Abstract
A sensor, sensor pad, and sensor array for detecting infrasonic signals in a living organism is provided. The sensor, sensor pad, and/or array can be utilized for detecting, determining, and/or diagnosing level of stenosis, occlusion, or aneurysm in arteries or other similar diagnoses. The sensor can include unique circuitry in the form of a piezoelectric plate or element sandwiched between two conductive O-rings.
Claims
1. A disposable single use acoustic sensor pad for transmitting acoustic signals from a body to a piezoelectric sensor comprising: a flexible circular disk having an upper contacting portion having a forward-facing surface for contacting the body, which extends above a housing, and a bottom portion having a flat surface for contacting a first side of said piezoelectric sensor, said bottom portion connected to said upper contacting portion by a side wall, and a circumferential lip on an outer portion of the flat surface, said circumferential lip being configured for being vertically compressed against the piezoelectric sensor by a securing feature; wherein the forward-facing surface is suitable for contacting the body and the bottom portion is suitable for being positioned onto the piezoelectric sensor, wherein the side wall has a uniform circumference along a height spanning between the circumferential lip to the forward-facing surface.
2. The disposable single use acoustic sensor pad of claim 1 wherein the forward-facing surface for contacting a body comprises a centralized raised semicircular portion that comprises a concave indentation region in the center of the raised semicircular portion.
3. The disposable single use acoustic sensor pad of claim 1 wherein the forward-facing surface for contacting a body comprises a raised contacting surface selected from the group consisting of: a plurality of raised nodules, a plurality of cylinders, a concentric ring, at least two concentric rings, a hemispherical shape, a concave shape, a circular shape, a square shape, a hexagonal shape, an octagonal shape, a dodecahedronic shape, ellipses, an oval, a triangular shape, a star, convex versions of each shape, concave versions of each shape, and combinations thereof.
4. The disposable single use acoustic sensor pad of claim 3 wherein the raised contacting surface comprises a central portion that comprises a concave indentation region in the center of the raised contacting surface.
5. The disposable single use acoustic sensor pad of claim 1 wherein said sensor pad is made of a low durometer value material.
6. The disposable single use acoustic sensor pad of claim 5 wherein the low durometer value material is a substantially silicone material and wherein said sensor pad is formed in a mold from said substantially silicone material thereby creating a homogeneous pad.
7. The disposable single use acoustic sensor pad of claim 1 wherein the forward-facing surface for contacting a body comprises a plurality of raised extensions substantially covering the surface of the forward-facing surface.
8. A sensor pod for sensing acoustic signals comprising: a housing having an interior chamber and a circular opening at one end defined to receive a single use disposable acoustic sensor pad, and a connector at an opposing end of the housing configured for attachment to a support structure for adjustably moving the sensor pod; a piezoelectric sensor in a form of a circular disk having a first side and an opposing second side contained in the interior chamber of the housing and aligned with the circular opening; said single use disposable acoustic sensor pad for transmitting the acoustic signals from a body to the piezoelectric sensor, comprising a flexible circular disk having an upper contacting portion having a circular forward-facing surface for contacting the body, which extends above the housing, and a bottom portion having a flat circular surface for contacting the first side of said piezoelectric sensor, said bottom portion connected to said upper contacting portion by a side wall, and a circumferential lip on an outer portion of the flat circular surface, said circumferential lip being configured for being vertically compressed against the piezoelectric sensor by a securing feature; and wherein the circular forward-facing surface is suitable for contacting the body and the bottom portion is suitable for being positioned onto the piezoelectric sensor, wherein the side wall has a uniform circumference along a height spanning between the circumferential lip and the circular forward-facing surface.
9. The sensor pod of claim 8 wherein the circular forward-facing surface for contacting the body comprises a raised contacting surface selected from the group consisting of: a plurality of raised nodules, a plurality of cylinders, a concentric ring, at least two concentric rings, a hemispherical shape, a circular shape, a square shape, a hexagonal shape, an octagonal shape, a dodecahedronic shape, ellipses, an oval, a triangular shape, a star, convex versions of each shape, concave versions of each shape, and combinations thereof.
10. The sensor pod of claim 9 wherein the raised contacting surface comprises a central portion that comprises a concave indentation region in a center of the raised contacting surface.
11. The sensor pod of claim 8 wherein the flexible circular disk is made of silicone.
12. The sensor pod of claim 8 wherein the flexible circular disk is comprised of silicone and wherein said single use disposable acoustic sensor pad is formed in a mold from said silicone thereby creating a homogeneous pad.
13. The sensor pod of claim 8 wherein the circular forward-facing surface for contacting the body comprises a plurality of raised extensions covering a region of the circular forward-facing surface.
14. The sensor pod of claim 8 wherein said single use disposable acoustic sensor pad is configured to be impedance matched with the body.
15. The sensor pod of claim 8 wherein the bottom portion of the single use disposable acoustic sensor pad comprises a tacky material for sticking to the piezoelectric sensor.
16. A sensor pod for sensing acoustic signals comprising: a housing defining an interior chamber for receiving a sensor and a single use disposable acoustic sensor pad, said housing having a circular opening at one end defined to receive the single use disposable acoustic sensor pad, and a connector at an opposing end of the housing configured for attachment to a support structure for adjustably moving the sensor pod; said sensor defined as a piezoelectric element having a first side and an opposing second side contained in the interior chamber of the housing and aligned with the circular opening at one end; said single use disposable acoustic sensor pad defined for transmitting the acoustic signals from a body to the first side of said piezoelectric element, said single use disposable acoustic sensor pad comprising a flexible gel pad having an upper contacting portion, said upper contacting portion having a circular forward-facing surface for contacting the body, and wherein said upper contacting portion is of a height so as to extend above the housing when positioned in contact with the piezoelectric element, said flexible gel pad further comprising a bottom portion having a flat surface for contacting the first side of said piezoelectric element, said bottom portion connected to said upper contacting portion by a side wall, and a circumferential lip on an outermost circumferential edge of the flat surface, said circumferential lip being configured for being vertically compressed against the first side of said piezoelectric element by a securing feature; and wherein the circular forward-facing surface is of a size and shape to selectably insert into the circular opening at one end, and wherein the single use disposable acoustic sensor pad is suitable for contacting the body and the bottom portion is suitable for being positioned onto the piezoelectric element, wherein the side wall has a uniform circumference along a height spanning between the circumferential lip and the circular forward-facing surface.
17. The sensor pod of claim 16 wherein said connector is defined for selective attachment of the sensor pod; and wherein said sensor pod is disposable and replaceable.
18. The sensor pod of claim 16 wherein said single use disposable acoustic sensor pad is configured to be impedance matched with the body.
19. The sensor pod of claim 16 wherein the single use disposable acoustic sensor pad further comprises a tacky material positioned on said bottom portion for sticking to the piezoelectric element.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0043] To understand the present invention, it will now be described by way of example, with reference to the accompanying figures and attachments in which:
[0044] FIG. 1 is top perspective view of a sensor pad in accordance with the present invention.
[0045] FIG. 2 is a cross-sectional view of a first embodiment of the sensor pad of FIG. 1.
[0046] FIG. 3 is a cross-sectional view of a second embodiment of the sensor pad of FIG. 1.
[0047] FIG. 4 is a cross-sectional view of a prior art sensor pad.
[0048] FIG. 5 is a side view of a sensor or sensor pod in accordance with the present invention.
[0049] FIG. 6 is a perspective view of the contacting portion of the sensor pod of FIG. 5.
[0050] FIG. 7 is a cross-sectional view of the sensor pod of FIG. 5.
[0051] FIG. 8 is an enlarged portion of the cross-sectional view of FIG. 7.
[0052] FIG. 9 is an exploded view of an embodiment of a sensor or sensor pod in accordance with the present invention.
[0053] FIG. 10 is an exploded perspective view of an O-ring-piezoelectric element assembly.
[0054] FIG. 11 is a perspective view of the O-rings and piezoelectric element of FIG. 10 assembled.
[0055] FIG. 12 is a cross-sectional view of a modified O-ring with a piezoelectric element in accordance with a further embodiment of the present invention.
[0056] FIG. 13 is a top plan view of one embodiment of a piezoelectric element in accordance with the present invention.
[0057] FIG. 14 is a top plan view of another embodiment of a piezoelectric element in accordance with the present invention.
[0058] FIG. 15 is a top plan view of another embodiment of a piezoelectric element in accordance with the present invention.
[0059] FIG. 16 is a top plan view of another embodiment of a piezoelectric element in accordance with the present invention.
[0060] FIG. 17 is a top plan view of another embodiment of a piezoelectric element in accordance with the present invention.
[0061] FIG. 18 is a perspective view of a sensor array having three sensors in accordance with apparatuses of the present invention.
[0062] FIG. 19 is a perspective view of the sensor array of FIG. 18 in use.
[0063] FIG. 20 is an exploded view of a sensor array and three sensors in accordance with one embodiment of the present invention.
[0064] FIG. 21 is a top plan view and a cross-sectional view of a mold for forming sensor pads in accordance with an embodiment of the invention.
[0065] FIG. 22 is a perspective view of an alternative sensor array positioned for use on a patient.
[0066] FIG. 23 is a perspective view of another alternative sensor array positioned for use on a patient.
[0067] FIG. 24 is a front perspective view of another alternative sensor array positioned for use on a patient.
[0068] FIG. 25 is a side perspective view of the array of FIG. 24.
[0069] FIG. 26 is a front perspective view of another alternative sensor array positioned for use on a patient.
[0070] FIG. 27 is a side perspective view of the array of FIG. 26.
[0071] FIG. 28 is a front perspective view of another alternative sensor array positioned for use on a patient.
[0072] FIG. 29 is a side perspective view of the array of FIG. 28.
[0073] FIGS. 30A-30X depict six different sensor pads shown from top down (30A-30F), side cutout profile (30G-30L), side profile (30M-30R), and top perspective view (30S-30X).
[0074] FIGS. 31A-31T depict five different sensor pads shown from top down (31A-31E), side cutout profile (31F-31J), side profile (31K-310), and top perspective view (31P-31T).
[0075] FIGS. 32A-32BB depict seven different sensor pads shown from top down (32A-32G), side cutout profile (32H-32N), side profile (320-32U), and top perspective view (32V-32BB).
[0076] FIGS. 33A-33BB depict seven different sensor pads shown from top down (33A-33G), side cutout profile (33H-33N), side profile (330-33U), and top perspective view (33V-33BB).
[0077] FIGS. 34A-34X depict six different sensor pads shown from top down (34A-34F), side cutout profile (34G-34L), side profile (34M-34R), and top perspective view (34S-34X).
[0078] FIGS. 35A-35T depict five different sensor pads shown from top down (35A-35E), side cutout profile (35F-35J), side profile (35K-350), and top perspective view (35P-35T).
[0079] FIGS. 36A-36T depict five different sensor pads shown from top down (36A-36E), side cutout profile (36F-36J), side profile (36K-360), and top perspective view (36P-36T).
[0080] FIGS. 37A-37T depict five different sensor pads shown from top down (37A-37E), side cutout profile (37F-37J), side profile (37K-37O), and top perspective view (37P-37T).
DETAILED DESCRIPTION OF THE INVENTION
[0081] While this invention is susceptible of embodiments in many different forms, there is shown in the figures and will herein be described in detail preferred embodiments of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.
[0082] The present invention provides a sensor, in the form of a sensor pod, for detecting infrasonic acoustic signals created or generated by a living organism, such as signals caused by blood flow through one or more veins or arteries. The invention also includes improved gel packs or pads utilized with the sensor. The pads act as an acoustic coupling mechanism between the sensor and the living organism. The pads are made from materials designed to match a body's impedance to allow acoustic signals to pass efficiently to the sensor. Additionally, the invention includes a sensor array containing one or more sensors. The array is utilized to allow someone (and in some cases the patient) to easily and quickly place and hold the sensors in appropriate locations on the living organism to detect signals generated by the organism. The array is preferably designed to be adjustable to fit living organisms of varying sizes.
[0083] The sensors, pads and arrays of the present invention are useful in detecting signals in the living organism that can be analyzed to determine various medical conditions. As noted above, U.S. Pat. No. 7,621,875 discloses one use for detecting and diagnosing possible stenosis, occlusion, aneurysm or other shape of wall irregularity in certain arteries.
[0084] FIG. 1 shows a sensor pad (10) having a generally circular shape in accordance with the present invention. The sensor pad (10) is design to contact a body of a living organism at a desired location and transmit acoustic signals from the body to a piezoelectric plate of a sensor (discussed in more detail below). The pad (10) is designed to match the impedance of the body to enable efficient transfer of signals (while it is contemplated that the disclosed sensors, pads and arrays could be used, either separately or in combination, with many types of living organisms, and possibly inanimate objects, the use of these components will be predominately described with respect to detection of signals generated by a human body). Such impedance matching reduces reflection of any sound waves and facilitates maximum signal transfer to the sensor.
[0085] Referring also to the cross section of FIG. 2, one embodiment of the sensor pad (10) is in the form of a flexible, soft bag filled with a gel or liquid. The bag is formed from a first, circular flat sheet or layer (12) of vinyl forming a bottom wall, and a second, outer sheet or layer (14) of vinyl forming a body contacting portion. A silicone-based fluid or gel (16) is contained between the two layers (12, 14). The pad (10) includes a lip (18) which is formed from a portion of the first, flat layer (12) extending radially outward from a location where the outer layer (14) contacts the flat layer (12). The lip (18) extends circumferentially around the pad (10).
[0086] The outer layer (14) includes a side wall (20) that extends upward from the flat layer (14) to a rim (22) (directional terms such as “upward” are used herein to help describe features of the components as shown in the drawings and are not meant to limit the invention, many of the components will be used in multiple orientations). The top portion of the outer layer (14) includes an outwardly concave indentation or dimple (24).
[0087] The outer sheet (14) initially starts as a flat sheet of material that is vacuum formed into a mold (134) having the desired outer shape of the pad (10) (see FIG. 21 for a top plan view and a cross-sectional view of a plurality of molds [134] for forming the pad [10]). The silicone gel or liquid (16) is then added, and the flat layer (12) is positioned over the outer layer (14) and gel/liquid (16). The flat layer (12) is then vacuum sealed to the outer layer (14). This process causes the outer layer (14) to slightly melt into the flat layer (14) where they contact each other.
[0088] In use, the flat layer (12) of the pad (10) is positioned against the outer surface of the piezoelectric plate or element of the sensor (again, discussed in more detail below). Portions of the outer layer (14) are used to contact the body to sense acoustic signals.
[0089] A prior, bag-type sensor pad (FIG. 30 from U.S. Pat. No. 5,853,005) is shown in cross section in FIG. 4. The reference numbers provided in FIG. 4 were the ones designated in U.S. Pat. No. 5,853,005 and are not related to the reference numbers used to describe the present inventions. As shown, the prior pad (designated as [186]) includes a domed, outwardly convex outer surface, which is used to contact a portion of the body. Upon such contact, when the outer surface of this prior pad meets resistance from the body the domed shape compresses, forcing fluid or gel in the bag back into the flat base surface on the bottom of the pad. This, in turn, causes the flat surface to distort (i.e., bend outward) and press into the sensor. The distortion of the flat surface results in an undesired acoustic spike or noise by the sensor.
[0090] In contrast to the prior art pads, the present pad (10) includes the concave indentation or dimple (24). Upon contact with a body, gel or liquid is dispersed evenly into the dimple region allowing the flat layer (12) to remain flat and not distort under typical use.
[0091] While a centrally located indentation or dimple (24) is shown in the figures, the pad (10) could have alternative configurations that create the same benefits. For example, the pad (10) could include additional dimples, or could have a plurality of smaller dimples rather than the large central dimple. Additionally, the dimples or indentations could be formed in different locations, such as in the side wall (20) of the outer layer (14).
[0092] A second embodiment of the pad (10) is shown in cross section in FIG. 3. This pad includes a flat, bottom surface (26), and an upper contacting surface (28). A rim (30) can extend around the outer contacting surface proximate the flat, bottom surface (26).
[0093] The second pad embodiment has generally the same (or substantially similar) outer shape as the fluid filled, bag-type sensor pad shown in FIG. 2. However, in this embodiment, the pad (10) is completely formed from a partially solidified gel or liquid, such as silicone. Such solidified gel or liquid provides for a substantially or completely homogeneous material for impedance matching. Accordingly, the sensor pad (10) of FIG. 3 is of one-piece construction. Notwithstanding this, the pad operates in a similar manner as the bag-type embodiment. That is, material in the pad moves or fills in the indentation or dimple region upon contact with a body rather than distorting the bottom flat surface (i.e., the sensor contacting surface).
[0094] Preferably, the sensor pad (10) has a “tacky” bottom surface, allowing it to stick to the piezoelectric element of the sensor in use. Because the tacky surface allows the pad to stick to the sensor, it may not be necessary to provide the lip (30) in this embodiment.
[0095] The pad of FIG. 3 can be formed from a single partially solidified material. Alternatively, it may be possible to use more than one partially solidified material to form the pad. The materials could be combined or formed in layers or other similar arrangements.
[0096] In both embodiments, the pads are designed to be very soft, having a low durometer value (e.g., in the range of 1-2 durometers). While soft silicone and vinyl materials are suitable for forming the pads (as discussed above), other similar (low durometer) materials may also be used.
[0097] The sensor pads (10) are preferably used as part of a sensor or sensor pod (32) shown in FIGS. 5-8. As illustrated in FIG. 5, the sensor pod (32) includes a housing having a first upper housing portion (34) and a second lower housing portion (36) connected to the first housing portion (34) (again, terms such as “upper” and “lower” are used with reference to certain figures and are not meant to limit the sensor pod to any particular orientations). The housing portions (34, 36) can be of single piece construction or can include multiple components or pieces.
[0098] A swivel connector (38) is connected to or integrally formed as part of the second housing portion (34). The swivel connector (38) is used to connect the sensor pod (32) to a sensor array and allows the sensor pod to pivot to an appropriate position in use. The housing portions (34, 36) can be formed from an injection molded plastic.
[0099] Referring also to FIGS. 7 and 8, the flat surface of the sensor pad (10) is placed in contact with a piezoelectric element (40). The contacting surface or portion of the sensor pad (10) extends above or outward from the first housing portion (34) and can be placed in contact with a body. The pad (10) acts as an acoustic coupling mechanism and relays acoustic signals sensed in the body to the piezoelectric element (40).
[0100] The piezoelectric element (40) is in the form of a circular metal plate having a ceramic coating on a first or upper side of the plate, however other piezo-type materials can be utilized. The piezoelectric element (40) is supported between a first or upper O-ring (42) and a second or lower O-ring (44). The O-rings (42, 44) are formed from a metalized rubber and are used to conduct electrical signals generated by the piezoelectric element (40) in response to infrasonic acoustic signals from the body. The O-rings (42, 44) replace direct contact wires that were typically soldered to portions of the plate.
[0101] The arrangement of the O-rings (42, 44) about the piezoelectric element (40) allows the piezoelectric element (40) to more freely vibrate and bend in response to sensed acoustic signals than it would have if direct contact wires were utilized. In this regard, the O-rings (42, 44) do not rigidly hold the piezoelectric element (40). The first O-ring is designed to abut or contact only the piezoelectric material on the first side of the metal plate. Accordingly, the radius of the O-ring should be chosen to with the radius and pattern of the coating material in mind. Additional aspects of the piezoelectric element (40) and O-rings (42, 44) are discussed in more detail below with respect to FIGS. 12-17.
[0102] The first housing portion (34) presents a circular face (46) with a central opening (48). As mentioned, an upper contacting portion of the pad (10) extends outward from the sensor pod (32) through the central opening (48) in the first housing portion (34). The first housing portion (34) further includes an inwardly directed, circumferential segment (50) extending from the face (46) toward the piezoelectric element (40). The inwardly directed segment (50) can be sized to extend over the lip (18) of the pad (10) to secure the pad (10) to the sensor pod (32). Again, if the pad (10) has a tacky bottom wall it may not be necessary to include the lip (18) in order to maintain the pad (10) in position on the sensor pod (32).
[0103] The first housing portion (34) also includes a circumferential outer side wall (52) which can be clipped, screwed, or otherwise attached to the second housing portion (36). The combined housing portions (34, 36) form a chamber for holding the piezoelectric element (40) and pad (10). The chamber also contains an amplifier board having an amplifier circuit for amplifying the signals generated by the piezoelectric element (40) and transmitting them to a computer (or other similar device) for analysis and/or display. In order to shield the amplifier board from noise and other stray signals, the housing portions (34, 36) are provided with a metal surface which, when combined with the metal plate of the piezoelectric element (40), form a Faraday cage around the amplifier board and any other circuitry positioned in the chamber.
[0104] Referring to FIG. 8, the first housing portion (34) includes a first conductive contact element (54) which is positioned to be in contact with the first O-ring (42). The second housing portion (44) similarly includes a second conductive contact element (56) in contact with the second O-ring (44). The conductive elements (54, 56) relay the signals to the amplifier board which in turn passes the amplified signal, preferably via shielded cable, to the computer. The first and second conductive contact elements (54, 56) can be in the form of metal rings secured in appropriate positions in the respective housing portions. One or both of the conductive contact elements can be spring loaded to maintain proper contact with the corresponding O-ring.
[0105] FIG. 9 discloses an exploded view of one embodiment of the sensor pod (32).
[0106] Starting at the top, the sensor pod (32) of FIGS. 5 and 6 includes a pad (10) followed by an outer portion (58) of the upper housing portion (34) and an inner portion (60) of the upper housing portion (34). Below the inner portion (60) is the first conductive contact element (54), followed by the upper O-ring (42), the piezoelectric element (40) and the lower O-ring (44). Two screws (62) are aligned with holes in a PCB assembly (64) positioned below the lower O-ring (44). An inner portion (66) of the lower housing portion (36) and an outer portion (68) of the lower housing portion (36) follow, with the swivel ball or connector (38) at the lowest point.
[0107] FIG. 10 discloses an exploded view of one embodiment of the O-rings (42, 44) and piezoelectric element (40), and FIG. 11 shows these components in an assembled state. The O-rings and piezoelectric element form an assembly that freely holds the piezoelectric element for optimal transmission of the sensed acoustic signals (this assembly formation, using O-rings, can also be utilized with other piezo-type devices and is not necessarily limited to the sensors and uses described with respect to the preferred embodiments herein). In this assembly, the upper O-ring (42) is the positive conductive element and the lower O-ring (44) is the negative or ground conductive element.
[0108] In accordance with a further embodiment of the invention, one or both of the O-rings can be modified to include structure to more effectively maintain the piezoelectric element (40). As shown in cross section in FIG. 12, the second O-ring (44) is provided with a circumferential channel or groove (70). The radius of the O-ring is set so that the edges of the piezoelectric element (40) sit in the channel (70).
[0109] Another key to optimal transmission of the sensed acoustic signals is for the O-ring-piezoelectric element assembly to be balanced. When wires are soldered to the piezoelectric element (in instances where O-rings are not used), the element is not necessarily balanced which can impair the acoustic signal.
[0110] Balancing of the piezoelectric element (40) is further enhanced by the pattern of the ceramic or other piezo-type material used. As shown in FIGS. 13-17 piezoelectric element (40) is provided with a centrally located region of ceramic coating (72) surrounded by two or more distinct (i.e., separate) sections (74) devoid of the ceramic material. Each section is defined by a spoke or segment (76) of material on either side extending radially from the centrally located region to a rim or edge of the metal plate of the piezoelectric element (40).
[0111] As shown in FIG. 13, a thin ring (78) of ceramic material can be provided at the edge. The ring (78) is connected to the central region of ceramic coating (72) by the segments (76). A ring (80) of the metal plate extends radially outward from the ring of ceramic material (78). The O-ring (42) is sized to abut the ring of ceramic material (78) without contacting the metal plate.
[0112] FIG. 13 shows twelve sections (74) devoid of ceramic material. FIG. 14 shows a pattern with three sections (74) devoid of ceramic material. In the embodiment of FIG. 14, the radially extending segments (76) are thicker than the segments used in the embodiment of FIG. 16 or 17.
[0113] FIG. 15 shows an alternative pattern having three sections (74) devoid of material. In this pattern, the radially extending segments (76) have a curved and flared appearance.
[0114] FIGS. 16 and 17 shows a piezoelectric element having a ceramic pattern with two sections and four sections (74) devoid of material, respectively. While certain patterns are shown in FIGS. 13-17, other potential patterns could be used.
[0115] The sensors or sensor pods (32), along with the sensor pads (10), are preferably used with an array that holds one or more sensor pods (32) in a structure designed to allow for fast and easy placement of the sensor pods (32) at the proper locations of the body. The array structure is designed based on the type of analysis being performed, the number of sensors needed and the approximate location of sensed signals on the body.
[0116] FIGS. 18 and 19 disclose a sensor array (90) for holding three sensor pods (32). The array (90) includes a generally cylindrical base portion (92) connected to a first sensor pod (32). A first arm (94) connected to a second sensor pod (32) and a second arm (96) connected to a third sensor pod (32) extend upward from an end of the base portion (92).
[0117] As shown in FIG. 19, the sensor array is designed to position the first sensor pod (32) over a patient's heart, and to locate the second and third sensor pods (32) proximate the carotid arteries in the patient's neck. Sensed infrasonic signals from these locations can be analyzed to detect potential occlusions. An example of a process for making such an analysis is disclosed in U.S. Pat. No. 7,621,875.
[0118] To facilitate proper placement, the first and second arms (94, 96) are designed to be able to twist and flex outward or inward relative to each other and the base portion (92). Additionally, the sensor pods (32) are preferably connected to the array (90) via the swivel ball connector (38) discussed herein. This allows the pods (32) to rotate about the connector and be moved and positioned in the proper sensing locations.
[0119] The base portion (92) of the array (90) can be sized or otherwise configured to function as a handle for the array (90). Alternatively, a separate handle structure can be connected to the array (90). The handle allows one (either the patient or someone else, such as a medical technician) to easily grasp the array and hold all three sensors in the proper positions with one hand. Straps are not needed to attach the sensor pods to the body.
[0120] The base portion (92) and/or the first arm (94) and/or the second arm (96), can be configured to be extendable (e.g., such as by having telescoping components) to enable one to adjust the size of the array (90). With the extension features and/or the other adjustable features described the array (90) can be used for a large variation in body sizes and shapes.
[0121] The array (90) can be made of plastic or other similar materials. The components (i.e., base portion [92], first arm [94] and second arm [96]) of the array (90) are hollow to allow a path for one or more wires or shielded cables to connect to the sensor pods (32) to transmit sensed signals from the pods (32) to a computer or other device for analysis and/or display.
[0122] As shown in FIG. 19, the array (90) disclosed is specifically sized and configured to position three sensors on a body for proper sensing of the carotid arteries. However, the structure of the array can be modified for sensing other arteries or veins, or other physiological aspects of a living organism. More or fewer sensors can be used as needed for such structures.
[0123] FIG. 20 provides an exploded view of a three-sensor array (100) with an embodiment of a sensor pod (102) that can be easily replaceable. The array (100) includes a base portion (104) having a first arm (106) and a second arm (108) extending from the top of the base portion (104). As shown, the features of the array (100) include a first side frame structure (110) and an overmold (112). A second side frame structure is broken into two pieces, a second side base portion (114) and an overmold base portion (116), and a second side arm portion (118) and second side overmold portion (120). An extendable tongue (122) is maintained in the base portion (104) between the first side frame structure and second side frame structure. A circular knob (124) is positioned at the juncture of the first and second arms (106, 108) with the base portion (104). Twisting of the knob (124) causes the arms (106, 108) to flex outward or inward, and holds the arms in the flexed position.
[0124] A connector element (126) is positioned at the distal ends of the first and second arms (106, 108), and in the base portion (104). The connector is configured to receive a swivel ball connector (128) on the sensor pod (102). Other connection elements can be used. Also, it is possible for the connection elements to be reversed (place the swivel ball on the array and the receiving structure on the pod).
[0125] The swivel ball (128) of the sensor pod (102) is formed in a plurality of segments (129) that can flex relative to each other. This allows the swivel ball (128) to snap fit into the connector element (126) at the base of the pod (102). This enables one to easily remove and replace a new sensor pod when necessary. It is anticipated that a new sensor pod will be needed after every 50,100 uses. New pads are used after each use.
[0126] As is evident in FIG. 20, the array (100) has an essentially hollow construction. This enables shielded cables to connect to the sensor pods and travel to central cable (130) plugged into the bottom of the base portion (104).
[0127] FIG. 22 illustrates another embodiment of an array structure (150) for positioning three sensor pods (152). The array (150) includes a handle or base portion (154) having a first arm (156) extending from the handle (154). A second arm (158) is connected to the first arm (156) proximate the handle (154) by a rotatable connector (160).
[0128] A first sensor pod (152) is connected to the first arm (156) by a connector (162). Similarly, a second sensor pod (152) is connected to the second arm by a connector (164). The connectors (162, 164) are mounted to the respective arms (156, 158) and (as indicated by the arrows) are configured to be slideable up and down the arms and to be able to rotate about the arms in order to position the pods (152) in the appropriate positions.
[0129] A third sensor pod (152) is connected to the second arm (158) at the juncture where the second arm is connected to the first arm (156). A cable (166) is plugged into an end of the handle (154) for transmitting sensed signals to a computing and/or display device.
[0130] FIG. 23 illustrates yet another array structure (168) for holding three sensor pods (152) (to sense signals from the femoral arteries). The array (168) includes a handle (170) and a single arm (172) extending upward from the handle (170). A first sensor pod (152) is connected at a distal end of the arm (172) (from the handle [170]) by a connector (173) similar to the connectors of FIG. 22. A double connector (174) is used to connect two sensor pods (152) proximate the handle (170). While the handle is shown below the double sensor connector (174), a patient or medical technician can grasp a midsection of the arm (172) to keep the sensors in place during testing.
[0131] FIGS. 24 and 25 disclose another embodiment of an array structure (180) having a base portion (182) and a first arm (184) and a second arm (186) extending outward from an end of the base portion (182). The base portion (182) includes a tongue (188) that is slideable within an upper portion of the base portion (182). The tongue (188) allows for extension of the base portion (182) to accommodate patients of varying sizes.
[0132] FIGS. 26 and 27 disclose yet another array structure (190) having a base portion (192) and a first arm (194) and a second arm (196) extending outward from an end of the base portion (192). The base portion (192) also includes a tongue (198) slidably engaging the base portion (192). However, unlike the embodiment of FIGS. 24 and 25, the tongue (198) utilizes a sliding mechanism wherein the tongue (198) is not contained completely within the base portion (192).
[0133] As shown in FIG. 26, a generally curvilinear cutout portion (200) is provided at the juncture where the arms (194, 196) connect to the base portion (192). This may provide additional flexibility allowing for easier adjustment of the arms.
[0134] FIGS. 28 and 29 disclose a further embodiment of an array structure (202) having a base portion (204) and a first arm (206) and a second arm (208) extending outward from an end of the base portion (204). The base portion (204) includes a tongue (210) that is slideable within an upper portion of the base portion (204). Notably, the arms (206, 208) have a greater degree of curvature than other embodiments shown in the figures.
[0135] Each arm (206, 208) includes a hook segment (212) or other similar connector extending outward from the arm. The hook segment (212) is provided for connection to a necklace attachment (214) made from a soft thermoplastic rubber or other similar or suitable material. The necklace attachment includes a plurality of spaced apart beads (216) (e.g., approximately 0.8 inches apart) that can be used to adjustably hold the array in place as shown. In place of the beads (216), other configurations (e.g., loops) can be used to adjust the necklace.
[0136] FIGS. 30A-30X depict six different embodiments of a sensor pad, as shown from a top profile, side cutout profile, side profile, and a top perspective view. Each of the six designs is shown in each of the four different views along a row. All drawings in a column are oriented the same. FIGS. 30A, 30G, 30M, and 30S depict a sensor pad having a semicircular groove wherein the concave side (402) opens to the rear side (403) and the convex side (401) of the groove is on the top side (404). Depicted on the top side (404) of the pad are a plurality of extension nodules (301). The rear portion of the pad, therefore, would contact the piezoelectric sensor and the top side would be open to the air for contacting another surface, such as a patient. The top view in FIGS. 30A-30F depicts some of the features of each of the embodiments, wherein the second column (FIGS. 30G-30L) depict the side cutout profile, to depict the size and length of raised or recessed features, and the grooves around the circumference. The side profile in the next column (FIGS. 30S-30X) shows the relative height of the various features as compared to the circumferential groove, and the perspective views (FIGS. 30S-30X) depict the embodiments and show additional detail of the raised and recessed portions of the sensor pads.
[0137] FIGS. 30B, 30H, 30N, and 30T depict a further sensor pad embodiment comprising a central extension ring (304) and two further extension rings (303 and 302) that protrude slightly on the top side (404) of the sensor pad. Similarly, FIGS. 30C, 30I, 300, and 30U depict a sensor pad having a single extension ring (305) and an opening, in place of the extension rings (304 and 303) from the prior embodiment.
[0138] FIGS. 30D, 30J, 30P, and 30V depict a further sensor pad embodiment comprising a single raised feature (306) having a filled in central portion (307) that is slightly concave, as depicted in 30J. In comparison FIGS. 30E, 30K, 30Q, and 30W depict a single raised feature (306) and a central portion (308) that is slightly convex as depicted in FIG. 30K. Then FIGS. 30F, 30L, 30R, and 30X depict a single raised feature (306) and a central portion (309) that is flat, as depicted in FIG. 30L.
[0139] FIGS. 31A-31T depict five embodiments (one in each row starting with FIGS. 31A and 31B) depicting a top plan view, a side cutout profile, a side profile, and a perspective view. All drawings in a column are oriented the same. FIGS. 31A, 30F, 31K, and 31P depict a sensor pad embodiment having a central raised conical like feature (310). Similarly, FIGS. 31B, 31G, 31L, and 31Q depict a sensor pad embodiment having a single raised spherical component (311), wherein the spherical component (311) extends to just about the interior edge of the concave portion of the groove (401). FIGS. 31C, 31H 31M, and 31R, by contrast, depict a similar spherical like component (313) but having a larger void space (312) between the edge of the spherical component (313) and the interior edge of the concave portion of the groove (401).
[0140] FIGS. 31D, 31I, 31N, and 31S, depicts an embodiment having three pie shaped features (314), each taking up about 120° of the circular shaped sensor pad. In comparison, FIGS. 31E, 31J, 310, and 31T depict an embodiment having four pie shaped features (315), wherein each pie is about 90°, instead of about 120°.
[0141] FIGS. 32A-32BB depict seven embodiments of a sensor pad wherein each of four views of a single embodiment are depicted along a row. All drawings in a column are oriented the same. In comparison to the embodiments in FIGS. 30 and 31, those in FIG. 32 do not contain a semicircular groove around the circumference of the sensor pad. FIGS. 32A, 32H, 320, and 32V depict four 90° pie shaped features (316). FIGS. 32B, 32I, 32P, and 32W depict a plurality of raised nodules (317). FIGS. 32C, 32J, 32Q, and 32X depict three concentric rings (320, 319, and 318). FIGS. 32D, 32K, 32R, and 32Y depict a single ring (321) and an empty space in place of rings (320 and 319) from the prior embodiment.
[0142] FIGS. 32E, 32L, 32S, and 32Z depict a single raised feature (322) having a filled in central portion (323) that is slightly concave, as depicted in 30L. In comparison FIGS. 32F, 32M, 32T, and 32AA depict a single raised feature (322) and a central portion (324) that is slightly convex as depicted in FIG. 30M. Then FIGS. 32G, 32N, 32U, and 32BB depict a single raised feature (322) and a central portion (325) that is flat, as depicted in FIG. 32N.
[0143] FIGS. 33A-33BB also depict seven embodiments, and four views of each of the seven embodiments along a row. All drawings in a column are oriented the same. FIGS. 33A, 33H, 330, and 33V depict a single ring (321) and disposed of inside the single ring (321) is a small spherical component (326). FIGS. 33B, 33I, 33P, and 33W depict a sensor pad having an angled face (327). FIGS. 33C, 33J, 33Q, and 33X depict a sensor pad having a top face (328) and curving to a bottom face (330) with an inflection point (329) disposed of along the curved face. FIGS. 33D, 33K, 33R, and 33Y, like FIG. 33B, has an angled face, but the face of the angled component (331) is bulbous, instead of flat like feature (327).
[0144] FIGS. 33E, 33L, 33S, and 33Z depict an embodiment having a raised rim (332) and extending centrally out from the edge and containing a central angular peaked tip (333). FIGS. 33F, 33M, 33T, and 33AA depict a raised edge extending centrally out from the edge to a point 334. FIGS. 33G, 33N, 33U, and 33BB depict a sensor pad having three pie shaped components (335), each taking up about 120° of a circle, wherein the pie shaped components (335) are raised and having a space between each component.
[0145] FIGS. 34A-34X depict six sensor pad embodiments and four views of each of the six embodiments along a row. All drawings in a column are oriented the same, and features (406 and 405), can be referred to generally as the top side and bottom side, when looking at side profiles. FIGS. 34A, 34G, 34M, and 34S depict a single donut or ring-shaped pad, having a flat bottom surface and rounded top surface. FIGS. 34B, 34H, 34N, and 34T depict an ellipsis shaped sensor pad (337), with the top surface (406) being rounded (338) and the bottom surface (405) being flat. FIGS. 34C, 34I, 34O, and 34U depict an embodiment having a circular shape with the top surface being rounded and the bottom surface flat. FIGS. 34D, 34J, 34P, and 34V depict an embodiment having a dodecahedron shape (339) and having three rows of facets that converge and taper to a point at the center of the pad. FIGS. 34E, 34K, 34Q and 34W depict a semicircular shaped pad (340) having a hollow center as depicted in FIG. 34K. FIGS. 34F, 34L, 34R, and 34X, depicts a semicircular shaped pad (341), but does not have a hollow center like the prior embodiment in 34K.
[0146] FIGS. 35A-35T depict five embodiments of sensor pads depicted in four views of each of the five embodiments along a row. All drawings in a column are oriented the same. FIGS. 35A, 35F, 35K, and 35P depict a hexagonal shaped pad (342) having a slightly rounded top and a flat bottom. FIGS. 35N, 35G, 35L, and 35Q depict a triangular shaped pad (343), having a slightly rounded sides, a slightly rounded top (406), and flat bottom (405). FIGS. 35C, 35H, 35M, and 35R, by comparison, also depicts a triangular shaped pad (344), but wherein the sides are straight and not rounded. FIGS. 35D, 35I, 35N, and 35S depicts a square shaped pad (345), having slightly rounded sides and top, whereas FIGS. 35E, 35J, 350, and 35T depict a square shaped pad (346) having straight sides.
[0147] FIGS. 36A-36T depict five embodiments of sensor pads depicted in four views of each of the five embodiments along a row. All drawings in a column are oriented the same. FIGS. 36A, 36F, 36K, and 36P depict a six-pronged star shaped feature (347), with each prong opposing another prong, and the angle between each prong being about 60°. The prongs have a slightly rounded top and the base on the pad is a flat bottom. FIGS. 36B, 36G, 36L, and 36Q depict a crescent shaped pad (348) having a slightly rounded top (406) and a flat bottom (405). FIGS. 36C, 36H, 36M, and 36R depict an oval or stadium shaped pad (349) having rounded ends and flat sides to the oval shape. The top is slightly rounded and the bottom is flat. FIGS. 36D, 36I, 36N, and 36S depict an ellipsis shaped pad (350) having a slightly rounded top and a flat bottom. FIGS. 36E, 36J, 360, and 36T depict a hexagonal shaped pad (351), having slightly rounded sides and a slightly rounded top with a flat base.
[0148] FIGS. 37A-37T depict five embodiments of sensor pads depicted in four views of each of the five embodiments along a row. All drawings in a column are oriented the same. FIGS. 37A, 37F, 37K, and 37P depict a caterpillar shaped feature having three rounded components (352, 353, and 354), connecting to a larger rounded feature (355) with the four combined in a crescent-like shape, wherein the tops are slightly rounded, and the bottom flat. FIGS. 37B, 37G, 37L, and 37Q depict a “pawprint” shaped feature situated on a circular flat disk, having three setoff “toes” (356) that are cylindrical in shape, and a single semicircular pad (357) wherein each of the top sides are slightly rounded and the bottom is flat. FIGS. 37C, 37H, 37M, and 37F depict a rounded circular disk base having a larger (359) raised, circular, angular feature, and smaller, raised, circular, angled feature, wherein the peak of the features is adjacent and sloping away from one another. FIGS. 37D, 37I, 37N, and 37S depict six oval shaped raised features (360) on a rounded circular disk base, wherein the six oval shaped raised features (360) are arranged in a pinwheel-like orientation leaving a central space. FIGS. 37E, 37J, 37O, and 37T depict a six-pronged star shape (361), having an angled taper, such that the central point (362) is higher than the edge of the arms.
[0149] In certain preferred embodiments, the sensor pads can be secured onto the piezoelectric unit via an adhesive, such as one of several common low tack adhesives for providing for a temporary securing of the sensor pad to the piezo element. Other embodiments may utilize a gel or other water or solvent based material that may secure the sensor pads without the need for an additional adhesive material. In further embodiments, the sensor pad fits into the sensor pod and secures onto the piezo without the need for any adhesive.
[0150] A particular feature of the sensor pads described in the embodiments herein is the fact that the top face shape (that contacts the patient), and the bottom face shape (that contacts the piezo) are made so that when the top face contacts the patient and thus applies pressure to the sensor pad and through to the bottom face, the shape of both the top face and the bottom face are designed so that the piezo does not flex when pressure is applied to the sensor pad. This is important to ensuring consistency and accuracy of the piezo device. Therefore, the sensor pad, in certain embodiments is designed such that the piezo does not flex when pressure is applied to the sensor pad. In a further preferred embodiment, the piezo flexes less than about 0.1%, 0.5%, 1.0%, 5.0%, 20%, and 25%, and all percentages in between. Accordingly, in certain embodiments, the amount of flex is greater than zero (i.e., rigid and does not flex), but the amount of flex is minimized to maintain accuracy of the piezoelectric unit.
[0151] It is also preferred that the sensor pads create a proper impedance matching with a patient. Accordingly, the sensor pad is designed to have a slight tackiness which ensures a proper impedance matching with the patient, which then successfully transfers sounds through to the piezo element so that the piezo can properly detect vibrations and noise signals from the patient.
[0152] While a touch panel PC is a preferred computing unit, any computer or computing system capable of running and displaying the processes described herein can be utilized with the components discussed. Additionally, both wired and/or wireless technology may be utilized with certain of the components of the system. Other components may require a shielded cable to avoid interference in the signal being transmitted. Many modifications and variations of the present invention are possible in light of the above teachings.
