Thrombin-Carrying Hemostatic Sheet for Spine Surgery
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Solution Overview
Problem
Current hemostatic materials, such as gelatin sponges, face challenges in effectively managing hemostasis during spine surgery, particularly in limited spaces and with eruptive hemorrhages, due to issues like shape maintenance, expansion, and biological absorption.
Innovation Solution
A hemostatic sheet comprising a thermally cross-linked gelatin sponge carrying an effective amount of thrombin, with specific properties such as constant density, shape maintenance capability, low expansion, and rapid biological absorption, is developed to address these challenges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a gelatin sponge is used as a hemostatic material, then it has high water absorption properties and high biological absorption properties, but it expands and softens when absorbing blood, making it difficult to maintain shape and potentially causing it to bend or rupture under pressure
Solution Approach 1:
The gelatin sponge undergoes thermal treatment at 120-165°C for 10-30 hours to induce cross-linking, fundamentally changing its physical and chemical parameters. This cross-linking creates a more stable three-dimensional network structure that maintains shape integrity while preserving hemostatic functionality, directly resolving the contradiction between absorption capability and shape maintenance.
Solution Approach 2:
The invention combines gelatin sponge with thrombin to create a composite hemostatic material. The gelatin sponge provides the structural framework and absorption capability, while thrombin provides the hemostatic function. This composite structure allows the material to maintain shape stability through the gelatin matrix while achieving effective hemostasis through thrombin activity.
2Volume of moving object
If the hemostatic material is made thin to fit limited spaces in spine surgery, then it can be closely attached to the hemorrhage area, but it becomes more susceptible to rupture or peeling due to aspiration pressure or contact with surgical tools
Solution Approach 1:
Thermal cross-linking fundamentally alters the mechanical parameters of the gelatin sponge, creating a denser and stronger molecular network. This cross-linked structure provides enhanced tensile strength and structural integrity, allowing the material to be made thin for surgical applicability while maintaining sufficient strength to withstand surgical manipulation and aspiration pressures without rupture or peeling.
3Reliability
If compression hemostasis is performed using gauze for approximately 10 minutes, then hemorrhage is controlled, but the surgical field is occupied and subsequent surgical manipulation is hindered, sometimes forcing the surgery to be paused
Solution Approach 1:
The gelatin sponge with thrombin is designed as a disposable, single-use hemostatic material that provides rapid and effective hemostasis. Unlike gauze that requires prolonged compression and removal, this material achieves hemostasis quickly and can be left in place or easily removed without pausing surgery, eliminating the need for prolonged occupation of the surgical field.
Solution Approach 2:
The hemostatic material is pre-loaded with thrombin during manufacturing, preparing it in advance for immediate hemostatic action. When applied to the hemorrhage area, it activates clotting mechanisms rapidly without requiring prolonged compression time, enabling quick control of hemorrhage and immediate resumption of surgical manipulation.
4Reliability
If a hemostatic material containing gelatin or collagen is used instead of gauze, then it compresses the hemorrhage area according to the absorption of blood and provides both physical compression and clotting function, but it requires complicated preparation procedures and aseptic preparation when coated with thrombin solution
Solution Approach 1:
Thrombin is pre-loaded onto the gelatin sponge during the manufacturing process under controlled conditions. This preliminary action eliminates the need for complicated intraoperative preparation and aseptic handling of thrombin solution, as the hemostatic material is ready for immediate use upon removal from packaging, significantly simplifying the surgical procedure while maintaining hemostatic effectiveness.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The hemostatic sheet effectively maintains shape and functionality in wet conditions, prevents rupture or bending, exhibits low expansion properties, and is promptly biologically absorbed, thereby enhancing hemostasis during spine surgery and reducing the risk of re-hemorrhage.
Implementation Method 1
A hemostatic sheet comprising a thermally cross-linked gelatin sponge carrying an effective amount of thrombin
Implementation Method 2
A gelatin sponge has high water absorption properties and high biological absorption properties
Implementation Method 3
A hemostatic sheet comprising a thermally cross-linked gelatin sponge carrying an effective amount of thrombin
Data Source
AI summary
Provided is a thrombin-carrying hemostatic sheet that is suitable for hemostasis during surgery, in particular, for hemostasis during spine surgery, that is convenient without preparation before use, and that is bioabsorbable and can be embedded in the body as it is. The hemostatic sheet is composed of a gelatin sponge carrying an effective amount of thrombin, wherein (A) the density is 30 to 55 mg/cm3, and (B) the shape maintaining angle in wet conditions is 55 to 120°.