關於WOUNDCLOT

關於WOUNDCLOT

總之，這是對於大量出血控制好用的產品。

WoundClot旨在解決技術限制，用戶需求以及現場和手術室臨床挑戰之間的一些固有衝突。第一個挑戰是設計一種非活性的生物可吸收產品，其將快速溶解以避免臨床並發症，同時又足夠強大，足以處理大量出血，並有足夠的時間讓自然的生物學過程發生，並在現場或醫院對患者進行明確的治療。

第二個挑戰是通過創造生物穩態而不是基於壓力屏障的穩態來改善止血器的性能，其在一些情況下形成穩定且天然的凝塊，其可以緩解侵入性手術，並且顯著縮短所有情況下的患者治療。

我們希望有廣泛的使用範圍，可以治療軟組織出血，嚴重的血管損傷以及在頭部，脊椎和其他創傷性損傷中發現的非常微妙的手術。

WoundClot是第一個被批准用於治療嚴重出血的III類生物可吸收止血劑。在傷口部位生物活性穩定24-36小時，7天內完全溶解。

該產品影響凝血級聯的許多階段，這提高了凝塊形成的速度和穩定性。它顯著減少了再出血，並在某些情況下消除了侵入性關閉程序的需要。

這一切怎麼可能？

WoundClot是一種以全新的分子結構設計的基於纖維素的產品。該產品採用獨特的非氧化製造工藝生產，使產品在吸收血液時形成凝膠和膨脹。該產品可以吸收自身重量的2500％至3500％之間，而不會長時間分離或溶解。這種獨特的凝膠結構以及其新的分子設計利用物理學，生物學，生理學和化學學來實現所有這些性質。

在將傷口急救敷料放置在出血部位上時，產品獨特的凝膠將利用粘膜層與其自身之間的水合作用力，這導致強烈的物理吸引力，導致產品粘附到組織上。傷口出血壓力越強，吸引力越強。

為此，產品轉化成的凝膠類型必須被精確設計為相對較慢的形成，具有吸收出血的巨大能力而不會分解。這種吸收和維持穩定膜的能力允許大量積聚活性凝血因子以隔離在膜中。分子凝膠結構的膜靈活性允許在其中由於毛細管力而存在大量凝血因子的情況下產生快速凝固級聯的血液動力學環境。

凝固因子附著在表面組織和膜上，並且在產品中摻入專利分子基團。通過增強血小板，多種凝血因子和氨基酸的存在，使凝血過程比傷口表面快多倍且更強地起始。這大大減少了傷口的血液流量。

反過來，該過程也增加了膜對組織的粘附性，確保其在傷口部位上穩定。一旦止血和凝血級聯形成，消除了毛細血管和水合物的物理作用力，如果需要的話，可以容易地除去傷口凝塊，而不會破壞已經形成的凝塊。

操作方式

在將WoundClot敷料放置在出血部位上時，該產品的獨特凝膠利用粘膜層與其自身之間的水合力，從而導致產品對組織的粘附。傷口出血壓力越強，吸引力越強。

為此，產品轉化成的凝膠類型必須被精確設計為相對較慢的形成，具有吸收出血的巨大能力而不會分解。這種吸收和維持穩定膜的能力允許將顯著量的活性凝血因子匯集在膜中。分子凝膠結構上的膜靈活性允許在其中由於吸收能力而存在大量凝結因子的情況下產生快速凝結級聯的血液動力學環境。

凝血因子附著在表面組織和膜上，同時在產品中摻入了專利分子基團，使凝血過程迅速啟動並增加傷口表面凝塊形成的強度，血小板，多種凝血因子和氨基酸。這大大減少了傷口的血液流量。

反過來，該過程也增加了膜對組織的粘附性，確保其在傷口部位上穩定。

一旦出血停止並形成凝血級聯，毛細血管和水合物的物理作用力就會降低，如果需要的話，可以容易地除去傷口碎屑，而不會破壞已經形成的凝塊。

資料來源:

http://www.woundclot.com/about-woundclot/

http://www.woundclot.com/mode-of-operation-surgical/

WoundClot was designed to answer several inherent conflicts between technology limitations, user requirements, and clinical challenges both in the field and in the operating room.The first challenge was to design a non-active bio-absorbable product which will dissolve fairly quickly to avoid clinical complications, while at the same time be strong enough to handle massive hemorrhage for enough time to allow both the natural biological process to take place and the definitive treatment of the patient either in the field or at the hospital.

The second challenge was to improve the performance of the hemostat by creating a biological homeostasis, rather than a pressure barrier based homeostasis, that forms a stable and natural clot which could alleviate invasive procedures in some cases, and dramatically shortening patient treatment in all cases.

It was our desire to have a wide scope of use, allowing the treatment of soft tissue bleeding, major vascular injuries, and extremely delicate procedures as found in head, spine, and other traumatic injuries.

WoundClot is the first Class III bio-absorbable hemostat that is approved for the treatment of severe bleeding. It is biologically active and stable on the wound site for 24 – 36 hours, before dissolving completely within 7 days.

The product influences many stages of the coagulation cascade, which enhances both the speed, and stability of clot formation. It provides a significant reduction in re- bleeding and in some cases eliminates the need for invasive closure procedures.

How is all this possible?

WoundClot is a cellulose-based product designed with an entirely new molecular structure. The product is produced with a unique non-oxidized manufacturing process allowing the gel formation and expansion of the product upon the absorption of blood. The product can absorb between 2500% – 3500% percent of its own weight without separating or dissolving for an extended period of time. This unique gel structure along with its new molecular design harnesses applied physics, biology, physiology, and chemistry to achieve all these properties.

Upon the placement of WoundClot dressing on the bleeding site, the products unique gel harnesses the hydration forces between the mucosal layer and itself which results in a strong physical attraction that leads to the adherence of the product to the tissue. The stronger the bleeding pressures in the wound, the stronger the attraction.

For this to happen, the type of gel the product transforms into has to be precisely designed to be relatively slow forming with a vast ability to absorb bleeding without breaking down. This ability to absorb and maintain a stable membrane allows for the pooling of active coagulation factors in significant quantities to be sequestered in the membrane. The membrane flexibility of the molecular gel structure allows a hemodynamic environment in which rapid coagulation cascades are created given the large amounts of coagulation factors present due to the capillary forces.

The coagulation factors attach to the surface tissue and the membrane with the presence of a patented molecular group incorporated into the product. The coagulation process is initiated many times faster and stronger than at the surface of the wound by enhancing the presence of platelets, multiple coagulation factors, and amino acids. This dramatically reduces the flow of blood from the wound.

In turn, this process also increases the adherence of the membrane to the tissue making sure it is stable on the wound site. Once bleeding has stopped and the coagulation cascade is formed, the capillary and hydration physical forces are eliminated, allowing for the easy removal of wound clot, if desired, as one piece without disrupting the clot already formed.

MODE OF OPERATION

Upon the placement of WoundClot dressing on the bleeding site, the product’s unique gel utilizes the hydration forces between the mucosal layer and itself which results in a strong physical attraction that leads to the adherence of the product to the tissue. The stronger the bleeding pressures in the wound, the stronger the attraction.

For this to happen, the type of gel the product transforms into has to be precisely designed to be relatively slow forming with a vast ability to absorb bleeding without breaking down. This ability to absorb and maintain a stable membrane allows for the pooling of active coagulation factors in signi cant quantities to be sequestered in the membrane. The membrane exibility on the molecular gel structure allows a hemo-dynamic environment in which rapid coagulation cascades are created given the large amount of coagulation factors present due to absorption capabilities.

The coagulation factors attach to the surface tissue and the membrane with the presence of a patented molecular group incorporated into the product, allowing the coagulation process to initiate quickly and increase the strength of the clot forming at the surface of the wound by enhancing the presence of platelets, multiple coagulation factors, and amino acids. This dramatically reduces the flow of blood from the wound.

In turn, this process also increases the adherence of the membrane to the tissue making sure it is stable on the wound site.

Once bleeding has stopped and the coagulation cascade is formed, the capillary and hydration physical forces are reduced, allowing for the easy removal of WoundClot, if desired, as one piece without disrupting the clot already formed.