BRPI1103434A2 - Medical device fixation method and method for ostomies, wounds, hypertrophic scars and chelids - Google Patents

Abstract

"MEDICAL APPARATUS DEVICE AND METHOD FOR FITTING OSTOMIES, WOUNDS, HYPERTRAPHIC SCARS AND CHELIDES". Current methods for ostomy care involve the use of collection bags that are attached to the skin around the stoma through adhesive elements. Successive application and removal of these adhesive elements can damage the skin around the stoma or lead to allergic reactions. Fixation of dressings on skin wounds with bandages and the like also causes aggression to the skin at the time of each change due to traumatic dislocation. The present invention consists of an assembly formed by a silicone module (18) and a variable number of silicone implants (6) for exclusive medical use, aiming at the attachment and removal of any medical apparatus on human skin. Said silicone implant (6) contains magnets (5) in a linear, fixed or mobile arrangement, encased in pure biocompatible silicone, resulting in a narrow, elongated and flat shape with rounded edges. The silicone implant (6) can be introduced into the subdermal plane atraumatically through a minimal skin incision (16) with the aid of a exchanger. An external flexible silicone module (18) containing a series of fixed or movable magnets (19) is used to attach any medical apparatus to the skin. The central part of the module (18) has a cavity (20) that may contain a hydrogel dressing to treat a chronic wound, or an extra soft silicone plate to treat a scar, or connect to a collection bag to treat an ostomy. Each side of the module (18) contains one or more magnets (19) along its edge. The groove and concave bottom surface of the module (18) fits over the convex skin, the surface of which is protruding due to the presence of the underlying implant (6). The magnetic attraction between the magnets (5) of the implant (6) and the magnets (19) in the module (18) holds the medical apparatus over the area of the skin in which the cutaneous lesion (22) is contained. In order to prevent the dermo-epidermal layer interposed between the magnetic poles from being subjected to continuous pressure, the periodic rotation of the silicone module (18) allows intermittent pressure relief as the arrangement of the magnets (19) on each edge is done alternately. Every spot of healthy skin is under pressure for intermittent and limited periods, preventing ischemic skin damage. The present invention makes use of magnetic force for fixation and removal of medical devices without compromising the integrity of healthy skin, and allows the introduction and permanence of magnetic implants through minimally invasive method, reducing the chance of implant-related complications such as infection. , rejection, extrusion or dislocation or those related to the patient's skin, such as infection, atrophy or necrosis.

Description

DEVICE AND METHOD FOR FIXING MEDICAL APPLIANCES ON OSTOMIES, WOUNDS, HYPERTROPHIC SCARS AND

Keloids

1) TECHNICAL FIELD

This application belongs to the technical field of medical devices for the sole purpose of treating ostomy, wounds, hypertrophic scars and keloids.

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2) TECHNICAL STATUS

Human skin is composed of subcutaneous tissue (1) or hypodermis (the deepest layer), dermis (2) which is the intermediate layer and epidermis (3), the most superficial layer. The hypodermis (1) and dermis (2) provide certain physical properties of the skin (such as elasticity and flexibility), while the epidermis of the epidermis (3) is responsible for certain physiological functions of the skin (such as being a barrier against microbial invasion or prevent water loss). An ostomy (or reversal) is a surgical opening made into the skin.

so that physiological eliminations can be expelled from the body. An ostomy allows such eliminations to come out of the intestines (ileostomy or colostomy) or bladder (urostomy). Ostomy may be permanent or transient, and in the latter case the patient waits for a definitive surgical reconstruction. Since most ostomies eliminate acidic products, the skin around the stoma needs to be protected from its harmful effects. A pouch or reservoir should be attached to the stoma in order to retain these acidic products such as urine or feces.

Current methods for ostomy care involve the use of pouches that are attached to the skin around the stoma through adhesive elements. Successive application and removal of these adhesive elements may damage the skin around the stoma or lead to allergic reactions. Current reservoirs (colostomy pouches) can consist of one or two pieces. In one-piece shells, there is an adhesive surface on one side of the collecting bag itself. In the two-piece shells, there is a skin-contact adhesive plate that fits into the collecting bag, allowing the bag to be changed without removing the adhesive plate, saving skin. However, such adhesive plates should be removed periodically as urine or feces may seep underneath them. In addition to ostomy, the skin is subject to wounds, which may occur

for various reasons: trauma, surgery, infection, etc. Most skin wounds heal in a few days or weeks. Some wounds, however, may remain open for long periods of time, such as ionizing radiation wounds, lower limb vascular ulcers, or decubitus bedsores. Such chronic wounds require daily dressing changes over months or years. Dressings may contain elements to protect against infections (such as antibiotics or silver ions) or elements to maintain a moist environment within the unepithelized wound (such as hydrocolloids or hydrogels). These dressings promote special conditions that improve and accelerate the healing process.

During the healing phase, the fixation of local dressings to accelerate wound healing is usually done with tape or bandages. Since most dressings require daily replacement, the application and successive removal of bandages can damage the previously unharmed skin adjacent to the wound. In addition, very loose bandages tend to loosen and fall with body movement, and very tight bandages can lead to local circulatory restrictions. When the wound is definitively closed and reepithelized, dressings are no longer needed, and the healing process ends and a scar results. In some individuals, however, pathological healing occurs, in which the scar tissue grows larger than normal, resulting in an aesthetically undesirable scar. When this abnormal scar remains within the bounds of the original wound, it is called a hypertrophic scar. When it grows beyond the limits of the original wound, it is called keloid. Although keloids are not considered stritu sensu tumors, in practice, keloids exhibit tumor behavior, since their growth is difficult to control. In addition to the unpleasant appearance, keloids and hypertrophic scars can cause other undesirable symptoms (such as pain, itching, burning sensation), causing much suffering for affected patients.

There are several recommended treatments for keloids and hypertrophic scars. These treatments may be pharmacological, surgical or physical in nature. After surgical removal of the keloid, the new scar is treated by non-surgical physical adjuvants to reduce the chance of recurrence. These adjuvant treatments may include the application of early postoperative radiotherapy, the use of pressotherapy (applying mechanical pressure on the scar through elastic clothing, braces or compressive dressings) and the use of silicone plaques on the scar.

After the initial healing phase, pressure treatment (pressotherapy) is done using bandages, elastic knits or compressive garments, which can be very inconvenient due to the tightness, heat, sweating of the patient and the inelegant appearance of these garments. . Silicone plaques should be applied directly to the scar, but their fixation to the desired anatomical region is problematic, since the perspiration and greasiness of the skin tend to make the plates move from their original site. These silicone plates can be fixed with adhesive or bandages, but with the same drawbacks mentioned above. A method of clamping silicone plates using magnetic force has been described by Vaena (PI10024123). The author describes the use of magnets inside the silicone plate, which is kept on the skin due to the attraction to magnetic implants placed surgically under the skin. In this case, the magnetic force that attracts the silicone plate also generates a constant and uniform pressure on the scar, bringing additional benefits in the treatment of keloids and hypertrophic scars, since it combines pressotherapy with the continuous contact of the silicone plates. Another author, Li Yiguo (CN2707294Y) describes the use of a single magnet in wound healing, defending supposed properties of magnetism as a healing agent, which would speed healing and reduce pain, but without support in the scientific literature. In other words, Li Yiguo does not use the magnetic properties of a magnet in order to facilitate the application of scientifically proven techniques (pressotherapy and silicone plaques) as adjuvants in the treatment of scars.

The use of magnetic force for fixation of medical devices is widespread. For example, the fixation of dental prostheses with magnetic devices has been described by Shiner et al. (US 4,997,372). Many mutilated patients with loss of nose (or ear), for example, make use of a magnetic nasal (or auricular) prosthesis, which in turn attaches to osteointegrated magnetic implants (attached to the bone) through titanium pins. Another author, Eaton (PI0008270-8 A), describes the attachment of an external breast prosthesis to the wearer's skin through magnets (contained in the prosthesis) that would be attracted to surgically implanted steel buttons under the patient's skin. Although the use of magnets to fix medical devices is widespread, it is clear that the way such magnets are used does not consider the simultaneous application of two scientifically proven techniques (pressotherapy and silicone plaques) to treat hypertrophic scars. and keloids. 3) PROBLEM FOUND IN TECHNICAL STATE

Current methods for treating ostomy, wounds, hypertrophic scars and keloids have some limitations:

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a) One-piece ostomy collection pouches, which are attached directly to the skin around the stoma through a self-adhesive face, damage the skin each time it needs to be replaced. In the case of two-piece collecting bags, despite the use of adhesive plates

If the bag can be changed without plaque removal, there may be stool or urine infiltration under the plaque, which also needs to be replaced periodically.

(b) Fixing dressings on skin wounds with bandages, band-aids or any other adhesive causes skin aggression on the skin.

moment of each change due to the traumatic detachment of the adhesive element. Using bandages to replace the bandages brings other problems: too loose bandages tend to loosen and fall with body movement, and too tight bandages can lead to local circulatory restrictions.

c) It is noteworthy that, besides not being in the technical field of the present application and not being employed considering the simultaneous application of pressotherapy and silicone plates for the treatment

With hypertrophic scars and keloids, the previously described methods of fixation to the skin using magnetic force employ implants that need to be inserted through open surgical incisions. In these cases, surgical incisions located very close to the implant permanence place increase the chance of complications such as infection. implant migration or extrusion. In addition, the skin located between the inner (subcutaneous implant) and the outer (above the skin) magnetic pole is under continuous pressure, leading to cutaneous microcirculation suffering, which may lead to dermal atrophy and even necrosis.

d) The use of a single magnet in wound healing, proposed by Li Yiguo (CN2707294Y), aims only at harnessing the supposed properties (without scientific validation) of magnetism as a healing agent, which would hasten healing and reduce pain. In other words, Li Yiguo does not take into account any other properties of the magnet that allow the use of magnetic force as a wound dressing fixative or pressure generating element for the treatment of hypertrophic scars or keloids.

4) PURPOSE OF THE INVENTION

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The invention aims to remedy the above limitations by using magnetic force to fix and remove medical devices (such as colostomy pouches, dressings, silicone plates or any other medical devices) on the skin or skin lesions ( such as ostomies, wounds, hypertrophic scars and keloids) without compromising the integrity of healthy skin, and allowing the introduction and permanence of magnetic implants through a minimally invasive method. reducing the chance of implant-related complications (such as infection, rejection, extrusion or displacement) or the patient's skin (such as infection, atrophy or necrosis).

5) DESCRIPTION OF THE FIGURES

· Figure 1 is a schematic representation of the implant with top view (A) and profile view (B), with its flexible silicone structure (6) and its magnets (5) inside, showing a ferrule (7) with a pin (8) pointed upwards.

Figure 2 is a schematic representation of the trocar with upper view (A) and profile view (B), consisting of the head (9), shank (10) and cable (11).

Figure 3 is a schematic representation of the upper face of the trocar head (9) in three-dimensional perspective showing the central opening (13), the upper groove (15), the lower slot (14), the blunt tip (12) and its continuity with the trocar stem (10).

Figure 4 is a schematic representation of the lower face of the trocar head (9) in three-dimensional perspective showing the central opening (13), the lower slot (14), the blunt tip (12) and its continuity with the stem ( 10) of the trocar.

Figure 5 is a schematic representation of human skin with three-dimensional perspective vision (with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)), showing the trocar head (9) being introduced. through the primary skin incision (16).

Figure 6 is a schematic representation of human skin with three-dimensional perspective view [with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)], showing the trocar stem (10) being introduced. through the primary skin incision (16).

Figure 7 is a schematic representation of human skin with three-dimensional perspective vision (with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)), showing the trocar stem (10) being introduced. through the primary skin incision (16) and the trocar head (9) being externalized through the secondary skin incision (17).

Figure 8 is a schematic representation of human skin with three-dimensional perspective vision (with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)), showing the trocar stem (10) being introduced. through the primary skin incision (16) and the trocar head (9), externalized through the secondary skin incision (17), connected to the silicone implant (6).

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Figure 9 is a schematic representation of human skin with three-dimensional perspective view (with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)), showing the trocar stem (10) being removed. through the primary skin incision (16) and the silicone implant (6) introduced into the subdermal plane through the secondary skin incision (17).

Figure 10 is a schematic representation of the top view (A) and profile view (B) 1 module with its flexible silicone structure (18) and its magnets (19) inside with a central cavity (20) and the grooves (21) on the underside of their side edges.

Figure 11 is a representative schematic view of the module (18) and implants (6) in three-dimensional perspective, with a cutaneous lesion (22) between them. The module (18) displays its grooves (21) from its lower face, its internal magnets (19) and its central cavity (20). The implants (6) display their magnets (5) internally.

Figure 12 is a schematic representation of human skin with three-dimensional perspective vision [with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)], showing a superficial skin lesion (22) with four underlying implants (6) placed in a perpendicular arrangement with each other.

Figure 13 is a schematic representation of human skin with three-dimensional perspective vision [with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)], showing a superficial skin lesion (22) covered by central cavity (20) of the silicone module (18) displaying its magnets (19) internally.

Figure 14 is a schematic representation of human skin with three-dimensional perspective vision (with its components: epidermis (3), dermis (2) and subcutaneous tissue (1)), showing a superficial skin lesion (22) covered the central cavity (20) of the silicone module (18) with its internal magnets (19) repositioned after a 90 ° clockwise rotation.

6) DESCRIPTION OF THE INVENTION

The present invention consists of an assembly formed by a silicone module (18) and a variable number of silicone implants (6) for exclusive medical use, aiming at the fixation and removal of medical devices on the human skin.

Said silicone implant (6) contains magnets (5) in a linear arrangement, which may be fixed in one position or movable within a limited space within the implant (6). The magnets (5) are encased in pure biocompatible silicone, resulting in a narrow, elongated, flattened implant shape (6) with rounded edges. In order to minimize tissue trauma and reduce the risk of extrusion, the implant should be flexible and have a smooth surface with no angles or tips, as shown in Figure 1. To facilitate its introduction, the implant features at one end. a rounded flexible silicone ferrule (7) having an upwardly pointed silicone pin (8). After the implant is properly inserted into the subdermal plane, this tip is cut and discarded.

To assist in the introduction of the silicone implant (6), a trocar (Figure 2) consisting of a head (9), a stem (10) and a cable (11) is used. The trocar head (9) has a blunt end (12) and is connected to the cable (11) through the long stem (10). This trocar can be made of any rigid sterilizable material. Single-use exchangers can be made of acrylic or plastic resin. A reusable trocar can be made of stainless steel to be resterilized like any surgical instrument. The trocar head (9) has a round shape to allow for blunt and minimally traumatic dissection in the subdermal plane, having a lock-shaped central opening (13) designed to receive the silicone tip (8) of the tip (7) as shown in figure 3. The upper surface of the head has a groove (15) allowing the pin (8) to slide and lock, keeping the implant (6) attached to the trocar. The lower surface of the head has a slot (14) for engaging the flexible silicone implant tip (7) as shown in Figure 4. The silicone implant (6) can be inserted into the plane.

through a minimal skin incision (16) with the aid of the trocar, as seen in figure 5. The trocar head (9) is introduced into the subdermal plane, and through blunt dissection (figure 6 - arrow), a rectilinear tunnel is created through the subdermal plane. A secondary incision (17) is made to allow exit and exposure of the trocar head (9) (Figure 7). Once exposed, the trocar head (9) can be fitted to the silicone implant tip (7) (6) as shown in Figure 8. When pulling the trocar cable (11), the head (9) retracts and The silicone implant (6) is inserted into the subdermal tunnel through the secondary incision (17) (Figure 9 - arrow). The trocar is removed through the primary incision (16), and the silicone tip (7) is then cut and discarded. With light fingertip pressure, the silicone implant (6) is placed in the center of the subdermal tunnel, equidistant from primary (16) and secondary (17) incisions. The skin incisions can be closed with conventional suture, taking one or two stitches each.

An external flexible silicone module (18) containing a series of magnets (19) is used to attach any medical apparatus to the skin. The magnets (19) may be fixed in the same position or movable within a limited space within the module (18). The shape of this module can be made according to the area of skin to be treated: triangular, square, pentagonal, hexagonal, rectangular, elliptical, circular, fusiform, semi-cylindrical, etc. The central part of the module acts as a platform for any medical device, featuring a central cavity (20) which may contain, for example, a hydrogel dressing (to treat a chronic wound), an extra soft silicone plate (to treat hypertrophic scars or keloids) or connect to a collecting bag (to treat an ostomy) as shown in Figure 10. Each side of the module (18) contains one or more magnets (19) along its edge, which in turn is grooved on its bottom surface. This lower grooved surface is designed to mate over the skin containing the underlying implant (6) so that most of the implant volume (6) will be contained under the groove (21). The groove and concave bottom surface of the module (18) fits over the convex skin, the surface of which is protruding due to the presence of the underlying implant (6). The magnetic attraction between the magnets (5) of the implant (6) and the magnets (19) on the module (18) holds the medical apparatus over the area of the skin in which the lesion (22) is contained, which in turn may be an ostomy, a wound, a hypertrophic or keloid scar (Figure 11 - arrows). In cases where the cutaneous lesion (22) is in a highly moved anatomical region, it is desirable to have some mobility of the magnets (5) inside the implant (6) and the magnets (19) inside the module (18). ), allowing an optimal position to be obtained for maintaining the force of magnetic attraction.

In Figure 12, we see the skin that will receive a square-shaped silicone module (18) to treat any skin lesion (22). Four separate incisions were made in healthy skin around the cutaneous lesion (22), positioned as angles of a square. Four silicone implants (6) were inserted into the subdermal plane in a perpendicular arrangement with each other. After suturing the incisions, Figure 13 shows the square-shaped silicone module (18) placed over the skin, with the cutaneous lesion (22) contained under the central cavity (20) of the silicone module (18).

As the dermo-epidermal layer interposed between the magnetic poles is subjected to continuous pressure, there may be circulatory impairment and local skin changes, with progressive dermal atrophy. These skin changes can lead to undesirable complications such as skin necrosis or implant extrusion. To avoid such complications, periodic relief of this pressure is recommended to allow circulatory reestablishment of the skin. Such relief can be obtained by periodically rotating the silicone module (18) since the arrangement of the magnets (19) on each edge is alternately arranged. Each point of the skin will be under pressure in intermittent periods, minimizing ischemic skin lesions. A square silicone module (18) requires 90 degree periodic rotations (figure 14 - arrow). For example, triangular modules will require 120 degrees of rotation, pentagonal modules require 72 degrees, hexagonal 60 degrees, etc. Round shape modules may require variable rotation.

The pressure on the dermo-epidermal layer interposed between the silicone module magnets (19) and the silicone implant magnets (5) must not excessively exceed the normal capillary pressure in order to maintain the flow. blood in the subdermal plexus. In patients with keloids and hypertrophic scars, the skin under the central cavity (20) of the silicone module (18) should be under constant pressure with a therapeutic range of 24 to 30 mmHg.

7) TECHNICAL TERMS

Adjuvants - Adjuvants - What a help, aide. In medicine, it is said of the medicine or treatment that reinforces the action of another.

Atrophy - Atrophy - Withering, wear, weakening.

Corticosteroids - Corticoids - It is said to be a group of hormones in the adrenal cortex, their derivatives and synthetic substitutes, used especially as anti-inflammatories. Glucocorticoids. Glucocorticoids. bedsores

Extrusion - Extrusion - Spontaneous expulsion from inside the body. Expulsion.

Hemostasis - Haemostasis - Act to contain a bleeding. Stagnation of the blood.

Hypertrophic - Hypertrophic - Concerning hypertrophy.

Hypertrophy - Hypertrophy - Abnormal development of the tissue of an organ.

Necrosis - Necrosis - death of cells, tissue or organ.

Pathological - Pathological - Related to a particular disease. Morbid. Keloids - Keloid - Tumor of the skin, fibrous, elongated, most often resulting from hypertrophy of a scar.

Radiotherapy - Radiotherapy - Therapeutic Medicine based on the use of radioactive energy. Treatment by means of radiation applications.

Relapse - Return - Resurgence of a disease after a longer or shorter healing period.

Exchange - Exchange - Cannula used for punctures.

Claims (7)

1. Medical device fixation device characterized by: • having a silicone module (18) and a variable number of silicone implants (6), • interleaving the magnetic attraction points according to the position of said module (18) in relation to said implants (6), • subject the skin interposed between said modules (18) and implants (6) to a pressure that does not compromise capillary microcirculation, subject the interposed skin scars between said module (18) and implants (6) at a therapeutic pressure between 24 and 30 mmHg Silicone module (18) characterized in that: • it is flexible, biocompatible and sterilizable, has a set of magnets (19) on each edge, fixed or movable, the arrangement of which varies according to the edge considered; variables according to the surface of the skin to receive said module (18), • have one or more concavities or grooves (21) on its lower face, have in its central segment a cavity (20) that houses the medical apparatus Silicone implant (6) characterized in that: • it is flexible, biocompatible and sterilizable, has a set of fixed or movable magnets (5) inside it, • has a narrow, elongated and flat shape with rounded edges without • have at one end a rounded flexible silicone tip (7) containing an upwardly pointed silicone pin (8) 4. A replacement characterized in that: • It is rigid and sterilizable, • has a head (9), a rod (10) and a handle (11), • said head (9) has rounded edges, a blunt end (12). , a lock central opening (13), a groove in the upper surface (15) and a slot (14) in the lower surface 5 Method of fixation of medical apparatus characterized by: • inserting the trocar into the subdermal plane through a minimal primary skin incision (16), • tunneling the subdermal plane through blunt dissection, • externalizing the trocar head (9) through a minimal secondary skin incision (17), • fit and lock the tip (7) of the implant (6) on the trocar head (9), • retract the trocar by inserting said implant (6) into the subdermal plane through the secondary incision (17), • cut and discard the silicone implant tip (7) (6), • press said implant (6) by hand pressure into desired end position, • close skin incisions (16 and 17)