Package for surgical suture material

Abstract

The invention relates to surgical suture materials (hereinafter "thread" / "surgical thread"), and more particularly to packages for storing, carrying and dispensing surgical threads, particularly with surgical needles (hereinafter "needle" / "surgical needle"). The claimed package for surgical suture material comprises an upper element (2) and a lower element (3) which, when assembled, form a channel (16) capable of receiving and holding a thread (12), and further comprises a holder (22) for a needle (21). The holder (22) for a needle (21) is formed by a pusher (24) with a spring element (25) on the proximal end thereof, which are provided in the upper element (2), and by a stop (23) and a guide (26) for the distal end of the pusher (24), which are provided in the lower element (3). The spring element (25) is designed to be capable of generating upon the pusher (24) a pressing force sufficient to hold in place a needle (21) disposed between the distal end of the pusher (24) and the stop (23). The proposed design of the package thus permits the use of a wide range of threads and needles, which can be securely held in the needle holder and the channel.

Description

[0001] Packaging for surgical suture material

[0002] The invention relates to surgical suture materials (hereinafter referred to as "thread / surgical thread"), namely to packaging used for storing, transporting and extracting surgical threads, in particular with surgical needles (hereinafter referred to as "needle / surgical needle").

[0003] Surgical suture is well known in the field. Currently, the industry offers a wide range of high-quality synthetic surgical suture materials with various characteristics (wide range), made of biocompatible materials such as polyesters, lactides, glucolides, polyolefins, caproactones, polyolefins, etc., as well as copolymers. However, surgical sutures can also be made of natural materials such as silk and "catgut". Surgical sutures are mainly used with standard surgical needles pre-attached to one or both ends. A surgical needle is usually a curved or partially curved elongated product with a distal penetrating end and a proximal end for attaching the thread. Surgical needles are usually made of biocompatible materials, in particular metals, including high-quality medical-grade steel.The design and shape of modern surgical needles are complex and varied. A hole may be drilled in the fastening end of the surgical needle to attach the end of the thread, or a groove may be made in the distal end of the needle to insert the end of the thread. In this way, the end of the surgical thread is mechanically fixed in the hole or groove of the needle, for example, by mechanically crimping or squeezing a portion of the proximal end of the needle around the thread. In some surgical procedures, such as ligation, surgical threads are used without surgical needles.

[0004] Packaging and packaging materials for surgical threads are crucial to provide doctors (surgeons) with undamaged sterile threads and needles for surgical operations, and also prevent tangling of the surgical thread and ensure its convenient extraction. Packages are manufactured in accordance with the nature of the surgical thread and its purpose, as well as in accordance with the specified nomenclature of surgical needles, i.e. different design options of packaging are used for different types of thread and needle nomenclature. Each combination of "needle-thread" has specific characteristics that determine the doctor's choice depending on the wound and the method of suturing. There is a whole range of packages that can be used for surgical threads and surgical needles.

[0005] The prior art discloses packages in the form of a roll [1-2]. These packages are usually made in the form of a rectangular vertically oriented scan, divided by fold lines into several parts (panels) having means for fastening relative to each other in the folded state. In such packages, a holder for standard surgical needles can be made, for example, in the form of cut tongues, protrusions or a strip of special foam with cuts, and is intended for installing and holding surgical needles. Packages in the form of a roll protect surgical threads during processing and transportation, and also ensure the convenience of sterilization, since they allow sterilizing gases to directly treat them.

[0006] The prior art discloses tray-shaped packages for surgical threads [3-4]. Tray-shaped packages for threads are typically molded products made from various standard polymeric materials. The molded product, namely the tray, typically consists of two elements that, when assembled, form a peripheral winding channel for the thread, designed to receive and hold the surgical thread. The package contains a needle holder, designed to receive and hold standard needles. To a greater extent, needle holders are designed as composites and include levers designed to press a needle of a certain type of nomenclature.

[0007] Tray packaging offers several advantages over roll packaging. It is known that surgical sutures can break or become entangled when removed from roll packaging, which is inconvenient for both the physician and the patient. Tray packaging generally avoids suture breakage, and allows for easy and quick removal of the suture without entanglement, as well as ensuring that the surgical needle is securely held in the appropriate needle holder. Another advantage of tray packaging is that it can be used in automatic or semi-automatic systems designed for winding surgical suture.

[0008] Tray-shaped packaging, known in this field, is used with some success; new packaging with new improved properties, design features and characteristics is constantly being developed, which would provide protection for the threads, facilitate their extraction during, for example, surgical operations, and allow for the reliable fixation of a wide range of sizes and thicknesses, etc. of needles (various types of nomenclature).

[0009] Thus, based on the results of the analysis of information known from the prior art, it was established that the closest in terms of the set of general technical features to the claimed packaging for surgical suture material is the packaging mentioned above with reference to the source of information [3].

[0010] The technical task of the invention is to develop new packaging for surgical suture material, which will allow holding a wide range of threads with needles (different length, type, size and cross-section of the needle, etc.) in the wound state, and will also allow holding threads without needles, i.e. development of universal packaging, which will ensure reliable holding of a wide range of needles and / or threads in the needle holder, and will also increase productivity when changing the type of thread and / or needle nomenclature in the production process.

[0011] The stated problem is solved, and the claimed technical results are achieved by the claimed packaging for surgical suture material, comprising an upper element and a lower element, which when assembled form a channel made with the possibility of receiving and holding a thread, and a needle holder. In this case, the needle holder is formed by a pusher with a spring element at its proximal end, formed in the upper element, and formed in the lower element by a stop and a guide of the distal end of the pusher. The spring element is made with the possibility of creating a pressing force applied to the pusher, necessary for holding the needle, placed between the distal end of the pusher and the stop.

[0012] The above-described design features of the packaging for surgical suture material allow for a wide range of threads and / or needles to be securely held in the needle holder during winding, for the thread / thread with the needle to be held in a wound state during transportation, and for the needle and thread to be easily removed from the packaging during use. The combination of design elements of the needle holder, as well as their arrangement, allows for the required amount of pusher travel relative to the stop and guide, and for a wide range of needles / threads to be fixed. In preferred embodiments, the claimed packaging is made of a polymeric material, for example, by injection molding.

[0013] In preferred embodiments, the claimed packaging is made essentially flat and oval in shape.

[0014] In preferred embodiments of the claimed packaging, the stop has a protruding edge in the upper part that prevents the needle from exiting the gap between the distal end of the pusher and the stop.

[0015] In preferred embodiments of the claimed packaging, the distal end of the pusher contains a protruding edge at the bottom that prevents the needle from exiting the gap between the distal end of the pusher and the stop.

[0016] In preference т In certain embodiments of the claimed packaging, the pusher additionally has a transverse cutout made on the side of the guide input in such a way that the thread placed in it is pressed against the end of the guide due to the force created by the spring element and is held in this position.

[0017] In preferred embodiments of the claimed packaging, the spring element is a flat compression spring.

[0018] In preferred embodiments of the claimed packaging, an additional stop for fixing the thread is provided in the upper element.

[0019] In preferred embodiments of the claimed packaging, a channel for receiving and holding a thread is formed between the upper surface of the lower element, the lower surface of the upper element, the inner surface of the walls of the lower element, and the outer surface of the walls of the upper element.

[0020] The above-mentioned other features and advantages of the claimed packaging for surgical suture material will be further examined in more detail using examples of some preferred, but non-limiting, forms of implementation with references to the positions of the figures of the drawings, which schematically represent:

[0021] Fig. 1 - top view of the package with wound thread and fixed needle;

[0022] Fig. 2 - isometric view of the packaging with spatial separation of the constituent elements;

[0023] Fig. 3 - general view of the lower element of the packaging;

[0024] Fig. 4 - general view of the upper element of the packaging;

[0025] Fig. 5 - cross-section of the package along the needle holder;

[0026] Fig. 6 - cross-section of the package along the needle holder with a fixed needle. Figures 1-6 show the claimed package for surgical suture material in the form of a tray. The package is preferably made flat and oval. The oval shape of the package ensures the straightness of the thread after its extraction, minimizes the occurrence of the "shape memory" effect. It should be noted that the shape of the package can also be made in a different configuration, including round, polygonal, square with rounded corners, etc.

[0027] The tray-shaped packaging for surgical sutures is made of polymer material such as polypropylene, high-density polyethylene, polyethylene terephthalate (PET), etc. The tray-shaped packaging for surgical sutures is manufactured using various standard manufacturing processes and methods, including injection molding, thermoforming, welding, machining, mechanical assembly, any combination thereof, etc. Particular preference is given to the use of injection molding.

[0028] As can be seen from figures 1-6, packaging 1 for surgical suture material consists of an upper element 2, a lower element 3 and a label (not shown in the figures). The label indicates the characteristics of the packaged material (threads, needles), as well as marking in accordance with GOST.

[0029] On the upper surface 4 of the lower element 3, two vertically upward protrusions 5 are formed, located at a distance from each other and made with through holes 6, intended for positioning the package 1 in the corresponding specialized winding device. On the side surface of the protrusions 5, horizontally protruding tenons 7 are made, which are intended for interaction with the corresponding grooves 8 of the upper element 2 and subsequently for the formation of a single product - the package 1. Along the periphery 9 of the lower element 3, external walls 10 are formed vertically upward in the form of a plurality of petals with corresponding interrib spaces 11. The walls 10 are made elastically deformable, i.e. they are capable of bending and / or deviating under the influence of, for example, an element of the specialized winding device, intended for laying the thread 12 in the package 1.

[0030] The upper element 2 is made hollow and contains an internal arc-shaped wall 13 located vertically downwards along the perimeter of the upper element 2. For fixing the label, horizontal projections 14 are provided, located on the upper surface 15 of the upper element 2.

[0031] The upper element 2 and the lower element 3 in assembly form a channel 16 for the thread 12, made for receiving and holding the thread 12, wherein the assembly of the upper element 2 and the lower element 3 is carried out by means of protruding pins 7 and corresponding grooves 8. The channel 16 for receiving and holding the thread 12 is formed between the upper surface 4 of the lower element 3, the lower surface 17 of the upper element 2, the inner surface of the walls 10 of the lower element 3 and the outer surface of the walls 13 of the upper element 2. The size of the resulting channel 16 is approximately 3x5 mm. In the course of development, testing and experiments, the size of the channel 16 was selected, which allows for the extraction of a wide range of threads 12 freely known from the prior art, i.e. there is no friction of the thread 12 against itself. Thus, this packaging 1 allows for the use of a wide range of threads 12 (different lengths, diameters, materials, structures, etc.), for example, with a thread thickness of 0.05-0.6 mm, length of 0.5-2.5 m, made of different materials, etc.

[0032] In order to reduce the friction of the thread 12 during its use (pulling it out of the package 1 for subsequent use), projections 18 are provided on the outer surface of the wall 13. The upper element 2 contains a groove 19, through which the thread 12 is placed and smoothly passes into the channel 16 for the subsequent process of winding the thread 12 by means of an element of a specialized winding device intended for placing the thread 12 in the channel 16. To fix (press) the thread 12 during the winding process, an additional stop 20 is provided, made in the upper element 2 and located near the groove 19, which makes it possible to remove the load from the holder 22 of the needle 21 during the winding process and to avoid damage to the fastening of the thread 12 in the needle 21, for example, to prevent the thread 12 from tearing off from the needle 21 during winding.

[0033] In the central part of the package 1, a holder 22 of the needle 21 is formed. The holder 22 of the needle 21 is formed by a pusher 24 with a spring element 25 located at its proximal (end of the pusher) end, a stop 23 and a guide 26 of the distal end of the pusher 24. The spring element 25, for example, a flat compression spring, is designed with the possibility of creating a pressing force applied to the pusher 24, necessary for holding the needle 21, located between the distal end of the pusher 24 and the stop 23, regardless of the diameter and cross-section of the needle 21, and also provides a significantly large stroke of the pusher 24.

[0034] In order to be able to manufacture the design of the holder 22 of the needle 21 specified above with the corresponding characteristics, the package 1 is made of two elements: the upper element 2 and the lower element 3. In this case, the spring element 25 with the pusher 24 are formed in the upper element 2, and the stop 23 and the guide 26 in the lower element 3. Such a design allows for the required stroke of the pusher 24 relative to the stop 23 and the guide 26 (in Fig. 2, the arrow indicates the direction of movement of the pusher 24) and allows for fixing a wide range of needles 21, as well as thread 12 without needle 21. The opening space allows for simply placing the needle 21 in the package 1 (namely, in the holder 22 of the needle 21), rather than pressing it between the elastic walls of the holder, as is implemented in some analogues.

[0035] The stop 23 is made with a protruding edge 27 in the upper part, preventing the needle 21 from exiting the gap between the distal end of the pusher 24 and the stop 23. The distal end of the pusher 24 has a protruding edge 28 in the lower part, preventing the needle 21 from exiting the gap between the distal end of the pusher 24 and the stop 23. The presence of edges 27 and 28, as well as their specially selected shape, are intended for reliable fastening (retention) of the needle 21 of a wide range. The pusher 24 additionally has a cutout 29, made on the side of the entrance of the guide 26, in such a way that the thread 12 of a wide range placed in it is pressed against the end of the guide 26 due to the force created by the spring element 25 and is held in this position.

[0036] In the pusher 24, a through hole 30 is additionally made, which is intended for interaction with a specialized device developed by the applicant, intended for winding the thread 12 into the package 1. The features of this device are described in the corresponding application for an invention.

[0037] The pusher 24 can be moved away from the stop 23 and the guide 26 by means of the spring element 25 using the operator’s fingers, for example, by pressing and holding the shoulders of the spring element 25, which will lead to the corresponding release of space for fixing the needle 21 and / or thread 12 in the holder 22 of the needle 21 (Fig. 1.6).

[0038] The above-presented holder 22 of the needle 21 allows for a wide range of sizes of needles 21 to be securely held, for example, with a needle 21 length from 10 to 50 mm, a triangular and round cross-section profile, as well as a wide range of threads 12, for example, with a thread thickness of 0.05-0.6 mm, a length of 0.5-2.5 m, made of different materials, etc.

[0039] In the lower element 3, a through hole 31 is provided, made in such a way that it is possible to lift the pusher 24 with the operator's fingers and release the needle 21 and / or the thread 12 from the holder 22 of the needle 21. In order to position the needle 21 to the desired depth in the branches, the lower element 3 contains a corresponding through hole 32, located near the stop 23. After the thread 12 is wound into the package 1, sterilization is carried out, therefore the lower element 3 contains a plurality of through cutouts 33, ensuring easy passage of the sterilizing agent into the channel 16 and the corresponding internal space of the package 1.

[0040] The claimed packaging 1 is intended for operation together with automatic or semi-automatic winding devices. In order to ensure the process of winding the thread 12 into the packaging 1, namely to increase productivity and ensure operator safety, it is recommended to use the claimed packaging 1 together with the device developed by the applicant. It should be noted that the use of the claimed packaging 1 with other automatic / semi-automatic devices also allows for the use of all the advantages of the above-described features of the packaging 1 and ensures reliable retention of a wide range of thread 12 and / or needle 21 in the corresponding holder 22 of needles 21.

[0041] The technology of winding the thread 12 into the package 1 on the specialized device is as follows. Securing the needle 21 in the holder 22 of the needle 21 by retracting the spring element 25 together with the pusher 24 and positioning the needle 21 in the corresponding vacated space between the stop 23 and the pusher 24, namely between the protruding edges 27 and 28. When releasing (straightening) the spring element 25, the pusher 24 presses the needle 21 against the stop 23 and holds it securely. And securing the thread 12 in the holder 22 of the needles 21 is carried out by retracting the spring element 25 together with the pusher 24 and positioning the thread 12 in the corresponding vacated space between the guide 26 and the pusher 24. When releasing (straightening) the spring element 25, the pusher 24 presses the thread 12 against the end of the guide 26 and holds it securely.The design of the spring element 25 ensures sufficient travel of the pusher 24 relative to the stop 23 and the guide 26 for convenient placement of the needles 21 and threads 12 of a wide range. Then the thread 12 is passed through the groove 19 and by means of an element of the winding device, for example, a stylus, the thread 12 is placed (wound) in the channel 16. After the winding of the thread 12 into the package 1 is completed, the package 1 and additional components are sterilized.

[0042] Thus, the developed design of the packaging allows using a wide range of threads and needles for reliable retention in the needle holder and channel. The claimed design of the packaging in the production process allows not to change the packaging in case of a change in the type of nomenclature of surgical threads and / or needles, which allows increasing the productivity of the winding process, for example, if it is necessary to prepare small batches of different nomenclature of threads / needles, which is necessary for individual clinics and hospitals. The use of a wide range of threads and needles in the claimed packaging is confirmed by tests conducted by the applicant, i.e. makes it universal.

[0043] Sources of information:

[0044] 1. Application SU1528328A3, priority 13.06.1985;

[0045] 2. Patent EP0055823, priority 12.11.1981; 3. WO 2020 / 183411 priority 13.03.2019;

[0046] 4. GB 2514994 priority 05.04.2013.

Claims

Invention formula 1. A packaging for surgical suture material comprising an upper element (2) and a lower element (3) which, when assembled, form a channel (16) configured to receive and hold a thread (12), and a holder (22) of a needle (21), characterised in that the holder (22) of a needle (21) is formed by a pusher (24) with a spring element (25) at its proximal end, formed in the upper element (2), and a stop (23) and a guide (26) of the distal end of the pusher (24) formed in the lower element (3), wherein the spring element (25) is configured to create a pressing force applied to the pusher (24) necessary to hold the needle (21) placed between the distal end of the pusher (24) and the stop (23).

2. Packaging according to paragraph 1, characterized in that it is made from a polymeric material using a method such as injection molding.

3. Packaging according to paragraph 1, characterized in that it is made in a substantially flat and oval shape.

4. Packaging according to item 1, characterized in that the stop (23) has a protruding edge (27) at the top, which prevents the needle (21) from exiting the gap between the distal end of the pusher (24) and the stop (23).

5. The packaging according to item 1, characterized in that the distal end of the pusher (24) contains a protruding edge (28) at the bottom, which prevents the needle (21) from exiting the gap between the distal end of the pusher (24) and the stop (23).

6. Packaging according to claim 1, characterized in that the pusher (24) additionally has a transverse cutout (29) made on the side of the entry of the guide (26) in such a way that the thread (12) placed in it, due to the force created by the spring element (25), is pressed against the end of the guide (26) and is held in this position.

7. Packaging according to item 1, characterized in that the spring element (25) is a flat compression spring.

8. Packaging according to item 1, characterized in that an additional stop (20) is provided in the upper element (2) for fixing the thread (12).

9. The packaging according to claim 1, characterized in that the channel (16) for receiving and holding the thread (12) is formed between the upper surface (4) of the lower element (3), the lower surface (17) of the upper element (2), the inner surface of the walls (10) of the lower element (3) and the outer surface of the walls (13) of the upper element (2).

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