RU2727577C1 - Skin wound closure device - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: present invention relates to medical equipment, namely to a device for wound closure. Proposed device comprises support plate, fastening element and adjusting rod. Support plate consists of two parts - left and right, made of air-permeable resilient material, having lower adhesive layer impregnated with antibacterial and antioxidant substance. From upper side of plate there arranged is two-part fastening element of control rod. One part of fastening element is located on left part of plate and includes guide slot holder with through hole for screw with internal thread. Second part of the fastening element is placed on the right part of the plate and includes a guide slot holder with a through hole for placement of a control rod made of a flexible material with an external thread on the distal end and equipped with a handle on the proximal end. Holder of guide slot of right part of fastening element can additionally have internal thread opposite to thread of guide slot of left part of fastening element. Left and right parts of attachment element interact with each other by means of control rod. Adjusting rod at the proximal end is equipped with a back stroke retainer, made in the form of a rectangular section part, installed by the lower rib along its length along the fastening element along the central axis of the control rod, and having arched element close to handle of upper rib end, capable to cover control rod. Adjusting rod at the proximal end is equipped with a stroke regulator made as a single part with it, representing lobes located along the circumference of the control rod. Stroke regulator is an element of the back stroke retainer, located between the guide slot holder and the arc-shaped element, interacts the lobes with the rectangular cross-section part and fixes the control rod in the closed position of the arc-shaped element. Left part of the fixing element contains a distal holder made in the form of an open chute arranged on the left part of the fastening element, and the upper part of the chute is partially or completely closed by a hollow half-cylinder with formation of a common through hole sufficient for placement of a control rod in it. Central axis of the chute, the axis of the semi-cylinder and the control rod coincide. Right part of the fastening element contains a limiter-holder consisting of two elements - a support located on the fastening element, and an annular ledge along the circumference of the control rod located closer to the handle. Support and annular ledge interact with each other.EFFECT: technical result consists in providing the device with high wound healing efficiency and possibility of medical manipulations in the healing process.7 cl, 19 dwg

Description

The present invention relates to the field of medicine, in particular to medical equipment, namely to a device that acts on the edges of the wound with a tightening force to facilitate its closure and can be used to fasten the edges of skin and subcutaneous tissue wounds formed during surgical procedures, and also for the healing of some types of traumatic wounds that have undergone surgical primary or secondary treatment, it is also intended for independent use for fastening the edges of traumatic wounds in a domestic environment.

Wounds can form as a result of injury, or as a result of surgery. The ability to quickly and reliably close the incision (wound) is of great importance in the successful outcome of the performed surgical intervention.

Often, wounds are closed using sutures or staples. However, the use of these mechanical closure methods requires additional punctures or wounds in the skin, which can lead to damage to the skin and tissues of the human body, and in the case of excessive edema, infection of the wound and the development of complications. In addition, mechanical wound closures such as staples and surgical sutures can cause highly localized stresses at the fixation points that can impede and disrupt normal skin wound healing processes.

Various devices are known for closing skin wounds. Such devices are described in US Patent Nos. 2012,755, 3,516,409, 3,863,640, 3,933,158, 4,114,624, 3,926,193, 4,535,772, 4,676,245, 4,881,546, 4,905,694, 5,377,695 and 7,455,681 and US Publication Nos. 2005/0020956 and 2008/0114396. Additional surgical devices for closing skin wounds are described in US Pat. Nos. 8,313,508, 8,323,313 and 8,439,945, US Patent Publication 2013/0066365 and PCT Publication No. WO 2011/139912, WO 2011/159623, WO 2011/043786 and WO 2013/067024.

A device for closing a wound is known, which consists of a left and right base plate and has a plurality of closing elements. The cover element connects the left and right base plates laterally to each other and has left and right ends connected to separate base plates. Covering elements are located on the left and right plates in the transverse direction. The cover elements located on the left and right are offset from each other in such a way that a serpentine engagement of the elements is formed. The base plates have an antimicrobial layer.

(Japanese Patent No. 2018-114382, IPC А61В 17/08, publ. 07/26/2018)

The main purpose of such surgical closure devices is to improve wound healing and reduce scarring from incisions. However, the known devices have several disadvantages. For example, the edges of a wound are not always straight, which can lead to scarring. Many of these closure devices do not have the ability to adjust the force of the wound edge convergence, have a rigid base, do not allow manipulation of wound care, and are difficult and inconvenient to use.

It is also known a device for closing skin wounds, consisting of two parts of a plate made of air-permeable elastic material, having a lower adhesive layer impregnated with antibacterial and antioxidant substances. On the upper side of the plate, the device contains fastening elements, wherein one part of the fastening element includes a distal guide groove holder with a through hole for a screw with an internal thread, and the second part of the fastening includes a proximal guide groove holder with a through hole for placing the regulating a rod made of a flexible material with an external thread and provided with a handle at the proximal end. The guide groove located on the proximal holder can have an internal thread opposite to the groove of the first part of the element, while the first and second parts of the fastening element are located on opposite parts of the plate and interact with each other.

(Patent CN No. 104905834, IPC A61B 17/08, publ. 09.16.2015)

The disadvantage is the insufficient efficiency of the device, so the lack of a backstop does not allow manipulations in the process of wound healing, and the absence of a stroke controller and a rod limiter creates inconvenience in use.

The object of the invention is to provide an easy-to-use device for closing skin wounds, increasing the efficiency of healing, allowing for various medical procedures for treating a wound and correcting tightening of the wound edges.

The technical result of the invention is to provide the device with a high efficiency of wound healing and the possibility of carrying out medical manipulations during the healing process.

This is achieved by the fact that in the inventive device for closing a wound, containing a support plate, an attachment element and a regulating rod, where the support plate consists of two parts - left and right, made of breathable elastic material, having a lower adhesive layer impregnated with an antibacterial and antioxidant substance ; on the upper side of the plate there is a two-part fastening element for the adjusting rod, where one part of the fastening element is located on the left side of the plate and includes a guide slot holder with a through hole for an internal screw, and the second part of the fastening element is located on the right side plate and includes a guide slot holder with a through hole to accommodate an adjusting rod made of a flexible material with an external thread at the distal end and provided with a handle at the proximal end, in addition, the guide slot holder of the right part of the fastening element may additionally have an internal thread opposite to the thread of the guide groove of the left part of the fastening element, while the left and right parts of the fastening element interact with each other by means of an adjusting rod, according to the invention, in addition, the adjusting rod at the proximal end is equipped with a backstop made in the form of a piece of rectangular cross-section, installed with the lower rib along the length on the holder along the central axis of the control rod, and having an arcuate element at the end of the upper rib close to the handle, capable of covering the control rod; additionally, the regulating rod at the proximal end is equipped with a travel regulator, made as a single part with it, which is petals located around the circumference of the regulating rod, in addition, the travel regulator is an element of the backstop lock, located between the guide groove holder and the arcuate element, interacts with the petals with the part rectangular section and in the closed position of the arcuate element fixes the regulating rod; additionally, the left part of the fastening element contains a distal holder made in the form of an open groove located on the left part of the fastening element, and the upper part of the groove is partially or completely closed by a hollow half-cylinder with the formation of a common through hole sufficient to accommodate a control rod in it, and the central axis of the groove , the axis of the half-cylinder and the control rod coincide; additionally, the right side of the fastening element contains a limiter-holder, consisting of two elements - a support located on the fastening element and an annular protrusion around the circumference of the control rod located closer to the handle, while the support and the annular protrusion interact with each other. The threaded control rod may have a tapered shape with an upward expansion. The control rod threads can have a variable pitch with decreasing gaps upward. The guide groove on the left fastening element can be provided with a non-threaded bushing for screwing in a rod with a variable thread pitch and a bushing diameter smaller than the control rod diameter, the bushing made of polymer, in particular silicone. The attachment element can have a platform of 0.01-0.4 cm.

The effectiveness of wound healing is achieved due to the fact that the device is well adjusted to the characteristics of the individual wound and allows you to control the convergence of the wound edges during the healing process.

Ease of use is characterized by the fact that no special skills are required to apply the device to the wound, as well as the possibility of its unhindered removal.

The essence of the invention.

The claimed device is illustrated by drawings.

FIG. 1 is a general view of a device for closing skin wounds.

FIG. 2 is a top view of a device for closing skin wounds.

FIG. 3 - an element for fastening the regulating rod.

FIG. 4A - control rod according to the basic version.

FIG. 4B - control rod without thread in the central part.

FIG. 4B - control rod with tapered thread.

Fig. 4D is a control rod with a variable thread pitch.

FIG. 5 is an enlarged view of the guide slot holder and the distal holder.

FIG. 6A is a top view of the travel regulator.

FIG. 6B - travel regulator, side view.

FIG. 7A is an enlarged view of the backstop.

FIG. 7B is an exploded view of the backstop.

FIG. 8A is a lead-through located inside the guide slot.

FIG. 8B - cutaway bushing.

It should be noted that the drawings presented in this embodiment only schematically reflect the main idea of the invention. Since the drawings show only the elements related to the invention, depicted in accordance with the actual design, and not the number, shape and size of the elements, their practical design, the number and proportions of elements can be arbitrarily changed, and the arrangement of these elements can be more complicated ...

The device for closing wounds 1 contains a protective layer 2, the left 3 part of the support plate, the right 4 part of the support plate and the control rod 5. On the upper side of the support plate there is a fastening element of the control rod, consisting of two parts.

One part of the fastening element is located on the left 3 part of the plate and includes the holder 31 of the guide groove 32 provided with a screw hole with an internal thread. Additionally, there is a distal holder 35 for fixing the distal end of the regulating rod 5. The distal holder 35 is made in the form of an open groove located on the left side of the fastening element, and the upper part of the groove is partially or completely closed by a hollow half-cylinder with the formation of a common through hole sufficient for placement it contains a control rod, and the central axis of the chute, the axis of the half-cylinder and the control rod coincide.

The second part of the fastening element is located on the right 4 part of the support plate and includes a holder 41 of the guide groove 42 for accommodating the control rod 5. The guide groove 42 can be made open or closed. If the guide groove is made open, there is no thread in it. It should be understood that this is insignificant and does not negatively affect the efficiency of the device. The number of fasteners placed on the base plate is ≥1.

The adjusting rod 5 has a distal and a proximal ends. At the distal end, the rod 5 is provided with an external thread 51, which mates with the internal thread of the guide groove 32 of the left 3 plate. The proximal end of the rod 5 is provided with a comfortable grip 55. Preferably, the grip 55 is rounded with notches applied to the surface to ensure that the fingers rub against the grip during twisting. In addition, the control rod 5 at the proximal end is equipped with a backstop 53, which is located on the right side of the fastening element. The backstop 53 is made in the form of a piece of rectangular cross-section, installed with the lower rib along the length of the holder 41 along the central axis of the control rod 5. At the end of the upper rib close to the handle 55, there is an arcuate element that encloses the control rod 5 when closed. To open the reverse lock 53, it is necessary to bend the arcuate element in the opposite direction. When twisting the adjusting rod 5 and setting the left 3 and right 4 parts of the plate at the required distance to tighten the edges of the wound, the retainer 53 blocks the adjusting rod 5 from rotating in the opposite direction to prevent the tightening of the edges of the wound from loosening.

The adjusting rod 5 at the proximal end is provided with a travel regulator 56, made as a single part with it, and being part of the backstop 53. The travel adjuster 56 is in the form of petals located around the circumference of the control rod 5, it is located between the holder 31 of the guide groove 32 and the arcuate element. When the control rod 5 is screwed in, the petals of the travel adjuster 56 interact with the rectangular piece, resulting in a click. This allows, in addition to visual observation of the degree of convergence of the edges of the wound, also tactile and auditory control of the process, to determine the turnover step when twisting the control rod. One “click” of a petal is equal to a mechanical step. The pitch is equal to 1 / n of the rod circumference, where n is the number of petals of the governor. The number of petals of the 56 stroke regulator is more than two. In the preferred embodiment, the number of travel regulator petals is four.

In addition, the travel adjuster 56 is part of the backstop 53. In the closed position, the arcuate element fixes the control rod 5 by blocking the petals.

Additionally, the right part of the fastening element contains a limiter-holder, consisting of two elements - a support 44, located on the holder 41 and an annular protrusion 54 around the circumference of the control rod, located closer to the handle 55. The limiter-holder performs several functions when using the device: it is a support when manipulations with the rod 55, and can also be an additional lock in relation to any direction of movement of the rod 55.

For the convenience of the user, when monitoring the closure of the wound, markers (not shown in the drawings) of the movement distance indicator can be mounted on the holder 31 and / or on the holder 41, which can be in the form of a recess, bulge, printed markers, etc.

To improve the efficiency of work, in practice, it is also possible to have a thread in the guide groove 42 and a thread 52 on the control rod 5 near the handle, but at the same time the screwing of the thread 52 in the guide groove 42 should act in the direction opposite to the screwing of the thread 51 in the guide groove 32 (in the drawings not shown). With this configuration, the holder 31 moves towards the handle of the control rod 5, and the holder 41 moves away from the handle of the control rod 5, which improves the working efficiency.

For the convenience of manual control of the handle, the adjusting rod 5 can be made of flexible material, and the guide groove 42 on the holder 41 can be installed inclined relative to the plane (not shown in the drawings) in which the right part of the plate is located. Thus, after inserting the adjusting rod 5 into the guiding groove 42, the handle 55 of the adjusting rod 5 will be above the plane on which the right 4 part of the plate is located, which will facilitate the user's work.

It is possible to make an adjusting rod 5, where the middle part of the rod is not provided with a thread, which makes it possible to leave a safe distance between the left 3 and right 4 parts of the plate to prevent excessive tightening of the wound and to provide access for wound treatment.

It is possible to make a part of the control rod 5 corresponding to the thread 51 of a tapered shape. This will provide tighter thread tightening.

It is possible to make an adjusting rod 5, where the thread 51 has a variable threaded pitch with decreasing gaps downward. In this case, the guide groove 32 is provided with a lead-through sleeve 34 without a thread for screwing in a rod with a variable thread pitch. The diameter of the sleeve 34 must be less than the diameter of the control rod 5. The sleeve 34 is made of polymer, in particular silicone.

It is possible to make holders 31 and 41 of fastening elements on a platform with a height of 0.01-0.4 cm (not shown in the drawings). This allows, in cases of complex wounds with torn edges, to raise the device 1 higher in order to prevent the edges of the wound from touching the regulating rod 5 and causing painful sensations as a result of injury.

The holders 31 and 41 on each side of the base plate have connecting elements 33 and 43 (respectively), with which the distance between the holders can be set, and thereby the rigidity of the plate parts 3 and 4 in the longitudinal direction can be set.

In addition, the distal and proximal holders are not only grouped in pairs, but can also be grouped as needed in a different number of groups and there may be a different number of holders in each group.

The lower adhesive layer of the left 3 and right 4 plate parts is not limited to one layer and can be laminated with several layers; in addition, the edges of the left 3 and right 4 parts of the plate are larger than the edges of the adhesive layer; the left 3 and right 4 parts of the plate are made of a breathable film material.

The above described embodiments of the device are only illustrative of the principles of the invention and its effects and are not intended to limit the invention. Any person skilled in the art can reproduce the claimed device with any set of elements without departing from the spirit and scope of the present invention.

The device is used as follows.

It is necessary to clean it with antiseptics and dry the skin surface so that the device fits snugly against the skin without gaps between the skin surface and the sticky plates and so that the adhesive force of the sticky layer is not reduced.

Before using the device 1 for closing a wound, the dimensions of the wound are visually determined and the required length of the plates is measured. Next, the protective paper layer 2 is removed and the left 3 and right 4 parts of the plate are glued to the left and right sides of the wound, respectively. The device is placed so that the second control rod 5 is located at the level of the end of the wound, and the wound itself is between two sticky parts of the plate, and then the plates are pressed against the skin. The distance from the edges of the wound to the adhesive base should be at least 0.5 cm. Then, using the handle 55, each adjusting rod 5 is sequentially tightened by mating the thread 51 with the guide groove 32. It is necessary to tighten the adjusting rods 5 clockwise, starting from the middle or from one of the edges of the plates, avoiding excessive and uneven stretching of the skin.

When twisting, the left 3 and right 4 plates converge towards each other, pulling the edges of the wound on both sides to the center until a uniform and sufficient compression of the wound is achieved. The degree of convergence of the edges of the wound is determined visually, depending on the damage. The adjusting rods 5 can be tightened incompletely in order to revise the subcutaneous tissues, and their tension can be adjusted and increased later. After twisting, the distal end of the adjusting rod 5 passes through the distal holder 35, which in turn prevents the end of the rod from bending (breaking) involuntarily. Retainer 53 for reverse, locks the rod from arbitrary loosening.

If necessary, you can remove one or more control rods 5 (unscrew the control rod 5 so that it protrudes from the guide groove 32 and the guide groove 42), opening access to the wound, which will facilitate the care and drainage of the wound by the user. Then return the rod to its place and twist.

The wound closure device can remain on the patient's skin for several days or weeks. After the wound has healed, the device can be effectively removed.

FIG. 9 shows a step-by-step diagram of using the claimed device.

Examples of using the claimed device.

Example 1.

The inventive device is used in obstetrics when suturing tissues in the case of a cesarean section with a transverse or longitudinal incision.

FIG. 10 shows the use of the device after a caesarean section in patient A.

Example 2.

The inventive device was used in orthopedic surgery. For curved or non-standard incisions, it is recommended to use a small (2-4 cm) intermittent closure device; or cut the required size from a large device according to the cut shape.

- in FIG. 11 shows the use of the proposed device after surgery on the knee joint in patient M.

- in FIG. 12 shows the use of the proposed device after surgery on the medial ankle in patient K.

- in FIG. 13 shows the use of the proposed device after wrist surgery in patient I.

- in FIG. 14 shows the use of the claimed device after surgery on the shoulder joint in patient R.

- in FIG. 15 shows the use of the proposed device when suturing the incision after hip arthroplasty in patient N.

Example 3.

In the case of a curved incision, such as in thyroid surgery, the handle of the adjusting rod should be in the direction of the outer circumference of the arch.

FIG. 16 shows the use of the claimed device after surgery on the thyroid gland in a patient.

FIG. 17 shows the use of the proposed device after surgery in patient T. in the case when the orientation of the control rod was determined in accordance with the anatomical features.

Example 4.

The inventive device was used in the departments of maxillofacial surgery.

FIG. 18 shows the use of the claimed device after removal of the inflamed lymph node in patient V.

FIG. 19 shows the use of the proposed device in plastic surgery for a forehead lift in patient V.

The claimed technical solution is industrially applicable, since it can be manufactured under conditions of production of any scale. It is efficient, feasible and reproducible, and the distinctive features of the solution make it possible to obtain the desired technical result.

Thus, the claimed device is convenient in operation, easily applied and removed, has a simple design, when using it, the degree of tension of the wound edges can be arbitrarily adjusted, there is access to the wound, facilitates its care, which ensures high healing efficiency. Therefore, the present invention effectively corrects various disadvantages of the prior art and has a high practical value.

Claims (11)

1. A device for closing a wound, including a support plate, an attachment element and a regulating rod, where the support plate consists of two parts - left and right, made of breathable elastic material, having a lower adhesive layer impregnated with antibacterial and antioxidant substances; on the upper side of the plate is a two-part fastening element for the adjusting rod, with one part of the fastening element located on the left side of the plate and includes a guide slot holder with a through hole for an internal screw, and the second part of the fastening element located on the right side of the plate and includes a guide slot holder with a through hole for accommodating an adjusting rod made of a flexible material with an external thread at the distal end and provided with a handle at the proximal end, in addition, the guide slot holder of the right part of the fastening element may additionally have an internal thread, opposite to the thread of the guide groove of the left part of the fastening element, while the left and right parts of the fastening element interact with each other by means of an adjusting rod, characterized in that, in addition, the regulating rod at the proximal end is equipped with a backstop, made in the form of a rectangular section, installed by the lower rib along the length on the fastening element along the central axis of the adjustment rod, and having an arcuate element at the end of the upper rib closest to the handle, capable of covering control rod; additionally, the regulating rod at the proximal end is equipped with a travel regulator made as a single part with it, which is the petals located around the circumference of the regulating rod, in addition, the travel regulator is an element of the backstop lock, located between the guide groove holder and the arcuate element, interacts with the petals with the part rectangular section and in the closed position of the arcuate element fixes the regulating rod; additionally, the left part of the fastening element contains a distal holder made in the form of an open groove located on the left part of the fastening element, and the upper part of the groove is partially or completely closed by a hollow half-cylinder with the formation of a common through hole sufficient to accommodate a control rod in it, and the central axis of the groove , the axis of the half-cylinder and the control rod coincide; additionally, the right side of the fastening element contains a limiter-holder, consisting of two elements - a support located on the fastening element, and an annular protrusion around the circumference of the control rod located closer to the handle, while the support and the annular protrusion interact with each other. 2. Device for closing a wound according to claim. 1, characterized in that the regulating rod has a conical shape along the thread with an upward expansion. 3. A device for closing a wound according to claim 1, characterized in that the thread of the control rod has a variable thread pitch with decreasing gaps upward. 4. The device for closing a wound according to claim 1, characterized in that the guide groove on the left fastening element is equipped with an unthreaded bushing for screwing in a rod with a variable thread pitch and a bushing diameter less than the control rod diameter, and the bushing is made of polymer. 5. Device for closing a wound according to claim 4, characterized in that the polymer is silicone. 6. Device for closing a wound according to claim 1, characterized in that the travel regulator has more than two petals. 7. A device for closing a wound according to claim 1, characterized in that the fastening element has a platform of 0.01-0.4 cm.

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