RU223311U1 - ATRAUMATIC COTTON PAD - Google Patents

Abstract

The utility model is intended for use as a wound covering in surgery, traumatology, cosmetology, dermatology, field or home conditions, and veterinary medicine as a local hemostatic agent for capillary, venous, arterial, and parenchymal bleeding. A sterile atraumatic cotton pad is intended for use in medical first aid packages with one or two pads, individual and ordinary bandages for self- and mutual aid for wounds. The pads are removed from the packaging of the first aid package immediately before use, observing the rules of asepsis, the pads are applied to the entrance and exit wound holes with the necessary pressure for 2-3 minutes. Once soaked in blood, the sponge adheres tightly to the bleeding surface, making the product an excellent wound sealant. Next, the atraumatic cotton pad is fixed to the body with a bandage. The technical problem being solved is the expansion of the arsenal of hemostatic agents. The technical result of the utility model is to reduce the time of blood loss in a person or animal. The sterile atraumatic cotton pad has a complex structure. To reduce the time to stop bleeding, the atraumatic hemostatic sponge is reinforced with an atraumatic textile surgical mesh, a hygroscopic soft layer of cotton and an atraumatic three-layer air bubble film made of polyethylene. Ultrasonic welding of the contact pad of the pad is carried out with a welding working tool, forming a weld in one operation. When wounded, a blood clot forms, which must contract by squeezing out blood serum (retraction) in order to bring the edges of the wound closer together in the vessel wall. For this reason, the pad uses a three-layer air bubble film; it protects the wound surface from aggressive external influences: mechanical, chemical, bacteriological. After the bleeding has stopped, the sponge is not removed, as it subsequently completely dissolves. The atraumatic cotton pad can then be safely separated from the sponge collagen on the wound surface. The innovative product has achieved a new quality of atraumaticity with broad-spectrum antimicrobial properties and thus increases the effectiveness of the hemostatic agent, which allows you to quickly stop or prevent bleeding.

Description

Utility model area.

The utility model relates to the production of disposable pads for medical and veterinary practice. The sterile atraumatic cotton pad is unique for use in military field surgery, in inpatient settings when providing specialized surgical care, outpatient medical institutions, in the field and at home, for transport injuries, cosmetology, veterinary surgery, to stop or prevent capillary, venous, arterial, parenchymal bleeding.

Prerequisites for creating a utility model.

Cotton pads are pads made of cotton and gauze that are used for medical and veterinary purposes. Pads are an important component in medical dressing packages and are necessary for early primary wound treatment during the evacuation stages. The pads are included in first aid kits, packs, kits and kits for first aid, emergency medical care, specialized medical care and palliative care.

Field medical service doctors should not forget that mortality among the wounded in most cases occurs not because the wound is fatal, but because self-help and first aid were not provided in a timely and proper manner, and the bleeding was not stopped. [1]

The currently used cotton-gauze pads produced in accordance with GOST 1179-93 (Medical dressing bags) have the following disadvantages:

The wick effect is the ability of gauze threads to absorb the contents of the wound, therefore, being in an infected wound, they support the suppurative process. All wounds, primarily gunshot wounds, are considered primarily infected.

The gauze sticks to the wound, which causes pain and disruption of the blood clot when changing the dressing.

The cotton-gauze pad is stitched at a distance of 2 cm from the edge with machine stitching, which creates depressions on the surface of the product; in these places there is no tight fit to the wound.

The pad gets wet from external moisture, such as rain. Does not protect the wound from external aggressive chemicals.

The pad does not maintain the moist environment in the wound, which is necessary for healing.

A cotton-gauze pad does not protect the wound from vibrations and mechanical shocks.

When stopping bleeding, cotton wool and gauze quickly become saturated with blood, the pad does not create the necessary protective barrier, and blood can get on the doctor’s hands.

A sterile atraumatic cotton pad is intended for use as a wound covering in surgery, traumatology, dermatology, field or home conditions, veterinary medicine as a local hemostatic agent for capillary, venous, arterial, parenchymal bleeding.

Description of the prior art.

US Pat. No. 5,230,119 A1, July 27, 1993, describes a disposable multi-layer liner consisting of a non-woven fiber core liner associated with an impervious screen having a handle. The protective shield is designed to prevent contact between the user and liquids being applied or removed. The absorbent properties of this type of pad are not ideal compared to cotton wool. [2]

Known patent EP 0819393 A1, 01/21/1998. A makeup removing pad characterized in that it contains a central part of absorbent material connected to two supporting layers of non-woven material. The absorbent properties of this type of pad are not ideal compared to cotton wool. [3]

RU 152017 U1, 04/27/2015 describes a cotton pad, oval in plan, which consists of a non-woven fabric, the relief side of which is made of cotton fibers, the flat side of the cotton pad is made of bamboo fibers. The disadvantage of this known product is that its surface cotton layer is embossed, which reduces the area of contact with the skin. [4]

Known patent RU 219063 06/27/2023. An atraumatic cotton pad is formed in the shape of a hemisphere, two absorbent cotton layers and a two-layer air bubble film sealed between them. The disc effectively cleanses, absorbs perfectly, and perfectly removes makeup with micellar water without rubbing the facial skin, while it is 400% more effective than other products. The disadvantage of the product is that when stopping bleeding, the wound must first be covered with a sterile gauze pad to prevent cotton fibers from getting into the wound. [5]

Problems solved by a utility model.

The objective of the claimed utility model is to create a sterile atraumatic cotton pad for medical and veterinary practice to stop or prevent bleeding.

Another goal is to create an atraumatic cotton pad, the layers of which can be joined using ultrasonic equipment with competitive production costs.

The technical problem being solved is the expansion of the arsenal of hemostatic agents. The technical result of the utility model is to reduce the time of blood loss in humans and animals.

Disclosure of the declared utility model.

A sterile atraumatic cotton pad is a disposable product that, having the advantages of a commonly used cotton-gauze pad, surpasses it in hemostatic quality, antimicrobial properties of a wide spectrum of action, while all elements of the product are atraumatic and are characterized by a tighter fit to the bleeding surface, stabilized pressure on the wound due to the addition of an impenetrable barrier layer of air bubble film.

The atraumatic cotton pad has a complex structure and consists of two identical layers of absorbent cotton material, connected by a middle layer of three-layer air bubble film made of polyethylene, which combines two load-bearing smooth layers and a corrugated fabric with bubbles, while one side of the pad is connected to a textile surgical mesh on which the hemostatic sponge is integrated.

The layer of absorbent cotton material must comply with GOST 5556-81 and be uniform in the pad without lumps or gaps.

The role of stabilized mechanical forces in regulating tissue growth, repair, and remodeling in cutaneous wound healing was recognized more than a century ago. [6]. When wounded, a blood clot forms, which must contract by squeezing out blood serum (retraction) in order to bring the edges of the wound closer together in the vessel wall. For this reason, the pad uses three-layer air bubble film, which must comply with GOST 16337-77. It combines two load-bearing smooth layers of polyethylene and a corrugated fabric with polyethylene bubbles between them:

has the ability to absorb vibrations and mechanical impacts;

durable, resistant to shock loads, rupture, puncture, abrasion;

provides good thermal insulation due to the low thermal conductivity of air in bubbles;

moisture- and dust-proof;

safe, non-toxic, can come into contact with an open wound;

does not lose its qualities at temperatures from -60°C to +80°C;

has light weight and low cost.

The claimed pad is atraumatic due to the damping of vibrations of polyethylene bubbles of a three-layer air bubble film; it works as stabilizers for a car in motion. The air bubble film protects the wound surface from aggressive external influences: chemical, mechanical, bacteriological. Polyethylene is non-toxic; it is used to create prosthetic products implanted into the human body. [7]

This pad is atraumatic due to the use of a textile surgical mesh, which quickly passes and distributes blood, while the covering itself remains dry, i.e. atraumatic, open weaving of the mesh reduces the risk of bacterial infections, eliminating the entry of cotton fibers into the wound. Textile surgical meshes for the treatment of redheads must comply with GOST R 50444-92.

In reconstructive surgery, textile prostheses made of nylon, lavsan, polypropylene, fluorlon, teflon, etc. are used as mesh implants. Meshes do not interfere with blood flow; they are biologically inert. The most suitable of medical polymers seems to be polypropylene, which has great softness and ductility. Scientists' long-term study of polypropylene on the human body did not reveal any signs of resorption, softening, wrinkling, stretching over time, rejection, inflammation or carcinogenic properties. Such meshes do not interfere with muscle contraction, and the patient does not experience discomfort when moving.

The pad according to the present utility model is atraumatic because a hemostatic sponge is integrated into the textile surgical mesh on the outside. After the bleeding has stopped, the sponge does not need to be removed, as it will subsequently completely dissolve. The collagen hemostatic sponge has a hemostatic and antimicrobial effect, stimulates tissue regeneration and epithelization. Prevents the spread of infection and prevents scarring. A collagen sponge on its own is not effective in cases of heavy bleeding, since it cannot withstand blood pressure during arterial and venous bleeding from large vessels; blood quickly washes the sponge out of the wound. For this reason, the atraumatic hemostatic sponge is reinforced with atraumatic textile surgical mesh, a hygroscopic soft cotton layer and atraumatic three-layer polyethylene. After the bleeding has stopped, the sponge is not removed, as it subsequently completely dissolves. The innovative product managed to achieve a new quality of atraumaticity and thus increase the effectiveness of the hemostatic agent.

The atraumatic cotton pad is made in such a way that the textile surgical mesh No. 1 (Fig. 1 and Fig. 2) with an integrated hemostatic sponge No. 2 and the middle layer of polyethylene air bubble film No. 3 are connected by ultrasonic welding with layers of cotton, while being soldered around the perimeter the edge of contact pad No. 4 runs along the perimeter and ends at a distance of 5-10 millimeters from the edge of the pad. Ultrasonic welding allows you to connect parts without the use of auxiliary materials, has high productivity and environmentally friendly technological processes. With ultrasonic welding and pressure, layers of cotton wool, polyethylene, surgical mesh and sponge are connected in a pad due to longitudinal and transverse mechanical vibrations. The result is a strong and elastic connection of the contact pad. The shape of an atraumatic cotton pad can be rectangular, round, oval, square, figured, hemisphere, or brick.

A variant of the atraumatic cotton pad (Fig. 3 and Fig. 4) according to the present utility model can be a pad that does not have a layer of absorbent cotton material on the back side. On the reverse side, the middle air bubble film is connected along its width to an overlay made of fabric No. 5; the size of the overlay should correspond to the size of the pad or be slightly smaller than it. The pad is necessary so that the unfolded end of the gauze bandage No. 6 can be passed under the pad, and the pad can be bandaged to the wound. The fabric used for the lining must have a high cotton content and meet the standards of GOST 11209-14, gauze bandage in accordance with GOST 9412-93.

Brief description of the drawings: Fig. 1. - top view of a hemisphere-shaped pad; Fig. 2. - cross-sectional view of the pad. Fig. 3. - arrangement of the details of the bandage of the first aid package with two brick-shaped pads; Fig. 4. - arrangement of the details of the first aid package bandage with two brick-shaped pads in section.

1 - textile surgical mesh;

2 - hemostatic sponge;

3 - a layer of polyethylene air bubble film;

4 - edge of the contact pad soldered around the perimeter;

5 - fabric overlay;

6 - gauze bandage;

7 - rolling up the bandage;

8 - sealed corners of the hemostatic sponge;

9 - absorbent cotton layer;

10 - fixed pad;

11 - movable pad.

A first aid package with two pads should consist of a bandage with an atraumatic cotton fixed pad, an atraumatic cotton movable pad, a gauze bandage and packaging (outer shell). The unfolded end of the bandage should be passed under the lining of the movable pad and attached by ultrasonic welding to the fixed pad No. 10 along the perimeter so that its longitudinal edges are at an equal distance from the longitudinal edges of the pad, and the length of the free end is 12-17 centimeters. Movable pad No. 11 should slide freely over the bandage. The roll of bandage No. 7 should face its open part in the direction of fastening the bandage. The atraumatic cotton pad can later be safely separated from the collagen of the sponge on the wound surface, since the hemostatic sponge is sealed to the contact area with two sides No. 8 or corners No. 9 to a depth of 5-10 millimeters. The hemostatic sponge can be integrated on one side with a textile surgical mesh by ultrasonic welding over the entire area of their contact. The elasticity of the polyethylene bubbles and the plasticity of the surgical mesh allows the pad to maintain its shape during use.

A sterile atraumatic cotton pad is intended for use in medical first aid packages, individual and ordinary bandages for self- and mutual aid in case of wounds. The pads are removed from the packaging of the first aid package immediately before use, observing the rules of asepsis, the pads are applied to the entrance and exit wound holes with the necessary pressure for 2-3 minutes. After soaking in blood, the sponge fits tightly to the bleeding surface, then the product is fixed with a bandage.

In veterinary surgery, the pad is used to stop heavy bleeding when docking ears, tails, and removing the mammary gland during mastectomy. In cosmetology, an atraumatic cotton pad is used for manicure and when cleaning the face from acne.

The innovative product managed to achieve a new quality of atraumaticity with broad-spectrum antimicrobial properties and thus increase the effectiveness of the hemostatic agent. This allows the victim or doctor to firmly press the pad into the wound cavity with the necessary force and quickly stop or prevent bleeding.

The competitive advantages of the innovative product are presented in Table 1.

The cotton-gauze pad is designated VMP in the table. The atraumatic cotton pad is designated AVP in the table.

Description of the preferred embodiment.

The following embodiment is an embodiment and may be modified accordingly within the scope of the utility model claims. The pads according to the declared usefulness can be of different sizes, for example, rectangular 10x12 cm for bandaging a first aid package. 32×17 cm for bandaging individual and regular packages. The pads can be square 6x6 cm, round with a diameter of 5.7 cm, oval 9x6 cm. The shape of the pad can follow the anatomical curves of the joint. The thickness of the pad in the center ranges from 12 mm to 18 mm.

Product purpose:

Sterile atraumatic cotton pad for use in medical first aid packages with one or two pads, when providing self- and mutual aid for wounds.

1.1 Preparation of product components:

When producing pads using this utility model, it is necessary to use high-quality, commercially produced three-layer polyethylene bubble film in accordance with GOST 16337-77, while the residual amount of foreign substances in polyethylene should not exceed standard standards. The technical characteristics of high-density polyethylene (LDPE) used as raw material for its production must comply with reference requirements.

Bubble film is a polymer material that combines two load-bearing smooth layers and a corrugated sheet with polyethylene bubbles between them. To produce an atraumatic cotton pad, it is preferable to use a commercially available three-layer film with a bubble height of 4 mm and a bubble diameter of 10 mm. Film density 180 g/m2, thickness of one layer of bubble film 90 microns. The size of the bubble film for the production of the product is 10x12 cm.

The layer of absorbent cotton material must comply with GOST 5556-81 and be uniform in the pad without lumps or gaps. The product must have a neutral ph. We use medical surgical cotton wool of a zigzag type in the product, measuring 9×11 cm. The mass of cotton wool in each pad is 4±1.5 grams. Gauze bandage according to GOST 9412-93, 10 cm wide and 5 m long.

To produce the product, a polypropylene surgical mesh measuring 10×12 cm is used according to TU 9393-001-24648800-2006. To produce the product, a hemostatic collagen sponge measuring 10×10 cm and 8 mm thick is used. On the back side of the product, the air bubble film is connected by ultrasonic welding along its width to a fabric lining. Fabric according to GOST 11209-14. the size of the pad is 9x12 cm. The pad is necessary so that the unfolded end of the gauze bandage can be passed under the pad, and the pad can be bandaged to the wound.

1.2. Ultrasound equipment. Main technical characteristics:

Power, VA, no more than 400. Ultrasonic vibration frequency, kHz 22±1.65. Power supply from AC mains voltage, V 220±22. Vibration amplitude of the working tool, microns, not less than 60. Continuous operation time, hours 8. Overall dimensions: electronic generator, mm 275×175×50. Oscillatory system, ∅70×260 mm.

1.3. Ultrasonic welding of the product:

The parts to be welded for the movable pad were placed in layers on a metal welding support in the following sequence: a fabric pad, an air bubble three-layer polyethylene film, medical cotton wool, a polypropylene surgical mesh, a hemostatic collagen sponge. For a stationary pad, instead of a fabric lining, it is necessary to weld a layer of gauze bandage along its length to the remaining components of the product. The bandage roll should be located to the right of the movable pad and face its open part towards the fabric lining.

Ultrasonic welding is carried out with a rectangular welding working tool with a radiating surface of 2.5 × 100 × 120 mm, forming a weld in one operation. The pressing force of the contact pad of the pad must be constant. Welding time 0.5 s. To form a high-quality welded joint, it is necessary to ensure parallelism between the welding support and the radiating surface of the working tool.

1.4. Product sterilization: Radiation sterilization.

1.5. Rules for storage and use:

In a dry place, protected from light, at a temperature from +4 to +25°C. Shelf life - 3 years from the date of sterilization.

Example 1.

PROTOCOL OF COMPARATIVE STUDIES OF ATRAUMATIC COTTON PAD CONDUCTED IN A VETERINARY CLINIC.

Samples of atraumatic cotton pads with collagen hemostatic sponge were provided to the veterinary clinic. When providing veterinary care (in the presence of an adult pet owner), the clinic conducted comparative studies of the time and effectiveness of stopping bleeding in animals using a real atraumatic cotton pad with a collagen sponge (hereinafter referred to as AVP) and a standard cotton-gauze pad (hereinafter referred to as VMP).

During aesthetic plastic surgery for ear cropping in dogs of different breeds, bleeding from the left ear was stopped with a standard sterile IMP with aminocaproic acid, and the right ear was stopped with a sterile collagen hemostatic sponge with AVP. A stopwatch was used to measure the time the bleeding stopped during cupping and suturing of the ears. The results of comparative studies are presented in Table 1.

Example 2.

Using the industrial method of pig slaughter, a model of stopping bleeding from the carotid artery of the animal was studied. Once soaked in blood, the sponge of the atraumatic cotton pad adheres tightly to the bleeding artery and can withstand blood pressure up to 290 mmHg, making the product an excellent wound sealant.

Links cited in the search report:

[1] Elansky N.N. Military field surgery. - 2nd edition. - M: Medgiz, 1942. - 308

[2] Patent US-5230119 A1, 07/27/1993.

[3] Patent EP 0819393 A1, 01/21/1998.

[4] Patent RU 152017 U1, 04/27/2015.

[5] Patent RU 219063 06/27/2023.

[6] Review of the role of mechanical forces in skin wound healing. PMID: 22005503 J Surg Res. 2011 Dec: 171(2): 700-8.

[7] List of medical devices implanted into the human body during the provision of medical care within the framework of the State Guarantees program for the free provision of medical care to citizens. Approved by order of the Government of the Russian Federation of October 22, 2016 No. 2229-r.

Claims (4)

1. An atraumatic cotton pad made of two identical layers of absorbent cotton material, connected by a middle layer of three-layer polyethylene bubble film, which combines two load-bearing smooth layers and a ribbed fabric with bubbles, while one side of the pad is connected to a textile surgical mesh, on which has an integrated hemostatic sponge. 2. An atraumatic cotton pad according to claim 1, characterized in that a textile surgical mesh with an integrated hemostatic sponge and a middle layer of polyethylene air bubble film are connected to layers of cotton, the contact pad is sealed around the perimeter of the pad by pressure and ultrasonic welding, while passing along the perimeter of the pad. 3. Atraumatic cotton pad according to paragraphs. 1, 2, characterized in that the pad is rectangular, round, oval, square, in the shape of a hemisphere, or a brick. 4. Atraumatic cotton pad according to paragraphs. 1-3, characterized in that one side of the hemostatic sponge is integrated with a textile surgical mesh over the entire area of their contact.