Aspects will now be described in more detail with reference to the figures illustrating several preferred embodiments and principles. Figure 1 shows a use of a set of a plug, an insertion guide and a plug pusher for pushing the plug. Figures 2A-2C show parts of a set, wherein 2A shows an insertion guide, figure 2B a plug pusher, figure 2C a plug.

Figure 3 shows a set wherein the plug pusher is situated in the guide channel of the insertion guide. Figures 4A-4B show examples of a plug.

Figures 5A-5B show examples of a plug body in respectively an uncontracted state and a contracted state.

Figure 6 shows a use of a set of a plug with a fixation element, an insertion guide and a plug pusher for pushing the plug.

Figures 7A-7B show respectively an insertion guide and a plug pusher which are provided with a fastening system.

Figure 8 shows an example of a modular handle for the plug pusher.

Figure 9 shows a use of a set with a plug, provided with a first and second thread which is connected to a casing.

Figures 10A-10B show parts of the set shown in figure 9 in more detail.

Figure 11 shows a set of a plug and a plug pusher and insertion guide.

Figure 12 shows the plug pusher shown in figure 11.

Figure 13 shows the plug shown in figure 11.

Figure 14 shows an embodiment of an insertion guide.

Figure 15 A shows a part of the insertion guide of figure 14 in more detail, and wherein a medical instrument is guided via the guide channel of the insertion guide.

Figure 15B shows a part of the insertion guide of figure 14 without an instrument in the guide channel. Figure 15C shows a part of the insertion guide of figure 14, wherein a plug and plug pusher are guided via the guide channel of the insertion guide.

The skilled person will appreciate on the basis of the description that the invention can be embodied in different ways and on the basis of different principles. It should further be appreciated that elements and features with the same reference numerals are intended to have the same features and to provide similar technical advantages.

Detailed fi

As described above, it can be challenging to stop difficult-to-reach bleeds in the body of a patient using already existing techniques. An example of difficult-to-reach bleeds are bleeds in or close to the thoracic cavity, such as bleeds between the ribs and/or on the inner side of the thoracic wall. Such bleeds can result from a procedure for gaining access to the thoracic cavity via incision and/or insertion of medical instruments. Figure 1 illustrates a part of the thoracic cavity TH and thoracic wall TW. The insertion guide 200 can be used to guide various medical instruments (not shown) through the thoracic wall TW via the guide channel 210. Following use of the medical instruments, any bleeds can be remedied using the plug 10, which can be arranged at the relevant location close to the bleed, preferably via the guide channel 210 of insertion guide 200, by means of plug pusher 300.

Figure 1 shows that plug 10 comprises a plug body 20 to which a thread 30 is connected. Plug 10, particularly the plug body 20, can be pushed through guide channel 210 of an insertion guide 200 by means of the pushing body 330 of the plug pusher 300 (see la- lb).

The plug 10 has a plug body 20 and a thread 30, the plug body 20 is arranged at a distal end of pushing body 330 and the thread 30 is fed via pushing body 330 to a proximal end thereof so that a surgeon has access to thread 30. Plug body 20 can hereby be contracted, wherein the first end 21 of plug body 20 can be pulled toward the second end 22 of plug body 20 using the thread 30, which extends outside plug body 20 (see Ib-lc). The thread thus has a thread part 30a through the plug body 20 and a free thread part 30b. The thread 30 is preferably provided with a handle element 35 to facilitate tightening of thread 30.

Figure 1 further shows that plug pusher 300 has an insertion portion 310 and an end portion 320. The insertion portion 310 is typically the part that is inserted into the insertion guide 200. The end portion 320 remains on the outside so that a surgeon can hold plug pusher 300 and can tighten thread 30 in order to make plug body 20 contract.

Once the plug body 20 has been inserted (see lb) it can be contracted by means of thread 30, preferably via handle element 35, so that body 20 is brought from an uncontracted state 10a (see lb) into a contracted state 10b (see 1c). The plug body 20 in contracted state thus forms a blood stemmer. After plug body 20 has contracted (see state 10b) the surgeon can remove insertion guide 200 and plug pusher 300 (see Id). The thread 30 can be cut by means of scissors and/or a scalpel and thread 30 can be attached in any suitable manner, for instance by means of a suture and/or knot (see le). This latter operation can be facilitated if the thread 30 has already been provided with a needle 34 (as described here) which is preferably encased by a casing 35 which can function as handle element 35.

Figures 2A-2C show respectively the insertion guide 200, the plug pusher 300 and the plug 10 in more detail. Figure 2A shows that insertion guide 200 has a guide channel 210. Guide channel 210 preferably extends from a distal end 201 to a proximal end 202 of the insertion guide 200. The insertion guide 200 is typically suitable for receiving various types of medical equipment and guiding them through the body of the patient so that a surgeon gains access to determined locations in the body. The distal end 201 of insertion guide 200 can be configured with a sharp edge and/or point (not shown) to facilitate insertion. Figure 2A further shows that insertion guide 200 is configured to prevent insertion portion 310 (see Fig. 2B) of pushing body 330 from sliding through too far. As shown, insertion guide 200 has a stop element 250 which can strike against the corresponding stop element 350 on plug pusher 300. In this way the plug pusher 300 can be prevented from being slid too deep into the insertion guide 200, and overall control is improved. Figure 2B shows that plug pusher 300 comprises an insertion portion 310 and an end portion 320. The length Ld of insertion portion 310 preferably corresponds with a length Li of guide channel 210 for the purpose of a desired positioning of the plug body 20.

Plug pusher 300 preferably has a handle 350 lying in the end portion 320 for improved handling and control. Handle 350 can be configured in various ways, as will be described further. Figure 2B further shows that plug pusher 300 has a first opening 331 and a second opening 332. The first opening 331 lies distally and is intended to be directed toward the patient and/or the location of the bleed. The second opening 332 lies proximally and is intended to lie close to the operator, typically the surgeon. The two openings 331, 332 of the plug pusher are connected to a channel 333 extending between the openings. The channel 333 thus forms a route along which the thread 30 of plug 10 can be fed. Because thread 30 is guided through a channel 333 of plug pusher 300, there is a reduced chance of undesired thread deformation or damage. The channel 333 of pushing body 330 is preferably configured to protect the thread 30 of plug 10.

Figure 2B shows that pushing body 330 of plug pusher 300 comprises a channel 333 which is configured to feed the thread 30 from a distal opening 331 of plug pusher 300 to a proximal opening 332 for the purpose of thread protection. Channel 333 preferably has dimensions that allow throughfeed of thread 30 and that stop throughfeed of plug body 20. Channel 333 and/or an opening 333a thereof is for instance not made large enough, so that plug body 10 cannot be pulled through the channel when thread 30 is tightened. In this way pushing body 300 provides for a desired resistance for contracting plug body 20 via thread 30.

Figure 2C shows an embodiment of the plug 10. Plug 10 comprises a plug body 20 and a thread 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 be directed toward the patient. The second end 22 is a proximal end which is intended to be directed toward the operator (for instance the surgeon).

Thread 30 is connected fixedly to the first end 21. In the first end 21 of plug body 20 the thread can be connected to any connecting point that allows contraction of plug body 20 by means of thread 30. For instance a connecting point close to or on the distal outer end 21 of plug body 20. In addition to the fixedly connected piece of thread 30, the thread is arranged slidably through the plug body 20 and extends further over a free thread part, up to handle 35. As shown, thread 30 has a first thread part 30a which is arranged slidably through plug body 20 and a free thread part 30b which extends away from plug body 20. The free thread part 30b is preferably provided with the handle 35. Thread 30 can be provided with barbs 31. In an embodiment the barbs 31 are arranged on the thread at the position of plug body 20, more specifically on the thread part 30a extending through plug body 20 (see Fig. 4A). Additionally or alternatively, barbs 31 can be arranged at the position of the free thread part 30b (see Fig. 4B) which extends away from the plug body, particularly for the purpose of an improved fixation of thread 30 by engagement of nearby objects such as nearby tissue and/or thread. Figure 2C (and figure 4A) show that barbs 31 are arranged to hold plug body 20 in contracted state 10b. Barbs 31 are more preferably arranged to engage the plug body 20 so that plug body 20 is unable to re-expand into an uncontracted or less contracted state 10a. Plug body 20 preferably has an elongate form, particularly in that an elongate body in contracted state 10b provides for a better blood seal.

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

Figure 3 shows a set wherein the plug pusher 300 is situated in the guide channel 210 of insertion guide 200. The plug 10 is arranged longitudinally in line with pushing body 330 and the thread 30 of plug 10 is fed through pushing body 330 via channel 333. It will be apparent that the thread can also be led along pushing body 330, optionally using one or more guide elements (not shown). More specifically, figure 3 shows that plug body 20 is located at the position of the distal end 331a of pushing body 330. Thread 30 is fed through pushing body 330 to a proximal end 332a so that when plug body 20 has been arranged in the body of the patient, plug body 20 is contractible from outside the body of the patient by means of thread 30. The distal end 331a and the proximal end 332a are preferably connected via channel 333, which is configured to allow throughfeed of thread 30 and stops plug body 20 being pulled further through.

Figure 3 further shows that plug pusher 300 comprises a tensioner 375 which is configured to maintain a tight tension on thread 30. Pushing body 330 preferably takes the form of a hollow tube in which the tensioner 375 is arranged or is attached at an opening 332 thereof. The tensioner 375 preferably functions as a rubber element which exerts a determined pressure on the thread, whereby it is slidable only under a determined pulling force, for instance when the surgeon exerts pulling force.

Figures 4A-4B show possible embodiments of the plug 20. Figure 4A shows that a fixation element 40 is arranged on thread 30. The fixation element 40 is preferably arranged at a predetermined distance d_a from plug body 20, more specifically a distance d_a of a maximum of 2.5 cm. Figure 4A shows that thread 30 extends centrally through the fixation element 40. Figure 4A further shows that fixation element 40 comprises a plurality of blades 41 which are attached to thread 30. The blade tips 42 of fixation element 40 are directed toward plug body 20 in order to prevent movement and/or deformation thereof. Figure 4B shows an embodiment of a plug 10 wherein thread 30 is arranged slidably through plug body 20. The figure shows that thread 30 has a first thread end 32 which is connected to plug body 20 and a second thread end 33 which comprises a needle 34 for suturing. The needle 34 is preferably protected via casing or sleeve 35 for the sake of safety. The sleeve 35 is preferably arranged slidably over thread 30, whereby sleeve 35 can be slid over thread 30 toward plug body 20 while the needle 34 is pulled out of sleeve 35. Figure 4B further shows an embodiment wherein plug 10 comprises in addition to first thread 30 a second thread 50. The second thread 50 is arranged to remove plug body 20 from the body of the patient again. The second thread 50 is preferably connected fixedly to plug body 20, more preferably to the proximal end 22 thereof. The second thread 50 is preferably further connected to a handle 35, such as the sleeve 35 functioning as handle. Connecting the second thread to sleeve 35 improves handling while the bleed is being remedied. This means that the person, typically a surgeon, performing the procedure to stem the bleeding has more control and can thereby act more effectively.

The first thread 30 and preferably the second thread 50 are preferably manufactured from resorbable materials, resorbing threads thus being formed. Such resorbing threads can be made of natural or synthetic materials which are gradually broken down by the body. Several examples of materials that are used are poly glycolic acid (PGA), poliglecaprone (PGCL), polydioxanone (PDO) and catgut (a natural material made of sheep intestine). The advantage of resorbing threads is that they obviate the need to remove the sutures, which reduces discomfort for patients. The thread may be made from any material as described earlier herein.

Figures 5A-5B show a plug body 20 in more detail. Figure 5A shows plug body 20 in an uncontracted state 10a and figure 5B shows plug body 20 in a contracted state 10b. Plug body 20 takes the form of a compressible body, this compressible characteristic meaning that the body can be contracted by means of thread 30, typically contracted into a wad (as shown in Fig. 5B). Plug body 20 can be made with one or several materials which are able to stem the bleeding. An example is a body 20 manufactured on the basis of cellulose and/or gelatine and/or collagen. The cellulose fibres can be compressed and formed into compact wadding, spongy structures or swabs. These can be placed in a wound in order to stem the bleed by absorption of blood and by encouraging coagulation. The plug body 20 is preferably resorbable, so that plug body 20 is able to be incorporated into or absorbed by tissues, organs and/or cells, and can thereby be incorporated into the body of the patient. The plug body preferably comprises collagen.

Figure 5A shows that the thread 30 is interwoven through plug body 20. The interwoven configuration of the thread provides for an improved wadding of the body for the purpose of a desired barrier formation to remedy the bleed. The thread 30 is more preferably fed through the body in a zigzag pattern (see Fig. 5A) so as to engage the body internally at various locations during contraction. The thread 30 is preferably interwoven from first end 21 to second end 22 over a part which is slidable relative to plug body 20, while thread 30 is connected fixedly in the distal end 21 of plug body 20, more preferably to the outermost distal outer end 21. Figure 5 A further illustrates that the tread is fed through the plug body in a zigzag pattern to engage the plug body internally at various locations during contraction (figure 5B), in this manner an improved contraction can be achieved. Preferably, the locations are spread out along the longitudinal direction, preferably spread out evenly. Preferably, the various locations comprises multiple locations located between the first and second end of the plug body, preferably at least three, even more preferably at least four locations are engaged between the first and second end to ensure a desired contraction. Figures 5A and 5B further show that barbs 31 can be arranged such that the contracted state 10b can be better maintained. Barbs 31 are preferably arranged at least on the thread part 30a which is arranged slidably through plug body 20, preferably through the plug body 20 in the interwoven or interlaced manner. The barbs 31 are preferably arranged on thread 30 in a row, one behind the other, particularly for an improved internal engagement of plug body 20. The term “barbs” comprises any hook element suitable for engaging the plug body 20 in order to prevent re-expansion into an uncontracted state and/or decompression thereof. The thread 30 further has a free part 30b, which part can be provided with barbs (see Fig. 4B). Figure 5B illustrates that the first distal end 21 of plug body 20 is pulled closer toward the second proximal end 22 using thread 30. Figure 5A further shows that the plug body has a length Lp (measured in uncontracted state 10a).

Figure 6 shows a use of a set of a plug 10 with a fixation element (as described with reference to Fig. 4A). Figure 6 further shows insertion guide 200 and a plug pusher 300 for pushing the plug body 20 of plug 10. Plug 10 is arranged so that plug body 20 and fixation element 40 are situated at the distal end 331a of pushing body 330. The thread 30 is fed through pushing body 330 and connected to handle 350, more specifically to a removable component 352 of the handle. Figure 6 shows particularly that the handle 350 of the shown embodiment takes a modular form. This means that the handle 350 is designed with the option of connecting and/or removing different modules or components. The handle thus preferably has a first handle component 351 and a second handle component 352, and preferably a third handle component 353.

The arranging process of plug body 20 with this set according to this embodiment will now be explained further with reference to figure 6 (see 6a-6g). Plug body 20 and fixation element 40 are inserted via the channel 210 of insertion guide 200 into the body of the patient (see 6a, 6b). The second handle component 352 is subsequently pulled rearward so that the plug body 20 is contracted into contracted state 10b (see 6c) by means of thread 30 and the plug can be placed close to the bleed (see 6d).

Figure 6 shows that handle component 353 is uncoupled from component 351 and component 352 and is removed (see 6d and 6e), while tension on thread 30 is maintained. The insertion guide 200 and the attached (for instance a snapped-in) component 351 (see 6e) are now retracted toward component 352. In such a case a fastening system 500 is preferably provided between component 351 and insertion guide 200, as described with reference to figure 7A (shows insertion guide 200) and figure 7B (shows plug pusher 300). The first handle component 351 is preferably provided with one or more snapping pins 325 which are configured to snap fixedly into (a) corresponding opening(s) of the insertion guide 200.

Plug pusher 300 as shown is further configured to push the fixation element 40 out of insertion guide 200 so that fixation element 40 is able to engage fixedly in the subcutaneous tissue of the thoracic wall (see 6e).

Plug pusher 300 can subsequently be removed (see 6e-6f) by means of cutting the thread 30. Fixation element 40 engages the thoracic wall (see 6f-6g) and thus provides for a favourable preservation of the position and state 10b of the plug body. Figure 6 thus shows per se an aspect of a plug pusher 300 for pushing the plug body 20 of a hemostatic plug 10, wherein a thread 30 is connected fixedly to a distal end 21 and is connected to a handle 352, and wherein all this is configured so that manipulation of the handle 352 allows contraction of plug body 20 by means of thread 30. In figure 6 the handle 350 is configured with a first handle component 351 and a second handle component 352. The first handle component 351 is slidable over thread 30, more preferably arranged slidably around pushing body 330. The second handle component 352 holds the thread 30 of plug 10 so that manipulation of the second handle component 352 manipulates the thread 30, pulling rearward of the second handle component 352 particularly providing for a contraction of thread 30 and a contraction of plug body 20 into a contracted state 10b. The slidable component 351 and the threadholding component 352 (thread holder) provide for improved handling and easier control.

Figure 6 further shows that the second handle component 352 is connected fixedly to the pushing body 330 of the plug. This enables the pushing body 330 to be manipulated through the first handle component 351 by means of a movement of the second handle component 352.

Figure 6 further shows that the second handle component 352 allows for cutting of the thread 30 (see 6e-6f). Any suitable handle design is possible, as long as a surgeon is able to cut thread 30 easily and then attach it, for instance via a suture.

In order to enhance overall handling, handle 350, particularly the first handle component 351, and insertion guide 200 can be configured to engage each other, preferably by means of fastening system 500b as shown in figures 7A and 7B. A snap system and/or a magnetic fastening system is preferably provided in order to fasten insertion guide 200 and handle 350 to each other. Insertion guide 200 can thus be configured with openings 225 which are configured to receive and temporarily hold snapping pins 325 of handle 350 or, in other words, the snapping pins 325 of handle 350, particularly of the first handle component 351, are configured to clamp fixedly in openings 225 temporarily. The reverse is also possible (not shown), wherein the insertion guide is provided with snapping pins which are able to snap fixedly into openings of handle 350. In addition or as alternative to the snap system, magnets can be provided so that insertion guide 200 and handle 350 can be fastened to each other. It is generally advantageous for insertion guide 200 and plug pusher 300 to be fastenable to each other for the purpose of improved handling, for instance via a fastening system, more preferably via a snap system and/or magnet system.

Figure 6 further shows that the fixation element 40 can engage the body of the patient subcutaneously using the blades 41 which are each provided with blade tips 42 which are configured to engage the body of the patient, for instance an engagement of tissue in the thoracic wall TW.

Figures 7A-7B show that insertion guide 200 and plug pusher 300 are provided with a fastening system 500 so that, once the insertion portion 310 of the plug pusher has been slid guide channel 210, plug pusher 300 and insertion guide 200 can be fastened removably to each other by means of the fastening system.

Figure 8 illustrates that the handle 350 of plug pusher 300 is connected to the thread 30 of the plug and is configured here to allow uncoupling of the thread by means of cutting. Figure 8 thus shows that the handle 350, particularly handle component 352, is configured to allow cutting of thread 30 via notch 350a which is configured to facilitate such cutting of thread 30. Figure 8 more specifically shows an example of a modular handle 350 of plug pusher 300. The modular handle comprises a first handle component 351, a second handle component 352, and preferably a third handle component 353. Thread 30 is fed through the handle component, more specifically through openings of each handle component which are located almost centrally. The first handle component 351 and third handle component 353 are configured to allow contraction of the thread 30 by means of the second handle component 352. More specifically, the thread 30 is detached relative to the first and third handle component and the thread is preferably connected fixedly to the second handle component 352 which functions as a thread holder.

Figure 8 shows that the third handle component 353 is arranged detachably between the first and second handle component 351 , 352 in order to maintain a predetermined distance (see distance d_C3) therebetween. This predetermined distance d_C3 preferably corresponds with a length Lp of the plug body 20 of plug 10 in an uncontracted state (see figure 5A). Figure 8 further shows that the third handle component 353 is fastened detachably between the first and second handle component 351 , 352, and wherein the second handle component 352 is fastenable after removal of the third handle component 353 to the first handle component 351 by means of a snap system provided with one or more snapping pins 352a.

Figure 8 further shows that 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 snap-in pins 352a on the second handle component 352 which can be snapped into a corresponding opening in the first handle component 351.

Figure 8 further shows that the snap-in pins 352a extend parallel to the longitudinal direction of the pushing body over a distance (d_p) which is substantially equal to a longitudinal length (Lp) of the plug body 20 of the plug in an uncontracted state 10a (see Fig. 5 A). In an embodiment the plug 20 further has a second thread 50 for pulling the plug body 20 of the plug out of the body of the patient. An example of such an embodiment is shown in figure 9.

Figure 9 shows an embodiment of a set with a plug 20, provided with a first thread 30 and second thread 50, the first thread 30 being arranged to contract the plug body 20. The second thread 50 is arranged to remove plug body 20 from the body of the patient. Principles of this set and the components therein will now be elucidated on the basis of the procedure shown in figure 9, wherein the plug body 20 is arranged in order to remedy a bleed. Figure 9 shows that insertion guide 200 is inserted through thoracic wall TW so as to provide access to the thoracic cavity TH (see 9a) for all manner of medical equipment (not shown in Fig. 9), particularly access via guide channel 210. Once the surgeon has performed the necessary operations in the thoracic cavity TH, any bleeding as a result of insertion of insertion guide 200 can be remedied.

Plug body 20 is pushed through guide channel 210 using plug pusher 300 (see 9b). Pushing through too far is prevented in that the plug pusher is provided with a stop element 350’ which is arranged to strike against a stop element 250 of the insertion guide 200, so that pushing through too far and therefore sliding through too far is prevented. This guarantees a favourable placing of plug body 20.

As shown in figure 9, plug pusher 300 has an insertion portion 310 for pushing plug 10, particularly the plug body 20 thereof, through the guide channel 210 of insertion guide 200 and into the body of the patient. The end portion 320 of plug pusher 300 remains outside insertion guide 200 and allows for holding.

Once plug body 20 has been positioned (see 9c) in the thoracic cavity TW, plug body 20 can be contracted from state 10a to state 10b so that a wad-like structure is formed which can remedy the bleed (see 9c-9d). Plug body 30 can be contracted by means of the (first) thread 30, particularly by tightening the free part thereof, more specifically the part outside the body. Thread 30 is preferably guided to a position outside the body of the patient by plug pusher 300 in order to provide easy access to thread 30. Tightening of thread 30 can be facilitated by a handle 35 which is arranged on the free part of thread 30. Tensioner 375 is preferably arranged so that, once thread 30 has been tightened, thread 30 remains in a tensioned state so as to hold 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 pulling resistance is exerted on thread 30. Figure 9 shows (as seen from a side view) that tensioner 375 is arranged as a rubber ring through which thread 30 is fed. The rubber ring is configured to exert a certain pulling resistance on thread 30, so that this thread 30 can be tightened with a certain pulling force, for instance by the surgeon, the pulling resistance further ensuring that a certain tension is maintained on thread 30 so that plug body 20 is unable to re-expand and remains in the contracted state 10b better.

Figure 9 further shows that the plug body is contracted (see 9d) against the distal end 331a of plug pusher 300, more specifically against a distal insertion opening 331 lying at the distal end 331a of plug pusher 300 (as shown in more detail in Fig. 11 and 12). Figure 9 further shows that plug pusher 300 can be removed after pushing of plug body 20 (see 9e). It is particularly in an embodiment wherein a handle 35 (or sleeve) is arranged on thread 30 that pushing body 330 is configured with an open free slot 341 along which the thread 30 can be removed from the pushing body (see Fig. 12). Figure 9 shows that the insertion guide 200 can be removed from the body of the patient (see 9f and 9g) so that plug body 20 can be arranged in contracted state 10b against the inner wall of the thoracic wall TW (see 9g). In the possible embodiments described with reference to Fig. 9 use can also be made of a plurality of barbs, as described herein (see element 31). Figure 9 further shows that thread 30 can be cut, for instance by means of a scalpel S, and can be attached so that plug body 20 remains at the desired position in or close to the bleed in contracted state 10b. The first thread 30 can be attached in any suitable manner, for instance by means of a suture (see 9i) or an adhesive strip (not shown). The second thread 50 is attached in an accessible manner so that it can be engaged at a later moment in order to retrieve plug body 20 from the patient again, if necessary.

Figures 10A-10B show parts of the set shown in figure 9 in more detail. Figure 10A shows the proximal end part of plug pusher 300 and the proximal end part of plug 10, wherein first thread 30 and second thread 50 are shown. Figure 10A shows that the second thread 50 is preferably connected to the handle 35. Manipulation of handle 35 hereby directly affects second thread 50, resulting in improved control. As described above, the free thread part of thread 30 can be provided with a handle 35, which channel 35 can be configured as a sleeve which surrounds needle 34. Pushing body 330 is preferably provided with the open free slot 341 in the side wall 345 of pushing body 330, so that pushing body 330 can be removed in that first thread 30 and second thread 50 can be guided out of pushing body 330. Figure 10B will be used to explain aspects of the slidable sleeve 35. The first thread 30 in particular is preferably provided with a handle 35 to facilitate tightening of thread 30. Figure 10B shows that plug body 20 is arranged in the body of the patient using insertion guide 200 and plug pusher 300 (see 10B_a). The first thread 30 and second thread 50 are fed through pushing body 330 of plug pusher 300 so that they are accessible from outside the body. The proximal end 332a of pushing body 330 preferably has a corresponding configuration to the handle 35 of plug 10, so that handle 35 is temporarily held (see 10B_a). The handle 35 can take the form of a sleeve which encases needle 34 (see 10Bb). It is further shown that sleeve 35 is arranged slidably over the first thread 30 so that handle 35 can be slid forward toward plug body 20 (see 10B_c). Handle 35 can be attached by means of first thread 30, and preferably using needle 34, via suture 30h (see 10Bd). The second thread 50 is connected to handle 35 so that plug body 20 can be pulled back out of the patient body via the second thread 50 using handle 35 if necessary, for instance after cutting of first thread 30 if attached to the patient body, for instance via a suture.

Figure 11 shows a set of a plug 10 and a plug pusher 300 and insertion guide 200. Plug body 20 of plug 10 is placed at the position of the first distal end 331a of pushing body 330 of plug pusher 300, more specifically longitudinally in line therewith. The thread 30 of the plug is fed through pushing body 330 to a second proximal end 332a. In figure 11 the thread is fed through pushing body 330 via an internal pushing 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.

It is further possible for the thread to be guided along the pushing body 330 (not shown), for instance along an outer side thereof and guided via one or more guide elements.

It will be apparent that thread 30 is preferably guided such that when plug body 20 has been arranged in the body of the patient, plug body 20 is contractible from outside the body of the patient by means of thread 30.

As shown, insertion guide 200 is provided with a stop element 250 which is struck against by corresponding stop element 350 on plug pusher 300 when plug pusher 300 is pushed further through the guide channel 210 of insertion guide 200. Figure 11 shows that the insertion guide is provided with a ring 250’ which is configured to receive thread 30. The ring 250’ is preferably arranged to function as stop element 250 to strike against the corresponding stop element 350 on plug pusher 300. Ring 250’ is preferably provided with one or more notches to facilitate thread attachment. In this way thread 30 can be attached to ring 250’ in simple manner when the plug body 20 is contracted (not shown). Ring 250’ is preferably manufactured from a silicone material for improved grip on thread 30. Ring 250’ otherwise improves overall handling. In figure 11 plug 10 is arranged so that plug body 20 lies longitudinally in line with pushing body 330. The thread 30 of plug 10 is fed through pushing body 330, more specifically through an internal throughfeed channel 337 of pushing body 330 so as to feed thread 30 through the pushing body. The internal throughfeed channel 337 is more specifically configured to feed thread 30 from a first distal opening 331, via the internal throughfeed channel 337 to the second proximal opening 332. The throughfeed channel 337 and/or the distal opening 331 are configured to allow throughfeed of thread 30 and to prevent throughfeed of the plug body.

Figure 12 shows an individually applicable concept of a plug pusher 300 for pushing the artificial hemostatic plug through an insertion guide. More specifically, a plug pusher 300 with an elongate pushing body 330 comprising an internal throughfeed channel 337 which extends from a first distal opening 331 in the distal end 331a to a second proximal opening 332 in the proximal end 332a of pushing body 330. It is preferably the case that the distal end 331a of pushing body 330 tapers toward the first distal opening 331. Because the pushing body 330 tapers toward the first distal opening 331, the pushing body 330 narrows gradually toward the opening 331. The tapering facilitates contraction of plug body 20. Figure 12 thus shows an example wherein the pushing body 330 has a distal insertion opening 331 through which the thread 30 of the plug can be fed, wherein this insertion opening 331 is configured to provide a resistance against which the body 20 of plug 10 can be contracted by means of thread 30.

Figure 12 shows that plug pusher 300 has a pushing body 330 with a substantially cylindrical form. The pushing body has an outer surface 345 between the first distal opening 331 and the second proximal opening 332. The outer surface is provided with an open free slot 341 extending from the first distal opening 331 up to the second proximal opening 332. Figure 12 further shows that pushing body 330 comprises a distal end 331a and a proximal end 332a. The proximal end 332a preferably has a corresponding configuration to handle 35, so that handle 35 is temporarily held.

Figure 13 shows the plug which is shown in figure 11 as being arranged at the position of the distal end 331a of pushing body 330. The plug 10 has a plug body 20 through which thread 30 is slidably arranged and is fixedly connected to distal end 21 , preferably connected to the outermost end. Thread 30 has a thread part 30a through plug body 20 and a free thread part 30b outside plug body 20. Figure 13 shows that the free thread part 30b is provided with a plurality of barbs 31. Figure 13 further shows that a second thread 50 is connected to the proximal end 22 (also referred to as the second end) of plug body 20, the first thread 30 being connected to the distal end 21 (also referred to as the first end).

The second thread 50 is preferably connected to the handle 35 (not shown in Fig. 13) as described above.

Figure 14 shows an embodiment of an insertion guide 200. The insertion guide has a guide channel 210 which is configured to guide medical instruments MI (see Fig. 15A). These can be instruments for cutting off tissue, vascular suturing, removal of tumours and so on and/or instruments such as imaging instruments, for instance by means of a camera, such as a thoracoscope. In order to prevent air leakage use is preferably made of a sealing system 275, 260 designed to close the guide channel while instruments are being inserted and removed. A suction system 278 can be used to remove liquids and other materials from the chest cavity during surgery.

Figure 15A shows that insertion guide 200 guides a medical instrument MI via the guide channel 210. Figure 15B shows that guide channel 210 is free and is sealed by the adjustable sealing system 275. The adjustable sealing system 275 is configured to provide an air seal in guide channel 210 in a first mode 275a (see Fig. 15B) and to allow passage of a medical instrument MI and/or plug pusher 300, particularly the plug body 330 thereof, in a second mode 275b (see Fig. 15A and Fig. 15C). Figures 14 and 15 further show that insertion guide 200 is provided with a plurality of pressure valves 260 and/or valve mechanisms 260 to prevent unintended introduction of air, for instance in order to prevent a collapsed lung. Figure 15C shows a part of the insertion guide of figure 14, wherein a plug and plug pusher are guided via the guide channel of the insertion guide.

The above described embodiments and the figures are purely illustrative and serve only to increase understanding of the invention. The invention is not therefore limited to the embodiments described herein, but is defined in the claims.

Claims

1. An artificial hemostatic plug (10) for stemming and/or preventing a bleed in a body of a patient, more specifically in a thoracic cavity of a patient, wherein the plug comprises a compressible plug body (20) with a first end (21) and a second end (22), wherein the plug further comprises a thread (30), wherein the thread is arranged slidably through the plug body (20) and is connected fixedly 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 the thread (30), which extends further outside the plug body.

2. The plug according to the foregoing claim, wherein the thread (30) is interwoven through the plug body (20) from the first end (21) to the second end (22).

3. The plug according to any one of the foregoing claims, wherein the plug body (20) is made from a compressible material, such as a wadding, a spongy structure or a swab.

4. The plug according to any of one of the foregoing claims, wherein the tread (30) is fed through the plug body (20) in a zigzag pattern to engage the plug body (20) internally at various locations during contraction of said plug body (20).

5. The plug according to any of one of the foregoing claims, wherein a part of the thread (30) is interwoven through the plug body (20) from the first end (21) to the second end (22) of the plug body (20), wherein said part of the thread (30) is slidable relative to plug body (20), while the thread (30) is connected fixedly to the first end (21) of the plug body (20).

6. The plug according to any one of the foregoing claims, wherein the plug body (20) is a compressible body which is contractable from an uncontracted state (10a) to a contracted state (10b) where it contracts into a wad; and wherein the thread (30) is attached to the first end (21) of the plug body (20) such that, upon pulling said tread (30), said first end (21) of the plug body is pulled towards the second end (22) of said plug body thereby putting the plug body into the contracted state (10b) where it contracts and forms the wad.

7. The plug according to any one of the foregoing claims, wherein the thread (30) is provided with a plurality of barbs (31).

8. The plug according to the foregoing claim, wherein the plurality of barbs (31) are arranged to allow compression of the plug body (20) into a compressed state (10b) and to prevent re-expansion and/or longitudinal expansion of the plug body (20) of the plug.

9. The plug according to any one of the foregoing claims, wherein a fixation element (40) is arranged on the thread (30) outside the plug body (20) and is configured to engage the body of the patient subcutaneously.

10. The plug according to any one of the foregoing claims, wherein the fixation element (40) is made from a resorbable material.

11. The plug of the previous claim, wherein both the fixation element (40) and the plug body (20) are made from a resorbable material.

12. The plug according to any one of the three foregoing claims, wherein the thread (30) extends through the fixation element (40), preferably wherein the thread extends centrally through the fixation element.

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

14. The plug according to any one of the foregoing five claims, wherein the fixation element (40) comprises one or more blades (41) which are attached to the thread.

15. The plug according to any one of the foregoing six claims, wherein the fixation element comprises a plurality of blades (41), blade tips (42) of which are directed toward the plug body (20) of the plug in order to prevent movement and/or deformation of the plug body (20) of the plug after being arranged in the body of the patient.

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

17. The plug according to the foregoing claim, wherein the second thread end comprises a sleeve (35) which encases the needle, wherein the sleeve is preferably arranged slidably on the thread.

18. The plug according to any one of the foregoing claims, wherein the plug further comprises a second thread (50) for pulling the plug body (20) of the plug out of the body of the patient.

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

20. The plug according to any one of the foregoing two claims, wherein the plug further comprises an engageable element (35), such as a handle or the sleeve, which is arranged slidably over the first thread (30) and wherein the second thread (50) connects the second end (22) of the plug body (22) and the engageable element (35).

21. The plug according to any one of the foregoing claims, wherein the plug body (20) of the plug and/or the thread (30) are manufactured from materials designed to dissolve in the body of the patient over time, preferably materials selected from resorbable or dissolvable materials.

22. A set (1) for inserting an artificial hemostatic plug (10) for stemming and/or preventing a bleed in a body of a patient, more specifically in a thoracic cavity of a patient, wherein the set comprises:

- the plug (10) according to any one of the foregoing plug claims;

- a plug pusher (300) with a pushing body (330) for pushing the plug body (20) of the plug (10) through a guide channel (210) of an insertion guide (200);

- preferably an insertion guide (200) with a guide channel (210) for guiding a medical instrument through a body wall of the patient, such as through a wall of the thoracic cavity.

23. The set according to the foregoing claim, wherein the plug pusher (300) has an insertion portion (310) which is configured to push the plug body (20) of the plug (10) through the guide channel (210) of the insertion guide (200) and into the body of the patient, and further has an end portion (320) which is configured to hold the plug pusher (300).

24. The set according to the foregoing claim, wherein the pushing body (330) has a first distal opening (331) lying in the insertion portion of the plug pusher and has a second proximal opening (332) lying in the end portion of the plug pusher (300).

25. The set according to any one of the foregoing set claims, wherein the pushing body (330) has a substantially cylindrical form with an outer surface (345) 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 up to the second proximal opening.

26. The set according to any one of the foregoing set claims, wherein the plug body (20) of the plug (10) is placed at the position of a first distal end (331a) of the pushing body (330) of the plug pusher (300), preferably longitudinally in line therewith; wherein the thread (30) of the plug is fed along and/or through the pushing body (330) to a second proximal end (332a) such that, when the plug body (20) has been arranged in the body of the patient, the plug body (20) is contractible from outside the body of the patient by means of the thread (30).

27. The set according to any one of the foregoing set claims, wherein the plug pusher (300) is provided with a handle (350) which lies in the proximal end portion (320) of the plug pusher.

28. The set according to the foregoing claim, wherein the handle (350) of the plug pusher (300) is connected to the thread (30) of the plug (10) and is preferably configured to allow uncoupling of the thread, preferably by means of cutting.

29. The set according to any one of the foregoing set claims, wherein the insertion guide (200) is configured to prevent the insertion portion (310) of the plug pusher (300) from sliding too far through the guide channel (210), for instance by means of a stop element (250) such as a stop edge or a ring on the insertion guide (200) to strike against a corresponding stop element (350, 350’) on the plug pusher (300).

30. The set according to any one of the foregoing set claims, wherein the guide channel (210) of the insertion guide (200) has a receiving opening (221) which is configured to receive the plug (10) and the insertion portion (310) of the plug pusher and wherein edges of this inlet opening are preferably configured to strike against a stop element (350, 350’), such as a handle or a ring, of the plug pusher (300) in order to prevent the plug pusher from sliding through too far.

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

32. The set according to the foregoing claim, wherein the fastening system (500a, 500b) is preferably a snap system with one or more clamps (325) and/or comprises one or more magnets.

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

34. The set according to the foregoing claim, wherein the second handle component is connected fixedly to the pushing body (330) of the plug, such that the pushing body is slidable through the first handle component (351) by means of a manipulation of the second handle component (352).

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

36. The set according to any one of the foregoing three claims, wherein the first handle component (351) and the insertion guide (200) are configured to engage each other, preferably by means of a snap system and/or by means of a magnetic fastening.

37. The set according to any one of the foregoing four claims, wherein the modular handle (350) further comprises a third handle component (353) which is arranged detachably between the first and second handle component in order to maintain a predetermined distance therebetween, wherein this predetermined distance preferably corresponds with a length of the plug body (20) of the plug (10) in uncontracted state.

38. The set according to the foregoing claim, wherein the third handle component (353) is fastened detachably between the first and second handle component (351, 352) of the pushing body (330) of the plug pusher (300), and wherein the second handle component (352) is fastenable to the first handle component (351), for instance by means of a snap system, after removal of the third handle component (353).

39. The set according to claim 27 and any one of the foregoing claims, wherein 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 to the first handle component; wherein the fastening system preferably comprises one or more snap-in pins (352a) which can be snapped into a corresponding opening.

40. The set according to the foregoing claim, wherein the plug pusher extends in longitudinal direction and wherein the snap-in pins (352a) extend parallel to this longitudinal direction over a distance (d_p) which is substantially equal to a longitudinal length of the plug body (20) of the plug in an uncontracted state (10a).

41. The set according to any one of the foregoing set claims, wherein the plug pusher (300) is provided with a tensioner (375) for preventing undesired sliding of the thread.

42. The set according to any one of the foregoing set claims, wherein the pushing body (330) takes the form of a hollow tube and wherein the tensioner (375) is arranged therein or on an opening thereof, and wherein the thread (30) of the plug is fed through the tensioner (375).

43. The set according to any one of the foregoing set claims, wherein the pushing body (330) has a distal insertion opening (331, 333a) through which the thread (30) of the plug is fed, wherein this insertion opening (331) is configured to provide a resistance against which the body (20) of the plug can be contracted by means of the thread (30).

44. The set according to the previous claim, wherein the insertion opening (331) of the pushing body (330) has dimensions that allow throughfeed of the thread (30) and that stop throughfeed of plug body (20).

45. The set according to any of the previous two claims, wherein the pushing body (330) tapers toward the distal insertion opening (331).

46. The set according to any one of the foregoing set claims, wherein the insertion guide (200) is provided with one or more pressure valves and/or valve mechanisms to prevent unintended introduction of air, for instance in order to prevent a collapsed lung.

47. The set according to any one of the foregoing set claims, wherein the insertion guide comprises an adjustable sealing system (275) which provides an air seal in the guide channel in a first mode (275a) and allows passage of a medical instrument and/or the plug pusher in a second mode (275b).

48. The plug and/or set according to any one of the foregoing claims for use in treatment of a bleed.

49. The plug and/or set according to the foregoing claim, wherein the bleed occurs in the thoracic cavity of a patient and/or is a bleed between ribs of a patient.