Artificial tourniquets for stopping and / or preventing internal bleeding in patients and kits including such tourniquets.

Abstract

This specification relates to an artificial hemostatic plug for stopping and / or preventing internal bleeding in a patient, more specifically, intrathoracic bleeding. The plug has a compressible plug body with a first end and a second end. The plug also has a thread slidably disposed through the plug body. The thread is also fixedly connected to the first end of the plug body, allowing the first end to be pulled toward the second end using the thread, which extends further outward from the plug body. This specification also includes a kit comprising the plug and a plug pusher.

Description

Technical Field

[0001] The present invention relates to an artificial hemostatic plug for stopping and / or preventing bleeding in a patient, and a kit for inserting the artificial hemostatic plug into a patient's body (e.g., into the chest cavity). Background Technology

[0002] Intraoperative bleeding control is crucial in modern medicine. A wide variety of hemostatic measures and techniques have been developed, such as the use of hemostatic gauze, surgical sutures, electrocautery, and applying pressure to the bleeding area.

[0003] Despite these existing techniques, they are not always appropriate, feasible, or sufficient in certain situations. This is especially true in cases of difficult-to-access bleeding, such as in minimally invasive thoracic surgery that has gained access to the patient's chest cavity. During such procedures, the surgeon makes small incisions between the ribs.

[0004] Stopping hard-to-reach bleeding during such surgeries using existing techniques is challenging. Although various methods have been developed for bleeding control, there remains a need for novel and improved techniques that are effective in a variety of surgical and medical settings, especially for stopping hard-to-reach bleeding, such as bleeding within or near the pleural cavity. Summary of the Invention

[0005] The purpose of embodiments of the present invention is to provide a technique for stopping and / or preventing bleeding in a patient, especially bleeding that is difficult to palpate, such as intrapleural bleeding, and more specifically, bleeding inside the chest wall.

[0006] For this purpose, a first aspect provides an artificial hemostatic plug for stopping and / or preventing bleeding within a patient, more specifically, bleeding within the patient's pleural cavity.

[0007] The plug has a compressible plug body, preferably an elongated body having a first end and a second end. The plug also has a wire slidably arranged through the plug body. The wire is also fixedly connected to the first end of the plug body, such that the first end can be pulled toward the second end using the wire, which extends further outward from the plug body.

[0008] Creative insights have shown that hard-to-reach bleeding, particularly chest wall bleeding, can be treated by providing a plug with cleverly arranged threads. Because the threads are slidably arranged through the plug body, the plug body can be contracted to a constricted state, in which the plug can be used to control bleeding that would otherwise be difficult to reach. One type of bleeding that can be controlled by the plug described herein is bleeding that occurs during minimally invasive thoracic surgery.

[0009] Preferably, the thread interweaves through the plug body from the first end, which is fixedly connected to the thread, to the second end. In this way, the thread interweaves through the plug body, and this interweaving provides the plug with improved hemostatic ability due to the ideal contraction of the plug body.

[0010] The first end of the plug body is typically the distal end, pointing towards the patient. Furthermore, the term "distal" as used herein generally refers to the side intended to point towards the patient. The second end of the plug body is typically the proximal end, pointing towards the operator, such as a surgeon. Furthermore, the term "proximal" as used herein generally refers to the side intended to be away from the patient and pointing towards the surgeon. Preferably, the plug body is made of a compressible material, such as filler, a sponge structure, or a cotton swab. In this way, the material of the plug body can be compressed, preferably reducing its size and / or increasing its density, when the thread is pulled through the plug body and slid through the plug body. Advantageously, this can provide a blood barrier, especially when the density of the plug body is increased by pulling the thread, which prevents or stops bleeding, particularly in the direction from the second end to the first end.

[0011] Preferably, the lines are fed through the plug body in a zigzag pattern so that the lines engage the plug body at various locations inside the plug body during contraction. Preferably, the zigzag pattern comprises a pattern that overlaps, preferably multiple times, with the longitudinal axis of the plug body, for example, the pattern overlaps with the longitudinal axis from left to right. Preferably, the plug body has a longitudinal axis, and the lines are interwoven to engage the body at various locations where they are spread at least 25%, preferably at least 50%, along the longitudinal axis. In this way, an improved compression shape can be formed when the lines are pulled, which further increases the blood-stopping effect and / or the density of the plug body, especially when the plug body is made of a compressible material as described herein. Furthermore, because the plug body itself is compressible, complex plug body designs (e.g., origami-style) are not required. This simplifies manufacturing. Preferably, a portion of the thread extends from the first end of the plug body through the plug body and interweaves to the second end, wherein the portion of the thread is slidable relative to the plug body while the thread is fixedly attached to the first end of the plug body. Advantageously, this increases the density of the plug by pulling the thread, which further improves the blood-stopping effect of the plug. According to a preferred embodiment, the plug body is a compressible body that can contract from an uncontracted state to a contracted state in which the plug body contracts into a clump; and wherein the thread is attached to the first end of the plug body such that when the thread is pulled, the first end of the plug body is pulled toward the second end of the plug body, thereby causing the plug body to enter the contracted state, in which the plug body contracts and forms the clump. The clump can be formed as a compressed bundle of fibers. Advantageously, by designing the compressible body as described above, an improved blood-stopping effect can be achieved, especially since the thread is attached to the first end, allowing the body to be compressed in an improved manner, which allows the plug body to stop blood more efficiently and effectively in the compressed state.

[0012] In one embodiment, the line is provided with a plurality of barbs. Such barbs have the advantage of preventing undesirable movement of the line and / or the plug body. The barbs can be positioned at appropriate locations on the plug body to prevent undesirable slippage, and / or the barbs can be positioned at locations on the free portion of the line extending outside the body for engagement with tissue. The barbs on the line are preferably configured as engagement elements extending away from the line and are configured to engage adjacent or nearby objects, such as the plug body and / or the patient's tissue. More specifically, according to one embodiment, the plurality of barbs are arranged to allow the plug body to compress into a compressed state and prevent the plug body from re-expanding and / or longitudinally expanding. According to one embodiment, a fixation element is arranged on the line outside the plug body, and the fixation element is configured to subcutaneously engage the patient's body. The fixation element can be used to hold the plug body in a desired state and / or at a desired location near the bleeding point to be treated. The fixation element is typically positioned on the free portion of the line extending outside the plug body.

[0013] The fixation element is preferably positioned at a maximum distance of 2.5 cm from the plug body to subcutaneously engage the patient's tissue near the plug body. Subcutaneous tissue is understood to refer to any tissue beneath the skin and is not limited to any specific layer of the patient's body. Positioning the fixation element at a suitable distance of at most 2.5 cm facilitates proper engagement of the appropriate tissue to be engaged by the fixation element. The fixation element preferably has one or more blades attached to the thread. Such blades are used to engage nearby tissue. The plurality of blades preferably have blade tips pointing towards the plug body to prevent movement and / or deformation of the plug body after it is placed in the patient's body. This orientation facilitates proper engagement and secure fixation using the fixation element.

[0014] The suture preferably extends through the fixing element, and preferably wherein the suture extends centrally through the fixing member. This configuration provides the desired fixation for the suture and other elements of the plug for the purpose of desired hemostasis.

[0015] The thread preferably has a first end connected to the plug body and a second end including a needle for suturing. The needle facilitates the attachment of the plug body after it has been positioned. The second end is preferably provided with a sleeve that encloses the needle. The sleeve provides improved security and protection. The sleeve can also function as a engageable element, such as a handle or grip for the second end of the thread, making it easier to manipulate the thread. For example, the sleeve can be engaged with one hand, and the thread and / or the needle can be engaged with the other hand, optionally using tweezers.

[0016] The sleeve is preferably slidably arranged on the line. This slidable arrangement increases the maneuverability of the line. More specifically, the sleeve is preferably slidably arranged such that the needle can be pulled from the sleeve while the plug body can be retracted.

[0017] According to one embodiment, the plug further has a second thread for pulling the plug body out of the patient's body. The second thread facilitates the removal of the plug body. The second thread is preferably attached to a second end of the plug body, typically the proximal end of the plug body. The second thread is thus securely connected to the second end such that pulling motion via the thread facilitates removal of the plug body from the patient's body.

[0018] In one embodiment, the plug also has an engageable element, such as a handle and / or the aforementioned sleeve, which is slidably arranged on the first line. The engageable element is typically arranged on the portion of the line extending to the outside of the plug body. The engageable element preferably functions as a handle to facilitate manipulation of the line. The second line preferably connects the plug body to the engageable element. Thus, the engageable element can be held, and thereby the plug body can be retracted from the patient via the second line between the plug body and the engageable element, the second line preferably being a handle and / or the aforementioned sleeve.

[0019] The plug body and / or the threads (including the first and second threads) are preferably made of one or more materials designed to dissolve in the patient's body over time, preferably selected from reabsorbable or soluble materials. These materials are those that are naturally broken down and absorbed by the body over time. This minimizes the need for a second surgery to remove the insert, as the insert disappears on its own. The plug body preferably comprises collagen. More preferably, the plug body is made of reabsorbable collagen engineered from "Type 1 collagen," preferably purified Type 1 collagen. Preferably, the collagen is derived from bovine Achilles tendon. Because "Type 1 collagen" is very abundant in the human body, the plug body is more biocompatible. That is, by selecting collagen type 1 to manufacture the plug body, the plug body can mimic the body's natural collagen structure, promoting better integration.

[0020] Preferably, the fixation element is made of a reabsorbable material, which may be made of collagen. Preferably, the plug body is made of intact collagen fibers. In this way, the plug body has inherent hemostatic properties, used to control bleeding while accelerating the healing process. According to a preferred embodiment, both the fixation element and the plug body are made of reabsorbable material. The thread can be made of any suitable material, for example, synthetic thread materials and / or reabsorbable or absorbable materials. Examples of materials used for the thread are: vicryl 910, monocryl 25, poly(p-dioxanone) (PDS), nylon (Ethilon, Dermlon), and polypropylene (Prolene, Surgipro). Examples of absorbable materials used for the thread are: vicryl 910, monocryl 25, and poly(p-dioxanone) (PDS). Preferably, the thread is made of a reabsorbable or absorbable material. Preferably, the thread is a monofilament structure, and / or the thread material comprises poly(p-dioxanone) or polycaprolactone or a combination thereof. The foregoing aspects provide a plug that can be used to treat a wide variety of hard-to-reach bleeding, particularly chest wall bleeding, such as bleeding near and / or between the ribs. Other hard-to-reach bleeding requiring cessation is, for example, bleeding occurring within or near the abdominal wall (e.g., during laparoscopy) or bleeding resulting from diagnostic chest punctures (e.g., thoracentesis, perforated biopsy).

[0021] On the other hand, a kit is provided for inserting an artificial hemostatic plug for stopping and / or preventing bleeding within a patient, more specifically, intrathoracic bleeding, wherein the kit comprises: - a plug as described herein; - a pusher having a pusher body for pushing the plug, preferably for pushing the plug through a guide channel of an insertion guide; - preferably, an insertion guide having a guide channel for guiding a medical device through the patient's body wall, for example, for guiding a medical device through the thoracic wall.

[0022] The inventors have demonstrated that the plug, particularly the plug body, can be easily guided to the relevant bleeding site using the pusher. Thus, the body of the hemostatic plug can be placed at or near the bleeding point and treat the bleeding. More specifically, the inventors have revealed that the plug body can be contracted using the thread, which is securely attached to the first end (the distal end) of the plug body. Preferably, an insertion guide, such as a conventional tracer, is further used. Typically, the insertion guide is used during surgical procedures for guiding medical instruments such as laparoscopic instruments, endoscopic instruments, and surgical tools. During such procedures, insertion of the insertion guide typically results in bleeding at hard-to-reach locations, such as on the inner side of the patient's chest wall and / or between the patient's ribs.

[0023] The insertion guide has a guiding channel for guiding a medical device, which includes the plug body and the pusher. In other words, the insertion guide has a guiding channel suitable for guiding the plug and the pusher. Insights have shown that such hard-to-reach bleeding can be treated with a cleverly configured artificial hemostatic plug as described herein, and the placement of the artificial hemostatic plug can be facilitated by using a pusher, preferably a pusher with an elongated pushing body. The pusher preferably has an insertion portion and also an end portion, the insertion portion being configured to push the plug through the guiding channel of the insertion guide into the patient, and the end portion being configured to hold the pusher. This configuration provides proper insertion of the plug, and in particular, proper insertion of the plug body. The pushing body preferably has a first distal opening in the insertion portion of the pusher and a second proximal opening in the end portion of the pusher. In this case, "distal" also refers to the side facing the patient, and "proximal" refers to the side facing the surgeon. Therefore, the opening provides a path for the line, allowing the plug body to contract with the aid of the line.

[0024] The pusher body preferably has a generally cylindrical shape, with its outer surface located between a first distal opening and a second proximal opening, and wherein the outer surface is provided with an open free slot extending from the first distal opening to the second proximal opening. This open free slot facilitates the placement process of the plug body, and in particular ensures that the pusher body can be more easily removed after the plug body has been pushed through the insertion guide.

[0025] The plug body is preferably positioned at the first distal end of the pusher, preferably aligned longitudinally with the first distal end of the pusher, wherein the thread of the plug is advanced along and / or through the pusher body to the second proximal end, such that the plug body is retractable from the patient's body by means of the thread when it has been placed inside the patient. In this way, the ingenious interaction of the plug and the pusher ensures that the plug body can be placed at or near the bleeding point, and that the bleeding can subsequently be treated by retracting the plug body by means of the thread. In other words, the plug body forms a physical hemostat in its retracted state.

[0026] The plunger preferably has a handle located in the proximal end portion of the plunger. The proximal end portion is typically the portion remaining outside the patient's body. The handle facilitates manipulation of the plunger. The handle of the plunger is preferably connected to the line of the plug, more specifically such that the line can be manipulated via the handle and consequently the plug body can be retracted via the handle. Preferably, the handle is configured to allow the line to be dislodged, preferably by cutting. It will be apparent that the handle can be configured in various ways such that the line can be dislodged from the handle. The handle is preferably configured such that the line (or at least a portion thereof) can be dislodged by cutting the line and / or cutting and / or removing the handle element connected to the line. Thus, the surgeon can provide dislodging in a simple manner using a scalpel or surgical scissors. The insertion guide is preferably configured to prevent the insertion portion of the plunger from sliding too far through the guide channel. In one embodiment, the insertion guide is provided with a stop element, for example, a stop edge or ring on the insertion guide, to strike a corresponding stop element on the plunger. In this way, it is possible to prevent sliding too far, thus preventing undesirable placement and / or excessively deep insertion.

[0027] The guide channel of the insertion guide preferably has a receiving opening configured to receive the plug and the insertion portion of the pusher, and wherein the edge of the inlet opening is preferably configured to strike a stop element of the pusher, such as the handle or ring of the pusher, to prevent the pusher from sliding too far through the inlet opening.

[0028] In one embodiment, the plunger and the insertion guide are provided with a fastening system such that once the insertion portion of the plunger has slid through the guide channel, the plunger and the insertion guide are detachably fastened to each other by means of the fastening system. This fastening uses the plunger and the insertion guide to facilitate the placement of the plug, making it easier for the surgeon to treat bleeding. Examples of desirable fastening systems are systems employing magnets and / or snap-fit ​​systems. Such fastening systems are, for example, snap-fit ​​systems with one or more clamps and / or systems including one or more magnets. With these removable systems, the plunger and the insertion guide can also be disassembled again, for example, for reuse.

[0029] The plunger is preferably provided with a modular handle, which is configured with a first handle component and a second handle component. The use of two handle components allows for more precise manipulation during the insertion process.

[0030] The first handle component is preferably slidably arranged on the line, more preferably slidably arranged around the push body. The second handle component is configured here to hold the plug on the line. Because the second handle component is designed to hold the line, a firm grip on the line is provided.

[0031] In one embodiment, the second handle component is fixedly connected to the push body, such that the push body can slide through the first handle component by means of the manipulation of the second handle component. The slidable first handle component allows the surgeon to pull the second handle component and the push body backward, so that the plug body can be retracted.

[0032] The second handle component is preferably configured to allow cutting of the line, for example, using surgical scissors or a scalpel. In this way, it facilitates the entire procedure for treating bleeding.

[0033] The first handle component and the insertion guide are preferably configured to engage with each other by means of a fastening system such as a snap-fit ​​system and / or by means of magnetic fasteners. This fastening can improve handling during the placement of the plug, thus enabling the surgeon to more easily treat bleeding.

[0034] In one embodiment, the modular handle further includes a third handle component detachably disposed between the first handle component and the second handle component to maintain a predetermined distance between them, wherein the predetermined distance preferably corresponds to the length of the plug body in its unretracted state.

[0035] The third handle provides the desired positioning and proper retraction of the plug body with the line. Preferably, after the third handle component is removed, it is detachably secured to the pusher body, and the second handle component can be secured to the first handle component, for example, by means of a snap-fit ​​system. This "three-part" handle, with the help of the pusher, provides and facilitates accurate positioning of the plug body.

[0036] In one embodiment, the first handle component and the second handle component are provided with a fastening system configured to fasten the second handle component to the first handle component. The fastening system preferably includes one or more snap-fit ​​pins that can be engaged into corresponding openings. This fastening can improve the surgeon's control.

[0037] Preferably, the pusher extends in a longitudinal direction, and the locking pin of the second handle component extends parallel to this longitudinal direction by a distance (d). p The distance is substantially equal to the longitudinal length of the plug body in its uncontracted state. In this way, the desired and correct contraction of the plug body is provided due to feedback via the locking pin.

[0038] During the placement of the plug body, a tight tension on the line is desired to treat bleeding. The plug injector is preferably equipped with a tensioner to prevent undesirable slippage of the line. In this way, the tensioner facilitates proper placement of the plug body. Preferably, the pusher body is in the form of a hollow tube, and the tensioner is disposed within the hollow tube or at an opening in the hollow tube, with the line of the plug fed through the tensioner. According to one embodiment, the tensioner is a rubber element that applies a certain pressure to the line, such that the line is slippery only under a defined tension, for example, when a surgeon applies a pulling force.

[0039] The pusher body preferably has a distal insertion opening through which the thread of the plug is fed, wherein the insertion opening is configured to provide resistance against which the body of the plug can contract by means of the thread. The plug body can thus be more easily contracted using the thread. Preferably, the insertion opening of the pusher body has dimensions that allow the thread to pass through for feeding while preventing the plug body from passing through for feeding. In this way, compression of the plug body by pulling the thread is facilitated, and the risk of tissue damage is reduced, especially since the plug body can contract against the pusher body and thus not against tissue contraction. More preferably, the pusher body tapers toward the distal insertion opening. In this way, compression of the plug body is even more convenient. In one embodiment, the insertion guide is provided with one or more pressure valves and / or valve mechanisms to prevent accidental introduction of air, for example, to prevent lung collapse.

[0040] In one embodiment, the insertion guide has an adjustable sealing system that provides an air seal in the guide channel in a first mode and allows the medical device and / or the plunger to pass through in a second mode.

[0041] On the other hand, plugs and / or kits, as described herein, are provided for use in the treatment of bleeding. This use also ensures that hard-to-reach bleeding can be treated, especially bleeding occurring within the patient's chest cavity and / or between the patient's ribs. Attached Figure Description

[0042] The aspects will now be described in more detail with reference to the accompanying drawings, which illustrate several preferred embodiments and principles.

[0043] Figure 1 The use of the kit is illustrated, which includes a plug, an insertion guide, and a pusher for pushing the plug.

[0044] Figures 2A to 2C The kit's components are shown, among which... Figure 2A The insertion guide is shown. Figure 2B Showing the plunger, and Figure 2C Show the plug.

[0045] Figure 3 The kit is shown, in which the pusher is located in the guide channel of the insertion guide.

[0046] Figures 4A to 4B An example of a plug is shown.

[0047] Figures 5A to 5B Examples of plug bodies in uncontracted and contracted states are shown.

[0048] Figure 6The kit is shown to be used, comprising a plug with a fixing element, an insertion guide, and a pusher for pushing the plug.

[0049] Figures 7A to 7B An insertion guide and a pusher are shown, each equipped with a fastening system.

[0050] Figure 8 An example of a modular handle for a plunger is shown.

[0051] Figure 9 The use of the kit is illustrated, the kit including a plug having a first wire and a second wire, the first wire and the second wire being connected to a sleeve.

[0052] Figures 10A to 10B Show in more detail Figure 9 The components of the kit shown.

[0053] Figure 11 The kit is shown, which includes a plug, a pusher, and an insertion guide.

[0054] Figure 12 Show Figure 11 The pusher shown in the image.

[0055] Figure 13 Show Figure 11 The plug shown in the image.

[0056] Figure 14 An embodiment of the insertion guide is shown.

[0057] Figure 15A Show in more detail Figure 14 It is part of the insertion guide, and the medical device is guided through the guidance channel of the insertion guide.

[0058] Figure 15B This illustrates the case where there are no instruments in the guide channel. Figure 14 It is part of the insertion guide. Figure 15C Show Figure 14 A portion of the insertion guide, wherein the plug and pusher are guided via the insertion guide's guide channel.

[0059] Those skilled in the art will understand from this description that the present invention can be embodied in different ways based on different principles. It should be further understood that elements and features having the same reference numerals are intended to have the same characteristics and provide similar technical advantages. Detailed Implementation

[0060] As mentioned above, a challenge lies in using existing techniques to stop difficult-to-access bleeding within a patient's body. Examples of difficult-to-access bleeding include bleeding within or near the pleural cavity, such as bleeding between the ribs and / or on the inner side of the chest wall. Such bleeding is often caused by surgical procedures that allow access to the pleural cavity via incisions and / or insertions using medical instruments.

[0061] Figure 1 A portion of the thoracic thorax (TH) and chest wall (TW) is shown. The insertion guide 200 can be used to guide various medical devices (not shown) through the chest wall (TW) via the guide channel 210. After the use of the medical device, a plug 10 can be used to treat any bleeding, the plug 10 being positioned at a relevant location near the bleeding point by means of a pusher 300, preferably via the guide channel 210 of the insertion guide 200.

[0062] Figure 1 As shown, plug 10 includes plug body 20, and wire 30 is connected to plug body 20. Plug 10, especially plug body 20, can be pushed through guide channel 210 of insertion guide 200 by means of pusher body 330 of plug pusher 300 (see...). Figure 1 a to Figure 1 b).

[0063] The plug 10 has a plug body 20 and a thread 30. The plug body 20 is positioned at the distal end of a pusher body 330, and the thread 30 is fed via the pusher body 330 to the proximal end of the plug body, allowing the surgeon to reach the thread 30. Thus, the plug body 20 can be retracted, wherein the thread 30, extending to the outside of the plug body 20, can be used to pull the first end 21 of the plug body 20 toward the second end 22 of the plug body 20 (see...). Figure 1 b to Figure 1 c). Thus, the line has a line member 30a passing through the plug body 20 and a free line member 30b. The line 30 is preferably provided with a handle element 35 to facilitate tensioning of the line 30.

[0064] Figure 1 As further shown, the plunger 300 has an insertion portion 310 and an end portion 320. The insertion portion 310 is typically a member inserted into the insertion guide 200. The end portion 320 remains on the outside, allowing the surgeon to hold the plunger 300 and to tension the line 30 to retract the plug body 20.

[0065] Once the plug body 20 has been inserted (see...) Figure 1 (b) The plug body 20 can preferably be retracted via the handle element 35 by means of the line 30, so that the body 20 is in the unretracted state 10a (see Figure 1 b) Entering a contraction state 10b (see...) Figure 1c). Therefore, the plug body 20 in its contracted state forms a hemostat. After the plug body 20 has been contracted (see state 10b), the surgeon can remove the insertion guide 200 and the pusher 300 (see...). Figure 1 d). Thread 30 can be cut with the aid of surgical scissors and / or a scalpel, and thread 30 can be cut, for example, with the aid of sutures and / or knots (see...). Figure 1 e) Attached in any suitable manner. This latter operation can be facilitated if the line 30 is already provided with a needle 34 (as described herein), which is preferably wrapped in a sleeve 35 that can serve as a handle element 35.

[0066] Figures 2A to 2C The insertion guide 200, pusher 300 and plug 10 are shown in more detail respectively. Figure 2A As shown, the insertion guide 200 has a guide channel 210.

[0067] The guiding channel 210 preferably extends from the distal end 201 of the insertion guide 200 to the proximal end 202. The insertion guide 200 is typically used to receive and guide various types of medical devices through the patient's body, allowing the surgeon to access a specific location within the body. The distal end 201 of the insertion guide 200 may be configured with sharp edges and / or tips (not shown) to facilitate insertion. Figure 2A As further shown, the insertion guide 200 is configured to prevent the insertion portion 310 of the body 330 from being pushed (see [reference]). Figure 2B (This prevents the pusher from sliding too far into the insertion guide 200.) As shown, the insertion guide 200 has a stop element 250 that can strike a corresponding stop element 350 on the pusher 300. In this way, the pusher 300 is prevented from sliding too deep into the insertion guide 200, and overall control is improved.

[0068] Figure 2B As shown, the pusher 300 includes an insertion portion 310 and an end portion 320. The length Ld of the insertion portion 310 preferably corresponds to the length Li of the guide channel 210 for the purpose of achieving the desired positioning of the plug body 20.

[0069] The pusher 300 preferably has a handle 350 located in the end portion 320 for improved handling and control. The handle 350 can be configured in various ways, as will be described further. Figure 2BFurther shown, the plunger 300 has a first opening 331 and a second opening 332. The first opening 331 is located distally and is intended to point towards the patient and / or the bleeding site. The second opening 332 is located proximally and is intended to be close to the operator, typically a surgeon. The two openings 331, 332 of the plunger are connected to a channel 333 extending between the openings. Thus, the channel 333 forms a route along the line 30 that can be fed into the plunger 10. Because the line 30 is guided through the channel 333 of the plunger 300, the chance of undesirable line deformation or damage is reduced. The channel 333 of the plunger body 330 is preferably configured to protect the line 30 of the plunger 10.

[0070] Figure 2B As shown, the pusher body 330 of the pusher 300 includes a channel 333 configured to feed the wire 30 from a distal end opening 331 to a proximal opening 332 of the pusher 300 for the purpose of protecting the wire. The channel 333 preferably has dimensions that allow the wire 30 to pass through while preventing the plug body 20 from passing through. The channel 333 and / or its opening 333a are, for example, not made large enough that the plug body 10 cannot be pulled through the channel when the wire 30 is tensioned. In this way, the pusher body 300 provides the desired resistance to the contraction of the plug body 20 via the wire 30.

[0071] Figure 2C An embodiment of the plug 10 is shown. The plug 10 includes a plug body 20 and a wire 30. The plug body has a first end 21 and a second end 22. The first end 21 is a distal end, which is intended to point towards the patient. The second end 22 is a proximal end, which is intended to point towards the operator (e.g., a surgeon).

[0072] The line 30 is fixedly connected to the first end 21. In the first end 21 of the plug body 20, the line can be connected to any connection point that allows the plug body 20 to contract via the line 30. For example, a connection point near the distal outer end 21 of the plug body 20 or a connection point located on the distal outer end 21 of the plug body 20. In addition to the fixed connection of the line 30, the line is slidably arranged through the plug body 20 and extends further over the free line member to the handle 35. As shown, the line 30 has a first line member 30a and a free line member 30b, the first line member 30a being slidably arranged through the plug body 20, and the free line member 30b extending away from the plug body 20. The free line member 30b is preferably provided with a handle 35.

[0073] The line 30 may be provided with barbs 31. In one embodiment, the barbs 31 are arranged on the line at the location of the plug body 20, more specifically on the line member 30a extending through the plug body 20 (see...). Figure 4AAlternatively or alternatively, the barb 31 may be positioned away from the freeline member 30b extending from the plug body (see [reference]). Figure 4B In particular, it is for the purpose of improving the fixation of line 30 by joining nearby objects (e.g., nearby tissue and / or lines). Figure 2C (and Figure 4A As shown, the barb 31 is arranged to hold the plug body 20 in a contracted state 10b. More preferably, the barb 31 is arranged to engage with the plug body 20 such that the plug body 20 cannot re-inflate to an uncontracted or less contracted state 10a. The plug body 20 preferably has an elongated form, especially because an elongated body in the contracted state 10b provides a better blood seal.

[0074] The “contracted state” typically refers to the state in which the opposite outer ends of the plug body 20 are brought toward each other (more specifically, the opposite outer ends of the plug body 20 are pulled toward each other using line 30). In other words, the opposite outer ends of the plug body are closer together in the contracted state compared to the uncontracted state (see state 10a) (see state 10b).

[0075] Figure 3 The kit is shown, in which the pusher 300 is located in the guide channel 210 of the insertion guide 200. The plug 10 is arranged longitudinally in line with the pusher body 330, and the line 30 of the plug 10 is fed through the pusher body 330 via the channel 333. It will be apparent that the line may also optionally be guided along the pusher body 330 using one or more guide elements (not shown). More specifically, Figure 3 As shown, the plug body 20 is located at the distal end 331a of the push body 330. A wire 30 is fed through the push body 330 to the proximal end 332a, such that the plug body 20 can be retracted from the patient's body by means of the wire 30 once it has been placed inside the patient. The distal end 331a and the proximal end 332a are preferably connected via a channel 333, which is configured to allow the wire 30 to pass through and prevent the plug body 20 from being pulled further through.

[0076] Figure 3 Further shown, the pusher 300 includes a tensioner 375 configured to maintain a tight tension on the line 30. The pusher body 330 preferably takes the form of a hollow tube in which the tensioner 375 is disposed or attached at or attached to an opening 332. The tensioner 375 preferably functions as a rubber element that applies a defined pressure on the line, thereby making the tensioner slidable only under a defined tension, for example, when a surgeon applies a tension force.

[0077] Figures 4A to 4BA possible embodiment of plug 20 is shown. Figure 4A As shown, the fixing element 40 is arranged on the line 30. The fixing element 40 is preferably arranged at a predetermined distance d from the plug body 20. a More specifically, the maximum distance d is 2.5cm. a . Figure 4A As shown, line 30 extends centrally through fixing element 40. Figure 4A As further shown, the retaining element 40 includes a plurality of blades 41 attached to the wire 30. The blade tips 42 of the retaining element 40 are directed toward the plug body 20 to prevent movement and / or deformation of the plug body 20. Figure 4B An embodiment of the plug 10 is shown, wherein a thread 30 is slidably arranged through the plug body 20. The figure shows that the thread 30 has a first thread end 32 connected to the plug body 20 and a second thread end 33 including a needle 34 for suturing. For safety, the needle 34 is preferably protected via a sleeve or tube 35. The tube 35 is preferably slidably arranged on the thread 30, whereby the tube 35 can slide along the thread 30 toward the plug body 20 as the needle 34 is pulled out of the tube. Figure 4B A further embodiment is shown in which the plug 10 includes a second thread 50 in addition to the first thread 30. The second thread 50 is arranged to remove the plug body 20 from the patient's body again. The second thread 50 is preferably fixedly connected to the plug body 20, more preferably to its proximal end 22. The second thread 50 is preferably further connected to a handle 35, for example, a sleeve 35 acting as a handle. Connecting the second thread to the sleeve 35 improves the procedure while treating bleeding. This means that the person performing the hemostasis procedure (typically a surgeon) has more control and can therefore act more efficiently.

[0078] The first suture 30 and preferably the second suture 50 are preferably made of a reabsorbable material, thus forming a reabsorbable suture. This reabsorbable suture can be made of natural or synthetic materials that are gradually broken down by the body. Several examples of materials used are polyglycolic acid (PGA), polycaprolactone (PGCL), polydioxanone (PDO), and catgut (a natural material made from sheep intestines). The advantage of reabsorbable sutures is that they eliminate the need for suture removal, which reduces patient discomfort. The suture can be made of any material as described earlier herein.

[0079] Figures 5A to 5B The plug body 20 is shown in more detail. Figure 5A The plug body 20 is shown in its unshrunken state 10a, and Figure 5BThe plug body 20 is shown in its contracted state 10b. The plug body 20 is in the form of a compressible body, a compressibility that means the body can be contracted by means of the line 30, typically contracting into a lump (e.g., Figure 5B (As shown in the diagram). The plug body 20 can be made of one or more materials capable of stopping bleeding. Examples include a body 20 based on cellulose and / or gelatin and / or collagen. Cellulose fibers can be compressed to form a dense filler, sponge structure, or cotton swab. These materials can be placed in the wound to stop bleeding by absorbing blood and by promoting coagulation. The plug body 20 is preferably reabsorbable, allowing it to be incorporated into or absorbed by tissues, organs, and / or cells, and thus incorporated into the patient's body. The plug body preferably comprises collagen.

[0080] Figure 5A As shown, the lines 30 interweave through the plug body 20. This interweaving configuration provides improved body packing for forming a desired barrier to treat bleeding. The lines 30 are more preferably arranged in a zigzag pattern (see [reference needed]). Figure 5A The wire 30 is fed through the body, thereby engaging the body at various locations inside the body during contraction. The wire 30 is preferably interwoven from the first end 21 to the second end 22 on a portion that can slide relative to the plug body 20, while the wire 30 is fixedly connected in the distal end 21 of the plug body 20, more preferably connected to the outermost distal end 21. Figure 5A Further illustrated, the line is fed through the plug body in a zigzag pattern to engage the plug body at various locations inside the plug body during contraction. Figure 5B In this way, improved shrinkage can be achieved. Preferably, these positions are spread out along the longitudinal direction, and preferably spread out uniformly. Preferably, the various positions include multiple positions located between the first end and the second end of the plug body, preferably at least three positions, and even more preferably at least four positions are engaged between the first end and the second end to ensure the desired shrinkage. Figure 5A and Figure 5B Further shown, the barbs 31 can be arranged to better maintain the contracted state 10b. The barbs 31 are preferably arranged at least on the line member 30a, which is slidably arranged through the plug body 20, preferably in an interlaced or staggered manner. The barbs 31 are preferably arranged one after another in a row on the line 30, particularly for improving the internal engagement of the plug body 20. The term "barb" includes any hook element suitable for engaging the plug body 20 to prevent the plug body 20 from re-expanding to the uncontracted state and / or to prevent decompression of the plug body. The line 30 also has a free member 30b, which may be provided with barbs (see...). Figure 4B ). Figure 5BAs shown, the first distal end 21 of the plug body 20 is pulled closer to the second proximal end 22 using line 30. Figure 5A Furthermore, it is shown that the plug body has a length L p (It was measured in the unshrinked state 10a).

[0081] Figure 6 The use of the kit is illustrated, the kit including a plug 10 with a fixing element (as shown in the reference). Figure 4A (As mentioned above). Figure 6 The insertion guide 200 and the pusher 300 for pushing the plug 10 are further shown. The plug 10 is arranged such that the plug body 20 and the retaining element 40 are located at the distal end 331a of the pusher body 330. A wire 30 is fed through the pusher body 330 and is connected to the handle 350, more specifically to the removable part 352 of the handle. Figure 6 In particular, the handle 350 of the illustrated embodiment is modular. This means that the handle 350 is designed with the option of connecting and / or removing different modules or components. Thus, the handle preferably has a first handle component 351 and a second handle component 352, and preferably has a third handle component 353.

[0082] Now refer to Figure 6 (See) Figure 6 a to Figure 6 g) Further explanation of the process of arranging the plug body 20 using the kit according to this embodiment. The plug body 20 and the fixation element 40 are inserted into the patient's body via the channel 210 of the insertion guide 200 (see...). Figure 6 a and Figure 6 b). Subsequently, the second handle component 352 is pulled back, causing the plug body 20 to retract into the retracted state 10b via the line 30 (see...). Figure 6 c), and the plug can be placed close to the bleeding point (see c). Figure 6 d).

[0083] Figure 6 As shown, while maintaining tension on line 30, handle component 353 disengages from and is removed from components 351 and 352 (see Figure 1). Figure 6 d and Figure 6 e).

[0084] Insert the guide 200 and the attached (e.g., snap-in) component 351 (see...) Figure 6 e) Now retract toward component 352. In this case, the fastening system 500 is preferably positioned between component 351 and insertion guide 200, as shown in reference. Figure 7A (It shows the insertion guide 200) and Figure 7B(As shown in the description of the pusher 300). The first handle component 351 is preferably provided with one or more snap-fit ​​pins 325, which are configured to be fixedly engaged into corresponding one or more openings of the insertion guide 200.

[0085] As shown in the figure, the pusher 300 is also configured to push the fixation element 40 out of the insertion guide 200, so that the fixation element 40 can be securely engaged in the subcutaneous tissue of the chest wall (see Figure 200). Figure 6 e).

[0086] Subsequently, the pusher 300 can be removed by cutting along line 30 (see...). Figure 6 e to Figure 6 f). Fixation element 40 engages with the chest wall (see f). Figure 6 f to Figure 6 g), and thus provides an advantageous preservation of the position and state 10b of the plug body. Therefore, Figure 6 The image itself shows one aspect of a pusher 300 for actuating the plug body 20 of the hemostatic plug 10, wherein a wire 30 is fixedly connected to the distal end 21 and is connected to a handle 352, and wherein all these aspects are configured such that actuation of the handle 352 allows the plug body 20 to retract by means of the wire 30. Figure 6 In this design, the handle 350 is configured with a first handle component 351 and a second handle component 352. The first handle component 351 is slidable on the line 30, and more preferably, the first handle component 351 is slidably arranged around the push body 330. The second handle component 352 holds the line 30 of the plug 10 such that operation of the second handle component 352 manipulates the line 30, and pulling the second handle component 352 backward in particular causes the line 30 to retract and the plug body 20 to retract into the retracted state 10b. The slidable component 351 and the line holding component 352 (line holder) provide improved handling and easier control.

[0087] Figure 6 As further shown, the second handle component 352 is fixedly connected to the push body 330 of the plug. This allows the push body 330 to be manipulated by means of the movement of the second handle component 352 through the first handle component 351.

[0088] Figure 6 Furthermore, the second handle component 352 allows for cutting of line 30 (see [reference]). Figure 6 e to Figure 6 f). Any suitable handle design is acceptable, as long as the surgeon can easily cut the suture 30 and then attach the suture, for example, via the suture.

[0089] To enhance overall handling, the handle 350, particularly the first handle component 351, and the insertion guide 200 can be configured preferably by means of, for example Figure 7A and Figure 7B The fastening systems 500b shown engage with each other. A snap-fit ​​system and / or a magnetic fastening system are preferably provided to fasten the insertion guide 200 and the handle 350 to each other. Thus, the insertion guide 200 may be configured with an opening 225, which is configured to receive and temporarily hold the snap-fit ​​pin 325 of the handle 350, or in other words, the snap-fit ​​pin 325 of the handle 350, particularly the snap-fit ​​pin 325 of the first handle component 351, is configured to be temporarily and securely clamped in the opening 225. The reverse is also possible (not shown), where the insertion guide is provided with a snap-fit ​​pin that can be securely engaged in the opening of the handle 350. In addition to or as an alternative to the snap-fit ​​system, a magnet may be provided so that the insertion guide 200 and the handle 350 can be fastened to each other. It is generally advantageous that the insertion guide 200 and the pusher 300 are fastened to each other for purposes such as improving the process via a fastening system, more preferably via a snap-fit ​​system and / or a magnet system.

[0090] Figure 6 Furthermore, the fixation element 40 can be subcutaneously engaged with the patient's body using blades 41, each blade 41 having a blade tip 42 configured to engage the patient's body, for example, to engage tissue in the chest wall TW.

[0091] Figures 7A to 7B As shown, the insertion guide 200 and the pusher 300 are provided with a fastening system 500, such that once the insertion portion 310 of the pusher has slid the guide channel 210, the pusher 300 and the insertion guide 200 can be removably fastened to each other by means of the fastening system.

[0092] Figure 8 As shown, the handle 350 of the plunger 300 is connected to the plug's wire 30 and is configured here to allow the wire to be dislodged by cutting. Therefore, Figure 8 As shown, the handle 350, and in particular the handle part 352, is configured to allow cutting of the line 30 via a notch 350a, which is configured to facilitate such cutting of the line 30. Figure 8 An example of the modular handle 350 of the plunger 300 is shown more specifically. The modular handle includes a first handle part 351, a second handle part 352, and preferably a third handle part 353. The line 30 is fed through the handle parts, and more specifically through an opening in each handle part located almost centrally. The first handle part 351 and the third handle part 353 are configured to allow the line 30 to retract by means of the second handle part 352. More specifically, the line 30 is detached relative to the first and third handle parts, and the line is preferably fixedly connected to the second handle part 352, which acts as a line retainer.

[0093] Figure 8 As shown, the third handle component 353 is detachably arranged between the first handle component 351 and the second handle component 352 in order to maintain a predetermined distance between them (see distance d). c3 The predetermined distance d c3 Preferably corresponding to the unshrinked state (see...) Figure 5A The length Lp of the plug body 20 of the plug 10 in the figure.

[0094] Figure 8 Further shown, the third handle component 353 is detachably fastened between the first handle component 351 and the second handle component 352, and wherein, after the third handle component 353 is removed, the second handle component 352 is fastened to the first handle component 351 by means of a snap-fit ​​system provided with one or more snap-fit ​​pins 352a.

[0095] Figure 8 Further shown, the first handle component 351 and the second handle component 352 are provided with a fastening system 453, which is configured to fasten the second handle component 352 to the first handle component 351. As shown, the fastening system preferably has one or more locking pins 352a on the second handle component 352, which can be engaged into corresponding openings in the first handle component 351.

[0096] Figure 8 Furthermore, it is shown that the locking pin 352a extends a distance (d) parallel to the longitudinal direction of the pushing body. p The distance is approximately equal to that in the uncontracted state 10a (see...). Figure 5A The longitudinal length (Lp) of the plug body 20 in the plug.

[0097] In one embodiment, the plug 20 further has a second thread 50 for pulling the plug body 20 out of the patient's body. Figure 9 An example of such an embodiment is shown in the figure.

[0098] Figure 9 An embodiment of a kit with a plug 20 is shown, the plug 20 being provided with a first line 30 and a second line 50, the first line 30 being arranged to cause the plug body 20 to retract.

[0099] The second line 50 is positioned to remove the plug body 20 from the patient's body. Now, according to... Figure 9 The procedure shown illustrates the principles of the kit and its components, wherein the plug body 20 is arranged to treat bleeding. Figure 9 As shown, the insertion guide 200 is inserted through the chest wall (TW) to accommodate various types of medical devices. Figure 9(Not shown in the image) provides access to the thorax in the pleural cavity (see [reference]). Figure 9 a) In particular, the access route to the thoracic thorax via the guide channel 210. Once the surgeon has performed the necessary surgery in the thoracic thorax, any bleeding can be treated due to the insertion of the guide 200.

[0100] Use the pusher 300 to push the plug body 20 through the guide channel 210 (see...) Figure 9 (b) The reason for preventing excessive pushing is that the pusher is provided with a stop element 350', which is arranged to impact the stop element 250 of the insertion guide 200, thereby preventing excessive pushing and thus preventing excessive sliding. This ensures favorable placement of the plug body 20.

[0101] like Figure 9 As shown, the pusher 300 has an insertion portion 310 for pushing the plug 10, particularly the plug body 20 of the plug 10, through the guide channel 210 of the insertion guide 200 into the patient's body. The end portion 320 of the pusher 300 remains outside the insertion guide 200 and is allowed to be retained.

[0102] Once the plug body 20 has been positioned in the thoracic TW (see...) Figure 9 c) The plug body 20 can then contract from state 10a to state 10b, forming a mass-like structure that can treat bleeding (see...). Figure 9 c to Figure 9 d). The plug body 20 can contract by means of the (first) line 30, particularly by means of the free member of the tensioning line (more specifically, by means of the portion tensioned on the outside of the body). Preferably, the line 30 is guided to a position outside the patient's body by the pusher 300 to provide easy access to the line 30. A handle 35 disposed on the free member of the line 30 can facilitate tensioning of the line 30. The tensioner 375 is preferably arranged such that once the line 30 has been tensioned, it remains in the tensioned state, thereby holding the plug body 20 in the contracted state 10b. For this purpose, the tensioner 375 can be arranged in any suitable manner, as long as a certain pull-out force is applied to the line 30. Figure 9 As shown (as viewed from the side view), the tensioner 375 is arranged as a rubber ring through which the line 30 is fed. The rubber ring is configured to apply a certain pull-out force to the line 30, such that the line 30 can be tensioned by a surgeon, for example, with a certain pulling force. This pull-out force further ensures that a certain tension is maintained on the line 30, so that the plug body 20 cannot re-expand and is better retained in the contracted state 10b.

[0103] Figure 9 Further shown is that the plug body contracts against the distal end 331a of the pusher 300 (see...). Figure 9 d), more specifically, retracts against the distal insertion opening 331 located at the distal end 331a of the pusher 300 (as in Figure 11 and Figure 12 (This is shown in more detail below). Figure 9 Furthermore, it is shown that after the pusher body 20 is pushed, the pusher 300 can be removed (see [reference]). Figure 9 e). Especially in embodiments where the handle 35 (or sleeve) is arranged on the line 30, the push body 330 is configured with an open free slot 341 along which the line 30 can be removed from the push body (see Figure 12 ). Figure 9 As shown, the insertion guide 200 can be removed from the patient's body (see [link]). Figure 9 f and Figure 9 g), so that the plug body 20 can be arranged against the inner wall of the chest wall TW in the contracted state 10b (see Figure 9 g). In reference Figure 9 In the possible embodiments described herein, multiple barbs may also be used, as described herein (see element 31). Figure 9 Further illustrating, the thread 30 can be cut, for example, using a scalpel S, and can be attached such that the plug body 20 remains in the desired location within or near the bleeding point in the contracted state 10b. The first thread 30 can be, for example, using a suture (see...). Figure 9 i) or tape (not shown) may be attached in any suitable manner. The second thread 50 is attached in an accessible manner so that the second thread 50 may be engaged at a later time so that the plug body 20 may be removed from the patient again if necessary.

[0104] Figures 10A to 10B Show in more detail Figure 9 The individual components of the kit shown. Figure 10A The proximal end member of the pusher 300 and the proximal end member of the plug 10 are shown, wherein the first line 30 and the second line 50 are shown. Figure 10A As shown, the second line 50 is preferably connected to the handle 35. The manipulation of the handle 35 directly affects the second line 50, thereby improving control. As described above, the free line member of the line 30 may be provided with the handle 35, and the channel 35 may be configured as a sleeve surrounding the needle 34. The push body 330 preferably has an open free slot 341 in its sidewall 345, allowing the push body 330 to be removed because the first line 30 and the second line 50 can be guided out of the push body 330. Figure 10B The various aspects of the sliding sleeve 35 will be used to explain them. In particular, the first line 30 is preferably provided with a handle 35 to facilitate tensioning of the line 30. Figure 10BAs shown, the plug body 20 is placed inside the patient using the insertion guide 200 and the pusher 300 (see [reference]). Figure 10B a The first line 30 and the second line 50 pass through the pusher body 330 of the pusher 300 for feeding, allowing them to approach from the outside of the body. The proximal end 332a of the pusher body 330 preferably has a configuration corresponding to the handle 35 of the plug 10, such that the handle 35 is temporarily held (see...). Figure 10B a The handle 35 can be in the form of a sleeve that wraps around the needle 34 (see...). Figure 10B b Further shown, the sleeve 35 is slidably arranged on the first line 30, such that the handle 35 can slide forward toward the plug body 20 (see...). Figure 10B c The handle 35 can be attached via suture 30h using the first thread 30 and preferably the needle 34 (see...). Figure 10B d The second thread 50 is attached to the handle 35 so that, if necessary, for example after cutting the first thread 30 (if, for example, the first thread is attached to the patient's body via sutures), the plug body 20 can be pulled out from the patient's body using the handle 35 via the second thread 50.

[0105] Figure 11 The kit shown includes a plug 10, a pusher 300, and an insertion guide 200. The plug body 20 of the plug 10 is positioned at a first distal end 331a of the pusher body 330 of the pusher 300, more specifically, the plug body 20 is longitudinally aligned with the first distal end 331a. A line 30 of the plug passes through the pusher body 330 and is fed to a second proximal end 332a. Figure 11 In the middle, the line is fed through the push body 330 via the internal push body channel 337, which extends between a first (distal) opening 331 in the distal end 331a and a second (proximal) opening 332 in the proximal end 332a.

[0106] Furthermore, for the line, it is possible for the line to be guided along the push body 330 (not shown), for example, along the outside of the push body 330, and via one or more guide elements.

[0107] It will be apparent that the line 30 is preferably guided such that when the plug body 20 has been placed inside the patient, the plug body 20 can be retracted from outside the patient by means of the line 30.

[0108] As shown in the figure, the insertion guide 200 is provided with a stop element 250. When the pusher 300 is further pushed through the guide channel 210 of the insertion guide 200, the stop element 250 is struck by the corresponding stop element 350 on the pusher 300. Figure 11 As shown, the insertion guide is provided with a ring 250', which is configured to receive the wire 30. The ring 250' is preferably arranged to act as a stop element 250 to strike a corresponding stop element 350 on the pusher 300. The ring 250' is preferably provided with one or more notches to facilitate wire attachment. In this way, when the plug body 20 is retracted (not shown), the wire 30 can be easily attached to the ring 250'. The ring 250' is preferably made of silicone material to improve grip on the wire 30. The ring 250' further improves overall handling in other ways. Figure 11 In this configuration, the plug 10 is arranged such that the plug body 20 and the push body 330 are longitudinally aligned. The wire 30 of the plug 10 is fed through the push body 330, and more specifically through the internal through-feed channel 337 of the push body 330, thereby feeding the wire 30 through the push body. The internal through-feed channel 337 is more specifically configured to feed the wire 30 from a first distal opening 331 to a second proximal opening 332. The through-feed channel 337 and / or the distal opening 331 are configured to allow the wire 30 to pass through and prevent the plug body from passing through.

[0109] Figure 12 This illustrates a separately applicable concept for a pusher 300 used to push an artificial hemostatic plug through an insertion guide. More specifically, the pusher 300, having an elongated pusher body 330, includes an internal through-feed channel 337 extending from a first distal opening 331a in the distal end 331a of the pusher body 330 to a second proximal opening 332a in the proximal end 332a of the pusher body 330. Preferably, the distal end 331a of the pusher body 330 tapers toward the first distal opening 331. Because the pusher body 330 tapers toward the first distal opening 331, the pusher body 330 gradually narrows toward the opening 331. This taper facilitates the contraction of the plug body 20. Thus, Figure 12 An example is shown in which the push body 330 has a distal insertion opening 331 through which the line 30 of the plug can be fed, wherein the insertion opening 331 is configured to provide resistance, and the body 20 of the plug 10 can contract against the resistance by means of the line 30.

[0110] Figure 12As shown, the pusher 300 has a pusher body 330, which is generally cylindrical in shape. The pusher body has an outer surface 345 between a first distal opening 331 and a second proximal opening 332. This outer surface is provided with an open free slot 341 that extends from the first distal opening 331 to the second proximal opening 332. Figure 12 As further shown, the actuating body 330 includes a distal end 331a and a proximal end 332a. The proximal end 332a preferably has a configuration corresponding to the handle 35, such that the handle 35 is temporarily held.

[0111] Figure 13 Show Figure 11 The plug shown is positioned at the distal end 331a of the push body 330. The plug 10 has a plug body 20, through which a line 30 is slidably arranged and fixedly connected to the distal end 21, preferably to the outermost end. The line 30 has a line member 30a passing through the plug body 20 and a free line member 30b outside the plug body 20. Figure 13 As shown, the freeline member 30b is provided with a plurality of barbs 31. Figure 13 As further shown, the second wire 50 is connected to the proximal end 22 (also referred to as the second end) of the plug body 20, and the first wire 30 is connected to the distal end 21 (also referred to as the first end).

[0112] As described above, the second line 50 is preferably connected to the handle 35. Figure 13 (Not shown in the image).

[0113] Figure 14 An embodiment of an insertion guide 200 is shown. The insertion guide has a guide channel 210 configured to guide a medical device MI (see [link to documentation]). Figure 15A These medical devices MI can be instruments used, for example, to cut tissue, suture blood vessels, remove tumors, etc., with the aid of a camera such as a thoracoscope, and / or instruments such as imaging instruments. To prevent air leakage, sealing systems 275 and 260 are preferably used, which are designed to close the guide passage during insertion and removal of the instrument. Aspiration system 278 can be used to remove fluid and other materials from the pleural cavity during surgery.

[0114] Figure 15A As shown, the insertion guide 200 guides the medical device MI via the guide channel 210. Figure 15B As shown, the guide channel 210 is free and sealed by an adjustable sealing system 275. The adjustable sealing system 275 is configured in a first mode 275a (see...). Figure 15BIn the second mode 275b, an air seal is provided in the guide channel 210 and in the second mode 275b (see Figure 15A and Figure 15C The medical device MI and / or pusher 300, especially its plug body 330, are allowed to pass through the guide channel. Figure 14 As further shown in Figure 15, the insertion guide 200 is provided with a plurality of pressure valves 260 and / or valve mechanisms 260 to prevent accidental introduction of air, for example, to prevent lung collapse.

[0115] Figure 15C Show Figure 14 A portion of the insertion guide, wherein the plug and pusher are guided via the insertion guide's guide channel.

[0116] The above embodiments and accompanying drawings are purely illustrative and are only intended to enhance the understanding of the invention. Therefore, the invention is not limited to the embodiments described herein, but is defined in the claims.

Claims

1. An artificial hemostatic plug (10) for stopping and / or preventing internal bleeding in a patient, more specifically internal bleeding in the patient's pleural cavity, wherein, The plug includes a compressible plug body (20) having a first end (21) and a second end (22), wherein the plug also includes a wire (30). in, The line is slidably arranged through the plug body (20) and fixedly connected to the first end (21) of the plug body (20), so that the first end (21) can be pulled toward the second end (22) using a line (30) that extends further to the outside of the plug body.

2. The plug according to the preceding claim, wherein, The line (30) passes through the plug body (20) from the first end (21) and interweaves to the second end (22).

3. The plug according to any one of the preceding claims, wherein, The plug body (20) is made of a compressible material, such as filler, sponge structure or cotton swab.

4. The plug according to any one of the preceding claims, wherein, The line (30) is fed through the plug body (20) in a zigzag pattern so that the line engages the plug body (20) internally at various locations during the contraction of the plug body (20).

5. The plug according to any one of the preceding claims, wherein, A portion of the line (30) passes through the first end (21) of the plug body (20) and interweaves with the second end (22), wherein the portion of the line (30) is slidable relative to the plug body (20), while the line (30) is fixedly connected to the first end (21) of the plug body (20).

6. The plug according to any one of the preceding claims, in, The plug body (20) is a compressible body that can contract from an uncontracted state (10a) to a contracted state (10b), in which the plug body contracts into a mass; and The line (30) is attached to the first end (21) of the plug body (20) such that when the line (30) is pulled, the first end (21) of the plug body is pulled toward the second end (22) of the plug body, thereby causing the plug body to enter the contracted state (10b), in which the plug body contracts and forms the clump.

7. The plug according to any one of the preceding claims, wherein, The line (30) is provided with multiple barbs (31).

8. The plug according to the preceding claim, wherein, The plurality of barbs (31) are arranged to allow the plug body (20) to be compressed into a compressed state (10b) and to prevent the plug body (20) of the plug from re-expanding and / or longitudinally expanding.

9. The plug according to any one of the preceding claims, wherein, A fixation element (40) is arranged on the line (30) on the outside of the plug body (20), and the fixation element is configured to subcutaneously engage with the patient's body.

10. The plug according to any one of the preceding claims, wherein, The fixing element (40) is made of reabsorbable material.

11. The plug according to the preceding claim, wherein, Both the fixing element (40) and the plug body (20) are made of reabsorbable material.

12. The plug according to any one of the preceding three claims, wherein, The line (30) extends through the fixing element (40), preferably wherein the line extends centrally through the fixing element.

13. The plug according to any one of the preceding four claims, wherein, The fixation element (40) is positioned at a maximum distance of 2.5 cm from the plug body (20) to subcutaneously engage the patient's tissue near the plug body.

14. The plug according to any one of the preceding five claims, wherein, The fixing element (40) includes one or more blades (41) attached to the wire.

15. The plug according to any one of the preceding six claims, wherein, The fixing element includes a plurality of blades (41) with the blade tips (42) of the plurality of blades pointing toward the plug body (20) of the plug in order to prevent the plug body (20) of the plug from moving and / or deforming after being placed in the patient's body.

16. The plug according to any one of the preceding claims, wherein, The thread has a first thread end (32) connected to the plug body (20) and a second thread end (33) including a needle (34) for suturing.

17. The plug according to the preceding claim, wherein, The second thread end includes a sleeve (35) that wraps around the needle, wherein the sleeve is preferably slidably arranged on the thread.

18. The plug according to any one of the preceding claims, wherein, The plug also includes a second line (50) for pulling the plug body (20) out of the patient's body.

19. The plug according to the preceding claim, wherein, The second line (50) is attached to the second end (22) of the plug body (20).

20. The plug according to any one of the preceding two claims, wherein, The plug also includes a engageable element (35), such as a handle or sleeve, which is slidably arranged on the first line (30), and wherein the second line (50) connects the second end (22) of the plug body (22) to the engageable element (35).

21. The plug according to any one of the preceding claims, wherein, The plug body (20) and / or the thread (30) are made of a material designed to dissolve in the patient’s body over time, preferably selected from reabsorbable or soluble materials.

22. A kit (1) for inserting an artificial hemostatic plug (10), said artificial hemostatic plug for stopping and / or preventing internal bleeding in a patient, more specifically internal bleeding in the patient's pleural cavity, wherein, The kit includes: - The plug (10) according to any one of the preceding claims of the plug; - A pusher (300) having a pusher body (330) for pushing the plug body (20) of the plug (10) through the guide channel (210) of the insertion guide (200). - Preferably, the insertion guide (200) has a guide channel (210) for guiding a medical device through the patient's body wall, for example, for guiding a medical device through the chest wall.

23. The kit according to the preceding claim, wherein, The pusher (300) has an insertion portion (310) configured to push the plug body (20) of the plug (10) through the guide channel (210) of the insertion guide (200) into the patient's body, and the pusher (300) also has an end portion (320) configured to hold the pusher (300).

24. The kit according to the preceding claim, wherein, The push body (330) has a first distal opening (331) in the insertion portion of the pusher and a second proximal opening (332) in the end portion of the pusher (300).

25. The kit according to any one of the preceding claims of the kit, in, The push body (330) has a generally cylindrical form, with its outer surface (345) located between a first distal opening (331) and a second proximal opening (332), and wherein the outer surface is provided with an open free slot (341) extending from the first distal opening to the second proximal opening.

26. The kit according to any one of the preceding claims of the kit, in, The plug body (20) of the plug (10) is positioned at the first distal end (331a) of the pusher body (330) of the pusher (300), the plug body preferably being longitudinally aligned with the first distal end; wherein the line (30) of the plug is supplied along and / or through the pusher body (330) to the second proximal end (332a) such that when the plug body (20) has been placed inside the patient, the plug body (20) can retract from the patient's body by means of the line (30).

27. The kit according to any one of the preceding claims, wherein, The plunger (300) is provided with a handle (350) located in the proximal end portion (320) of the plunger.

28. The kit according to the preceding claim, wherein, The handle (350) of the pusher (300) is connected to the line (30) of the plug (10) and is preferably configured to allow the line to be dislodged preferably by cutting.

29. The kit according to any one of the preceding claims, wherein, The insertion guide (200) is configured to prevent the insertion portion (310) of the pusher (300) from sliding too far through the guide channel (210), for example by means of a stop element (250), the stop element (250) being, for example, a stop edge or ring on the insertion guide (200) to strike a corresponding stop element (350, 350') on the pusher (300).

30. The kit according to any one of the preceding claims, wherein, The guide channel (210) of the insertion guide (200) has a receiving opening (221) configured to receive the plug (10) and the insertion portion (310) of the pusher, wherein the edge of the inlet opening is preferably configured to strike a stop element (350, 350') of the pusher (300) to prevent the pusher from sliding too far, the stop element being, for example, a handle or a ring.

31. The kit according to any one of the preceding claims, wherein, The pusher (300) and the insertion guide (200) are provided with fastening systems (500a, 500b) such that once the insertion portion (310) of the pusher has slid through the guide channel, the pusher and the insertion guide are detachably fastened to each other by means of the fastening systems.

32. The kit according to the preceding claims, in, The fastening system (500a, 500b) is preferably a snap-fit ​​system having one or more clamps (325) and / or includes one or more magnets.

33. The kit according to any one of the preceding claims, wherein, The plunger (300) is provided with a modular handle (350), which is configured with a first handle component (351) and a second handle component (352). The first handle component is slidably arranged on the line, more preferably slidably arranged around the pusher body (330) of the plunger; and The second handle component (352) holds the line (30) of the plug (10).

34. The kit according to the preceding claims, in, The second handle component is fixedly connected to the push body (330) of the plug, such that the push body can slide through the first handle component (351) by means of the operation of the second handle component (352).

35. The kit according to any one of the preceding two claims, wherein, The second handle component (352) is configured to allow cutting of the line (330).

36. The kit according to any one of the preceding three claims, in, The first handle component (351) and the insertion guide (200) are configured to engage with each other preferably by means of a snap-fit ​​system and / or by means of magnetic fasteners.

37. The kit according to any one of the preceding four claims, in, The modular handle (350) further includes a third handle component (353) which is detachably arranged between the first handle component and the second handle component to maintain a predetermined distance between them, wherein the predetermined distance preferably corresponds to the length of the plug body (20) of the plug (10) in the unretracted state.

38. The kit according to the preceding claims, in, The third handle component (353) is detachably fastened between the first handle component and the second handle component (351, 352) of the pusher body (330) of the pusher (300), and wherein, after the third handle component (353) is removed, the second handle component (352) can be fastened to the first handle component (351) for example by means of a snap-fit ​​system.

39. The kit according to claim 27 and any of the preceding claims, in, The first handle component (351) and the second handle component (352) are provided with a fastening system (453) configured to fasten the second handle component to the first handle component; wherein the fastening system preferably includes one or more locking pins (352a) that can be engaged into corresponding openings.

40. The kit according to the preceding claims, in, The pusher extends in the longitudinal direction, and the locking pin (352a) extends parallel to this longitudinal direction by a distance (d). p The distance is substantially equal to the longitudinal length of the plug body (20) of the plug in the unshrinked state (10a).

41. The kit according to any one of the preceding claims, wherein, The pusher (300) is provided with a tensioner (375) to prevent undesirable slippage of the line.

42. The kit according to any one of the preceding claims, wherein, The push body (330) is in the form of a hollow tube, and the tensioner (375) is arranged in the hollow tube or on the opening of the hollow tube, and the line (30) of the plug is fed through the tensioner (375).

43. The kit according to any one of the preceding claims, wherein, The push body (330) has a distal insertion opening (331, 333a) through which the line (30) of the plug is fed, wherein the insertion opening (331) is configured to provide resistance, and the body (20) of the plug can retract against the resistance by means of the line (30).

44. The kit according to the preceding claim, wherein, The insertion opening (331) of the push body (330) has a size that allows the line (30) to pass through for feeding while preventing the plug body (20) from passing through for feeding.

45. The kit according to any one of the preceding two claims, wherein, The push body (330) gradually narrows toward the distal insertion opening (331).

46. ​​The kit according to any one of the preceding claims, wherein, The insertion guide (200) is provided with one or more pressure valves and / or valve mechanisms to prevent accidental introduction of air, for example, to prevent lung collapse.

47. The kit according to any one of the preceding claims, wherein, The insertion guide includes an adjustable sealing system (275) that provides an air seal in the guide channel in a first mode (275a) and allows the medical device and / or the plunger to pass through in a second mode (275b).

48. The plug and / or kit according to any one of the preceding claims for use in the treatment of bleeding.

49. The plug and / or kit according to the preceding claims, wherein, The bleeding refers to bleeding occurring within the patient's chest cavity and / or between the patient's ribs.

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