted embodiment, the housing 11302 includes afirst pressure sensor 11314 and a second pressure sensor 11320 disposed at different sides of the housing 11302 along a fluid pathway defined by the fluid channel 11304. Each of the first pressure sensor 11314 and the second pressure sensor 11320 is exposed to the pressure of the CSF along the fluid pathway. A valve assembly 11322 is positioned between the first pressure sensor 11314 and the second pressure sensor 11320, with inlet and outlet valve ports of the valve assembly 11322 aligned with the fluid pathway between the pressure sensors 11314, 11320. The valve assembly 11322 is operatively connected to the fluid pathway via valve ports 11324 of the valve assembly 11322. The second pressure sensor 11320 is disposed at a side of the valve port 11324 opposite the first pressure sensor 11314 along the fluid pathway. Positioning the first pressure sensor 11314 and the second pressure sensor 11320 on opposite sides of the valve port of the valve assembly 11322 along the fluid pathway may enable differential pressure measurement across the valve assembly 11322, which may be used to detect obstruction within the fluid pathway,verify that the valve assembly 11322 is open or closed, or provide redundant pressure sensing to confirm that the valve assembly 11322 is regulating CSF flow as intended.

[0327] FIG. 115 depicts a top perspective view of the cranial shunt system 11300 with a lid removed from the housing 11302. In the depicted embodiment, internal components disposed within the housing 11302 are visible, including electronic components that control operation of the valve assembly 11322 and receive pressure measurements from the pressure sensors 11314. 11320.

[0328] FIGS. 116 and 117 depict a cranial shunt system 11600 according to another embodiment. FIG. 116 depicts a top perspective view of the cranial shunt system 11600 including a housing 11602 and a fluid channel 11604 extending generally straight along the housing 11602 between a proximal catheter segment 11610 and a distal catheter segment 11612. In the depicted embodiment, the housing 11602 contains internal components that regulate flow of CSF through the fluid channel 11604 and monitor operation of the cranial shunt system 11600.

[0329] FIG. 117 depicts an exploded view of the cranial shunt system 11600 illustrating assembly of system components. In the depicted embodiment, internal components including a valve assembly 11614, electronic components 11620, and associated structures are mounted to a base 11622 that is that is integrally formed with the fluid channel 11604 and received within the housing 11602. The base 11622 forms a straight exterior wall of the housing 11602 to which the fluid channel 11604 is attached, and the internal components 11614, 11620 are arranged along the base 11622 on a side of the base 11622 opposite the fluid channel 11604. The base 11622 positions the internal components relative to the fluid channel 11604 and supports assembly of the cranial shunt system 11600 within the housing 11602.

[0330] FIG. 118 depicts a cranial shunt system 11800 according to another embodiment. In the depicted embodiment, the cranial shunt system 11800 includes multiple housings arranged generally in line and flexibly connected to each other. The housings include an antenna housing 11802, an electronics housing 11804, and a valve housing 11810, each of which is connected to an adjacent housing by a flexible connector 11812 that permits relative movement between the housings.

[0331] In the depicted embodiment, the housings 11802, 11804, 11810 are arranged sequentially along a longitudinal direction of the cranial shunt system 11800, while a fluid channel 11814 is positioned at an end of the valve housing 11810 and extends generally transverse to the direction of the aligned housings. The fluid channel 11814 is located at a side of the valve housing 11810 opposite the electronics housing 11804 and the antenna housing11802. The antenna housing 11802 contains an antenna 11820 arranged to he flat against the cranium of the patient when implanted, enabling the antenna 11820 to have a relatively large area while maintaining a low profile. This configuration may improve wireless communication and energy transfer performance with a relatively large antenna design, while minimizing implant height and reducing the external profile of the cranial shunt system 11800.

[0332] FIGS. 119 and 120 depict a cranial shunt system 11900 according to another embodiment. FIG. 119 depicts a side perspective view of the cranial shunt system 11900 including multiple housings arranged generally in line and flexibly connected to each other. In the depicted embodiment, the cranial shunt system 11900 includes an antenna housing 11902, an electronics housing 11904, and a valve housing 11910 coupled by flexible connectors 11912, with a fluid channel 11914 extending generally along the direction of alignment of the housings and terminating at a proximal catheter segment 11920 and a distal catheter segment 11922.

[0333] FIG. 120 depicts the cranial shunt system 11900 in the same perspective view with the fluid channel 11914 removed. In the depicted embodiment, removal of the fluid channel 11914 reveals a pressure sensor 11924 and valve assembly connections 11930 disposed along the valve housing 11910, the pressure sensor 11924 measuring pressure of CSF conveyed through the fluid channel 11914 when the fluid channel 11914 is installed.

[0334] FIG. 121 depicts a circuit board assembly 11932 used with the cranial shunt system 11900. In the depicted embodiment, the circuit board assembly 11932 includes a first board portion 11934 and a second board portion 11940 connected by an interconnect portion 11942. The first board portion 11934 defines a first board, the second board portion 11940 defines a second board, and the interconnect portion 11942 defines an interconnect coupling the first board and the second board. The interconnect is flexible relative to the first board and the second board. The board portions 11934, 11940 are arranged such that the interconnect portion 11942 permits the board portions 11934, 11940 to be folded toward each other during assembly.

[0335] In the depicted embodiment, the board portions 11934, 11940 fold toward each other and are positioned within a housing of the cranial shunt system 11900 adjacent to a battery and a pressure sensor. In the folded configuration, at least one of the first board and the second board overlaps the electronic component, such as the battery' or the pressure sensor, in a second direction orthogonal to the first direction defined by the fluid pathway. The electronic component is a coin cell battery, and the first board and the second board are folded toward each other across the interconnect in the housing.

[0336] Each of the board portions 11934, 11940 includes a curved edge 11944 along a top side of the respective board portion. The curved edges 11944 correspond to a curvature of the coin cell battery used in the cranial shunt system 11900, and the first board or the second board defines the curved edge 11944 that maintains constant offset from the coin cell battery, allowing the circuit board assembly 11932 to be positioned adjacent to the coin cell battery within the housing. By maintaining constant offset from the coin cell battery, the curved edge 11944 ensures uniform spacing between the board edge and the battery surface, which may avoid mechanical interference between the board and the battery while maximizing circuit area adjacent to the coin cell battery'.

[0337] FIGS. 122 and 123 depict a cranial shunt system 12200 according to another embodiment. FIG. 122 depicts a top perspective view of the cranial shunt system 12200 including a housing 12202, a fluid channel 12204 extending between a proximal catheter segment 12210 and a distal catheter segment 12212, a pressure sensor, and a valve assembly that regulates flow of CSF through the cranial shunt system 12200. The pressure sensor is positioned inline along the fluid channel 12204.

[0338] In the depicted embodiment, the housing 12202 further includes a sensor port 12222 that receives or connects with a separate pressure sensor, which may be disposed within brain tissue of a patient to measure intracranial pressure. FIG. 123 depicts a side view of the cranial shunt system 12200, illustrating the relative arrangement of the housing 12202, the fluid channel 12204. the pressure sensor, the valve assembly, the sensor port 12222, and the catheter segments 12210, 12212.

[0339] FIG. 124 depicts a circuit board 12224 used with the cranial shunt system 12200. In the depicted embodiment, the circuit board 12224 is formed as a single circuit board including an elongated body 12230 having a widened central region and narrower end regions extending from opposite sides of the central region. The circuit board 12224 includes a curved edge 12232 formed along a side of the elongated body 12230, and may further include contoured regions along its perimeter that correspond to or accommodate adjacent components within the cranial shunt system 12200.

[0340] In the depicted embodiment, the curved edge 12232 corresponds to a curvature of a coin cell battery used within the cranial shunt system 12200. The curved edge 12232 maintains constant offset from the coin cell battery'. The curved geometry' allows the circuit board 12224 to be positioned adjacent to the outer circumference of the coin cell battery, reducing unused space within the housing and enabling a more compact arrangement of electronic components. By conforming to the curvature of the coin cell battery', the circuit board 12224 may also allowelectronic components mounted on the board to be positioned closer to the coin cell battery and other system components, improving packaging efficiency within the implant housing.

[0341] FIGS. 125 and 126 depict comparative external profiles of several cranial shunt systems described in this application. In the depicted embodiments, the figures illustrate representative external geometries of the cranial shunt systems 10000, 10400, 11300, 11600, 11800, 11900, 12200, each arranged along a catheter pathway defined by respective fluid channels and housings containing electronics and valve assemblies. The figures illustrate variations in housing geometry, relative placement of fluid channels along the housing, and overall external profiles of the respective cranial shunt systems when arranged along the catheter pathway.

[0342] In each of FIGS. 125 and 126, an additional cranial shunt system 12500 is shown at a rightmost position. In the depicted embodiment, the cranial shunt system 12500 includes a housing 12502 having a fluid channel 12504 positioned generally along a central axis of the housing 12502. This configuration results in a more symmetric implant geometry', which may allow the cranial shunt system 12500 to sit more evenly relative to surrounding anatomy when implanted. Positioning the fluid channel 12504 along the central axis of the housing 12502 may also permit electronic components, batteries, and antennas to be distributed on opposite sides of the fluid channel 12504, which may improve packaging efficiency and enable a more balanced distribution of mass within the implant.

[0343] What has been described above includes examples of the present specification. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present specification, but one of ordinary' skill in the art may recognize that many further combinations and permutations of the present specification are possible. Each of the components described above may be combined or added together in any permutation to define embodiments disclosed herein. Accordingly, the present specification is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term ■'includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term “including’’ as “including” is interpreted when employed as a transitional word in a claim.

Claims

CLAIMSWhat is claimed is:

1. A cranial shunt system comprising:at least one housing;a fluid channel fixed with the at least one housing, the fluid channel extending between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing, wherein the fluid channel defines a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port;a valve assembly fixed inside the at least one housing and operatively connected to the fluid channel between the proximal fluid port and the distal fluid port along the fluid pathway; anda pressure sensor disposed along the fluid channel between the proximal fluid port and the distal fluid port, the pressure sensor including a sensing portion exposed to a pressure of the CSF along the fluid pathway, and a conductor extending from the pressure sensor into the at least one housing.

2. The system of claim 1, wherein the fluid channel includes a wall that defines the fluid pathway and an opening to the fluid pathway, and the pressure sensor is positioned in the opening and welded, brazed, or adhered to the wall such that the sensing portion defines the fluid pathway with the wall.

3. The system of claim 1, further comprising a circuit board assembly disposed within the at least one housing and operatively connected to the valve assembly, wherein the conductor extends from a side of the pressure sensor opposite the sensing portion at the fluid pathway, and directly to the circuit board assembly within the at least one housing.

4. The system of claim 1 , wherein the at least one housing defines an opening, the pressure sensor is fixed with the at least one housing or the fluid channel at the opening, where a connection portion of the pressure sensor opposite the sensing portion defines or is disposed within an interior of the at least one housing, and the conductor extends from the connection portion.

5. The system of claim 1, wherein the at least one housing is formed from a metallic material, the metallic material defines an opening, and the system further comprises:an antenna positioned outside the at least one housing, at a side of the opening opposite the valve assembly or the pressure sensor; anda ceramic layer fixed with the metallic material, where the ceramic layer extends across and closes the opening, and supports the antenna outside the at least one housing; ora glass layer fixed with the at least one housing, where the glass layer extends across and covers a side of the antenna opposite the opening, retaining the antenna with the at least one housing.

6. The system of claim 1, wherein the valve assembly or the pressure sensor are fixed directly to the fluid channel, and the fluid channel includes a flange fixed directly to the at least one housing such that the pressure sensor or the valve assembly are fixed with the at least one housing through the fluid channel.

7. The system of claim 1, wherein the fluid channel extends along a side of the at least one housing, across an entire length of the at least one housing in a first direction along the fluid pathway, andwherein the fluid channel occupies a same position as each of the valve assembly and the pressure sensor in a second direction orthogonal to the first direction.

8. The system of claim 1. further comprising:a circuit board in the at least one housing, operatively connected to the valve assembly and the pressure sensor; anda battery in the at least one housing, operatively connected to the circuit board, wherein the at least one housing includes a first housing and a second housing, the valve assembly is disposed within the first housing, and the battery and the circuit board are disposed within the second housing.

9. The system of claim 8, further comprising a flexible connector j oining the first housing with the second housing, wherein the first housing and the second housing each include a bottom surface that faces a cranium of a patient, and the flexible connector is less rigid than the bottom surface of the first housing and the second housing.

10. The system of claim 1, further comprising an overmold that encapsulates extenor portions of the at least one housing and the fluid channel as a unitary body fixing the fluidchannel with the housing, wherein the overmold fixes the fluid channel with the at least one housing.

11. The system of claim 1, wherein the pressure sensor is a first pressure sensor, the valve assembly is operatively connected to the fluid pathway via a valve port, and the cranial shunt system further comprises a second pressure sensor exposed to the pressure of the CSF along the fluid pathway at a side of the valve port opposite the first pressure sensor.

12. A cranial shunt system, comprising:a housing having at least one wall defining an interior and an opening to the interior; a fluid channel fixed with the housing, the fluid channel extending between a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing, and a distal fluid port that conveys CSF away from the housing, wherein the fluid channel defines a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port;an electronic component disposed in the interior of the housing;a cover extended across the opening; andan antenna supported on the cover, outside of the housing, at a side of the opening opposite the electronic component.

13. The system of claim 12, wherein the at least one wall is formed from a metallic material, and the cover includes a first layer formed from a ceramic material extending across the opening, and a second layer formed from a glass material extending across the first layer, at a side of the first layer opposite the electronic component.

14. The system of claim 13, wherein the first layer extends across and closes the opening, the second layer covers a side of the antenna opposite the opening, retaining the antenna with the first layer,the first layer includes a conductor extended through the ceramic material, forming an electric circuit connection between the antenna and the electronic component in the interior.

15. The system of claim 14, wherein the fluid pathway extends in a first direction, the antenna occupies a same position as the electronic component in a second direction orthogonal to the first direction, and the electronic component includes at least one of a battery, a circuitboard assembly, a valve assembly operatively connected to the fluid channel along the fluid pathway, and a pressure sensor exposed to a pressure of the CSF along the fluid pathway.

16. The system of claim 15, wherein the second direction is orthogonal to a cranium.

17. A cranial shunt system comprising:a housing;a fluid channel fixed with the housing, wherein the fluid channel includes a proximal fluid port that conveys cerebrospinal fluid (CSF) toward the housing and a distal fluid port that conveys the CSF away from the housing, defining a fluid pathway of CSF flow between the proximal fluid port and the distal fluid port in a first direction;an electronic component disposed within the housing, including at least one of a valve operatively connected to the fluid channel along the fluid pathway, a pressure sensor exposed to a pressure of the CSF along the fluid pathway, or a battery; anda circuit board assembly disposed within the housing and operatively connected to the electronic component, the circuit board assembly including a first board, a second board, and an interconnect coupling the first board and the second board, wherein the interconnect is flexible relative to the first board and the second board, and at least one of the first board and the second board overlaps the electronic component in a second direction orthogonal to the first direction.

18. The system of claim 17, wherein the electronic component is interposed between and separates the first board and the second board in the second direction.

19. The system of claim 17, wherein the housing includes a bottom and a wall extended away from the bottom along a perimeter of the bottom such that the bottom and the wall define an interior of the housing containing the electronic component,the first board is disposed between the bottom and the electronic component in the second direction, andthe wall defines a cutout from an edge opposite the bottom such that the interconnect in an unfolded condition extends from the first board in the interior, through the wall at the cutout.

20. The system of claim 17, wherein the electronic component is a coin cell battery', the first board and the second board are folded toward each other across the interconnect in the housing, and the first board or the second board defines a curved edge that maintains constant offset from the coin cell battery.

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