TW413628B - Biofeedback device for an incontinent person - Google Patents

Biofeedback device for an incontinent person Download PDF

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TW413628B
TW413628B TW088110975A TW88110975A TW413628B TW 413628 B TW413628 B TW 413628B TW 088110975 A TW088110975 A TW 088110975A TW 88110975 A TW88110975 A TW 88110975A TW 413628 B TW413628 B TW 413628B
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sphincter
scope
patent application
electrical activity
feedback device
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TW088110975A
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Donald Carroll Roe
Peter Nmn Coles
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Procter & Gamble
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/45—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the shape
    • A61F13/49—Absorbent articles specially adapted to be worn around the waist, e.g. diapers
    • A61F13/495—Absorbent articles specially adapted to be worn around the waist, e.g. diapers with faecal cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/56—Supporting or fastening means
    • A61F13/66—Garments, holders or supports not integral with absorbent pads
    • A61F13/82—Garments, holders or supports not integral with absorbent pads with means for attaching to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/20—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing organic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/56—Wetness-indicators or colourants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads
    • A61F2013/8473—Accessories, not otherwise provided for, for absorbent pads for diagnostic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads
    • A61F2013/8476—Accessories, not otherwise provided for, for absorbent pads with various devices or method
    • A61F2013/8479—Accessories, not otherwise provided for, for absorbent pads with various devices or method including electric or magnetic devices
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/905—Feedback to patient of biological signal other than brain electric signal

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Urology & Nephrology (AREA)
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  • Tropical Medicine & Parasitology (AREA)
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  • Inorganic Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Absorbent Articles And Supports Therefor (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analyzing Materials By The Use Of Fluid Adsorption Or Reactions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Description

413628 五、發明說明¢1) 發明領域 . 本發明係關於用於監視人體解剖功能之裝置，用於失禁 者，預測其即將排放身體排泄物，及輔助失禁者達成收縮· 括約肌之生物回饋裝置。 發明背景 有多種可購得的產品可輔助失禁者避免失禁造成不舒服 及困窘，包括用於容納、隔離及抛棄身體排泄物的拋棄式 物件。也發現某些拋棄式物件甚至可用於排便、排尿或排 放發生後提供信號，因而可即刻更換。此等物件雖然對其 預定目的而言為滿意，但僅能於事後有幫助。 丨_ 如此瞭解希望預測何時即將-發生此種排放情況，俾便失 禁者或照顧提供者可於事件發生前準備及採行必要動作， 此乃優於先前產品之處8就此方面而言，一種嘗示揭示於 Colling之美國專利5, 416 ,469，感溫器埋設於尿片内並連 結至抽樣/記錄儀。儀器以規定的時間間隔測量並記錄感 溫器溫度經歷一段預定時間。藉此方式，溫度及時間資料 可繪圖成為線圖而識別排放事件。經由應用此資料經歷一 段時間後，即可預測未來排放時間的約略時間。雖然 Co 1 Π ng之方法乃技術上之一項改良，但仍有某些特有的 不準確性。不只是該方法假定失禁者將在計算時間範圍内 排泄，同時也受到其它介入動作的影響（例如主動排泄， 排泄量或時間，或攝取食物、液體或藥物上的顯著變化， 或活動量的顯著變化）。 因此仍然需要有一種可更準_.3崔預測及警告失禁者及/或
第5頁 413628 _ 五、發明說明（2) _ 照顧提供者身體即將排泄的裝置。此外，此種裝置最佳用_ 於輔助失禁者達成有意且隨意地收縮括約肌。 發明概述 根據本發明之第一具體例，揭示一種生物回饋裝置包括 —感測元件，接觸使用者某一區而可偵測該區關聯括約肌 之電活性，及一信號發送元件以工作式連結至感測元件， 其當於括約肌出現預定電活性時發出一信號。 根據本發明之第二具體例，揭示一種預測失禁者即將排 放身體排泄物之方法，包括下列步驟：識別失禁者括約肌 與其收縮關聯的特定電活性；監視括約肌之電活性；以及（ 決定括-約肌是否出現特定電活j生。該方法也較佳包括當偵 測得特定電活性時提供一信號之步驟。 根據本發明之第三具體例，揭示一種輔助失禁者達成收 縮其括約肌之方法，包括下列步驟：埤別括約肌之與即將 排放身體排泄物有關聯之特定電活性；監視括約肌之電活 性；決定是否發生括約肌之特定電活性·，以及當出現該特 定電活性時提供一信號。 本發明之一種生物回饋裝置包括先前任一種或多種功 能，除了前述實例外也包括其它功能。 其它本發明之特點及優點將參照本發明之較佳具體例之（1 說明予以描述。 圖式之簡單說明 雖然說明書特別指出且直接請求被視為本發明之主題之 專利，但相信由後文說明連同附圖將更為瞭解本發明。
第6頁 _：_ 五、發明說明（3) ' 圖1為本發明之生物回饋裝置之方塊圖； . 圖2為線圖說明由圖1之生物回饋裝置之感測元件感測得 括約肌電活性之第一例； 圖3為線圖說明由圖1之生物回饋裝置之感測元件感測得 括約肌電活性之第二例； 圖4為線圖說明由圖1之生物回馈裝置之感測元件感測得 括約肌電活性之第三例；以及 圖5為流程圖說明圖1所示生物回饋裝置當用於預測失禁 者的即將排放身體排泄物或用於輔助失禁者達成收縮其括 約肌時執行的方法步驟。 f - 發明之詳細說明 本發明係關於一種生物回饋裝置用於預測即將排放身體 排泄物以及響應於此預測提供一信號。藉此方式，生物回 饋裝置可警告失禁者及/或照顧提供者，因而可響應於此 採行適當動作，以及輔助失禁者達成及/或維持收縮其括 約肌，因而至少提供暫時控制排放。須瞭解用於本發明之 目的，「失禁者」一詞包括兒童及嬰兒以及成人其無法主 動控制括約肌，因此此處所述本發明可合併用於便溺訓 練。 用於此處，「生物回饋裝置」一詞表示一種裝置其可直（_ 接或間接由人體獲得資料，並響應於此利用此種資料來執 行預定功能。也須瞭解此處所述生物回饋裝置較佳可再利 用1抛棄式電極除外。更特別本發明之生物回饋裝置較佳 感測人體括約肌之電活性，以_及當出現與即將排放身體排
第7頁 413628 五、發明說明（4) ' 泄物關聯的預定電活性時提供一信號。 _ 如圖1可知，生物回饋裝置1 0包括一感測元件，概略標 示為參考編號1 2，其接觸人體一區而偵測該區關聯括約肌· 的電活性。須瞭解此區可為人體肛門周圍區因而偵測外肛 門括約肌之電活性；或另外*此區可為人體會陰區，來偵 測外尿道括約肌的電活性。雖然感測元件1 2可包括任一型 電極1 4，該種電極可可靠地提供括約肌的電活性，例如針 電極、線電極、或肛門插塞電極，但較佳為表面黏著電 極，其可黏著於人體皮膚，用於維持非干擾性接觸配用人 皮膚。藉此方式，電極1 4可放置於儘可能接近人體預定區/
V 域（例如肛門）來偵測來自預定^約肌（例如外肛門括約 肌，其於解剖上接近肛門口該點皮膚）的電信號。須瞭解 一或多個參考電極可置於人體皮膚接近前述區域或位在遠 端部位例如大腿或腹部。 . 黏著拋棄式表面電極之一例係由丹麥史高儉得之丹特克 (Dantec)醫療A/S公司製造。其它適當黏著表面電極包括 得自丹麥歐史堤克美蒂寇堤史（Medicotest) A/S之電極例 如 M-00-S ， N-00-S ， M-00-A/F > Bs 3400 ， BS3500 ， BR及 β R S以及得自德州艾帕索多生物感測器（M u 11 i B i 〇 Sensor)公司之電極例如3ST3，3SG3N及2DT2。其它適當電 感測器揭示於美國專利5 , 7 8 5，0 4 0 ; 5，7 2 7 , 5 4 9 ; 5,3 3 7,7 4 8 ； 5，2 0 3 , 3 3 0 及 5，2 5 5，6 7 7，全部皆併述於此以 供參考。若感測器非自黏式，則將導電性黏著凝膠置於感 測元件1 2之電極1 4上隨後貼於j膚上。
第8頁 413628 五、發明說明（5) 感測元件1 2較佳包括一單元丨6工作式連結至電極丨4，用 以接收且較佳顯示其鄰近括約肌的電活性。接收器單元之 一例由丹特克醫療A / S製造稱作丹特克£ μ G (型號丨4 β 1 1 )。 須瞭解感測元件1 2經由電極丨4及接收單元〗6較佳係以約5 赫茲至約500赫茲及更佳包括赫茲至約35〇赫茲之範圍偵 測括約肌的電活性。進一步接收單元丨6較佳設計成許可使 用者輸入及交互作用而控制預定電活性之參數，容後詳 述。 替代具體例中，本發明之接收單元丨6可為任何其它市售 EKG (心電圖）或EMG (肌電圖）電極及/或測量系統。例如得 自美國·亞歷桑那州史格特代爾_各諾拉克松（N〇rax〇n)公司 之肌追蹤（MyoTrace) 20 0，包含一寬頻電極可感測16赫茲 至b 0 0赫茲祀圍之肌電活性（此範圍適合骨盆緩慢抽動 肌）。另一種市售EMG感測系.統為肌感測（My〇Sense)系統， 得自英國理德Μ I E醫療研究公司。 雖然感測元件1 2可撰俾u & ., * ^ 選擇性整合拋棄式物件，如揭示於審 查中之專利申請案名摇「B丄 . ^ /、有生物活性感測器之拋棄式物 件」’案號第09/107 5R1 π „ t 安 夂安比；+ * ’ bl破及與本案同時提出申請之申請 案’各案白由本發明之夸讀 ^ ^ 又讓人所擁有且併述於此以供參 考’ 1·員期本案之生物 此電極丨4利用導電元件饋^^置10為分開且可再度使用。如 1虛線19指示，接收單元f接連結至接收單元16 ;或如圖 置（亦即紅外線、微波當〉&位在電極1 4遠端而透過遙測裝 型包括-發送器2。待整極通訊。當然後述具體例典 σ电極-丄4及一相容接收器2 2位於接
4136^8 五、發明說明（6) 收單元1 6内部。遙測系統可為任何商用EMG或EKG遙測系. 統。一種遙測系統可得自美國諾拉克松公司為遙肌 (Telemyo)系統包含一電池作動的配戴式發送器。另一種 適當遙測系統為MT8遙測系統得自Μ I E醫療研究公司。又另， 一種適當遙測系統揭示於美國專利5, 7 0 4 , 3 5 1。 生物回饋裝置10進一步包括一信號發送元件24工作式連 结於感測元件1 2 (及特別連結於接收單元1 6 )，故信號發送 元件2 4於發生括約肌的預定電活性時可提供一信號。供本 發明之目的之用，「工作式連結」表示一種通訊手段使電 極1 4偵測到括約肌的預定或特定電活性時，感測元件1 2可^ 通知信.號發送元件2 4。 「工作_系連結」例如包括通訊裝置 例如透過導線或導電件之電聯結，或透過發送信號如射 頻、紅外線或其它發送頻率通訊。如'此信號發送元件2 4可 整合感測元件1 2之接收單元1 6或分開單元。因此應瞭解訊 號發送元件2 4可結合人體衣著，可為分開元件由人體配 戴，結合某一件傢俱或為分開之基於臺面之裝置。 「預定電活性」或「規定電活性」等此表示括約肌之任 何電活性其指示即將排放身體排泄物。須瞭解預定電活性 可為指定的電數值變化或為指定的絕對電數值變化。如圖 2及3所見，線圖說明就電壓相對時間而言感測得之括約肌（ 之電活性，識別與此種括約肌之基礎電活性有某種變化。 須瞭解括約肌的基礎電活性以信號2 6表示，此處信號2 6係 經由感測括約肌經過一段規定時間（例如數小時至數日）建 立。因括約肌之基礎電活性2 6_左相對微小變化可能來自於
第10頁 413628 五、發明說明¢7) 數種起因（亦即人體活動，焦慮等）之任一種，因此要緊地 必須與即將排泄事件區別。可經由設定基礎電活性被修改 的指定閾值量達成。 決定預定電活性之較佳方式係偵測括約肌的收縮。例如， 眾所周知外肛門括約肌的收縮是一種迫切或可能的排便信 號。於失禁成人及較為年長的兒童及嬰兒，直腸快速填滿 來自乙狀結腸（亦即結腸下區）的糞便造成外肛門括約肌之 反射性（亦即非隨意）收縮。此種反射被稱作肛門直腸反 射。外肛門括約肌活性急劇增高伴隨著外肛門括約肌收縮 可透過本發明之電極1 4偵測為電信號。如圖2指示，外肛 門括約.肌電活性增高之肛門填$訊息（亦即距基礎電活性 增高達規定的閾值量）較佳至少為基礎外肛門括約肌活性 之約兩倍（標示為參考編號2 8 )，但較佳至少為基礎電活性 之約三倍（標示為參考編號30 )。最佳外肛門括約肌電活性 之增高至少為基礎電活性之五倍或以上（標示為參考編號 32)= 另一較佳具體例中，電極1 4偵測括約肌電活性的銳減或 無活性。此種減少發生於外肛門括約肌例如恰於排糞之前 或排糞之中括約肌鬆弛而開啟肛門頸。一般而言外肛門括 約肌之電活性於肌肉鬆弛時將銳降至少經歷數秒。恰於排^ 泄過程之前以及之中該活性係於零或接近於零。此等具體 例中（參考圖3 )，預定電活性可被識別為括約肌之基礎電 活性急劇下降，較佳降低大於或等於約5 0 % (標示為參考編 號3 4 )。更佳識別預定電活性I低大於或等於基礎電活性
第11頁 413628 五、發明說明ί8) 之約7 5 % (標示為參考編號3 6 )，或最適當等於或大於基礎. 電活性之於約9 5 % (標示為參考編號3 8 )。 第三具體例中，括約肌之預定電活性被視為等於具有指' 定電值之一信號至少經歷指定時間（參考圖4 )。此等參數 _ 可預設於接收單元1 6内部（亦即基於典型或平均電值及收 縮時間）或程式規劃於其中因而反映出特定失禁者之適當 電值及時間。如此指定電值較佳至少為約2 0 0微伏及更佳 至少約4 0 0微伏。最佳可反映括約肌之預定電活性之信號 之指定電值至少為約6 0 0微伏。至於於指定電值之信號被 視為預定電活性的指定時間間期或持續時間，較佳指定電f
V 值維持·至少約2秒及更佳至少约J3秒。最適合於指定電值之 持續時間至少約5秒。 至於發生括約肌之預定電活性時由信號發送元件24提供 的信號，可由視覺指標器4 α (例如發.光二極體或其它光信 號），聽覺指示器42 (例如警報或其它噪音製造裝置）或觸 覺指標器44 (例如振動機構）作出指示。此外於某些具體例 中，無論使用形式如何，較佳由信號發送元件2 4提供的信 號可於一旦達到基礎電活性或指定電值之適用闉值變化 後，可隨括約肌電活性的增減而增減發出的信號強度。藉 此方式，指示變得更亮，更大聲或振動更大。 （ 雖然此處所述生物回饋裝置1 0可預測何時將發生迫切排 放身體棑泄物，且於該事件發生前提供警告或警報，但也 預期裝置1 0可輔助失禁者達成收縮其括約肌。如此生物回 饋裝置1 0之信號發送元件2 4較/娃發出一種信號，其指示失
第12頁 413628 五、發明說明（9) 禁者及/或照顧提供者必須嘗試及/或繼續蓄意且隨意的收-縮括約肌。藉此方式，若直接回饋表示失禁者括約肌狀態 以及是否有時間上廁所或其它設備。 另外，提供的信號可為對失禁者解剖部分之刺激而達到. 暫時性收縮括約肌。特別連結至接收單元1 6及電極1 4之刺 激裝置4 6可視需要傳送電脈衝（或電刺激）至肛門周圍皮膚 來誘發暫時收縮而具有失禁輔助功能。（此種過程於醫療 文獻上另外稱作動態細微整形神經刺激）。供本發明之目 的之用，此處電活性表示括約肌之電活性，可額外包括來 自其它與外肛門括約肌關聯的骨盆底肌之電活性。此種辦广
V 法也適·用於外尿道括約肌。 電脈衝係由一或二電脈衝组成或可為連續脈衝。雖然電 脈衝之最高強度可高達約3 5伏，但電脈衝之電壓較佳為約 0 . 0 5至約5伏及更佳於約0 . 3至約1伏.之範圍。較佳電脈衝 電流係於約0, 1至約1 0 0毫安之範圍。較佳刺激頻率係於約 1 0至約1 0 0赫茲之範圍，更佳約2 0至約8 0赫茲及又更佳約 6 0至約8 0赫兹之範圍。若該剌激為脈衝（一或多個脈衝）， 則各個脈衝之持續時間較佳為約0, 1至約5毫秒及更佳為約 0. 5至約1毫秒之範圍。某些具體例中刺激包含多個脈衝， 則整組脈衝或稱作「脈衝列j之持續時間為約0. 1秒至約 （ 1 5秒，而各脈衝列間之間隔為約丨秒至約6 0秒。較佳電刺 激電壓、頻率、一脈衝列之各脈衝數目及頻率，及各脈衝 列之數目及持續時間及間隔時間可由失禁者或照顧提供者 調整及/或控制。任何業界已知~可符合此等參數的電路皆
第13頁 413628 五、發明說明¢10) 可用於輸送或控制電刺激至外肛門括約肌或其它身體部 -位。例如3伏觀察電池附有脈衝產生系統可工作式連結感 測元件1 2電極1 4，然後用於輸送一或多個電脈衝至失禁者 皮膚之肛門周圍區。範例電刺激裝置為普羅斯波 (P r 〇 s p e r ) e , i. s. 5 0 0 0系統*得自德國積布魯克之
Rowedder Biomedizinische Geraete博士。本裝置另外可 如此處所述用於黏著表面電極。 刺激（亦即收縮）外括約肌作為失禁輔助之替代具體例 中，來自感測元件1 2之信號可被導引至失禁者身體另一部 位來提引出肛門直腸反射。例如感測元件1 2可觸動肛門周/ 圍皮膚-之電或機械刺激，失禁~考膝蓋背側皮膚，腳底或任 何其它可表現出肛門直腸反射部位。 須瞭解生物回饋裝置1 0之各組件當用於預測失禁者即將 排放身體排泄物或訓練失禁者控制其括約肌的反射動作時 進行某些方法步驟。為了更瞭解此等過程’提供圖5之流 程圖並說明如後。 就預測失禁者即將排放身體排泄物過程而言，圖5指出 生物回饋裝置1 0首先識別失禁者括約肌之與其收縮關聯的 特定電活性（方框1 0 0 )。因特定電活性可為括約肌之電活 性或指定電值之指定變化，可知感測元件1 2之接收單元1 6 ( 決定特定電活性是否為預設/程式規劃電值（決策方框1 〇 2 ) 。若答案為否定（亦即特定電活性為指定的電力程度變 化），則感測元件1 2利用電極1 4及接收單元1 6感測失禁者 括約肌電活性經歷一段規定時(方框1 0 4)。藉此方式，
第14頁 413628 五、發明說明（11) 感測元件1 2可建立括約肌之基礎電活性2 6 (方框1 0 6 )，其― 指示此種括約肌於正常（穩態）作業期間經驗的典型電活 性。其次，識別括約肌之基礎電活性變化是否與即將排放 身體排泄物有關（方框1 0 8 )。因括約肌活性劇增，伴隨有 . 直腸肛門反射期間之收縮（例如至少為基礎電活性之約2倍 至至少約5倍）或括約肌活性的銳減發生於恰於排便之前或 之中，括約肌鬆弛而開啟肛門頸（例如比基礎電活性低約 5 0 %至約9 5 % )，此種電活性的增減用於識別迫切排泄事 件。若於決策方框1 0 2的答案為肯定，則由管線Π 0跳過方 框1 0 4，1 0 6及1 0 8識別的方法步驟。 {
V 一！特定電活性係與迫切排~笔事件關聯，則生物回饋裝 置1 0監視括約肌之電活性（方框U 2 )，以及決定括約肌是 否發生此種規定的電活性（決策方框π 4)。只要未偵測得 括約肌之特定電活性（亦即決策方框.1 1 4的答案為否定）， 則生物回饋裝置1 0較佳繼續監視（亦即連續或於預定間隔） 括約肌之電活性（參考回饋Π 6 )。若偵測得括約肌之特定 電活性（亦即決策方框1 1 4之反應為正），則較佳生物回饋 裝置丨0提供一（視覺、聽覺、及/或觸覺）信號（方框1 1 8)。 此種信號無論於失禁者附近或遠端，可用來提醒失禁者及 /或照顧提供者即將排泄因而可事先採行某些動作。於規 （ 定警告時間後其中維持指示，生物回饋裝置丨0較佳復置 (方框1 2 0 )，然後可再度利用感測元件1 2監視括約肌的電 活性（反饋線路1 2 2 )。 至於利用生物回饋裝置1 0輔助失禁者達到收縮其括約肌
第15頁 413628 五、發明說明（12) 的過程，須瞭解由圖5方框1 0 0之處理步驟，括約肌之特定 電活性係與迫切排放身體排泄物有關。雖然可以其它方式 達成，但較佳係藉預設或程式規劃接收單元1 6建立指定電— 值（參照決策方框1 0 2 )，或以前文對方框1 0 4、1 0 6及1 0 8所. 述方式建立電值的指定變化（亦即感測括約肌電活性經歷 規定時間，建立於正常操作期間括約肌的基礎電活性，以 及識別括約肌之基礎電活性與迫切排放身體排泄物關聯的 變化）。當然若決策方框1 0 2的答案為肯定則可經由線路 1 1 0跳過方框1 0 4、1 0 6及1 0 8詳細說明之各步驟。一旦決定 括約肌之特定電活性，則生物回饋裝置1 0 (經由電極1 4及 / 接收單·元1 6 )監視括約肌之電活生（方框1 1 2 )。其次生物回 饋裝置1 0決定是否出現括約肌之規定電活性（決策方框 1 1 4 )。若答案為否定，則生物回饋裝置1 〇返回監視括約肌 之電活性步驟（回饋線1 1 6)。但一旦.出現括約肌的特定電 活性，則發信號輔助失禁者達成收縮括約肌（方框1 1 8 )。 雖然信號可呈多種形式，包括前文詳細說明電剌激，但顯 然係輔助失禁者有蓄意隨意的收縮功能作為失禁的輔助。 於信號以對生物回饋裝置1 〇之程式規劃方式提供後，裝置 1 0被復置（方框1 2 0 )及返回監視功能（回饋線1 2 2 )。 雖然已經舉例說明及敘述本發明之特定具體例及/或個 別特點，但業界人士顯然易知可未悖離本發明之精髓及範 圍作出多種變化及修改。進一步須瞭解所有此等具體例及 特點的組合為可能且可獲得本發明之較佳執行。
第16頁

Claims (1)

  1. 413628 [7~~ _索號 88110975 约车、月曰 。i二^ 六、申請專利範園 '------ 1. 一種生物回饋裝置，包含： (a) —感測元件接觸使用者一區，因而偵測該區關聯括 約肌之電活性；以及 (b) —信號發送元件以工作式連結該感測元件，其當出 現括約肌之預定電活性時可發出一信號。 2. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係與迫切排放身體排泄物有關聯。 3. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係與括約肌之隨意收縮有關聯。 4. 如申請專利範圍第1項之生物回饋裝置，其中該感測 元件可偵測於約5赫茲至約5 0 0赫茲頻率範圍之括約肌之電 活性。 置，其中該感測 5.如申請專利範圍第1項之生物回饋襄 元件進一步包含： 該括約肌；以及 該接收單元係配置 之t號且識別何時 (a) —電極設置於使用者皮膚且毗鄰 (b ) —接收單元工作式連結至電極， 成可接收來自電極對應於括約肌電活性 出現該預定電活性。 其中該預定 其中該預定 其中該預定 6. 如申請專利範圍第5項之生物回饋装置 電活性係預设於接收單元内部。 7. 如申請專利範圍第5項之生物回饋裝 電活性係程式規劃於接收單元内部。 8·如申請專利範圍第5項之生物回饋裝 電活性係呈括約肌之基礎電活性之 /，其中該預定 部。 歌儲存於接收單元内
    O:\59\59252_fHc
    2000. 08. 09. on 413628 [7~~ _索號 88110975 约车、月曰 。i二^ 六、申請專利範園 '------ 1. 一種生物回饋裝置，包含： (a) —感測元件接觸使用者一區，因而偵測該區關聯括 約肌之電活性；以及 (b) —信號發送元件以工作式連結該感測元件，其當出 現括約肌之預定電活性時可發出一信號。 2. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係與迫切排放身體排泄物有關聯。 3. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係與括約肌之隨意收縮有關聯。 4. 如申請專利範圍第1項之生物回饋裝置，其中該感測 元件可偵測於約5赫茲至約5 0 0赫茲頻率範圍之括約肌之電 活性。 置，其中該感測 5.如申請專利範圍第1項之生物回饋襄 元件進一步包含： 該括約肌；以及 該接收單元係配置 之t號且識別何時 (a) —電極設置於使用者皮膚且毗鄰 (b ) —接收單元工作式連結至電極， 成可接收來自電極對應於括約肌電活性 出現該預定電活性。 其中該預定 其中該預定 其中該預定 6. 如申請專利範圍第5項之生物回饋装置 電活性係預设於接收單元内部。 7. 如申請專利範圍第5項之生物回饋裝 電活性係程式規劃於接收單元内部。 8·如申請專利範圍第5項之生物回饋裝 電活性係呈括約肌之基礎電活性之 /，其中該預定 部。 歌儲存於接收單元内
    O:\59\59252_fHc
    2000. 08. 09. on 413628 案號 88110975 2? Ά(0 修上 tv%。· 六、申請專利範圍 9. 如申請專利範圍第丨項之生物回饋裝置，其中該括約 肌之預疋電活性係等於括約肌之基礎電活性提高至少2 一 5 倍之範園。 10. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係減低括約肌之基礎電活性提高至少 50-95¾之範圍。 11. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係等於一信號具有指定電準位於至少 20 0 -6 00微伏之範圍》 3 12. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係等於一信號具有指定電準位經歷至少 卜5秒範圍之時間間期》 1 3 ·如申請專利範圍第1 元件係接觸使用者肛門周 性。 1 4,如申請專利範圍第1 元件係接觸使用者尿道區 15_如申請專利範圍第1 發送元件於發生括約肌之 者：一視覺信號 聽覺 16.如申請專利範圍第1 號發送元件提供的信號係 增減強度。 17·如申請專利範圍第1項之生 發送元件及該感測元件係利用一 項之生物回#裝置，其中該感測 圍區來偵測升肛門括約肌之電活 項之生物回錄裝置’其中該感測 來偵測外展道括約肌之電活性。 項之生物回饋裝置’其中該信號 預定電活性後提供下列至少一 信號及一觸覺信號。 項之生物回饋裝置，其中由該信 可隨括約肌電活性之增減而分別 物回饋裝置’其中該信號 導電元件直接連結。
    O:\59\59252.ptc 第2頁 2000. 08. 09.018 413628 案號 88110975 2? Ά(0 修上 tv%。· 六、申請專利範圍 9. 如申請專利範圍第丨項之生物回饋裝置，其中該括約 肌之預疋電活性係等於括約肌之基礎電活性提高至少2 一 5 倍之範園。 10. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係減低括約肌之基礎電活性提高至少 50-95¾之範圍。 11. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係等於一信號具有指定電準位於至少 20 0 -6 00微伏之範圍》 3 12. 如申請專利範圍第1項之生物回饋裝置，其中該括約 肌之預定電活性係等於一信號具有指定電準位經歷至少 卜5秒範圍之時間間期》 1 3 ·如申請專利範圍第1 元件係接觸使用者肛門周 性。 1 4,如申請專利範圍第1 元件係接觸使用者尿道區 15_如申請專利範圍第1 發送元件於發生括約肌之 者：一視覺信號 聽覺 16.如申請專利範圍第1 號發送元件提供的信號係 增減強度。 17·如申請專利範圍第1項之生 發送元件及該感測元件係利用一 項之生物回#裝置，其中該感測 圍區來偵測升肛門括約肌之電活 項之生物回錄裝置’其中該感測 來偵測外展道括約肌之電活性。 項之生物回饋裝置’其中該信號 預定電活性後提供下列至少一 信號及一觸覺信號。 項之生物回饋裝置，其中由該信 可隨括約肌電活性之增減而分別 物回饋裝置’其中該信號 導電元件直接連結。
    O:\59\59252.ptc 第2頁 2000. 08. 09.018 Μ年浐月（0
    其中該信號 413628 案號 88110975 六、申請專利範圍 18.如申請專利範圍第^項之生物回饋裝^1， 發送元件係位在感測元件遠端。 19_如申請專利範圍第丨8項之生物回饋裝置，其中該感 測元件進一步包含一發送器，及該信號發送元件進一+勺 含一接收器，故感測元件可透過遙測裝置與信 通訊。 2 0.如申請專利範圍第1項之生物回饋裴置，其中該信號 =送元件係結合使用者衣物，結合傢俱或結合S開的“ 臺面之裝置β 21. 如申請專利範圍第1項之生物回饋裝置，其進一步包 含裝置兩於提供一刺激給使用者解剖部分因而達成暫時 收縮括約肌。 22. 如申請專利範圍第21項之生物回饋裝置，其中該刺 激係外加至下列各區的至少一區來達成暫時收縮關聯的括 約肌：肛門周圍皮膚及尿道皮膚。 23. 如申請專利範圍第21項之生物回饋裝置’其中該刺 激為具有電壓於0.1伏至5伏之電刺激。 24. 如申請專利範圍第21項之生物回饋裝置，其中該刺 激為具有電流0.1毫安至i〇〇毫安範圍之電刺激。 25. 如申請專利範圍第21項之生物回饋裝置’其中該刺 激為具有頻率於1〇赫茲至1〇〇赫茲範圍之電刺激° 26. 如申請專利範圍第21項之生物回饋裝置’其中該刺 激為具有至少一個脈衝之電刺激。 27.如申請專利範圍第26項之生物回饋裝置，其中該電 刺激之脈衝具有持續時間於〇, 1 - 1. 〇毫秒之範圍。
    O:\59\59252. 第3頁 2000.08.09. 019 Μ年浐月（0
    其中該信號 413628 案號 88110975 六、申請專利範圍 18.如申請專利範圍第^項之生物回饋裝^1， 發送元件係位在感測元件遠端。 19_如申請專利範圍第丨8項之生物回饋裝置，其中該感 測元件進一步包含一發送器，及該信號發送元件進一+勺 含一接收器，故感測元件可透過遙測裝置與信 通訊。 2 0.如申請專利範圍第1項之生物回饋裴置，其中該信號 =送元件係結合使用者衣物，結合傢俱或結合S開的“ 臺面之裝置β 21. 如申請專利範圍第1項之生物回饋裝置，其進一步包 含裝置兩於提供一刺激給使用者解剖部分因而達成暫時 收縮括約肌。 22. 如申請專利範圍第21項之生物回饋裝置，其中該刺 激係外加至下列各區的至少一區來達成暫時收縮關聯的括 約肌：肛門周圍皮膚及尿道皮膚。 23. 如申請專利範圍第21項之生物回饋裝置’其中該刺 激為具有電壓於0.1伏至5伏之電刺激。 24. 如申請專利範圍第21項之生物回饋裝置，其中該刺 激為具有電流0.1毫安至i〇〇毫安範圍之電刺激。 25. 如申請專利範圍第21項之生物回饋裝置’其中該刺 激為具有頻率於1〇赫茲至1〇〇赫茲範圍之電刺激° 26. 如申請專利範圍第21項之生物回饋裝置’其中該刺 激為具有至少一個脈衝之電刺激。 27.如申請專利範圍第26項之生物回饋裝置，其中該電 刺激之脈衝具有持續時間於〇, 1 - 1. 〇毫秒之範圍。
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ATE509571T1 (de) 2011-06-15
US6570053B2 (en) 2003-05-27
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US6149636A (en) 2000-11-21
US20020019615A1 (en) 2002-02-14
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AU4728099A (en) 2000-01-17
WO2000000083A1 (en) 2000-01-06

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