TWI471115B - 用於肢體之壓縮裝置 - Google Patents

用於肢體之壓縮裝置 Download PDF

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TWI471115B
TWI471115B TW94136753A TW94136753A TWI471115B TW I471115 B TWI471115 B TW I471115B TW 94136753 A TW94136753 A TW 94136753A TW 94136753 A TW94136753 A TW 94136753A TW I471115 B TWI471115 B TW I471115B
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sleeve
limb
units
unit
compression device
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TW200628121A (en
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Patrick Gerard Linnane
Ian Stewart Tabron
Arsenio Fernandez
Anders Lennart Bostroem
Peter Lucien Hansen
Muhammad Salim Mirza
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Swelling Solutions Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/10—Leg
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2209/00—Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
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  • Veterinary Medicine (AREA)
  • Massaging Devices (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Professional, Industrial, Or Sporting Protective Garments (AREA)

Description

用於肢體之壓縮裝置
本發明係關於一種用於肢體之壓縮裝置，特定言之，係關於一種用於腿部上之裝置。該裝置特別適合用於在治療腿部靜脈潰瘍中使用的壓縮療法類型中。
已知有各種壓縮裝置用於將壓縮壓力施加至患者肢體。此等類型之裝置主要用來輔助預防深部靜脈栓塞(DVT)、脈管病症及減少水腫。先前技術裝置適於用於一醫院配置，在該醫院配置中，其主要用於對具有患上DVT之高風險的患者預防DVT。US 5117812、US 5022387及US 5263473(The Kendall Company)、US 6231532(Tyco International Inc)、US 6440093(McEwen等人)及US 6463934(Aircast Inc)揭示了此種裝置。
將壓縮療法應用於腿部靜脈潰瘍的治療。該治療依達到減少水腫及改良的經由靜脈系統之血液回流之壓縮而定。此又減少了供應至該下部肢體之血液的滯留時間及該肢體內可導致組織崩潰之缺血期的嚴重性。
肢體壓縮可藉由一氣動壓縮裝置達到。該已知的裝置經由影響患者活動性且從審美學上講很多患者難以接受的(多個)厚套(cuff)將壓力施加至肢體。產生壓縮之泵大且重，且可經由很多導管向該等套提供流體。此等特徵使得該等已知的裝置不適合家用(domestic use)。眾人咸信壓縮術後之即刻運用有利於預防DVT且現有的氣動壓縮裝置並不適合，此係因為其尺寸、重量以及當應用該治療時，將病人限制於床上。
然而，氣動壓縮裝置確實具有優勢。其提供一有效的治療，當放氣時，該或該等充氣的套很容易應用於該患者的腿部上，且該壓力可更容易地得到控制及監視。其亦不受半徑效應的支配，其中，壓縮之級別視該肢體之圓周而定，使得高壓發生於踝與脛骨處，其中，減少了繃帶以下的半徑且低壓點發生於諸如該踝周圍的凹陷處。該半徑效應係有鬆緊性的繃帶及長襪之一基本侷限性。
氣動壓縮裝置確實有問題，即當該套被充氣時，該套之形狀及構型可導致壓力的變化。此是不合需要的，因為為了使治療最有效，需要治療之全部區域皆應受到壓力。最令人滿意地，該壓力分佈應儘可能地保持均勻。Barak之US 6494852描述了一據說可攜帶及移動的裝置。然而，此裝置包含一具有複數個沿著套筒自其末端部分至近端部分縱向排列的單元之充氣套筒。該等單元係一在已充氣時，呈現一圓柱形截面形狀之簡單袋狀構造。吾人已發現在已充氣時，此形狀引起該肢體上的壓力高點及低點。
因而，存在對一套之一需要，當已充氣時，該套在該治療區域沿著該肢體藉由微小高壓及低壓囊(pocket)提供一均衡壓力分佈。
現在，吾人發明了一種用於將壓縮壓力施加於一患者肢體之裝置，其可藉由提供一可簡便應用於該肢體、小巧質輕並向該肢體提供一均勻壓力之裝置而減輕上述問題。本發明之第一態樣提供一種用於肢體之壓縮裝置，其包含：適於環繞該肢體之一套筒，該套筒包含一非彈性層；以及一自一藉由一或多個側壁接合至一外部部件之內部部件建構之單元，使得該單元具有一盒形構型，當該單元經充氣以向該肢體提供一均勻壓力時，該內部壁被調適成與該肢體的形狀一致。
吾人已發現此種裝置給該肢體帶來均勻壓力的優勢。
較佳地，該裝置進一步包含：一附著在該套筒之管道，用於將流體傳遞至該套筒；以及一附著在該管道之控制器，其產生並控制裝置中流體的流動。
較佳地，該控制器包含一微處理器控制系統及一泵。更佳地，該裝置包含至少一在該管道內或位於該裝置內的壓力感測器，歸因於藉由該控制器之該套筒的充氣，該感測器提供該肢體所受到的壓力之讀數。
較佳地，該套筒包含一或多個個別充氣套。該等套包含一或多個形成自一外部部件及一內部部件之單元。較佳地，該內部部件係彈性且藉由壁或角牽板接合至外部部件。在該等單元充氣時，該等壁允許該內部部件將自身與該外部部件分隔開以呈現一與該肢體接觸之連續或大體上連續的表面。該等單元一個緊挨著一個放置的情況下，該等壁可大體毗鄰，使得產生低壓之微小區域。因而，在充氣時，該等單元具有一大體盒形構型。
該等單元可以許多方式進行建構。較佳地，該內部部件係一可藉由該等側壁固定至套筒以形成一(或多個)閉合單元之與該套筒共平面之一層。該內部部件係一連續層的情況下，可使用該等側壁將該連續層分隔為許多鄰近的閉合單元。或者，該內部部件及該等側壁可自一稍後固定至該套筒之單一薄片真空成形。
或者，該等單元可自一藉由側壁接合至一外部部件之內部部件建構，然後，該外部部件接合至該套筒。在此構造中，該外部部件與該內部部件可由藉由側壁接合在一起之相同材料的層製成。此類型之一三層組件對於上述之兩層組件而言具有優勢，因為單元之內部部件與外部部件可為使該單元更有可能密封且可靠封閉之相同的材料。因為該套筒並非該單元之外部部件，所以該套筒不需要由一密封材料製成，例如，其可由織物製成。該三層組件亦意謂用以將該等單元部件接合在一起之焊縫在該套筒之外部表面係不可見的，且該等單元不需要將整個表面與該套筒附著。此意謂有可能使該套筒成形以更充分地適合該肢體之形狀。
較佳地，該套筒係低輪廓且離散。此允許患者使用該裝置時穿著普通的衣服與鞋子。該非彈性套筒引導朝向該患者的腿部對該等單元充氣。該非彈性套筒引導朝向該肢體對該彈性內部部件充氣，且允許該單元在充氣時與該肢體之輪廓相配。較佳地，該等單元適於當局部實體充氣時，向該肢體施以所需壓力。此允許該單元之彈性內部部件與該肢體緊密相配。
較佳地，該套筒包含一腿套及一足套，兩者皆係低輪廓且離散的。更佳地，腿及足套係按解剖學成形以向對血液流動具有最大作用的腿部或足部之該等部分提供壓縮。此給出減少該裝置以及因此該套之輪廓之整體尺寸的優勢。視該等套之形狀而定，其亦可減少來自對該肢體之骨骼突出區域的壓力之不適。
較佳地，該套筒包含兩個套，其中之每一個較佳地包含至少一單元。該非彈性套筒較佳地形成自兩種或兩種以上材料之結合層壓物，或者形成自兩種或兩種以上緊密附在一起之獨立材料。例如，該套筒可由一聚胺基甲酸酯襯底耐綸製成。本發明之內容中所提非彈性係指該套筒在正常作業壓力下使用時不變形。舉例而言，該套筒較佳地具有一介於150 MPa與300 MPa之間的一楊氏模量，更佳地，介於200 Mpa至250 MPa之間。該單元之相配部件相對較薄、具有可撓性且較佳地具有彈性特性以使與該肢體之輪廓緊密相配。本發明之內容中所提相配係指單元之內部部件能夠採用肢體之輪廓。其可形成自一單層或者兩種或兩種以上適合結合或焊接以形成一密封結構的材料之一層壓物。較佳地，該單元材料係聚胺基甲酸酯或聚氯乙烯。較佳地，該單元材料具有一自15 MPa至35 MPa之楊氏模量，更佳地，自20 MPa至30 MPa。在該裝置之一特定實施例中，每一單元皆包覆著下部肢體，但其包含在該腿套之內。
圖1展示了本發明之壓縮裝置。該裝置包含一具有連接至一足套(6)之一腿套(4)之套筒(2)。該套筒(2)可藉由一導管(未展示)連接至一控制器。該裝置可與一墊襯層(例如穿在該患者腿部與套筒(2)間的一短襪)一起使用。當存在該短襪時，其吸收來自該患者腿部之任何水分，但卻不應用顯著壓縮。該套筒(2)形成自一具有一內部表面(16)與一外部表面(18)之非彈性材料。該腿套分為三個單元(8)、(10)、(12)，其藉由將該單元之內部部件黏接至該套筒(2)而形成。在一替代實施例中，該等單元包含一與一外部部件接合之內部部件，該單元之外部部件接合至該套筒。
如自圖1所見，該患者藉由將該腿套(4)與該足套(6)包覆在腿部或足部，並將其緊固來穿上該套筒。然後，對該腿套(4)及該足套(6)充氣以對該肢體施壓。
圖2展示了緊固在一肢體(22)上之一先前技術套筒(20)之一橫截面圖，該套筒(20)處於一已充氣狀態。該套筒(20)具有一簡單袋狀構造，當充氣時，其採用一圓柱形截面。如自圖2所見，充氣時，該套筒與肢體之輪廓不相配。圖4展示了本發明之該套筒(2)的一橫截面圖。如自圖4所見，充氣時，該單元(8)之相配內部部件與該肢體(22)之輪廓相配。
圖3展示了具有簡單袋狀單元之一先前技術套筒之一橫截面圖，當其被充氣時，該等間隙(24)產生於此等單元間。圖5展示了該套筒(2)之一橫截面圖，其包含單元(8、10)，其中該等單元具有側壁(26)，當充氣時，其呈現一盒形構型。此種構型意謂當充氣時，該等單元之壁可毗鄰在一起，閉合圖3中所見的該等間隙。
圖6展示了本發明之一單元(8)之一橫截面圖，其中單元(8)之該內部部件(30)藉由焊接至該內部部件及套筒以形成一盒形結構之側壁(26)之獨立部分接合至套筒壁(16)。
圖7展示了該套筒之單元結構之一替代實施例，其中，該等單元之內部部件(30)藉由獨立壁(26)接合至該套筒(16)之內壁，但該內部部件(30)係一連續薄片。該等單元(8、10)之外部部件(32)在該等單元邊緣處接合至該套筒內表面(未展示)。
圖8展示了該套筒之單元結構之一替代實施例，其中，該內部部件(30)及側壁(26)藉由真空成形一稍後結合或焊接至該外壁(16)之材料的單一平板來在一打開的盒構型中預先形成。
圖9展示了該套筒之單元結構之另一實施例，其中，該內部部件(30)及側壁(26)藉由真空成形一單一薄片在一打開的盒構型中預先成形但經切割以允許鄰近該焊縫的過量的材料形成一袋狀構型。然後，該預先形成的打開的盒子焊接或結合至該外壁(18)。
圖10展示了本發明之套筒的替代實施例，其中，該套筒(2)包含三個鄰近單元(8、10、12)。該等單元之外邊緣(28)不具備側壁，但該等單元之內邊緣具備側壁(26)。
現在，將藉由下列非限制性的實例對本發明進行說明。
實例1
與圖1所示相似之一裝置之兩個鄰近單元係一用以當使用該裝置時模擬肢體所受到的壓力分佈之有限元分析的對象。進行該分析時，假設一例如圖3所使用之單元構造，且將其與一例如圖7所使用之單元構造進行比較，圖7中該等單元具有側壁。使用Abacus UK Ltd軟件版本6.41進行該分析。圖11展示了為圖3裝置產生之曲線，其中該等單元具有一簡單袋狀構造。該壓力分佈不均勻，在每個單元之邊緣處展示峰值，其在該等單元之間快速下降為大範圍的零壓力。該壓力在每個單元之中心亦降低。藉由對比，圖12所示之圖7裝置之壓力分佈均勻得多，一均勻壓力穿過該單元寬度且在該等單元間僅有一小範圍的零壓力。此等圖展示了本發明的優勢，其中該可充氣套筒包含一非彈性外壁及一分割成套之相配的內壁，該內壁在充氣時與肢體之形狀相配以向該肢體提供一均勻壓力。
2．．．套筒
4．．．腿套
6．．．足套
8．．．單元
10．．．單元
12．．．單元
16．．．套筒壁
18．．．外壁
20．．．先前技術套筒
22．．．肢體
24．．．間隙
26．．．側壁
28．．．外邊緣
30．．．內部部件
32．．．外部部件
圖1為該肢體上該裝置之套筒之一透視圖；圖2為緊固在該肢體上之一先前技術套筒之一橫截面圖，該套筒處於一已充氣狀態；圖3為一先前技術套筒之一橫截面圖，展示了已充氣時產生在相鄰單元間的間隙；圖4為本發明之裝置之一橫截面圖，該裝置緊固在肢體上，該圖展示了一已充氣狀態下的該裝置；圖5為一橫截面圖，其中該等單元具有一帶壁或角牽板構型；圖6至圖9為單元構造之替代實施例之橫截面圖；圖10為該套筒之一平面圖，展示了單元之內部部件與排列；圖11為展示圖3之裝置的沿著肢體之壓力分佈的一圖表；以及圖12為展示圖7之裝置的沿著肢體之壓力分佈的一圖表。
2．．．套筒
4．．．腿套
6．．．足套
8．．．單元
10．．．單元
12．．．單元
16．．．套筒壁
18．．．外壁

Claims (7)

  1. 一種用於肢體之壓縮裝置，其包含：一適於環繞該肢體之套筒，該套筒包含一非彈性層及至少二相鄰之單元，其自一包含藉由一或多個側壁接合至一外部部件之一連續表面的內部部件所建構，使得該等單元之至少一個具有一盒形構型，當該單元被充氣以向該肢體提供一均勻壓力時，該盒形構型允許該至少二相鄰之單元之該內部部件呈現一與該肢體接觸之連續表面，，且進一步其中該至少二相鄰之單元之各個沿該至少二相鄰之單元之一周長形成一外邊緣之一部分並在二相鄰單元之間形成至少一內邊緣，其中該至少二相鄰之單元之各個的該內部部件與該外部部件係彈性且能夠在充氣時採用該肢體之輪廓，其中該套筒、該單元之該內部部件與該外部部件係為共平面層，且進一步其中該至少二相鄰之單元之外邊緣之至少一部分係固定於該套筒且不具有側壁，及其中該至少一內邊緣具備有與該內部部件及外部部件接合之一或多個側壁中之一側壁。
  2. 如請求項1之用於肢體之壓縮裝置，其特徵在於該套筒被分為兩個或兩個以上的套，每一套包含至少一單元。
  3. 如請求項1或2之用於肢體之壓縮裝置，其特徵在於該裝置進一步包含：一附著至該套筒之管道，其用於將流體傳遞至該套筒；及一附著至該管道之控制器，其產生並控制該裝置中流 體的流動。
  4. 如請求項1或2之用於肢體之壓縮裝置，其特徵在於在該裝置充氣時，相鄰單元之該等側壁毗鄰。
  5. 如請求項1或2之用於肢體之壓縮裝置，其特徵在於該非彈性套筒在使用中不會變形。
  6. 如請求項1或2之用於肢體之壓縮裝置，其特徵在於該單元之該外部部件係固定於該套筒。
  7. 一種具有一套筒及一或多個單元之壓縮裝置之使用方法，該一或多個單元是自藉由一或多個側壁接合至一外部部件的一內部部件建構，以用於治療或預防腿部靜脈潰瘍。
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