TW201941798A - Intelligent negative pressure wound therapy system - Google Patents
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本發明係有關於一種可以隨時監測並調整負壓的壓力,以及使負壓泡棉敷料可以在傷口內完全密合的負壓傷口控制系統。The invention relates to a negative pressure wound control system which can monitor and adjust the negative pressure at any time, and allows the negative pressure foam dressing to be completely tightly sealed in the wound.
依據台灣糖尿病協會指出:目前全球約有一億五千萬個糖尿病患,是二十一世紀罹患率增加最快的慢性疾病,未來估計罹病人口會超過三億人。糖尿病足潰瘍不僅影響患者的生活品質,對醫療團隊更是一大挑戰。許多研究證實,負壓傷口治療(Negative Pressure Wound Therapy;NPWT)運用於複雜傷口上,能促進肉芽組織生長、吸收多餘滲液、幫助傷口癒合、預防組織感染以及降低糖尿病足患者截肢機率。According to the Taiwan Diabetes Association: At present, there are about 150 million people with diabetes in the world, which is the chronic disease with the fastest increase in incidence in the 21st century. It is estimated that the number of patients will exceed 300 million in the future. Diabetic foot ulcers not only affect the quality of life of patients, but also pose a major challenge to the medical team. Many studies have confirmed that Negative Pressure Wound Therapy (NPWT) can be used on complex wounds to promote the growth of granulation tissue, absorb excess fluid, help wound healing, prevent tissue infections, and reduce the chance of amputation in patients with diabetic foot.
負壓傷口治療對於患有慢性傷口的病人而言,是相當有效的治療工具,近年來NPWT在臨床上普及率越來越高,受惠的患者愈來愈多;因此相對的,也有愈來愈多使用者提出在臨床使用NPWT上所遭遇到的問題及併發症。例如現行的NPWT是以海綿狀的聚氨酯(Polyurethane;PU)敷料填塞進傷口後,再埋入抽吸用之負壓管,最後以不透氣膠膜(如3M Tegaderm)黏貼後開始負壓抽吸。這樣的使用過程,往往在敷料裁切以及填充傷口時,就讓使用者感到相當麻煩以及棘手。另外,在最後黏貼不透氣膠膜的步驟上,使用者也經常抱怨無法密合,導致漏氣,必須重覆執行「抓漏」以及黏貼的動作,造成使用上存在有極大的困擾。Negative pressure wound treatment is a very effective treatment tool for patients with chronic wounds. In recent years, the clinical penetration rate of NPWT has become higher and higher, and more and more patients have benefited; therefore, relative, More and more users have raised the problems and complications encountered in the clinical use of NPWT. For example, the current NPWT is filled with a sponge-like polyurethane (Polyurethane; PU) dressing into the wound, and then buried in a suction tube for suction. Finally, it is adhered with a gas-impermeable film (such as 3M Tegaderm), and suction is started. . Such a use process often makes the user feel quite troublesome and troublesome when cutting the dressing and filling the wound. In addition, in the last step of pasting the air-tight adhesive film, users often complained that they could not be tightly adhered, leading to air leakage. They must repeatedly perform the "catch-leak" and sticking actions, which caused great problems in use.
常見之負壓傷口治療裝置之構造,例如有中華民國107年2月21日所公告之發明第I615163號「封閉傷口導流裝置」專利案,其係揭露:該裝置可為二種形式,形式一:一不規則狀發泡含藥覆蓋材、一導流管、一收集罐及一壓力源;形式二:一平面狀發泡含藥覆蓋材、一導流管、一收集罐及一壓力源;其功用為覆蓋於傷口上,當壓力源作用時作為導流、增進細胞生長,加速傷口癒合;其作業方法將不規則狀或平面發泡含藥覆蓋材覆蓋於傷口上,使黏膠層貼於正常皮膚上,再將導流管連接於收集罐且連結壓力源,當壓力源啟動時使不規則狀或平面發泡含藥覆蓋材貼附於傷口表面,加速傷口癒合;治療期間,由視窗觀察傷口、必要時可經沖洗注藥腔沖洗或注藥,使傷口復原。The structure of a common negative pressure wound treatment device is, for example, the patent case of the invention No. I615163 “Closed Wound Diversion Device” published on February 21, 107 of the Republic of China, which discloses that the device can be in two forms. 1: An irregular foamed medicated covering material, a diversion tube, a collection tank, and a pressure source; Form 2: a planar foamed medicated covering material, a diversion tube, a collection tank, and a pressure Its function is to cover the wound. When the pressure source acts, it acts as a guide to promote cell growth and accelerate wound healing. Its operation method covers the wound with an irregular or flat foaming medicated covering material to make the adhesive Apply the layer to the normal skin, then connect the drainage tube to the collection tank and connect the pressure source. When the pressure source is activated, the irregular or flat foaming medicated covering material is attached to the wound surface to accelerate wound healing; during the treatment period Observe the wound from the window, if necessary, rinse or inject the medicine through the flushing cavity to make the wound recover.
由於該專利前案並未隨時監測負壓輸出的壓力變化,因此一旦有漏氣造成壓力改變時,則無法立即查覺並做處置,而會造成負壓輸出的壓力不足。同時也無法根據臨床傷口的不同受傷程度,而選擇適合的壓力值設定模式。若傷口為潛行深度深且呈現不規則形狀的深凹,常有敷料與傷口密合度不佳的問題。同時也常在敷料移除時,因發生敷料斷裂或沾黏而造成筋膜炎或出血的問題。惟該專利前案之敷料,必須先根據傷口的形狀,再剪裁成適當大小的面積,因此會造成傷口處理上之時間浪費。Because the pre-patent case does not monitor the pressure change of the negative pressure output at any time, once the pressure changes due to air leakage, it cannot be immediately detected and disposed of, which will cause the pressure of the negative pressure output to be insufficient. At the same time, it is not possible to choose a suitable pressure value setting mode according to the different injuries of the clinical wound. If the wound is a deep recess with a submerged depth and an irregular shape, there is often a problem of poor adhesion of the dressing to the wound. At the same time, when the dressing is removed, the problem of fasciitis or bleeding is caused by the breakage or sticking of the dressing. However, the dressing of the pre-patent case must first be cut to an appropriate size according to the shape of the wound, so it will cause a waste of time in wound treatment.
又有中華民國106年9月1日所公告之發明第I597080號「負壓治療裝置」專利案,其係揭露:包含一填充材及一氣密單元。該填充材的材質是親水性聚氨酯發泡體,其是使一親水性聚氨酯及一發泡組分發泡而得,且該親水性聚氨酯發泡體的孔洞為非連續式的封閉孔洞,該親水性聚氨酯是使第一聚醚多元醇與多異氰酸酯反應,接著與第二聚醚多元醇及透明質酸反應而得的星狀嵌段聚氨酯,該第一聚醚多元醇含有至少三個末端羥基。該氣密單元覆蓋於該填充材上,形成大體上密封且含有該填充材之傷口空間。該負壓治療裝置在置入傷口前不需多次裁切及修整填充材,能有效促進傷口癒合,並避免移除更換時因沾黏導致的傷害。There is also a patent case of Invention No. I597080 "Negative Pressure Therapy Device" announced on September 1, 106, Republic of China, which disclosed that it includes a filling material and an airtight unit. The material of the filling material is a hydrophilic polyurethane foam, which is obtained by foaming a hydrophilic polyurethane and a foaming component, and the holes of the hydrophilic polyurethane foam are discontinuous closed holes, and the hydrophilic Polyurethane is a star-shaped block polyurethane obtained by reacting a first polyether polyol with a polyisocyanate, and then reacting with a second polyether polyol and hyaluronic acid. The first polyether polyol contains at least three terminal hydroxyl groups. . The airtight unit covers the filling material to form a wound space that is substantially sealed and contains the filling material. The negative pressure treatment device does not need to cut and trim the filling material multiple times before being placed in the wound, which can effectively promote wound healing and avoid the injury caused by sticking when removing and replacing.
惟該專利前案同樣並未設有隨時監測負壓的壓力變化之裝置,因此於使用上同樣不盡理想。However, the pre-patent case also does not have a device for monitoring the pressure change of the negative pressure at any time, so it is also not ideal in use.
爰此,有鑑於目前習知的負壓傷口治療裝置具有上述之缺點。故本發明提供一種智慧型控制負壓傷口系統,包含有:一負壓泡棉敷料;一負壓控制器,係可供設定一輸送壓力值,以控制輸出一壓力至該負壓泡棉敷料,使該負壓泡棉敷料產生一負壓環境;一壓力感測器,係訊號連接至該負壓控制器,該壓力感測器係設置於該負壓泡棉敷料,以隨時感應該負壓環境內的該壓力變化,於該壓力超出該輸送壓力值時,該壓力感測器會控制該負壓控制器調整所輸出之該壓力,使該負壓環境維持在該輸送壓力值之範圍內。Therefore, it is considered that the conventional negative pressure wound treatment device has the above-mentioned disadvantages. Therefore, the present invention provides a smart negative pressure control wound system, including: a negative pressure foam dressing; and a negative pressure controller, which can set a delivery pressure value to control and output a pressure to the negative pressure foam dressing To make the negative pressure foam dressing produce a negative pressure environment; a pressure sensor is connected to the negative pressure controller by a signal, and the pressure sensor is arranged on the negative pressure foam dressing to sense the negative pressure at any time The pressure changes in the pressure environment. When the pressure exceeds the conveying pressure value, the pressure sensor controls the negative pressure controller to adjust the output pressure, so that the negative pressure environment is maintained within the range of the conveying pressure value. Inside.
上述負壓泡棉敷料係使用2~2.5mol二異氰酸酯、0.1~1mol親水性多元醇、0.5mol聚二甲矽氧烷-聚氧化烯共聚物、0.1mol乙二胺與0.1mol異辛酸辛,於25~50ºC下操作3分鐘,再經由發泡灌注而成之發泡體材料。The above-mentioned negative pressure foam dressing uses 2 to 2.5 mol of diisocyanate, 0.1 to 1 mol of hydrophilic polyol, 0.5 mol of polydimethylsiloxane-polyoxyalkylene copolymer, 0.1 mol of ethylenediamine, and 0.1 mol of caprylic acid It is a foam material which is operated at 25 ~ 50ºC for 3 minutes and then foamed and poured.
上述負壓泡棉敷料於發泡灌注後,再分別經由一化學熱反應、一發泡體流動、一發泡體固及一表面抗沾黏處理之程序而製成。The above-mentioned negative pressure foam dressing is made through the procedures of a chemical thermal reaction, a foam flow, a foam solid and a surface anti-sticking treatment, respectively, after foaming and infusion.
上述負壓泡棉敷料的吸水膨潤率為>800%、保水率為>50%、水氣穿透率為≥1500g/m2 ~24hrs、密度為0.15~0.20g/cm3 、熱裂解溫度為>200℃、回彈性為>15%及延展性為35%~45%。The above-mentioned negative pressure foam dressing has a water swelling ratio of> 800%, a water retention rate of> 50%, a water vapor transmission rate of ≥1500 g / m 2 to 24 hrs, a density of 0.15 to 0.20 g / cm 3 , and a thermal cracking temperature of > 200 ° C, resilience is> 15%, and ductility is 35% ~ 45%.
本發明進一步設有一傳輸單元,該傳輸單元係訊號連接至該負壓控制器,以供將該輸送壓力值及該壓力之數據資料傳輸至一遠端裝置進行監控及一雲端資料庫進行大數據分析及整合。The invention further includes a transmission unit, which is connected to the negative pressure controller for transmitting the transmission pressure value and the pressure data to a remote device for monitoring and a cloud database for big data. Analysis and integration.
上述負壓泡棉敷料之表緣係覆蓋有一氣密件,以維持該負壓環境之氣密性。The surface edge of the negative pressure foam dressing is covered with an airtight member to maintain the airtightness of the negative pressure environment.
上述負壓控制器係提供一循環負壓模式,該循環負壓模式之壓力值設定區分為四種模式,第一種模式為連續式壓力抽吸傷口,持續性地給予負壓-125mmHg;第二種模式為間歇式壓力抽吸傷口,先施予負壓-125mmHg抽吸5分鐘,接著進入2分鐘休息模式0mmHg為一循環;第三種模式為動態式,動態地給予負壓循環於3分鐘內達到負壓-125mmHg,接著在3分鐘內回到-25mmHg為一循環;第四種模式為循環模式,係結合該第一種模式、該第二種模式及該第三種模式交互選擇使用。The above-mentioned negative pressure controller provides a cyclic negative pressure mode. The pressure value setting of the cyclic negative pressure mode is divided into four modes. The first mode is continuous pressure suction wound, which continuously gives negative pressure -125mmHg; The two modes are intermittent pressure suction wounds. First, a negative pressure of -125mmHg is applied for 5 minutes, and then a 2 minute rest mode is entered. 0mmHg is a cycle. The third mode is dynamic, and the negative pressure cycle is dynamically given at 3 A negative pressure of -125mmHg is reached in minutes, and then it returns to -25mmHg as a cycle in 3 minutes. The fourth mode is a cyclic mode, which is interactive selection based on the first mode, the second mode, and the third mode. use.
上述循環負壓模式包含該第一種模式與該第二種模式,於該循環負壓模式進行到該第一種模式時,會持續提供該壓力,當進行到該第二種模式時,該負壓控制器會連續以負壓抽吸5分鐘後,再休息釋放壓力2分鐘。The cyclic negative pressure mode includes the first mode and the second mode. When the cyclic negative pressure mode reaches the first mode, the pressure is continuously provided. When the cyclic negative pressure mode reaches the second mode, the The negative pressure controller will continuously pump at the negative pressure for 5 minutes, then rest and release the pressure for 2 minutes.
上述負壓控制器係設有一負壓管與該負壓泡棉敷料相連通,又該負壓控制器係設有一顯示螢幕,以供顯示該負壓控制器輸出之該壓力及該輸送壓力值。The negative pressure controller is provided with a negative pressure tube in communication with the negative pressure foam dressing, and the negative pressure controller is provided with a display screen for displaying the pressure and the conveying pressure value output by the negative pressure controller. .
上述負壓控制器所輸出之該壓力係介於-40mmHg至-140mmHg之間。The pressure output by the negative pressure controller is between -40mmHg and -140mmHg.
上述技術特徵具有下列之優點:The above technical features have the following advantages:
1.係可隨時監測負壓輸送的壓力變化,因此一旦有漏氣造成壓力改變或壓力輸出異常時,則可立即查覺並調整該負壓控制器,使其壓力可維持於所設定的輸送壓力值範圍內。藉以利用負壓可促進肉芽組織生長,吸收多餘滲液,並幫助傷口癒合,預防組織感染,以及降低糖尿病足患者截肢的機率。1. It can monitor the pressure change of the negative pressure conveyance at any time, so once the pressure changes or the pressure output is abnormal due to air leakage, it can immediately detect and adjust the negative pressure controller so that the pressure can be maintained at the set conveyance. Within the pressure range. The use of negative pressure can promote the growth of granulation tissue, absorb excess exudate, and help wound healing, prevent tissue infection, and reduce the chance of amputation in patients with diabetic foot.
2.藉由負壓泡棉敷料本身具有高度膨潤率,可以於接觸傷口的滲液後予以吸收,並且快速的膨脹,使其可依據傷口的形狀而自行發生形變,使負壓泡棉敷料可以在傷口內完全密合。2. The negative pressure foam dressing itself has a high swelling rate, which can be absorbed after contact with the exudate of the wound, and expand rapidly, so that it can deform itself according to the shape of the wound, so that the negative pressure foam dressing can Completely tight in the wound.
請參閱第一圖及第二圖所示,本發明實施例係包含有負壓泡棉敷料(1)、負壓控制器(2)、壓力感測器(3)及傳輸單元(4),其中:Please refer to the first and second figures. The embodiment of the present invention includes a negative pressure foam dressing (1), a negative pressure controller (2), a pressure sensor (3), and a transmission unit (4). among them:
負壓泡棉敷料(1),其係使用2~2.5mol二異氰酸酯、0.1~1mol親水性多元醇、0.5mol聚二甲矽氧烷-聚氧化烯共聚物(界面活性劑)、0.1mol乙二胺(交聯劑)與異辛酸辛(催化劑)所合成之發泡體材料,於25~50ºC下操作3分鐘,再經由發泡灌注而成為該負壓泡棉敷料(1),如第三圖所示。負壓泡棉敷料分別經由一化學熱反應、一發泡體流動、一發泡體固及一表面抗沾黏處理等程序而製成,即可製造得到該負壓泡棉敷料(1)。並藉由調整該親水性多元醇與該乙二胺之間的比例,可控制該負壓泡棉敷料(1)的吸水膨潤率為(g/g)>800%(DIN EN13726~1Part3.2/3.3)、保水率為(g/g)>50%(DIN EN13726~1Part3.2)、水氣穿透率為(g/m2 ~24hrs)≥1500g/m2 ~24hrs(ASTM E96~93BW)、密度為0.15~0.20g/cm3 (ASTM D792)、熱裂解溫度為>200℃(ASTM D3850)、回彈性為>15%(ASTM D3574)、延展性為35~45%(ASTM D41275)等特性。藉以填塞於一傷口(B)內時,而能迅速吸收該傷口(B)之滲液而膨脹,使其可以自行配合該傷口(B)的形狀產生形變,而完全密合於該傷口(B),以調整符合臨床負壓傷口治療時所需特性。又該負壓泡棉敷料(1)之表緣係覆蓋有一氣密件(11),藉以維持該負壓泡棉敷料(1)之氣密性,該氣密件(11)係可為一不透氣膠膜。Negative pressure foam dressing (1), which uses 2 to 2.5 mol of diisocyanate, 0.1 to 1 mol of hydrophilic polyol, 0.5 mol of polydimethylsiloxane-polyoxyalkylene copolymer (surfactant), 0.1 mol of ethyl The foam material synthesized by diamine (crosslinking agent) and octanoic acid (catalyst) is operated at 25 ~ 50ºC for 3 minutes, and then is made into the negative pressure foam dressing (1) through foaming infusion, as described in Section See three pictures. The negative pressure foam dressing (1) can be manufactured through procedures such as a chemical thermal reaction, a foam flow, a foam solidification and a surface anti-adhesion treatment. And by adjusting the ratio between the hydrophilic polyol and the ethylenediamine, the water absorption swelling ratio of the negative pressure foam dressing (1) (g / g)> 800% (DIN EN13726 ~ 1Part3.2 /3.3), water retention rate (g / g)> 50% (DIN EN13726 ~ 1Part3.2), water vapor transmission rate (g / m 2 ~ 24hrs) ≥1500g / m 2 ~ 24hrs (ASTM E96 ~ 93BW ), Density is 0.15 ~ 0.20g / cm 3 (ASTM D792), thermal cracking temperature is> 200 ° C (ASTM D3850), resilience is> 15% (ASTM D3574), ductility is 35 ~ 45% (ASTM D41275) And other characteristics. When it is packed in a wound (B), it can quickly absorb the exudate of the wound (B) and swell, so that it can cooperate with the shape of the wound (B) to deform itself, and completely fits in the wound (B ) To adjust the characteristics required for clinical negative pressure wound treatment. The surface of the negative pressure foam dressing (1) is covered with an airtight member (11), so as to maintain the airtightness of the negative pressure foam dressing (1), the airtight member (11) may be an airtight Film.
負壓控制器(2),其係設有一負壓管(21)與該負壓泡棉敷料(1)相連通。該負壓控制器(2)係可供設定一輸送壓力值,然後根據該輸送壓力值,該負壓控制器(2)可控制該負壓管(21)輸出一壓力至該負壓泡棉敷料(1),使該負壓泡棉敷料(1)產生一負壓環境。The negative pressure controller (2) is provided with a negative pressure tube (21) and communicates with the negative pressure foam dressing (1). The negative pressure controller (2) can be used to set a conveying pressure value, and then according to the conveying pressure value, the negative pressure controller (2) can control the negative pressure pipe (21) to output a pressure to the negative pressure foam The dressing (1) causes the negative pressure foam dressing (1) to create a negative pressure environment.
該負壓控制器(2)係為可提供一循環負壓模式之負壓抽吸泵浦,該負壓控制器(2)可以設定一輸送壓力值從-40mmHg至-140mmHg之間。該負壓控制器(2)係設有一顯示螢幕(22),以供顯示該負壓控制器(2)輸出至該負壓環境之該壓力及所設定之該輸送壓力值。該負壓控制器(2)係以電池做為動力的來源。The negative pressure controller (2) is a negative pressure suction pump capable of providing a cyclic negative pressure mode. The negative pressure controller (2) can set a delivery pressure value from -40mmHg to -140mmHg. The negative pressure controller (2) is provided with a display screen (22) for displaying the pressure output by the negative pressure controller (2) to the negative pressure environment and the set delivery pressure value. The negative pressure controller (2) uses a battery as a source of power.
又該循環負壓模式之壓力值設定區分為四種以供交互選擇使用,第一種為連續式(continuous)壓力抽吸傷口,持續性地給予固定負壓(-125mmHg)在傷口敷料;第二種為間歇式(intermittent)壓力抽吸傷口,先施予固定負壓(-125mmHg)抽吸5分鐘,接著進入2分鐘休息模式(0mmHg)為一循環;第三種為動態式(Dynamic),動態地給予負壓循環,3分鐘內達到特定負壓(-125mmHg),接著在3分鐘內回到較小負壓(-25mmHg)為一循環;第四種為循環模式,結合上述多種模式循環。In addition, the pressure value setting of the cyclic negative pressure mode is divided into four types for interactive selection. The first type is continuous pressure suction wound, and a fixed negative pressure (-125mmHg) is continuously given to the wound dressing. Two types are intermittent pressure suction wounds. First, a fixed negative pressure (-125mmHg) is applied for 5 minutes, and then a 2 minute rest mode (0mmHg) is entered for one cycle. The third type is dynamic. , Give the negative pressure cycle dynamically, reach a specific negative pressure (-125mmHg) within 3 minutes, and then return to a smaller negative pressure (-25mmHg) as a cycle within 3 minutes; the fourth is a circulation mode, combining the above multiple modes cycle.
因此本發明實施例之該循環負壓模式包含一連續模式與一間歇模式,其係採用上述第一種連續式及第二種間歇式予以混合交互使用。當該負壓控制器(2)之該循環負壓模式進行到連續模式時,則會提供負壓之該壓力持續供給該傷口(B),當進行至該間歇模式時,該負壓控制器(2)會轉換壓力,連續以負壓抽吸5分鐘後,再休息釋放壓力2分鐘。Therefore, the cyclic negative pressure mode of the embodiment of the present invention includes a continuous mode and an intermittent mode, which are mixed and used by using the first continuous type and the second intermittent type described above. When the cyclic negative pressure mode of the negative pressure controller (2) proceeds to the continuous mode, the pressure that provides negative pressure is continuously supplied to the wound (B), and when it proceeds to the intermittent mode, the negative pressure controller (2) The pressure will be changed. After 5 minutes of continuous suction with negative pressure, rest and release the pressure for 2 minutes.
壓力感測器(3),其係訊號連接至該負壓控制器(2),該壓力感測器(3)係可設置於該負壓泡棉敷料(1)內,藉以隨時感應該負壓環境內的該壓力變化,當該壓力超出該負壓控制器(2)所設定之該輸送壓力值時,該壓力感測器(3)則會輸出一訊號至該負壓控制器(2),藉以調整輸出之該壓力,以確保該傷口(B)之該負壓環境維持在該輸送壓力值之範圍內。A pressure sensor (3), whose signal is connected to the negative pressure controller (2), the pressure sensor (3) can be set in the negative pressure foam dressing (1) to sense the negative pressure at any time The pressure change in the pressure environment, when the pressure exceeds the delivery pressure value set by the negative pressure controller (2), the pressure sensor (3) will output a signal to the negative pressure controller (2 ) To adjust the output pressure to ensure that the negative pressure environment of the wound (B) is maintained within the range of the delivery pressure value.
傳輸單元(4),其係訊號連接至該負壓控制器(2),以供將該輸送壓力值及該壓力之數據資料傳輸至一遠端裝置(C)進行監控及一雲端資料庫(D)進行大數據分析及整合。該遠端裝置(C)係可為醫護人員、使用者、照護者等相關人員所持有之一智慧型手機、一平板電腦、一個人電腦或一筆記型電腦。又該傳輸單元(4)係可透過網際網路、行動通訊網路、Wi-Fi、ZigBee或藍牙進行數據資料的傳輸。A transmission unit (4) is connected to the negative pressure controller (2) for transmitting the pressure value and the pressure data to a remote device (C) for monitoring and a cloud database ( D) Perform big data analysis and integration. The remote device (C) can be a smart phone, a tablet computer, a personal computer, or a notebook computer held by medical personnel, users, caregivers and other related personnel. The transmission unit (4) can transmit data through the Internet, mobile communication network, Wi-Fi, ZigBee or Bluetooth.
使用時,如第一圖及第二圖所示,係將該負壓泡棉敷料(1)予以填塞於該傷口(B)上,再於該負壓泡棉敷料(1)之表緣覆蓋有該氣密件(11),藉以維持該負壓泡棉敷料(1)之該負壓環境內的氣密性。利用該負壓泡棉敷料(1)是一個特製的多孔開放性泡棉,使用二異氰酸酯、親水性多元醇、聚二甲矽氧烷-聚氧化烯共聚物(界面活性劑)、乙二胺(交聯劑)與異辛酸辛(催化劑)所合成,透過在傷口(B)上施加負壓,使創面均勻接受負壓而縮小,還能起到引流的作用,同時充填局部缺損,去除過多的滲出物,藉由提供該傷口(B)閉合一個相對濕潤的環境,減輕該傷口(B)周圍組織水腫,並刺激肉芽組織增生。如此,有別於現今習知所使用之敷料必須要經過裁切適當尺寸後,再予以填塞入傷口中的方式。而本發明實施例是透過該負壓泡棉敷料(1)本身具有高度膨潤率,及接觸該傷口(B)滲液後予以吸收,並依據該傷口(B)的形狀而自行發生形變的特性,使該負壓泡棉敷料(1)可以在該傷口(B)內進行膨脹並迅速完全密合。During use, as shown in the first and second figures, the negative pressure foam dressing (1) is stuffed on the wound (B), and then the surface edge of the negative pressure foam dressing (1) is covered. The airtight member (11) is used to maintain the airtightness in the negative pressure environment of the negative pressure foam dressing (1). The negative pressure foam dressing (1) is a special porous open foam, which uses diisocyanate, hydrophilic polyol, polydimethylsiloxane-polyoxyalkylene copolymer (surfactant), and ethylenediamine. (Crosslinking agent) Synthesized with octanoic acid (catalyst). By applying negative pressure on the wound (B), the wound surface can be evenly reduced by negative pressure, and it can also play the role of drainage, while filling local defects and removing too much. The exudate of the wound reduces the edema of the tissue surrounding the wound (B) by providing the wound (B) with a relatively humid environment, and stimulates the growth of granulation tissue. In this way, it is different from the way in which the dressing used in the conventional practice must be cut into an appropriate size and then packed into the wound. In the embodiment of the present invention, the negative pressure foam dressing (1) itself has a high degree of swelling, and is absorbed after contacting with the exudation of the wound (B) and deforms itself according to the shape of the wound (B). , So that the negative pressure foam dressing (1) can be swelled in the wound (B) and quickly and completely adhered.
再經由啟動該負壓控制器(2),以設定負壓之該輸送壓力值,使該負壓控制器(2)可藉由該負壓管(21)輸出該壓力至該負壓泡棉敷料(1)。利用該負壓控制器(2)搭配該負壓泡棉敷料(1)形成該負壓環境,使該負壓泡棉敷料(1)填塞進入傷口後,當該負壓管(21)開始負壓抽吸,藉由產生的負壓以移除該傷口(B)多餘滲液、傳染性物質、壞死的組織碎片,又該負壓的循環負壓模式係為連續模式與間歇模式,該輸送壓力值最大可低至-140mmHg。Then, by activating the negative pressure controller (2), the delivery pressure value of the negative pressure is set, so that the negative pressure controller (2) can output the pressure to the negative pressure foam through the negative pressure pipe (21). Dressing (1). The negative pressure controller (2) is used with the negative pressure foam dressing (1) to form the negative pressure environment. After the negative pressure foam dressing (1) is stuffed into the wound, the negative pressure tube (21) starts to be negative. The vacuum suction is used to remove the excess exudate, infectious substances, and necrotic tissue fragments of the wound (B) by the negative pressure generated, and the cyclic negative pressure mode of the negative pressure is continuous mode and intermittent mode. The delivery The maximum pressure value can be as low as -140mmHg.
又再藉由該壓力感測器(3)可以隨時感應該負壓環境內的該壓力變化,藉以於該壓力超出該負壓控制器(2)所設定之該輸送壓力值時,該壓力感測器(3)則會輸出該訊號至該負壓控制器(2),藉以調整該輸送壓力值,使該壓力維持於該輸送壓力值的範圍內,藉以確保該傷口(B)之該負壓環境維持在一定的壓力下。Then, the pressure sensor (3) can sense the pressure change in the negative pressure environment at any time, so that when the pressure exceeds the delivery pressure value set by the negative pressure controller (2), the pressure feeling The detector (3) will output the signal to the negative pressure controller (2), so as to adjust the delivery pressure value so that the pressure is maintained within the range of the delivery pressure value, thereby ensuring the negative pressure of the wound (B). The pressure environment is maintained under a certain pressure.
同時該傳輸單元(4)係會將該輸送壓力值傳輸至該遠端裝置(C),進行監測該傷口(B)之癒合或感染狀態,一旦該壓力超出該輸送壓力值時,例如漏氣或壓力異常時,則會發出警示,以通知位於該遠端裝置(C)之相關人員進行維修或處置,可防止該傷口(B)因延遲處理造成惡化的情形出現。以及可傳輸至該雲端資料庫(D)進行大數據分析及整合,以供其他相關單位做為治療時之參考。At the same time, the transmission unit (4) will transmit the delivery pressure value to the remote device (C) to monitor the healing or infection status of the wound (B). Once the pressure exceeds the delivery pressure value, such as air leakage If the pressure is abnormal, a warning will be issued to notify the relevant personnel located at the remote device (C) for repair or treatment, which can prevent the wound (B) from worsening due to delayed treatment. And can be transferred to the cloud database (D) for big data analysis and integration, for other related units as a reference when treatment.
又本發明係已經由動物試驗,以證明其確實可據以實現,試驗內容如下所示。The present invention has been tested by animals to prove that it can be implemented. The test content is shown below.
(a)第一年以兔、豬等動物(E)做為動物傷口癒合模型之研究。兔子及豬為動物實驗中之中、大型動物,使用兔子較為方便做測試以及觀察,得到初步的結果後,進行至以豬為動物傷口癒合模型。實驗的豬雖然價格較為昂貴,但長久以來運用於研究發展,其遺傳、生理、解剖、營養及育種的知識與技術都已非常成熟,並且與人類更為相近,因此成為臨床前動物試驗的最佳選項。(a) In the first year, rabbits, pigs and other animals (E) were used as animal wound healing models. Rabbits and pigs are medium and large animals in animal experiments. It is more convenient to use rabbits for testing and observation. After obtaining preliminary results, pigs are used as animal wound healing models. Although the experimental pigs are more expensive, they have been used for research and development for a long time. Their genetics, physiology, anatomy, nutrition, and breeding knowledge and technology have been very mature and closer to humans, so they have become the most preclinical animal experiments. Good option.
負壓傷口治療(NPWT)用於蘭嶼豬之治療,係於蘭嶼豬背上脊椎兩側創建直徑為5cm之圓形全層皮膚傷口,左右兩側各5處共10處傷口。傷口創建後使用0.9%生理食鹽水潤濕的紗布輕壓傷口以止血,以相鄰(對側)的兩個傷口為一組。實驗過程在第2天及第5天更換敷料,負壓治療系統〔負壓控制器(2)及壓力感測器(3)〕與壓力監測系統〔遠端裝置(C)〕連接,經由值班人員看顧,以盡量減少治療中斷。傷口在第0、2、5、7天拍照紀錄並測量傷口面積及深度,於第7天安樂死。取下傷口處及周圍全層皮膚組織,使用組織切片不同染色方法,觀察傷口在使用敷料後癒合的情形。Negative Pressure Wound Therapy (NPWT) is used in the treatment of Lanyu pigs. It creates a circular full-thickness skin wound with a diameter of 5cm on both sides of the spine on the back of Lanyu pigs. There are 10 wounds on the left and right sides. After the wound was created, the wound was gently pressed with gauze moistened with 0.9% physiological saline to stop bleeding, and two adjacent (opposite) wounds were used as a group. The dressing was changed on the 2nd and 5th days of the experiment. The negative pressure treatment system [negative pressure controller (2) and pressure sensor (3)] was connected to the pressure monitoring system [remote device (C)] and was on duty. Staff visits to minimize interruptions in treatment. The wound was photographed and recorded on day 0, 2, 5, and 7 and the area and depth of the wound were measured. On day 7, the wound was euthanized. Take off the wound and the whole layer of skin tissue, and use tissue sections with different staining methods to observe the wound healing after using the dressing.
(b)使用智慧型控制負壓傷口系統於動物傷口癒合過程中,觀察細胞分化、功能及分泌細胞激素的影響與其機制。取下傷口處小塊的組織,加入Trizol與少量鋼珠均質,進行RNA純化,透過PCR的放大作用觀察傷口內細胞的分化、功能的情形,以及各傷口癒合階段細胞激素的分泌情況,以了解聚氨酯敷料對於幹細胞與內皮細胞接受分化刺激、基因表現量、細胞激素的分泌以及功能性測試的改變。可利用COX2,IL1-β以及TNF-α觀察發炎反應,以及CD31觀察血管新生進而促進傷口癒合之反應。(b) Use the intelligent control negative pressure wound system in the process of animal wound healing to observe the effects of cell differentiation, function, and secretion of cytokines and their mechanisms. Remove the small piece of tissue at the wound, add Trizol and a few steel balls to homogenize it for RNA purification, observe the differentiation and function of cells in the wound through the amplification of PCR, and the secretion of cytokines in each wound healing stage to understand the polyurethane Changes in dressings on stem cells and endothelial cells undergoing differentiation stimulation, gene expression, cytokine secretion, and functional testing. COX2, IL1-β, and TNF-α can be used to observe the inflammatory response, and CD31 can be used to observe the response of angiogenesis to promote wound healing.
(c)第二年以智慧型控制負壓傷口系統促進糖尿病大鼠慢性傷口癒合。在慢性的傷口癒合中,傷口由於某些不利影響因素如感染、異物等導致傷口癒合過程受阻,癒合時間超過三個月,則稱之為慢性傷口。參考實驗室先前所建立之糖尿病大鼠模型(Hsueh et al.,2016),模擬慢性難癒合之傷口經由藥物釋放敷料覆蓋後,促進傷口癒合之效果。禁食48小時後,腹腔內注射SD大鼠(270-300g)。糖尿病組動物每日接受腹腔內注射Streptozotocin(STZ)70mg/kg(STZ溶於檸檬酸鹽緩衝液,pH4.5),連續注射21天。注射後大鼠需禁食8小時。在STZ注射後每天觀察及記錄每隻大鼠的血糖以及體重,通過監測確認大鼠糖尿病狀態,血糖升高至超過250mg/dl。便可證實成功誘導糖尿病大鼠。(c) Promote chronic wound healing in diabetic rats with intelligent control of negative pressure wound system in the second year. In chronic wound healing, the wound healing process is blocked due to certain adverse factors such as infection and foreign bodies. The healing time is more than three months, which is called chronic wound. Reference to a previously established diabetic rat model in the laboratory (Hsueh et al., 2016) simulates the effect of chronic wounds that are difficult to heal after being covered with a drug release dressing to promote wound healing. After fasting for 48 hours, SD rats (270-300g) were injected intraperitoneally. Animals in the diabetic group received intraperitoneal injection of Streptozotocin (STZ) 70 mg / kg (STZ in citrate buffer, pH 4.5) daily for 21 consecutive days. Rats need to fast for 8 hours after injection. After STZ injection, the blood glucose and weight of each rat were observed and recorded daily. The diabetes status of the rats was confirmed by monitoring, and the blood glucose increased to more than 250 mg / dl. This confirms the successful induction of diabetic rats.
在傷口癒合的過程中,分為發炎期、增生期以及修復期,傷口區需要大量的細胞聚集以進行組織再生,在手術後第2、5、7天進行傷口處觀察,並且於第2、5天進行敷料更換。犧牲蘭嶼豬並取下皮膚後,使用組織切片不同染色方法,觀察傷口在使用敷料後癒合的情形。皮膚傷口組織採樣分析在五個取樣時間點(第0、2、5、7天)分別取下傷口周圍之皮膚、肌肉及脂肪組織樣本。以及於第28天將小鼠犧牲後,取下其傷口處皮膚組織,將以上之組織樣本以4% paraformaldehyde固定後,將標本置於一系列遞增的酒精中脫水,再置換成二甲苯,最後以石臘浸潤包埋。石臘標本以滑動式切片機,切成10微米厚度之切片,將切片於溫水浴中展平,並載於玻片上。將玻片置於40℃烤盤過夜,幫助切片與玻片之黏著。之後再將含切片之玻片置於二甲苯與酒精中漸漸置換為水,進行脫臘的步驟,將脫臘後的標本做以下染色分析。In the process of wound healing, it is divided into the inflammatory phase, the proliferative phase, and the repair phase. A large number of cells need to be aggregated for tissue regeneration in the wound area. Dressing changes were performed 5 days. After sacrificing the Lanyu pig and removing the skin, different staining methods of tissue sections were used to observe the wound healing after using the dressing. Skin and wound tissue sampling and analysis At five sampling time points (days 0, 2, 5, and 7), skin, muscle, and adipose tissue samples were taken from the wounds. And on the 28th day, the mice were sacrificed, and the skin tissue at the wound was removed. After fixing the above tissue samples with 4% paraformaldehyde, the specimens were dehydrated in a series of increasing alcohols, and then replaced with xylene. Soak in paraffin. The paraffin specimen was cut into 10 micron thick slices using a slide microtome, and the slices were flattened in a warm water bath and placed on a glass slide. Place the slides on a baking tray at 40 ° C overnight to help the section adhere to the slides. After that, the slides containing the sections were gradually replaced with water in xylene and alcohol, and the dewaxing step was performed. The dewaxed samples were subjected to the following staining analysis.
(c1)蘇木素-伊紅染色Hematoxylin & eosin(H&E)stain:比較不同組別之間傷口發炎反應的差異性,以及組成。(c1) Hematoxylin & eosin (H & E) stain staining: comparing the differences in wound inflammation and composition between different groups.
(c2)梅森三色染色法Masson’s trichrome stain:觀察膠原蛋白纖維的成分是否改變,於正常處的膠原蛋白表現為藍色低張力膠原蛋白(Low tension COL),而在傷口處表現為紅色高張力膠原蛋白(High tension COL)。並利用影像處理軟體量化梅森三色染色影像,以證實高張力與低張力膠原蛋白的改變。(c2) Masson's trichrome stain: observe whether the composition of the collagen fibers has changed. The collagen in the normal place appears as blue low tension collagen (COL) and the wound shows red high tension. Collagen (High tension COL). The image processing software was used to quantify Mason's trichrome staining images to confirm the changes in high tension and low tension collagen.
(c3)免疫組織化學染色法immunohistochemistry(IHC):觀察發炎細胞因子介白素-1(IL-1)、介白素-6(IL-6)IL-6屬於前發炎型細胞激素及抗發炎型細胞激素,以及膠原蛋白第一型collagen I,觀察傷口表皮癒合的情形。(c3) immunohistochemistry (IHC): observe the inflammatory cytokines interleukin-1 (IL-1), interleukin-6 (IL-6), and IL-6 are pre-inflammatory cytokines and anti-inflammatory Type I cytokines, and collagen type I collagen I, observe the wound epidermal healing.
本發明經由上述動物試驗後證實成效卓著未來將會朝向以醫療院所(F)之人體實際的臨床試驗著手,藉以證明本發明確實可以達到上述之功效。The invention has proved to be very effective after the above-mentioned animal tests. In the future, it will be started with actual clinical tests on humans in medical institutions (F), so as to prove that the invention can indeed achieve the above-mentioned effects.
綜合上述實施例之說明,當可充分瞭解本發明之操作、使用及本發明產生之功效,惟以上所述實施例僅係為本發明之較佳實施例,當不能以此限定本發明實施之範圍,即依本發明申請專利範圍及發明說明內容所作簡單的等效變化與修飾,皆屬本發明涵蓋之範圍內。Based on the description of the above embodiments, the operation, use and effects of the present invention can be fully understood, but the above-mentioned embodiments are only preferred embodiments of the present invention, and the implementation of the present invention cannot be limited in this way. The scope, that is, the simple equivalent changes and modifications made according to the scope of the patent application and the description of the invention, are all within the scope of the present invention.
(1)‧‧‧負壓泡棉敷料(1) ‧‧‧Negative pressure foam dressing
(11)‧‧‧氣密件(11) ‧‧‧Airtight parts
(2)‧‧‧負壓控制器(2) ‧‧‧Negative pressure controller
(21)‧‧‧負壓管(21) ‧‧‧Negative pressure tube
(22)‧‧‧顯示螢幕(22) ‧‧‧Display screen
(3)‧‧‧壓力感測器(3) ‧‧‧Pressure sensor
(4)‧‧‧傳輸單元(4) ‧‧‧Transmission unit
(A1)‧‧‧混合攪拌頭(A1) ‧‧‧ Mixing Mixer
(A2)‧‧‧模穴(A2) ‧‧‧Mould Cavity
(B)‧‧‧傷口(B) ‧‧‧ wound
(C)‧‧‧遠端裝置(C) ‧‧‧Remote device
(D)‧‧‧雲端資料庫(D) ‧‧‧Cloud Database
(E)‧‧‧動物(E) ‧‧‧Animal
(F)‧‧‧醫療院所(F) ‧‧‧Medical Institution
[第一圖]係為本發明實施例之配置使用示意圖。[First Figure] This is a schematic diagram of the configuration and use of the embodiment of the present invention.
[第二圖]係為本發明實施例使用於傷口處理之示意圖。[Second figure] is a schematic diagram of wound treatment used in the embodiment of the present invention.
[第三圖]係為本發明實施例負壓泡棉敷料之簡單製造流程圖。[Third figure] is a simple manufacturing flow chart of a negative pressure foam dressing according to an embodiment of the present invention.
Claims (10)
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CN204655770U (en) * | 2015-04-23 | 2015-09-23 | 广州新诚生物科技有限公司 | The Novel negative-pressure drainage system of wound surface pressure size can be monitored in real time |
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