Haemostasis device for surgical procedures

Abstract

The present invention relates to a haemostasis device for surgical procedures, characterised in that it comprises a spherical structure having three main structures: the first structure is an instrument (1) for pulling or recovering the device, and that is actuated once the device has been used in the surgical procedure; the second structure (2) is a releasable layer of oxidised cellulose that is in turn attached to the pull structure (1); and the third structure is a sterile cotton core (3), with controlled expansion, which is also attached to the pull structure (1). The pull structure (1) is able to remove the third structure (3) from a surgical cavity without removing the second structure (2).

Description

[0001] HEMOSTASIS DEVICE FOR SURGICAL PROCEDURES

[0002] FIELD OF INVENTION

[0003] The present invention relates to a hemostasis device that can be used in surgical procedures to control intraoperative bleeding through a combined mechanism of action between fluid absorption expansion and chemical adhesion via hemostatic substances.

[0004] BACKGROUND OF THE INVENTION

[0005] During any surgery, it is essential to control blood loss as effectively as possible. Intraoperative bleeding causes numerous problems, including visual impairment during surgery, and in extreme cases, patient instability and even death. Effective bleeding control allows the surgeon to clearly see the working area, minimizing risks and improving precision. The presence of blood hinders vision and can lead to errors or complications when accessing nearby vital structures. If adequate hemostasis is not achieved at the end of a surgical procedure, there is a high risk of postoperative bleeding, which dramatically increases the risk of complications. In some surgical procedures, such as spinal operations, the bone is broken to provide access to the area requiring surgery.When cutting and dissecting tissues, which are mostly supplied by blood vessels, the patient's own coagulation mechanisms are often insufficient to control bleeding. Therefore, coagulation methods are used, including monopolar and bipolar coagulation techniques, irrigation, and the application of coagulation-inducing substances.

[0006] Other advantages of reducing bleeding in the surgical area include minimizing the risk of complications for the patient, as excessive blood loss can affect blood pressure and increase the risk of infections and other postoperative complications. Reducing bleeding also speeds up the procedure, which is beneficial for patient recovery and decreases exposure to anesthesia and other risks associated with prolonged interventions. Patient health is also a key factor, and with advances in the understanding of infections and wound healing, blood pooling at the incision site has become a known risk factor and should be minimized.

[0007] Currently, in the field of surgical hemostasis, several tools exist for the local control of bleeding, such as Gelfoam (which comes in sponge or liquid form), as well as different combinations of human thrombin with liquid cellulose, collagen sponges, and oxidized cellulose in the form of layers to be applied directly to the bleeding site. However, these solutions present many drawbacks because they rely solely on physical pressure without offering adequate chemical control. This has several limitations because the effectiveness of some hemostatic solutions can be limited by the difficulty of applying pressure to deep or hard-to-reach areas during complex surgeries. Furthermore, existing products do not always offer rapid and efficient control, and some have problems with ease of removal or interference with surrounding tissues.

[0008] Among the state-of-the-art hemostasis devices that can be found in patent literature is, for example, the United States patent application US2022143263A1, which discloses a thrombin-bearing hemostatic sheet that has biological absorption properties and is suitable for hemostasis during surgery, in particular, hemostasis during spinal surgery.The hemostatic sheet includes a gelatin sponge that carries thrombin, which has properties such as not causing a crack even when a hemostatic sheet in a dry state is deformed to adhere closely to a bleeding area, shape retention capacity whereby the hemostatic sheet in a moist state when absorbing blood is impermeable to eruptive bleeding, and properties where swelling properties after blood infiltration are not high and it exhibits good biological absorption properties.

[0009] Another example of hemostatic devices available in the prior art is that shown in patent application W02009109963, which describes gelatin sponges manufactured by whipping a gelatin solution and drying the foam, typically by freeze-drying. Unlike collagen, which is naturally insoluble in neutral aqueous solutions, gelatin is soluble at temperatures above 300 °C, especially at 37 °C, the physiological temperature. This characteristic makes the sponge unsuitable for in vivo use, as it would dissolve rapidly and lose its structural integrity and porous structure. Therefore, the gelatin must be cross-linked to prevent its rapid dissolution in blood. Cross-linking methods include treating the sponge with a chemical cross-linking agent such as formaldehyde, glutaraldehyde, and carbamimidimides (e.g., EDC) or by treating the dried sponge with dry heat (100–1600 °C for several hours).While its mechanism of action is not fully understood, it is currently believed that its effect appears to be related to the gelatin sponge's ability to absorb and retain many times its weight in blood and other fluids within its interstices. The trapped blood platelets interact with the sponge and become activated, leading to the formation of a hemostatic plug and the cessation of bleeding. This hemostatic plug resembles the natural plug that typically forms in the body after an injury; the activated platelets also initiate the coagulation cascade, which culminates in the conversion of soluble fibrinogen into an insoluble fibrin network by the action of thrombin. Factor XIII, which is activated by thrombin in the presence of Ca2+, cross-links and stabilizes the fibrin monomers of the clot.

[0010] Patent application W02009109963 discloses an improved dry, flexible, cross-linked gelatin sponge comprising a highly concentrated, thin layer of thrombin on the sponge surface. A method for manufacturing an improved cross-linked gelatin sponge comprising a protein or peptide active ingredient is also provided, comprising the steps of: a) providing a cross-linked gelatin sponge having at least one surface; b) homogeneously applying a liquid comprising a protein or peptide active ingredient to said at least one surface of said sponge, wherein the volume of the applied liquid is equal to or less than 5% of the volume of the sponge in a); and c) drying the sponge, thereby obtaining a dry, flexible, cross-linked gelatin sponge comprising a stable layer of protein or peptide active ingredient on at least one surface of the sponge.

[0011] However, despite the above demonstrated by the state of the art, there remains a need to provide a hemostasis device that does not depend on physical pressure exerted on the device by medical personnel, that offers adequate chemical control, that provides rapid and efficient bleeding control in a surgical cavity area, that is easily removable, and that does not interfere with surrounding tissues.

[0012] BRIEF DESCRIPTION OF THE FIGURES

[0013] Figure 1 presents a cross-sectional view of the hemostasis device for surgical procedures of the present invention.

[0014] Figure 2 presents a perspective view of the device showing details of the structures that make it up.

[0015] Figure 3 shows how the device is applied in a surgical cavity.

[0016] Figure 4 is a view of the device inside the surgical cavity in its inactive or dehydrated phase.

[0017] Figure 5 shows a view of the device inside the surgical cavity while it is being hydrated. Figure 6 shows a view of the device inside the surgical cavity in its active or hydrated phase.

[0018] Figure 7 is a view of the device being removed from the surgical cavity, leaving the oxidized cellulose structure lining the surgical cavity.

[0019] OBJECT OF THE INVENTION

[0020] The object of the present invention relates to a hemostasis device that can be used in surgical procedures to control intraoperative bleeding by means of a combined mechanism of action between expansion by absorption of fluids and chemical adhesion through hemostatic substances.

[0021] Another object of the present invention is to provide a procedure for installing and removing the hemostasis device for surgical procedures that require hemostatic procedures.

[0022] DETAILED DESCRIPTION OF THE INVENTION

[0023] An object of this invention is to provide a hemostasis device that supplies a mechanism that not only acts physically by expanding an absorbent structure that is hydrated with saline solution, but also chemically, using a hemostatically active substance such as oxidized cellulose, which, once released into a surgical cavity by the hemostasis device of the invention, may adhere to the bleeding area and facilitate coagulation.The absorbent structure expands, covering the surgical cavity. When the structure is hydrated, its surface layer, containing the active substance (oxidized cellulose), adheres to the bleeding tissue, providing additional hemostasis. The device is then removed with a pulling instrument attached to the compressed (now expanded) absorbent structure, leaving only the oxidized cellulose adhered and covering the surgical cavity. This allows for the almost automatic use of a combined process that leads to coagulation through pressure from the absorbent structure and chemical coagulation from the action of the oxidized cellulose. In neurosurgery and other specialties, it is crucial to have a product that can expand appropriately to exert controlled pressure on small areas without causing additional damage.Current products sometimes require multiple applications or are difficult to remove without causing injury.

[0024] According to Figures 1 and 2, which detail the hemostasis device for surgical procedures of the present invention, it comprises a spherical surface of between 1 and 5 cm that can be placed in a surgical cavity of any body tissue requiring hemostasis. The spherical structure has three main structures: the first of these structures is a retrieval or pull-out instrument (1) that is activated once the device has been used in the surgical procedure; the second structure (2) is a layer of releaseable oxidized cellulose that is attached to the pull-out structure (1); the third structure is a core (3) of sterile, controlled-expansion cotton that is also attached to the pull-out structure (1). This pull-out structure has a length of between 15 and 25 cm.

[0025] The internal structure (3) consists of an absorbent material, such as a sterile compressed cotton core, which has been treated under a pressure of approximately 205 to 690 kPa so that, upon contact with liquids, it expands in a controlled manner. The surface of this compressed cotton core is coated with oxidized cellulose, which acts as a hemostatic agent, adhering to the tissue and aiding in the coagulation process. Once hydrated, the absorbent structure of the oxidized cellulose is easily released with gentle pulling.

[0026] Upon contact with fluids, the compressed internal absorbent structure (3) expands, applying a calculated pressure of approximately 2.5 to 7 kPa to the bleeding area for a short time. This is usually sufficient to stop the bleeding without damaging the surrounding tissues. Simultaneously, the oxidized cellulose reduces the local pH and serves as a matrix for platelet adhesion, thus promoting coagulation. The oxidized cellulose has a hemostatic effect due to the formation of artificial clots by cellulosic acid, which has a high affinity for hemoglobin.

[0027] The unique characteristic of oxidized cellulose in clinical practice lies in its ability to be absorbed when introduced into tissues. It also exerts an efficient hemostatic effect in surgical procedures as a bioabsorbable hemostatic agent. Upon contact with blood, oxidized cellulose decomposes into an acid that lowers the pH of the application area, facilitating platelet aggregation and clot formation. This helps to stop bleeding in areas where suturing or the use of other hemostatic devices is not feasible or is difficult to apply. One of its advantages is that, being bioabsorbable, the material degrades and is reabsorbed by the body in a short period of time, eliminating the need for subsequent removal. This makes it particularly useful in hard-to-reach surgical areas or in minimally invasive surgeries.Oxidized cellulose is effective in a variety of procedures, from abdominal and thoracic surgeries to cardiovascular and orthopedic procedures, where bleeding control is critical to improve visibility and reduce risks associated with blood loss.

[0028] In the present invention, the concentration of oxidized cellulose used in said structure (2) depends on the size of the spherical surface, which, as already indicated, can be between 1 and 5 cm in diameter; for example, for a surface of 1 cm in diameter, that is, 3.14 cm 2 On the surface, the concentration of oxidized cellulose is in the range of 63 to 157 mg; for a sphere 3 cm in diameter, this is 28.27 cm 2 On the surface, the concentration of oxidized cellulose is in the range of 565 mg to 1.41 g; for example, for a sphere 5 cm in diameter, this is a surface area of ​​78.54 cm². 2, the concentration of oxidized cellulose is between 1.57 g and 3.93 g.

[0029] Another object of this invention is to provide a procedure for installing and removing the hemostasis device for surgical procedures described above; according to Figures 3 to 7, the procedure consists first of introducing with suitable surgical material such as a clamp (4) the hemostasis device for surgical procedures into a surgical cavity (5) in an inactive or dehydrated state.

[0030] Once the hemostasis device for surgical procedures is placed inside the surgical cavity (5), in an inactive or dehydrated state, a hydrating saline solution is applied to hydrate the device. When the hemostasis device expands in a controlled manner, it completely covers the area of ​​the surgical cavity (5) while exerting a controlled pressure of between 2.5 and 7 kPa on the surrounding area. When the hemostasis device is expanded, its outer structure (2), composed of oxidized cellulose, comes into contact with the tissue of the surgical cavity (5) requiring hemostasis.Once the oxidized cellulose of the hemostasis device has been fixed in the surrounding tissue of the surgical cavity (5), the absorbent structure (3) of the hemostasis device is removed by means of the pulling device (1) of the device structure without affecting or removing the structure (2) containing the oxidized cellulose.

[0031] Although the present invention has been described with the preferred embodiments shown, it is understood that modifications and variations that preserve the spirit and scope of this invention are understood to be within the scope of the attached claims.

Claims

CLAIMS 1. A hemostasis device for surgical procedures characterized in that it comprises a spherical structure having three main structures; the first of said structures is a retrieval or pull instrument (1) of the device that is activated once it has been used in the surgical procedure; the second structure (2) is a releaseable oxidized cellulose layer that is in turn attached to said retrieval structure (1); the third structure is a sterile, controlled-expansion cotton core (3) that is also attached to said retrieval structure (1); said retrieval structure (1) is capable of removing said third structure (3) from a surgical cavity without removing said structure (2).

2. The hemostasis device for surgical procedures of claim 1 characterized in that said third structure (3) in an inactive or dehydrated phase is in a compressed state at a pressure of between 205 and 690 Kpa.

3. The hemostasis device for surgical procedures of claim 1 characterized in that said third structure (3) in an active or hydrated phase deploys a pressure of between 2.5 and 7 Kpa against a determined surrounding area.

4. The hemostasis device for surgical procedures of claim 1 characterized in that said second structure (2) on a surface of 1 cm diameter of spherical structure, i.e. 3.14 cm 2 The surface area has a concentration of oxidized cellulose in the range of 63 to 157 mg; for a spherical structure of 3 cm in diameter, this is 28.27 cm 2On the surface, the concentration of oxidized cellulose is in the range of 565 mg to 1.41 g / cm² for a spherical structure of 5 cm in diameter, that is a surface of 78.54 cm² 2 , the concentration of oxidized cellulose is between 1.57 g and 3.93 g.

5. The hemostasis device for surgical procedures of claim 1 characterized in that said spherical surface has a diameter of between 1 and 5 cm and said pulling structure (1) of said spherical surface has a length of between 15 and 25 cm.

6. The hemostasis device for surgical procedures of claim 1 characterized in that the spherical surface has a diameter of between 1 and 5 cm; said spherical surface can be placed in a surgical cavity of any body tissue requiring hemostasis.

7. A procedure for placing and subsequently releasing the hemostasis device for surgical procedures described in claim 1 into a surgical cavity, characterized in that it comprises: a) Introducing the hemostasis device for surgical procedures into a surgical cavity (5) in an inactive or dehydrated state. b) Once inside the surgical cavity (5) in an inactive or dehydrated state, a hydrating saline solution is applied to hydrate the hemostasis device. c) The hemostasis device expands in a controlled manner, completely covering the area of ​​the surgical cavity (5) and exerting a controlled pressure of between 2.5 and 7 kPa on the surrounding area of ​​the surgical cavity (5).d) Once the hemostasis device has been expanded, the outer structure (2) of said device, which is made of oxidized cellulose, is allowed to come into contact with the tissue of the surgical cavity that requires hemostasis. e) Once the oxidized cellulose of the hemostasis device has been fixed in the surrounding tissue of the surgical cavity, the absorbent structure (3) of the hemostasis device is removed by means of the pulling device (1) of the device structure allowing only the absorbent structure (3) to be removed without removing the outer structure (2) based on oxidized cellulose from the surgical cavity.

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