Disposable antibacterial surgical incision protection sleeve

Abstract

The application discloses a disposable antibacterial surgical incision protective sleeve, which comprises a flexible inner ring, an elastic film sleeve, an outwardly folded sleeve, an antibacterial layer and a liquid absorption layer. The flexible inner ring is used for being placed into the incision to provide radial support; one end of the elastic film sleeve is connected with the inner ring and extends along the circumference of the inner ring, and the other end is outwardly folded to form the outwardly folded sleeve to cover the skin surface; the antibacterial layer is arranged on the surface of the film to achieve active sterilization; and the liquid absorption layer is arranged on the lower surface of the outwardly folded sleeve to absorb exudate. The antibacterial surgical incision protective sleeve has simple structure, and the operation time of the basic version is about 50 seconds, so that surgical site infection can be effectively prevented, and the antibacterial surgical incision protective sleeve is suitable for laparoscopic surgery, open surgery, contaminated surgery and emergency trauma surgery.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a disposable antibacterial surgical incision protector, which is particularly suitable for incision isolation and infection prevention in laparoscopic surgery, open surgery, contaminated surgery and emergency trauma surgery. Background Technology

[0002] Current status of surgical site infections Surgical site infection (SSI) is one of the most common complications of surgery. SSI not only prolongs the patient's hospital stay by three to seven days and increases medical costs, but in severe cases it can lead to surgical failure, organ dysfunction, or even endanger life.

[0003] 2.1.1 Main hazards of SSI Hazard types Specific manifestations Economic impact Prolonged hospital stay On average, it lasts three to seven days. Increased medical expenses Second surgery Approximately 5% of SSI patients require a second surgery. Increased medical expenses Antibiotic use Extend the duration of antibiotic use by five to ten days. Increased medical expenses Serious complications Sepsis, organ failure Mortality rate increased by 2% to 5%. 2.1.2 Classification of Existing Incision Protection Devices type Representative products Main features Traditional gauze covering sterile gauze Passive isolation, no antibacterial function Disposable hard ring protector Multiple domestic and foreign manufacturers Fixed structure, poor elasticity 2.2 Shortcomings of existing technologies Traditional surgical incision protection primarily involves covering with sterile gauze or using disposable incision protectors. Traditional incision protectors typically consist of a rigid plastic inner ring and a thin film, and have the following significant drawbacks: (1) Passive isolation, no antibacterial function Traditional surgical incision sheaths can only physically separate the incision from external tissues; they cannot actively kill bacteria. During surgery, repeated insertion and removal of instruments may introduce surface bacteria (such as Staphylococcus epidermidis, Staphylococcus aureus, and Escherichia coli) into deeper tissues, increasing the risk of surgical site infection (SSI).

[0004] According to the US CDC's Surgical Site Infection Prevention Guidelines (2017 edition), approximately 30% to 40% of SSI pathogens originate from the edges of skin incisions, areas that traditional protective sleeves cannot cover.

[0005] (2) Limited leachate treatment capacity Intraoperative exudate and blood seep down the outer wall of the protective sheath, easily contaminating the sterile area and affecting the clarity of the surgical field. According to clinical research, approximately 40% of laparoscopic surgeries require the additional use of suction devices and wiping due to exudate issues, increasing surgical time and the risk of infection.

[0006] (3) Biocompatibility of materials Some traditional products use materials such as polyvinyl chloride (PVC), which contain phthalate plasticizers. These plasticizers may leach out after prolonged contact with tissues, affecting tissue healing and potentially causing foreign body reactions in severe cases. According to the ISO 10993 series of standards, materials implanted or in contact with the human body must undergo rigorous biocompatibility evaluation.

[0007] (4) Insufficient ease of operation Some high-end protective cases have complex structures, including multi-layer structures, valves, connecting pipes and other components. The installation process involves many steps, which affects the efficiency of the operation, and they are not suitable for emergency rescue scenarios.

[0008] (5) Limited scope of application Existing products are mostly available in a single specification, which makes it difficult to meet the surgical needs of different incision sizes, especially for pediatric surgery and patients with special body types (such as obese patients).

[0009] 2.3 Clinical Needs and Market Prospects With the rapid development of minimally invasive surgery, laparoscopic surgery has placed higher demands on incision protection: Demand type Specific requirements Active antibacterial Continuous sterilization of the incision edges reduces the incidence of SSI. Leakage Management Effective absorption or drainage of exudate, keeping the surgical field dry. Easy to operate Installation can be completed in one minute with one hand. Biocompatibility The material is safe and does not cause foreign body reactions. Applicable to multiple specifications Adaptable to different incision sizes and surgical types Cost controllable Suitable for large-scale clinical application Therefore, developing a novel incision protective sleeve that integrates simple structure, convenient operation, active antibacterial function, and exudate management has significant clinical value and market prospects. Summary of the Invention

[0010] 3.1 Purpose of the Invention The purpose of this invention is to provide a disposable antibacterial surgical incision protector. By setting an antibacterial layer on the surface of an elastic film and setting an absorbent layer on the lower surface of the everted sleeve, it achieves the dual functions of active antibacterial and exudate absorption. At the same time, it has a simple structure and is easy to operate (the basic version can be completed within one minute), which can effectively reduce the incidence of surgical site infection.

[0011] 3.2 Technical Solution 3.2.1 Overall Architecture The present invention adopts the following technical solution: a disposable antibacterial surgical incision protective sleeve, comprising five core components: a flexible inner ring, an elastic thin film sleeve, an everted sleeve, an antibacterial layer, and an absorbent layer.

[0012] Serial Number Component Name Functional positioning Core features 1 Flexible inner ring Support structure It can automatically recover from deformation and support the cut edges. 2 Elastic film sleeve isolation structure Covers the entire incision layer, providing a protective barrier. 3 Outward-facing sleeve Fixed structure Cover the skin surface and fix the overall position. 4 Antibacterial layer Functional layer Actively kill contact bacteria 5 Absorbent layer Functional layer Absorb exudate and keep the surgical field dry. 3.2.2 Core Technical Features Feature 1: Shape memory alloy flexible inner ring The flexible inner ring is made of nickel-titanium shape memory alloy and has the following technical features: characteristic parameter Technical effect Deformation capability It can be compressed to 30% of its original diameter. Easy to insert the incision recovery ability Automatic recovery after external force is removed No additional fixing required support force Keep the incision open Facilitates instrument operation Surface treatment Medical silicone coating Smooth and non-irritating Specification 20 / 30 / 40 / 50 / 60 / 80 mm Adaptable to different incisions Optionally, the inner ring can be an inflatable hollow silicone structure, and the diameter of the inner ring can be adjusted by the amount of air inflated, which is suitable for scenarios that require precise control of the inner diameter.

[0013] Feature 2: Elastic film sleeve The elastic film sleeve is made of medical-grade thermoplastic polyurethane elastomer (TPU) film and has the following technical characteristics: characteristic parameter Technical effect elasticity Elongation greater than or equal to 400 percent Adapt to different incision depths strength Tensile strength greater than or equal to 20 MPa Tear Resistance thickness Fifty micrometers to one hundred and fifty micrometers Lightweight and space-saving Biocompatibility Compliant with ISO 10993 Safe and non-irritating Surface treatment Plasma pretreatment Enhance coating adhesion Optionally, the elastic film material may be thermoplastic polyester elastomer (TPEE), silicone elastomer, or other medical-grade elastic materials.

[0014] Feature 3: Nano-silver antibacterial coating The antibacterial layer is disposed on the inner surface of the elastic film (facing the cut side) and adopts nano-silver coating technology: characteristic parameter Technical effect Antibacterial ingredients Nano silver particles Broad-spectrum antibacterial Particle size Ten to fifty nanometers Large specific surface area and high sterilization efficiency Coating methods Dip coating or spray coating The process is simple and the cost is controllable. Silver content Approximately 0.5 to 2 milligrams per square centimeter Sustained release Antibacterial spectrum Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, etc. Covering common pathogens Optionally, the antibacterial layer may be made of silver ion exchange resin coating, silver chitosan composite coating, or other inorganic or organic antibacterial materials with broad-spectrum antibacterial function.

[0015] Feature 4: Composite liquid absorption layer The absorbent layer is located on the lower surface of the outward-facing sleeve (towards the skin) and is made of a high-molecular absorbent material. Material Liquid absorption ratio Features Sodium carboxymethyl cellulose fiber felt Eight to twelve times Mature technology Alginate fiber felt Ten to fifteen times Gel formation, bacteria-proof and breathable Chitosan fiber felt Six to ten times Natural antibacterial Sodium polyacrylate superabsorbent resin fiber Fifteen to twenty times Large liquid absorption Composite fiber felt Twelve to twenty times Excellent overall performance Optionally, the liquid-absorbing layer may be any combination or composite structure of the aforementioned materials.

[0016] Feature 5: Traffic Generation Design The elastic film sleeve is provided with at least one drainage hole with a diameter of two to five millimeters for natural gravity drainage.

[0017] The full-featured version can be equipped with a negative pressure drainage interface, located on the edge of the everted sleeve, for connecting to the central negative pressure system of the operating room to achieve active drainage.

[0018] Optionally, the drainage port may be equipped with a one-way valve to prevent backflow contamination.

[0019] 3.2.3 Overall Structural Relationships 3.3 Beneficial Effects Compared with the prior art, the present invention has the following beneficial effects: Serial Number Beneficial effects Technical Mechanism 1 Active antibacterial The nano-silver coating continuously releases silver ions, killing bacteria upon contact and effectively reducing the risk of SSI (Solar Infection Syndrome). 2 Leakage Management The aspirating layer effectively absorbs exudate, keeps the surgical field dry, and reduces the need for suction devices. 3 Easy to operate The basic version requires only three steps and can be completed in under a minute; the shape memory alloy inner ring automatically restores its shape. 4 Multiple specifications available Six inner diameter options to accommodate different incision sizes 5 Biocompatibility TPU material contains no plasticizers, has good biocompatibility, and meets ISO 10993 requirements. 6 Cost controllable Suitable for large-scale clinical application 7 Wide range of applications Suitable for various scenarios including laparoscopic surgery, open surgery, contaminated surgery, and emergency trauma surgery. 8 Dual-version strategy The basic version meets basic needs, while the full-featured version meets advanced needs. 3.4 Overview of the Invention's Key Elements The core inventive point of this invention is: Structural innovation: For the first time, active antibacterial function is combined with elastic film cut-out protective sleeve to form a three-in-one structure of "isolation, antibacterial and liquid absorption"; Material innovation: The combination of nano-silver coating and TPU elastic film achieves sustained-release antibacterial function; Technological innovation: The shape memory alloy inner ring design enables one-handed operation and rapid installation within one minute; Product strategy: A dual-track strategy of basic and full-featured versions to meet the needs of different market segments. Attached Figure Description

[0020] The present invention has the following figures. Serial Number, Attachment Name, View Direction, Content Description Figure 1 Overall structural diagram and front view. The overall structure of the product, showing the positional relationship between the inner ring, membrane, and outward-facing sleeve. Figure 2 Schematic diagram of the inner ring structure (top view); schematic diagram of the circular structure and compression deformation of the shape memory alloy elastic ring. Figure 1 Explanation of serial numbers: 1—Flexible Inner Ring 2—Elastic Film Sleeve 3—Everted Sleeve 4—Antibacterial Layer 5—Absorbent Layer Figure 2 Explanation of serial numbers: 1—Flexible Inner Ring, made of shape memory alloy Detailed Implementation

[0021] 6.1 Example 1: Basic Version (Standard Product) 6.1.1 Product Specifications part Material Specification Supplier Requirements Inner Ring Nickel-titanium shape memory alloy 30 mm in diameter, 2 mm in wire diameter Medical grade membrane sleeve Thermoplastic polyurethane elastomer (TPU) Thickness 80 micrometers, width 40 millimeters Medical grade, ISO 10993 Antibacterial layer Nano silver coating The silver content is approximately one milligram per square centimeter, with a particle size of twenty to thirty nanometers. food grade Absorbent layer Sodium carboxymethyl cellulose fiber felt Weight: 80 grams per square meter; Thickness: 2 millimeters Medical grade Drainage hole - Two, each three millimeters in diameter, arranged symmetrically. - 6.1.2 Manufacturing Process Process flow (8 steps in total): Step 1: Drying TPU granules → Temperature 80 degrees Celsius, time 4 hours, to remove moisture. Step 2: Blowing film → Temperature 180 to 220 degrees Celsius, thickness 80 micrometers ± 10 micrometers Step 3: Plasma pretreatment → Power 100 to 200 watts, time 2 to 5 minutes, to increase surface tension Step 4: Nano silver coating → Dip coating or spray coating, concentration 0.5% to 2%, dry and cure. Step 5: CMC fiber felt lamination → Hot pressing lamination onto the outward-facing part, temperature 80 to 100 degrees Celsius. Step 6: Installation of the shape memory alloy ring → Bend it into a ring and weld it to one end of the film. Step 7: Fold the outward-facing sleeve → Punch the drainage hole Step 8: Packaging sterilization → Ethylene oxide sterilization, 50 degrees Celsius ± 5 degrees Celsius, 12 hours 6.1.3 Usage Method Steps, operation descriptions, time considerations 1. Open the aseptic packaging and check the expiration date and packaging integrity within five seconds. 2. Compress the inner ring of the shape memory alloy for ten seconds until it is reduced to fifty percent of its original diameter. 3. Insert the inner ring into the incision. After ten seconds, the inner ring will be fully inserted into the incision. 4. Release the inner ring; it will automatically return to a circular shape. Confirm the inner ring supports the cut edge within five seconds. 5. Flip the sleeve over the skin surface for fifteen seconds to ensure complete coverage. 6. Check the fixation for five seconds to confirm there is no looseness or leakage. Total - Approximately 50 seconds - 6.1.4 Quality Standards Testing items, standards, requirements, and testing methods Tensile strength greater than or equal to 20 MPa (ISO 527) Elongation at break ≥ 400% ISO 527 Silver content is approximately 0.8 to 1.2 mg per square centimeter (ICP-MS) Liquid absorption volume greater than or equal to eight times its own weight (GB / T 2294) Ethylene oxide residue must be less than or equal to 10 micrograms per gram (GB / T 14233.1) Aseptic technique GB / T 14233.2 6.2 Example 2: Full-featured version (optional upgrade) 6.2.1 Differences from the Basic Version feature Basic version Full-featured version Inner Ring Shape memory alloy (fixed diameter) Inflatable silicone (adjustable diameter 30 to 50 mm) Absorbent layer CMC fiber (eight to twelve times) Composite fibers (12 to 20 times) Traffic generation methods Gravity drainage hole Negative pressure active drainage Accessibility none One-way valve to prevent backflow Operation time Approximately fifty seconds Approximately 90 seconds 6.2.2 Negative Pressure Drainage System Components of a negative pressure drainage system: Central negative pressure system (provided by the operating room) Negative pressure range: -50 to -150 kPa → Pressure regulation Negative pressure drainage port (located on the edge of the outward-facing sleeve) - Interface diameter: 6 mm (standard suction tube interface) - Check valve: Prevents backflow of exudate → Traffic generation Exudate collection bag (disposable) - Capacity: 500 to 1000 ml - Transparent material for easy observation 6.2.3 Recommended Indications Surgical type Recommended version reason Laparoscopic cholecystectomy Basic version The amount of exudate was moderate and the duration was short. Colorectal surgery Full-featured version Large leakage volume, high risk of SSI Appendectomy Basic version Simple to operate and quick Emergency Trauma Surgery Basic version The operation needs to be fast. Surgery for obese patients Full-featured version Excessive exudate, large incision 6.3 Example 3: Children's Version 6.3.1 Product Specifications part Material Specification Inner Ring Nickel-titanium shape memory alloy 20 mm in diameter, 1.5 mm in wire diameter membrane sleeve TPU Thickness 50 micrometers, width 25 millimeters Antibacterial layer Nano silver coating The silver content is approximately 0.8 milligrams per square centimeter. Absorbent layer Chitosan fiber felt 50 grams per square meter 6.3.2 Scope of Application Applicable to pediatric surgical procedures, including but not limited to: Pediatric laparoscopic appendectomy Pediatric laparoscopic hernia repair (inguinal hernia, umbilical hernia) Pediatric laparoscopic cholecystectomy Exploratory surgery for abdominal trauma in children.

Claims

1. A disposable antibacterial surgical incision protector, characterized in that, include: A flexible inner ring is used to provide radial support when inserted into the cut; An elastic film sleeve, one end of which is connected to the inner ring and extends circumferentially along the inner ring; An outward-folding sleeve, the other end of which is folded outward to cover and fix it to the skin surface around the incision; An antibacterial layer is disposed on at least one surface of the elastic film sleeve; An absorbent layer is disposed on the lower surface of the outward-facing sleeve to absorb the exudate flowing down the film.

2. The disposable antibacterial surgical incision protector as described in claim 1, characterized in that, The antibacterial layer is a nano-silver coating, which is disposed on the inner surface of the elastic film sleeve, and the nano-silver particles have a particle size of ten to fifty nanometers.

3. The disposable antibacterial surgical incision protector as described in claim 1 or 2, characterized in that, The antibacterial layer is selected from one of the following: nano silver coating, silver ion exchange resin coating, silver chitosan composite coating, or a combination coating of the aforementioned antibacterial materials.

4. The disposable antibacterial surgical incision protector as described in claim 1, characterized in that, The flexible inner ring is selected from one of the following: a shape memory alloy elastic ring, an inflatable hollow structure, an elastic solid ring, a spring support ring, or a combination of the foregoing structures.

5. The disposable antibacterial surgical incision protector as described in claim 4, characterized in that, The shape memory alloy elastic ring is made of nickel-titanium shape memory alloy, which has the characteristics of being compressible and automatically restoring a preset shape after the external force is removed.

6. The disposable antibacterial surgical incision protector as described in claim 1, characterized in that, The absorbent layer material is selected from one or more combinations of sodium carboxymethyl cellulose fiber felt, alginate fiber felt, chitosan fiber felt, sodium polyacrylate superabsorbent resin fiber, or composite fiber felt of the aforementioned materials.

7. The disposable antibacterial surgical incision protector as described in claim 1, characterized in that, The elastic film sleeve is provided with at least one drainage hole for natural gravity drainage.

8. The disposable antibacterial surgical incision protector as described in claim 7, characterized in that, It also includes a negative pressure drainage interface, which is located on the edge of the outward-facing sleeve and is used to connect a negative pressure suction device to achieve active drainage.

9. The disposable antibacterial surgical incision protector as described in claim 8, characterized in that, The negative pressure drainage interface is equipped with a one-way valve to prevent backflow of exudate.

10. The disposable antibacterial surgical incision protector as described in claim 1, characterized in that, The material of the elastic film sleeve is selected from thermoplastic polyurethane elastomer, thermoplastic polyester elastomer, silicone elastomer, or a blend of the aforementioned materials.

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