SYSTEM, DEVICE AND GARMENT FOR DELIVERING TRANSCUTANEOUS ELECTRICAL STIMULATION

Abstract

An electrode connector assembly for the use in transcutaneous electrical stimulation includes a flexible web extending in a plane and first, second, third and fourth electrode connectors carried by the web and spaced from each other about the web in the plane. The electrode connector assembly further includes an electrical connector and first, second, third and fourth conductors electrically coupling the respective first, second, third and fourth electrode connectors to the electrical connector.

Claims

1-60. (canceled)

61. A method of providing interferential transcutaneous electrical stimulation, the method comprising: positioning a first flexible web comprising a first plurality of electrodes at a lumbar area of a user; positioning a second flexible web comprising a second plurality of electrodes at a lower abdominal area of the user; and providing transcutaneous electrical stimulation to the first and second plurality of electrodes to create at least first and second electrical currents between the lumbar area and the lower abdominal area of the user, wherein the at least first and second electrical currents cross to create interferential transcutaneous electrical stimulation between the lower abdominal area and the lumbar area of the user.

62. The electrical stimulation method of claim 61, wherein providing transcutaneous electrical stimulation comprises providing the transcutaneous electrical stimulation to a first and second plurality of electrode connectors.

63. The electrical stimulation method of claim 62, wherein the first and second plurality of electrode connectors each comprises first, second, third and fourth electrode connectors.

64. The electrical stimulation method of claim 62, wherein each of the first and second flexible webs has a quadrilateral shape to define respective vertices, and wherein the first and second plurality of electrode connectors each comprise first, second, third and fourth electrode connectors positioned at the respective vertices.

65. The electrical stimulation method of claim 61, wherein positioning a first flexible web comprises putting a front portion of a wearable belt on the user, and positioning a second flexible web comprises putting a back portion of the wearable belt on the user.

66. The electrical stimulation method of claim 61, wherein the first and second flexible web each has a first face that is generally planar and an opposite second face.

67. The electrical stimulation method of claim 61, additionally comprising: supporting first and second conductors via respective first and second conductor support structures; and encasing at least part of each of the respective first and second conductors and at least partially encasing the respective first and second conductor support structures via a respective encasing material.

68. The electrical stimulation method of claim 67, additionally comprising coupling the first and second conductors to respective first and second electrical connectors.

69. The electrical stimulation method of claim 68, additionally comprising electrically coupling the first and second electrical connectors via a four-pole jack or a four pin port to a stimulation generation device.

70. The electrical stimulation method of claim 67, wherein at least one conductor of each of the first and second conductors passes through the respective conductor support structure.

71. A method of providing interferential transcutaneous electrical stimulation to a user, the method comprising: electrically coupling a first plurality of electrode connectors to respective mating connectors of a first electrode connector assembly of a wearable garment; electrically coupling a second plurality of electrode connectors to respective mating connectors of a second electrode connector assembly of the wearable garment; coupling together a first part of the wearable garment and a second part of the wearable garment such that the first plurality of electrode connectors are positioned at a lumbar area of the user and the second plurality of electrode connectors are positioned at a lower abdominal area of the user; and receiving electrical stimulation signals at the first and second electrode connectors to create first and second electrical currents between the first and second plurality of electrode connectors, wherein the first and second electrical currents cross to create interferential transcutaneous electrical stimulation between the lower abdominal area and the lumbar area.

72. The method of claim 71, further comprising receiving the first electrode connector assembly via an opening of a first pocket of the wearable garment.

73. The method of claim 71, further comprising receiving a stimulation generation device in a pocket of the wearable garment.

74. The method of claim 72, further comprising securing an electrical connector of the first electrode connector assembly with a first side pocket of the first pocket.

75. The method of claim 72, further comprising receiving the second electrode connector assembly via an opening of a second pocket of the wearable garment.

76. The method of claim 74, further comprising securing an electrical connector of the second electrode connector assembly with a second side pocket of the second pocket.

77. An electrical stimulation system for use in transcutaneous electrical stimulation, the system comprising: a first web configured to carry a first plurality of electrode connectors for positioning at a lumbar area of a user; and a second web configured to carry a second plurality of electrode connectors for positioning at an abdominal area of the user, wherein providing transcutaneous electrical stimulation to the first and second plurality of electrode connectors with the first web positioned at the lumbar area and the second web positioned at the lower abdominal area creates first and second electrical currents between the first and second plurality of electrode connectors that cross to create interferential transcutaneous electrical stimulation between the lower abdominal area and the lumbar area of the user.

78. The system of claim 77, wherein the first and second webs are flexible.

79. The system of claim 77, further comprising an electrical stimulation generation device configured to electrically couple with and provide the transcutaneous electrical stimulation to the first and second plurality of electrode connectors.

80. The system of claim 77, further comprising a wearable garment to carry the first and second webs.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Embodiments are described in further detail below, by way of example, with reference to the accompanying drawings, in which:

[0044] FIG. 1 is a schematic diagram of a transcutaneous electrical stimulation system;

[0045] FIG. 2 is an illustration of a garment usable as part of the system of FIG. 1, showing the garment in a fully open position;

[0046] FIG. 3 is an illustration of the garment of FIG. 2, shown in a position ready to be affixed to a patient;

[0047] FIG. 4 is an illustration of the garment, showing the garment in a closed position in which it can be worn by the patient;

[0048] FIGS. 5A, 5B and 5C are front, side and rear views of a pocket to be worn with the garment and to carry a stimulation device;

[0049] FIG. 6A is an illustration of one side of a first part of the garment;

[0050] FIG. 6B is an illustration of an opposite side of the first part of the garment;

[0051] FIG. 7A is an illustration of one side of a second part of the garment;

[0052] FIG. 7B is an illustration of an opposite side of the second part of the garment;

[0053] FIG. 8A is a perspective view showing an underside of an electrode connector assembly according to some embodiments;

[0054] FIG. 8B is a perspective view of an upper side of the electrode connector assembly;

[0055] FIG. 9 is a schematic illustration of a support frame used to support conductors in the electrode connector assembly;

[0056] FIG. 10 is a schematic illustration of a substrate or flexible web of the electrode connector assembly;

[0057] FIG. 11 is a schematic illustration of the substrate or flexible web, showing the location and position of the frame within the web;

[0058] FIG. 12A is an illustration of a connector jack at one end of the electrode connector assembly;

[0059] FIG. 12B is a perspective view of the connector jack of FIG. 12A;

[0060] FIG. 13A is a top view of a connector plug at one end of the electrode connector assembly;

[0061] FIG. 13B is a side view of the connector plug of FIG. 13A; and

[0062] FIG. 14 is a side view of a stimulation generation device of the transcutaneous electrical stimulation system of FIG. 1 comprising a socket configured to cooperate with the connector plug of FIGS. 13A and 13B.

DETAILED DESCRIPTION

[0063] Described embodiments generally relate to systems, devices, assemblies and garments for delivering transcutaneous electrical stimulation. Such embodiments may be employed to deliver electrical stimulation in the treatment of a waste evacuation dysfunction, for example.

[0064] As noted in the background above, WO 2012/116407 is concerned with delivering transcutaneous electrical stimulation to a patient and discusses the fixing of electrodes to lumbar and/or lower front abdominal areas of patients on regions. However, WO 2012/116407 does not envisage or anticipate problems associated with placement of the electrodes on individuals of different body shapes or changes in an individual's body shape due to associated movement i.e., as the person moves between a standing position and a sitting position. Some embodiments address or ameliorate some or all of these problems as discussed below. Other issues relating to ease and comfort of assembly and use of the transcutaneous stimulation system may be addressed by various features of the described embodiments.

[0065] Referring to FIG. 1, there is illustrated a stimulation system 1000 according to some embodiments. The stimulation system 1000 comprises a stimulation generation device 1005 arranged to deliver transcutaneous electrical stimulation to a patient wearing a garment 1010 by transmitting transcutaneous electrical stimulation to a first electrode connector assembly 1015 housed or mounted to the garment 1010. In some embodiments, the stimulation generation device 1005 is further arranged to deliver transcutaneous electrical stimulation to a second electrode connector assembly 1020 housed or mounted to the garment 1010.

[0066] International Patent Publication No. WO 2012/116407, the content of which is incorporated herein by reference, discusses various methods and regimes for treating a waste evacuation dysfunction by administering transcutaneous electrical stimulation (TES) to a patient. In some embodiments, the stimulation generation device 1005 of the stimulation system 1000 is configured to generate and transmit transcutaneous electrical stimulation in accordance with the teachings of WO 2012/116407 to treat a waste evacuation dysfunction. For example, the stimulation generation device 1005 may be configured to provide a stimulation current of magnitude less than about 40 mA and greater than zero. The current may be provided at a carrier frequency of between about 1 kHz and about 10 kHz, with a modulated frequency of about 20 to about 300 Hz. Alternatively, the carrier frequency may be about 4 kHz and the modulated frequency is about 80 Hz to 150 Hz. Furthermore, the electrical stimulation may comprise interferential electrical current stimulation.

[0067] In some embodiments, the stimulation generation device 1005 may be configured to provide transcutaneous electrical stimulation to the first and/or second second electrode connector assembly 1015, 1020 for at least one treatment period per day over a treatment term of at least one week, and/or for two or three treatment periods per day. In some embodiments the treatment period may be between about 10 minutes and about 90 minutes, or between about 20 minutes and about 60 minutes.

[0068] The stimulation generation device 1005 may be arranged to communicate with a computing device 1025, for example, via a cable 1030 such as a USB cable. However, in other embodiments, the stimulation generation device 1005 may communicate with the computing device 1025 via a telecommunications network, such as a WiFi network, Bluetooth, or the Internet. In some embodiments, the stimulation generation device 1005 communicates with the computing device 1025 to upload or download data associated with transcutaneous electrical stimulation being generated by the stimulation generation device 1005. For example, such data may include a log of transcutaneous electrical stimulation transmitted to a given patient for a particular duration of time or treatment period, or may include instructions for transmitting transcutaneous electrical stimulation to a given patient for a particular duration of time or treatment period.

[0069] The first electrode connector assembly 1015 may include a first substrate 1035 carrying a plurality of electrode connectors 1040 electrically coupled to an electrical connector 1045. The electrical connector 1045 may be arranged to connect to the stimulation generation device 1005 to thereby enable the transmission of transcutaneous electrical stimulation from the stimulation generation device 1005 to the plurality of electrode connectors 1040.

[0070] The second electrode connector assembly 1020 may include a second substrate 1050 carrying a plurality of electrode connectors 1055 electrically coupled to an electrical connector 1060. The electrical connector 1060 may be arranged to connect to the stimulation generation device 1005 to thereby enable the transmission of transcutaneous electrical stimulation from the stimulation generation device 1005 to the plurality of electrode connectors 1055.

[0071] In some embodiments, the stimulation generation device 1005 may be arranged to receive a power cable 1065 to enable the stimulation generation device 1005 to be connected to a power source (not shown).

[0072] Referring to FIG. 2, there is depicted a top view of the garment 1010. The garment 1010 comprises a first part 1070 arranged to receive the first substrate 1035 and a second part 1075 arranged to receive the second substrate 1050. In some embodiments, the garment 1010 is a two-piece belt.

[0073] The first part 1070 comprises a first or major surface 1080 having a plurality of electrode connectors 1085 disposed thereon. The electrode connectors 1085 are configured to electrically couple to respective mating electrode connectors 1040 of the first substrate 1035 of the electrode connector assembly 1015. The first part 1070 further comprises a body portion 1087, a first end 1090 and a second end 1095. In some embodiments, the plurality of electrode connectors 1085 is disposed on the body portion 1087 of the first part 1070. In some embodiments, the first and second ends 1090, 1095, may be elongated belt parts extending from the body portion 1087.

[0074] The second part 1075 comprises a first or major surface 1100 having a plurality of electrode connectors 1105 disposed thereon and configured to electrically couple to respective mating electrode connectors 1055 of the second substrate 1050 of the first electrode connector assembly 1020. The second part 1075 further comprises a body portion 1107, a first end 1110 and a second end 1115. In some embodiments, the plurality of electrode connectors 1105 is disposed on the body portion 1107 of the second part 1075.

[0075] The first and second ends 1090 and 1095 of the first part 1070 may be arranged to connect or fasten to the first and second ends 1110 and 1115 of the second part, respectively. In some embodiments, the first ends 1090 and 1110 and/or the second ends 1095 and 1115 are fixedly fastened or secured together. In other embodiments, the first ends 1090 and 1110 and/or the second ends 1095 and 1115 are detachably connectable to one another, for example, by means of a hook and loop fastener, such as Velcro, or a hook and eye fastener.

[0076] In some embodiments, as depicted in FIG. 2, the first part 1070 includes a fastening portion 1120, such as a hook fastener, for example, Velcro, disposed on the major surface 1080 toward the second end 1095, and may be arranged to engage with a reverse or opposed second surface 1125 (FIG. 3) of the second part 1075 toward the second end 1115. For example, a corresponding fastening portion (not shown) may be disposed on the reverse surface 1125 of the second part 1075. In some embodiments, the second end 1115 of the reverse surface 1125 of the second part 1075 may be composed of a looped fabric or may have disposed thereon a strip of looped fabric arranged to engage with the fastening portion 1120.

[0077] FIG. 3 depicts a perspective view of the garment 1010 wherein the second ends 1095 and 1115 of the first and second parts, 1070 and 1075, respectively, are engaged or connected to one another and the first ends 1090 and 1110 of the first and second parts, 1070 and 1075, respectively, are disengaged or disconnected from one another such that the garment 1010 is in an open configuration or position for affixing to a person. FIG. 4 depicts a perspective view of the garment 1010 wherein both the first ends 1090 and 1110 and the second ends 1095 and 1115 of the first and second parts, 1070 and 1075 respectively, are engaged or connected to one another, such that the garment 1010 is in a closed configuration or position in which it can be worn by a person.

[0078] As depicted in FIGS. 2, 3, and 4, the garment may include a pocket 1130 for receiving the stimulation generation device 1005. In some embodiments, and as depicted in FIG. 2, the pocket 1130 is disposed at or toward the first end 1090, 1110 of the first and second parts 1070, 1075, respectively, as may be more convenient for a left-handed person. In other embodiments, and as depicted in FIGS. 3 and 4, the pocket 1130 is disposed at or toward the second ends 1095, 1115 of the first and second parts 1070, 1075, respectively, as may be more convenient for a right-handed person. In some embodiments, the pocket 1130 is fixedly attached to the garment 1010. In other embodiments, the pocket 1130 is detachably connected to the garment 1010, for example, by means of a hook and loop fastener, for example, Velcro, or a hook and eye fastener, or a loop arranged to slidably receive the first or second ends 1090, 1095, of the first part 1070 and/or first or second ends 1110, 1115, of the second part 1075.

[0079] FIGS. 5A, 5B, and 5C are front, side and rear views of a pocket 1130 according to one embodiment. As illustrated in FIG. 5A, the pocket 1130 comprises a sleeve portion 1135 arranged to receive the stimulation generation device 1005 through an opening 1140 disposed on a major or first surface 1145 of the pocket 1130.

[0080] Referring to FIG. 5C, the pocket 1130 includes a first fastening portion 1150 disposed on or toward an upper section 1155 of a reverse or second opposed surface 1160 of the pocket 1130. The first fastening portion 1150 is arranged to engage with or fasten to the major surface 1080, 1110 of the first or second parts 1070, 1075, respectively. Thus, in use, the upper section 1155 is arranged to bend or fold about a lateral axis A-A of the pocket 1130 to thereby sandwich the first and/or second parts 1070, 1075 of the garment 1010 between the upper section 1155 and a lower section 1165 of the reverse surface 1160 of the pocket 1130.

[0081] In some embodiments, the first fastening portion 1150 is arranged to engage with or fasten to a corresponding fastening portion (not shown) provided on the major surface 1080, 1110. In other embodiments, the major surface 1080, 1110 is composed of a material suitable for engaging with or fastening to the fastening portion 1150. For example, the fastening portion 1150, and/or fastening portion (not shown) provided on the major surface 1080, 1110, and/or the major surface 1080, 1110 may be composed of a hook and/or loop type fabric, for example, Velcro.

[0082] In some embodiments, the pocket 1130 includes a second fastening portion 1170 disposed on or toward the lower section 1165 of the reverse surface 1160 of the pocket 1130. The second fastening portion 1170 is arranged to engage with or fasten to a second opposed or reverse surface 1175 (FIG. 6B) of the first part 1070 of the garment 1010. In some embodiments, the second fastening portion 1170 is arranged to engage with or fasten to a fastening portion (not shown) provided on the reverse surface 1175 (FIG. 6B) of the first part 1070. In other embodiments, the reverse surface 1175 of the second part 1075 is composed of a material suitable for engaging with or fastening to the fastening portion 1170. For example, the fastening portion 1170, and/or fastening portion (not shown) provided on the reverse surface 1175, and/or the reverse surface 1175 of the first part 1070 may be composed of a hook and/or loop type fabric, for example, Velcro. In some embodiments, the second fastening portion 1170 may be arranged to engage with or fasten to the second opposed or reverse surface 1125 of the second part 1075 of the garment 1010.

[0083] In some embodiments, the pocket 1130 includes a third fastening portion 1177 disposed towards the upper section 1155 of the opposed surface 1160 of the pocket 1130. The third fastening portion 1177 may be arranged to capture and manage flexible cables 1265 (FIGS. 8A and 8B) interconnecting the electrical connectors 1045, 1060 and the substrates 1035, 1050, respectively. In other embodiments, the pocket 1130 includes only the first fastening portion 1150 and the second fastening portion 1170.

[0084] In some embodiments, the first fastening portion 1150 extends from the upper section 1155 towards the lower section 1165 of the reverse surface 1160 such that in use, the first fastening portion 1150 disposed on the upper section 1155 is arranged to engage with the major surface 1080, 1110 of the first or second parts 1070, 1075, respectively and the first fastening portion disposed on the lower section 1165 is arranged to engage with the reverse surface 1175, 1125 of the first or second parts 1070, 1075, respectively.

[0085] Referring now to FIG. 6A, there is illustrated a detailed top view of the first or major surface 1080 of the first part 1070 of the garment 1010. As depicted, the electrode connectors 1085 are disposed on the major surface 1080 of the first part 1070 in a spaced-apart manner.

[0086] In some embodiments, each electrode connector 1085 is associated with at least one location indicator 1180 disposed on the major surface 1080 for identifying a preferable or suggested location for the positioning of an electrode pad (not shown). The electrode pad is arranged to make contact with a user's skin and suitable positioning of the electrode pads at the location indicator 1180 of the garment 1010 ensures or assists in an efficient transmission of transcutaneous electrical stimulation from the electrode connectors 1085 to the electrode pads, and therefore, to the user wearing the a garment 1010. In some embodiments and as illustrated in FIG. 5A, each electrode connector 1085 is associated with a plurality of location indicators 1180, for example, in the form of markings provided on the major surface 1080, to identify various suitable locations for the positioning of the electrode pad (not shown). For example, the plurality of location indicators 1180 may identify a positioning for the electrode pads for small, medium and large sized patients, to thereby facilitate or accommodate for persons of varying sizes. In some embodiments, the electrode pads are adhesive pads, such as UltraStim Pad Electrodes, as produced by AXELGAARD Manufacturing Co., Ltd, and may be easily replaceable.

[0087] In some embodiments, the garment 1010 includes a measurement indicator 1185 disposed along the major surface 1080 of the first and/or second ends 1090 and 1095. The measurement indicator 1185 serves to assist in selecting and adjusting the garment to a suitable size for a given patient.

[0088] As illustrated in FIG. 6A, the garment 1010 may include an alignment tab 1190 disposed on an upper central section 1195 of major surface 1080 of the first part 1070 to assist in aligning the first part 1070 of the garment 1010 with a patient's spine. In some embodiments, by aligning the alignment tab 1190 with the patient's spine, the garment 1010 may be suitably placed on a patient to achieve efficient and effective transmission of transcutaneous electrical stimulation to the patient.

[0089] Referring now to FIG. 6B, there is illustrated a detailed top view of the reverse or second opposed surface 1175 of first part 1070 of the garment 1010. As depicted, the first part 1070 of the garment 1010 comprises a pocket 1200 arranged to receive the substrate 1035 via a first pocket opening 1205 provided toward the upper central section 1195.

[0090] In some embodiments, the pocket 1200 extends along a length of the first part 1070 toward the first and second ends, 1090, 1095. A second pocket opening 1210 may be disposed toward the first end 1090 and/or a third pocket opening 1215 may be disposed toward the second end 1095. The second pocket opening 1210 and/or the third pocket opening 1215 may be employed to allow the electrical connector 1045 connected to the substrate 1035 to exit the pocket 1200 for connection to the stimulation generation device 1005. In some embodiments, the second and/or third pocket openings 1210, 1215, may include a plurality of pocket opening sections (not shown) to provide a plurality of exits for the electrical connector 1045 so that a suitable exit may be selected depending on a waist measurement of the patient.

[0091] In some embodiments, the electrode connectors 1085 disposed on the major surface 1080 extend from the major surface 1080 through the first part 1070 to the reverse surface 1175 such that they are accessible from within the pocket 1200. Thus, when the electrode conductor assembly 1015 is positioned within the pocket 1200, the electrode connectors 1040 of the substrate 1035 may engage or mate with the respective electrode connectors 1085. In some embodiments, the electrode connectors 1085 each comprise a snap connector component (not shown) arranged to engage or connect to a corresponding snap connector component (not shown) provided on respective mating connectors 1040 of the first substrate 1035 of the first electrode connector assembly 1015. The snap connector components (not shown) may be one of male or female snap connector components. In some embodiments, the electrode connectors 1085 and respective mating connectors 1040 may be colour coded to assist with correct attachment of the electrode connectors 1085 to the respective mating connectors 1040.

[0092] Referring now to FIG. 7A, there is illustrated a detailed top view of the major surface 1100 of the second part 1075 of the garment 1010. As depicted, the electrode connectors 1105 are disposed on the major surface 1100 of the second part 1075 in a spaced-apart manner.

[0093] In some embodiments, each electrode connector 1105 is associated with at least one location indicator 1220 disposed on the major surface 1100 for identifying a preferable or suggested location for the positioning of an electrode pad (not shown) to ensure or assist in an efficient transmission of transcutaneous electrical stimulation from the electrode connectors 1085 to the electrode pads, and therefore, to a user wearing the garment 1010. In some embodiments and as illustrated in FIG. 7A, each electrode connector 1105 is associated with a plurality of location indicators 1220, for example, in the form of markings provided on the major surface 1100, to identify various suitable locations for the positioning of the electrode pad (not shown). For example, the plurality of location indicators 1220 may identify a positioning for the electrode pads for small, medium and large sized patients, to thereby facilitate or accommodate for persons of varying sizes. In some embodiments, the electrode pads are adhesive pads, such as UltraSam Pad Electrodes, as produced by AXELGAARD Manufacturing Co., Ltd, and may be easily replaceable.

[0094] In some embodiments, the garment 1010 includes a measurement marker 1225 disposed toward the first and/or second ends 1110 and 1115 of the major surface 1100. The measurement marker 1225 may be arranged to cooperate with the measurement indicator 1185 to select a suitable sizing for the garment to be worn by the patient and so determine where the first part should be fastened to the second part. In some embodiments, the measurement marker is a measurement tab.

[0095] In some embodiments, the second part is configured or shaped to assist in a positioning of the garment on a patient relative to the patient's navel. For example, and as depicted in FIGS. 7A and 7B, the second part 1075 comprises an alignment tab in the form of a concave or indented section 1230 provided at an upper central section 1235 of the second part 1075 and which is arranged to accommodate the patients navel.

[0096] Referring now to FIG. 7B, there is illustrated a detailed top view of the reverse surface 1125 of second part 1075 of the garment 1010. As depicted, the second part 1075 of the garment 1010 comprises a pocket 1240 arranged to receive the substrate 1050 via a first pocket opening 1245 provided toward the upper central section 1235 on the reverse surface 1125 of the second part 1075.

[0097] In some embodiments, the pocket 1240 extends along a length of the second part 1075 toward the first and second ends, 1110, 1115. A second pocket opening 1250 may be disposed toward the first end 1110 and/or a third pocket opening 1255 may be disposed toward the second end 1115. The second pocket opening 1250 and/or the third pocket opening 1255 may be employed to allow the electrical connector 1060 connected to the substrate 1050 to exit the pocket 1240 for connection stimulation generation device 1005. In some embodiments, the second and/or third pocket openings 1250, 1255, may include a plurality of pocket opening sections (not shown) to provide a plurality of exits for the electrical connector 1060 so that a suitable exit may be selected depending on a waist measurement of the patient.

[0098] The electrode connectors 1105 disposed on the major surface 1110 extend from the major surface 1110 through the second part 1075 to the reverse surface 1125 such that they are accessible from within the pocket 1240. Thus, when the electrode conductor assembly 1020 is positioned within the pocket 1240, the electrode connectors 1055 of the substrate 1050 may engage or mate with the respective electrode connectors 1105. In some embodiments, the electrode connectors 1105 each comprise a snap connector component (not shown) arranged to engage or connect to a corresponding snap connector component (not shown) provided on respective mating connectors 1055 of the second substrate 1050 of the electrode connector assembly 1020. The snap connector components (not shown) may be one of male or female snap connector components. In some embodiments, the electrode connectors 1105 and respective mating connectors 1055 may be colour coded to assist with correct attachment of the electrode connectors 1105 to the respective mating connectors 1055.

[0099] In some embodiments, the garment 1010 is composed of a flexible material. For example, the garment 1010 may be composed of a stretchable material. In some embodiments, the garment 1010 may be stretchable in parts and non-stretchable in other parts. For example, the body portions 1087 and 1107 of the garment 1010 may be composed of a non-stretchable material and the ends 1090 and 1095 of the first part 1070 and/or the ends 1110 and 1115 of the second part 1075 may be composed of a stretchable material. In some embodiments, the garment 1010 includes flexible or stretch zones 1257 (FIGS. 3 and 4), such as may be provided at an intersection of the body portions 1087 and 1107 and the ends 1090, 1095 and 1110, 1115, respectively, and/or toward a lower section (not shown) of the garment 1010 to thereby accommodate for movement of the patient as they assume different positions, for example, as they move between a sitting and standing position. In some embodiments, the garment 1010 is composed of at least one of a breathable material, a washable material, a soft material and a comfortable material. In this way, the garment 1010 may be capable of flexing, adapting or stretching to accommodate for a range of movements of a patient wearing the garment, such as movement from a standing to a sitting position or gentle play activities, and may thereby prevent or at least mitigate such activities interfering with a delivery of treatment to the patient via the electrode connector assembly 1015, 1020 provided on or within the garment 1010.

[0100] FIG. 8A depicts a perspective view of an underside of an electrode connector assembly 1015, 1020 and FIG. 8B depicts a perspective view of an upper side of the electrode connector assembly 1015, 1020. The electrode connector assembly 1015, 1020 comprises a substrate 1035, 1050 with a plurality of electrode connectors 1040, 1055 disposed thereon. The electrode connector assembly 1015, 1020 further comprises an electrical connector 1045, 1060 electrically coupled to the plurality of electrode connectors 1040, 1055 and arranged to connect to the stimulation generation device 1005. In some embodiments, and as described below in connection with FIGS. 9 to 11, the plurality of electrical connectors 1045, 1060, are electrically coupled to the electrode connector 1040, 1055 by means of a respective plurality of electrical conductors 1260 (FIGS. 9, 10, and 11). In some embodiments, the electrode connectors 1040, 1055 and electrical conductors 1260 may be colour coded to assist with correct attachment of the electrode connectors 1040, 1055 to the respective electrical conductors 1260.

[0101] In some embodiments, the electrode connector assembly 1015, 1020 further comprises a flexible cable 1265 interconnecting the electrical connector 1045, 1060 and the substrate 1035, 1050. The flexible cable 1265 may be arranged to enclose a length of each of the plurality of conductors 1260. In some embodiments, the cable 1265 is integrally formed with the substrate 1035, 1050. In some embodiments, the flexible cable is available in a variety of lengths to accommodate for varying waist measurements, and for example, the flexible cable 1265 connecting electrical connector 1045 to the substrate 1035 may have a length which is a multiple of a length of the flexible cable 1265 connecting electrical connector 1060 to the substrate 1050.

[0102] As illustrated in FIGS. 8A and 8B, the substrate 1035, 1050 may be a substantially flexible web extending a plane. The substrate 1035, 1050 or web may comprise a generally planar first face 1270 and a second opposite face 1275. In some embodiments, the second opposite face 1275 comprises at least one curved surface (not shown).

[0103] In some embodiments, each of the plurality of electrode connectors 1040, 1055 may be disposed on or housed in a respective outer portion 1280 of the substrate, 1035, 1050 extending outwardly from, and in the same plane as a central hub portion 1285 of the substrate 1035, 1050.

[0104] For example, in some embodiments, the substrate 1035, 1050 may be arranged in a substantially star configuration with each of the outer portions 1270 being displaced from one another and extending in different directions to one another in the same plane. In some embodiments, the substrate 1035, 1050 or web may be configured or shaped to define respective vertices of a quadrilateral shape, for example, a trapezoid, with each of the plurality of electrode connectors 1040, 1055 positioned at respective vertices of the quadrilateral shape. In some embodiments, the substrate 1035, 1050 may be arranged in a substantially X-shaped configuration.

[0105] Referring to FIG. 9, there is depicted a schematic illustration of a support frame 1290 of the substrate 1035, 1050. The support frame 1290 may be employed to support the plurality of conductors 1260 in the electrode connector assembly 1015, 1020. In some embodiments, at least one of the plurality of conductors 1260 passes through a central hub portion 1295 of the support frame 1250 corresponding to the central hub portion 1285 of the substrate 1035, 1050.

[0106] In some embodiments, the support frame 1290 of the substrate 1035, 1050 is encased at least partially within an encasing material 1300 as illustrated in FIGS. 10 and 11. For example, the encasing material may be a molded elastomeric material. In some embodiments, the encasing material 1300 encases the support frame 1290 but only partially encases each of the plurality of electrode connectors 1040, 1055. In this way the plurality of electrode connectors 1040, 1055 may be exposed and capable of engaging or connecting to respective mating electrode connectors 1085, 1105 of the garment 1010.

[0107] Referring now to FIGS. 12A and 12B, there is depicted a top view and a perspective view of an electrical connector 1045, 1060 according to some embodiments. The electrical connector 1045, 1060 comprises a connector jack 1305 disposed at a distal end of the electrical connector 1045, 1060. In some embodiments, the connector jack 1305 is a multiple-pole jack and is arranged to electrically couple the plurality of electrical conductors 1260 of the electrode connector assembly 1015, 1020 to the stimulation generation device 1005. In some embodiments, the connector jack 1305 is a four-pole jack and each pole 1310 is associated with and arranged to electrically couple a respective electrical conductor 1260 of the electrode connector assembly 1015, 1020 to the stimulation generation device 1005. In some embodiments, the connector jack is arranged to connect to a corresponding port (not shown) of the stimulation generation device 1005 to thereby allow transcutaneous electrical stimulation to be delivered to the electrode connector assembly 1015, 1020.

[0108] Referring to FIGS. 13A and 13B, there is a top view and a side view of an electrical connector 1045, 1060 for connecting to the support frame 1290 of the substrate 1035, 1050 according to some embodiments. The electrical connector 1045, 1060 comprises a connector plug 1315 and is arranged to electrically couple the plurality of electrical conductors 1260 of the electrode connector assembly 1015, 1020 to the stimulation generation device 1005, as depicted in FIG. 14. For example, in some embodiments, the stimulation generation device 1005 comprises a socket 1400 which is configured to cooperate with the connector plug 1315 to electrically couple the electrode connector assembly 1015, 1020 to the stimulation generation device 1005.

[0109] In some embodiments, the connector plug 1315 comprises a body portion 1320 and a projecting portion 1325 protruding from the body portion 1320. For example, the body portion 1320 may be a suitably shaped gripping portion.

[0110] In some embodiments, the body portion 1320 comprises a curved shoulder portion 1330 shaped to be received in a recessed portion 1405 of the socket 1400 of the stimulation generation device 1005. In some embodiments, the body portion 1320 comprises a substantially flat base portion 1335 and a rounded or curved surface portion 1340 and is configured to cooperate with a correspondingly shaped recessed portion 1405 of the socket 1400 of the stimulation generation device 1005. The socket 1400 may be recessed into a corner of the stimulation generation device 1005.

[0111] The projecting portion 1325 may include multiple pin ports 1345, such as four pin ports, and each pin port 1345 may be associated with and arranged to electrically couple to the electrical conductor 1260 of the electrode connector assembly 1015, 1020. Each pin port 1345 may be a separate electrically isolated signal channel. For example, the connector plug 1315 may have 2, 3, 4, 5, 6, or another number of electrically isolated signal channels, each corresponding to a pin port 1345.

[0112] In some embodiments, each pin port 1345 may be associated with and arranged to electrically couple to a respective pin 1410 recessed within the socket 1400 of the stimulation generation device 1005, as depicted in FIG. 14, to thereby allow transcutaneous electrical stimulation to be delivered to the electrode connector assembly 1015, 1020. For example, the pins 1410 may be configured for insertion into the pin ports 1345.

[0113] As depicted in FIGS. 13A and 13B, in some embodiments, the projection portion 1325 of the connector plug 1315 may be substantially elongate and the pin ports 1345 may be aligned in a row along a major axis A-A of the projection portion 1325. Alternatively, the pin ports 1345 may be aligned in a column perpendicular to the major axis A-A of the projection portion 1325. In other embodiments, the pin ports 1345 may be arranged in any suitable configuration, for example, in a square or circular formation.

[0114] In some embodiments, the projection portion 1325 may include a notch 1350 configured to cooperate or align with a corresponding protrusion 1415 provided within a recess 1420 of the socket 1400 to assist a user to correctly orientate the connector plug 1315 for insertion into the socket 1400.

[0115] Studies involving some described embodiments are described by the following non-limiting prophetic example:

Example

[0116] This example involves the use of a system or kit of some described embodiments comprising a garment, a first and second electrode connector assembly and a stimulation device for delivering transcutaneous electrical stimulation to treat individuals with a faecal waste elimination dysfunction condition.

[0117] Patient Group:

[0118] The patient group includes individuals suffering from faecal waste elimination dysfunction of the gastrointestinal tract that have failed to respond significantly to medical treatments such as dietary modifications, oral and rectal laxatives. Given the diversity of human body shapes, individuals participating will be of a variety of body shapes and sizes associated with weight, age, ethnicity and gender.

[0119] Stimulation Regime:

[0120] Parents of the children, and/or adults with faecal waste elimination dysfunction of the gastrointestinal tract will be trained to use the system or kit for delivering transcutaneous electrical stimulation. Stimulation will be performed and monitored (for a variety of times, for example, including up to one hour for at least three times a week or greater for a minimum of 2 months). During the stimulation period the participants will be encouraged to continue to perform normal activities of daily life which may include a range of movements from standing to sitting or gentle play activities.

[0121] Outcome Measures:

[0122] The number of spontaneous and sit defecations, number of antegrade enema washouts, amount of medication (laxatives) and number of incidents of soiling will be recorded daily in a specially designed continence dairy. The daily dairy will be kept one month prior and for two months using flexible web in a plane, connector, and system during electrical stimulation. The (a) frequency of defecation, (b) frequency of soiling and (c) frequency of episodes of abdominal pain per month will be compared with post-test analysis and paired t-tests (two tailed).

[0123] In some embodiments, a successful treatment of a patient by administration of transcutaneous electrical stimulation treatment delivered using the system or kit of some of the described embodiments is one that may include at least one or more of the following features: (a) number of defecations have increased per week; (b) the number of soiling incidents decreased; (c) reduced use of laxatives; (d) changes in the consistency of the stool from hard to increased softness; and (e) increase in sensory awareness of urge to defecate.

[0124] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.