Tissue sample fixator and arrangement comprising such a tissue sample fixator and a sample carrier

Abstract

Tissue sample fixator comprising a base body (2) with a tissue sample recess (G) for receiving an edge section of a tissue sample (20, 20.1), at least one fixation needle (5) extending into or through the tissue sample recess (G), and a mounting shaft (6) arranged adjacent to the tissue sample recess (G) for fastening the tissue sample fixator (1, 1.1) to a sample carrier (16), characterized in that the base body (2) further has a tissue support (7, 7.1) projecting therefrom in a direction opposite to the tip of the fixation needle (5) and having at least one retaining structure (11, 11.1) on its side facing a tissue sample (20, 20.1) to be fixed, for holding the part of the tissue sample (20, 20.1) caught thereon in position with respect to its distance from the base body (2).

Description

[0001] The invention relates to a tissue sample fixator comprising a base body with a tissue sample recess for receiving an edge portion of a tissue sample, at least one fixation needle extending into or through the tissue sample recess, and a mounting shaft arranged adjacent to the tissue sample recess for attaching the tissue sample fixator to a sample carrier. The invention further relates to an assembly comprising at least one such tissue sample fixator and a sample carrier.

[0002] Tissue surgically removed from a human or animal body, for example a tumor, is typically subjected to a number of examinations. Such examinations include microscopic histological examinations, also to determine whether, in the case of a tumor, it has been completely removed. This is the case if there is a safety margin of healthy tissue around the removed tumor. If such a tumor has not been removed with a sufficient safety margin of healthy tissue, a re-resection is performed at the location in the human or animal body that does not have a sufficient safety margin. For this purpose, it is necessary that the orientation of the removed tissue sample within the body and the storage of the tissue sample are and remain documented.

[0003] To document their orientation within the human or animal body, removed tissue samples are mounted on or in a sample carrier. This carrier either has directional markings indicating the sample's orientation within the body, or such directional markings are subsequently applied. This allows the exact location in the body's spatial orientation where a resection is to be performed to be indicated on the removed tissue sample.

[0004] In addition to microscopic examinations, such tissue samples are also subjected to imaging examinations such as ultrasound and / or X-ray examinations. Since the tissue remains fixed to or in the sample carrier during these examinations, these are preferably designed so that the sample carrier does not adversely affect the ultrasound or X-ray images. If directional markings are used, they are ultrasound- or X-ray-opaque.

[0005] An arrangement for transporting and / or storing a human or animal tissue sample, comprising a sample carrier and fixation means for fixing a tissue sample to the sample carrier, is known from WO 2009 / 144202 A2. The fixation means is a fixation pin with a tip that is undercut in the piercing direction. The sample carrier is a tray constructed like a sandwich and has a support body, typically made of rigid foam, which is laminated on its two flat sides with two cover layers. The penetration resistance of the support body is significantly lower than the resistance that must be overcome to pierce such a fixation pin through the cover layer intended for tissue sample contact. The fixation pin pierces the tissue sample. With its undercut tip, the tissue sample is secured against withdrawal because it acts against the inside of the cover layer.

[0006] DE 20 2009 013 353 U1 describes a tissue sample fixator with a sample fixation needle and a mounting shaft equipped with a piercing tip. This tissue sample fixator is used to fix a tissue sample at its edge, eliminating the need to insert the mounting shaft through the tissue sample. The fixation needle and the mounting shaft are held by a handle and are offset from and spaced from each other. The sample fixation needle is long enough to penetrate a tissue sample recess formed by the handle and also engage the sample carrier when the tissue sample fixator is used.

[0007] Depending on the consistency of the tissue samples, they may collapse due to their own weight. This is not uncommon, especially with larger tissue samples. For this reason, sample carriers have been developed with which a tissue sample can be fixed at least largely in its spatial extent within the body. For this purpose, WO 2002 / 059571 A2 proposes enclosing the tissue sample in a grid-like housing. WO 2011 / 140374 A1 proposes placing the tissue sample in a gel in a storage container, with the gel hardening after insertion in order to thus preserve the spatial shape of the tissue sample. According to US 9,733,167 B2, a receiving foam is used instead of the previously described gel, into which the tissue sample is placed.EP 3 058 877 B1 describes a tissue sample carrier comprising two brackets, each supporting several adjacent fixation needles, which are attached to a grid-like sample carrier. The needles of the two brackets are angled toward each other with their tips, thus providing a certain degree of shape support for the obliquely pierced tissue sample when stored on the sample carrier.

[0008] The aforementioned concepts, which allow tissue samples to be stored in their spatial dimensions, as if taken from the body, are complex and sometimes problematic to handle. At the very least, it regularly requires several manual steps to fix a tissue sample, in contrast to the very simple fixation described in WO 2009 / 144202 A2. However, the collapse of a tissue sample and thus a change in shape compared to the shape of the tissue sample in the body is not possible with this previously known arrangement.

[0009] Based on this discussed prior art, the invention is therefore based on the object of proposing a tissue sample fixator with which not only a tissue that at least largely retains its shape can be fixed on a sample carrier, but which is also characterized by easy handling for fixing a tissue sample.

[0010] This object is achieved according to the invention by a tissue sample fixator of the generic type mentioned at the outset, in which the base body further comprises a tissue support projecting therefrom in a direction opposite to the tip of the fixation needle, with at least one retaining structure on its side facing a tissue sample to be fixed, for holding the part of the tissue sample caught thereon in position with respect to its distance from the base body.

[0011] This tissue sample fixator has a tissue support protruding from the base body in such a way that the tissue support also protrudes from the contact surface of the sample carrier when the tissue sample fixator is attached thereto. This protrusion does not necessarily have to be perpendicular to the plane of the sample carrier. The base body carries its at least one fixation needle and the mounting shaft on its side facing a sample carrier. The tissue support protruding from the base body has at least one retaining structure. This at least one, typically the plurality of spaced-apart retaining structures are located on the side of the tissue support facing a tissue sample to be fixed. The one or more retaining structures serve to catch the edge of a tissue sample arranged adjacent to the tissue sample fixator.This means that this edge section of the tissue sample is held in place with respect to its basal surface, with which the tissue sample rests on a sample carrier. This tissue sample fixator cleverly exploits the fact that tissue samples usually do not collapse immediately after removal, but rather after a time delay. The tissue sample is usually fixed to a sample carrier immediately after removal, before it tends to collapse under its own weight. Such a tissue sample is typically held in shape using several tissue sample fixators arranged around the circumference of the tissue sample. A particular advantage is that this shape-keeping fixes the tissue sample at its surface. The interior of the tissue sample remains untouched and thus unchanged for the purposes of its fixation.If imaging examinations are carried out on the tissue sample, supporting devices that otherwise intervene in or penetrate the tissue sample, such as needles, do not interfere with the result.

[0012] With this tissue sample fixator, the fixation needle, which is significantly smaller in diameter than the mounting shaft, is arranged at a distance from the mounting shaft in the transverse direction to the longitudinal extent of the tissue sample fixator. This means that only an edge section is pierced by the fixation needle when fixing the tissue sample to a sample carrier. Furthermore, fixing it to a sample carrier is extremely simple because the process of fixing the tissue sample to the sample carrier and fixing the tissue sample fixator to the sample carrier is a single process. The tissue sample is positioned on a sample carrier. A tissue sample fixator is placed at the edge of the sample and then fixed to the sample carrier by a pressing-in movement, with the edge section of the tissue sample being pierced by the fixation needle at the same time.A tissue sample that already collapses during mounting can be manually held in its original form on a sample carrier until the tissue sample fixator, or typically several tissue sample fixators, are attached. A further particular advantage is that the mounting shaft of this tissue sample fixator can be easily configured to be attached to a sandwich plate as a sample carrier, as in WO 2009 / 144202 A2.

[0013] According to one embodiment, the tissue support is designed in the manner of a strip and has a rectangular cross-sectional area. With one narrow side, this strip-shaped tissue support faces the tissue sample to be fixed. Thus, the at least one retaining structure is arranged in or on this narrow side. The at least one retaining structure is preferably designed so that the tissue sample is held thereon in the manner of a barb and thus prevented from collapsing, thus keeping it in shape, without necessarily being pressed into the tissue itself. In order to bring about the engagement position between the retaining structure and the outer side of the tissue sample, the resilience of the tissue sample itself or its tendency to collapse is used to create a positive connection between the tissue sample and the at least one retaining structure.

[0014] According to one embodiment, the at least one retaining structure is provided by a contour forming an edge on the side of the tissue support facing the tissue sample. This can be provided, for example, by a recess made in the side of the tissue support facing the tissue sample, which recess is designed, for example, in the manner of a notch. According to one embodiment, such a recess designed in the manner of a notch is inclined relative to the longitudinal axis of the tissue support in the direction of the base body. This supports the process of catching the outer side of a tissue sample on such a retaining structure. The process of catching and thus clamping the surface of the tissue sample contacting the tissue support can also be designed such that the side of the cutout directly opposite the edge is a release, if a recess in the manner of a notch is provided.This means that the edge does not necessarily protrude from the outer surface of the tissue support facing the tissue sample, but it does facilitate access to the tissue sample retention structure formed by the edge. The advantage of this edge is that it prevents damage to the tissue sample being secured. Depending on the type of tissue sample, such a tissue sample fixator can also be designed with a tip, even a rounded one.

[0015] The provision of such a tissue support allows it to be easily equipped with several retention structures, each arranged at a different distance from the base body. Depending on the size of the tissue sample to be fixed, one or more of these retention structures are then engaged with the tissue sample.

[0016] Furthermore, regardless of its specific design, the tissue support can be used to accommodate one or more tension guides on the side facing away from the tissue sample. These can also be designed as notches. If a tissue sample is secured to a sample carrier using several of these sample fixators, the tissue sample can be held in place by wrapping it, for example, with a band. The tissue fixators serve to guide such a band and prevent excessive deformation of the tissue sample.

[0017] The base body of such a sample fixator can be designed in the manner of a Z-angle and feature a fixation needle holding leg and a mounting shaft leg. These are arranged offset from each other and spaced apart transversely to the longitudinal extent of the tissue sample fixator. A wall defining the tissue sample recess connects these two legs.

[0018] According to a preferred embodiment, the longitudinal axes of the at least one fixing needle and those of the mounting shaft run parallel to each other.

[0019] Such a tissue sample fixator may comprise one fixation needle or a fixation needle arrangement provided by two or more fixation needles.

[0020] The invention is described below with reference to exemplary embodiments in the accompanying figures. They show: Fig. 1: a perspective view of a tissue sample fixator according to the invention according to a first embodiment, Fig. 2: a side view of the tissue sample fixator of the Fig. 1, Fig. 3: a representation of the tissue sample fixator according to Fig. 2, attached to a sample carrier, Fig. 4: two tissue sample carriers according to the invention, which fix a tissue sample on a sample carrier, Fig. 5: a plan view showing the arrangement of the Fig. 4, Fig. 6: another arrangement with several tissue sample fixators according to the invention, which fix a tissue sample on a sample carrier and Fig. 7: a side view of another tissue sample fixator according to the invention.

[0021] A tissue sample fixator 1 comprises a base body 2 which, in side view, is designed like a Z-angle. This shape of the base body 2 is provided by a fixation needle holding leg 3, a mounting shaft holding leg 4, and a wall W connecting the two legs 3, 4. The two legs 3, 4 are offset with respect to the longitudinal extent of the tissue sample fixator 1 and arranged at a longitudinal axial distance from one another. This design of the base body 2 provides a tissue sample recess G below the fixation needle holding leg 3 and laterally delimited by the wall W. The fixation needle holding leg 3 carries a fixation needle 5. This is used to fix a tissue sample on a sample carrier. The mounting shaft holding leg 4 carries a mounting shaft 6. This is used to fasten or anchor the tissue sample fixator 1 on or to a sample carrier. The base body 2 is formed on the part formed by the fixing needle 5 orA tissue support 7 is provided on the side facing away from the mounting shaft 6. In the illustrated embodiment, this support is designed in the manner of a strip. The upper end of the tissue support is formed by a head 8, which increases the cross-sectional area of ​​the tissue support 7. The head 8 also serves as a handle for the tissue sample fixator 1, enabling it to be pressed into a sample carrier with its mounting shaft 6.

[0022] In the narrow side 9 facing a tissue sample to be fixed, a plurality of recesses 10 designed like notches are provided in the tissue support 7, arranged at a longitudinal axial distance from one another, in order to each form a retaining structure. Starting from the narrow side 6, the recesses 10 are inclined toward the base body 2 of the tissue sample fixator 1. The upwardly facing edge 11 between the narrow side 9 and the lower flank of the respective recess 10 serves as the retaining structure. These edges 11 serve like barbs for clamping to the outside of a tissue sample to be fixed by the tissue sample fixator 1.

[0023] In the illustrated embodiment, further recesses 13 in the form of notches are formed in the narrow side 12 of the fabric support 7 opposite the narrow side 9. These recesses are inclined at the same angle as the recesses 10 formed in the other narrow side 9 and in the same direction, but with their openings pointing toward the base body 2.

[0024] The mounting shaft 6 is designed in the manner of a harpoon and has a double undercut insertion tip 14. The underside 15 of the mounting shaft holding leg 4 serves as a stop for limiting the insertion amount of the mounting shaft 6 into a sample carrier.

[0025] The tissue sample fixator 1 is made of an X-ray transmissive plastic material.

[0026] The sample carrier 16, on which the tissue sample fixator 1 is to be attached, is, as shown Fig. 3, is designed as a sandwich plate. The sample carrier 16 has a support body 17, the two flat sides of which are each laminated with a cover layer 18, 19. The support body 17 in the illustrated embodiment is a rigid foam, typically a PUR rigid foam. The cover layers 18, 19 are each provided by a plastic-coated cellulose cardboard layer. The cover layer 18 is the cover layer on which the tissue samples are to be placed. This upper side thus forms the contact surface with a tissue sample. Applied to this surface are X-ray-opaque markings (not shown in the figures) relating to the directions, as well as a grid, so that the sample can be oriented on the sample carrier 16 in the same way as it was oriented in the body.

[0027] The cover layer 18 can be pierced with the piercing tip 14 of the mounting shaft 6 and offers greater penetration resistance than the material of the support body 17. Due to the reshaping of the cover layer 18, the second undercut of the piercing tip 14 in the illustrated embodiment counteracts the withdrawal of the tissue sample fixator 1 from the sample carrier 16. In the illustrated embodiment, the fixation needle 5 is sufficiently long to pierce the cover layer 18 and thus also be positively anchored in the cover layer 18 in the plane of the sample carrier 16.

[0028] The tissue sample fixator 1 is attached to the sample carrier 16 during the process of fixating a tissue sample. For this purpose, the tissue sample fixator 1 is arranged adjacent to a tissue sample 20 so that a lower edge portion located on the sample carrier 6 can be pierced by the fixation needle 5. By successively pushing further, the fixation needle 5 pierces the cover layer 18. At the same time, the mounting shaft 6 is pushed through the cover layer 18. Fig. Figure 4 shows a section through a tissue sample 20 secured to the sample carrier 16 by two tissue sample fixators 1. In the illustrated embodiment, the planar extension of the mounting shaft holding leg 4 runs in the plane of the cover layer. The underside of this leg 4 serves as a stop to limit the insertion process and also to ensure the intended alignment of the tissue sample fixator 1, which in this position protrudes perpendicularly from the plane of the sample carrier 16. In an embodiment not shown in the figures, the tissue support 7 extends at a certain inclination relative to the two legs 3, 4 compared to the perpendicular arrangement shown in the previous figures.

[0029] The tissue sample carriers 1 are pressed slightly into the tissue sample 20 with their side facing the tissue sample 20, as shown in Fig. 5. This pressing or pressing in serves the purpose of bringing the narrow sides 9 and thus at least some edges 11 of the fabric support 7 as retaining structures to the outside of the fabric sample 20. Due to the flexibility of the fabric sample 20, this results in some of the fabric being pushed into the recesses 10, as can be seen from Fig. 4, is pressed in and in this way a clamping connection is created between the tissue sample 20 and the tissue sample fixators 1, by which the tissue sample 20 is held in shape on the tissue sample fixators 1. By this clamping, the tissue sample is in its Fig. 4, which counteracts a collapse towards the sample carrier 16. In Fig. 4, the tissue sample 20 is held in place by two tissue sample holders 1. It is understood that more than two sample holders 1 can be used, which are then arranged circumferentially distributed around the tissue sample. An advantage of the sample carrier 16 is that a tissue sample holder 1 can be mounted or attached to it at any location.

[0030] Fig. 6 shows an arrangement corresponding to that of Fig. 4, wherein the tissue sample 20.1 is shown in a side view and in which arrangement three tissue sample fixators 1 are used to fix the tissue sample 20.1. The clamping of the tissue samples 20.1 with the tissue sample fixators 1 is carried out in the same way as described above. Fig. 4. In the Fig. In the embodiment shown in Fig. 6, the recesses 13 of the tissue supports 7 are used to stabilize the tissue sample 20.1 by a band 21, which is wrapped around the tissue sample 20.1, enclosing the tissue sample fixators 1, in addition to the shape retention achieved by the tissue sample fixators 1.

[0031] Fig.7 shows a further tissue sample fixator 1.1 according to the invention, which is constructed in the same way as tissue sample fixator 1. Therefore, the above statements apply equally to tissue sample fixator 1.1. Tissue sample fixator 1.1 differs from tissue sample fixator 1 only in that the recesses 10.1 made in the narrow side 9.1 of its tissue supports 7.1 have a release 22 above their respective edges 11.1 forming a retaining structure. This release 22 is indicated by a dashed line for one of the recesses 10. Thus, the release 22 enlarges the opening of each recess 10.1 in the direction of the head 8.1 of tissue sample fixator 1.1. This supports the process of clamping the sample fixator 1.1 to the outside of the tissue sample 20.1.

[0032] The invention has been described using exemplary embodiments. Without departing from the scope of protection described by the applicable claims, numerous further embodiments for implementing the inventive concept will become apparent to those skilled in the art without the need for further explanation within the scope of these statements. List of reference symbols 1, 1.1 Tissue sample fixator 2 basic bodies 3 Fixing needle holding legs 4 mounting shaft holding legs 5 Fixing needle 6 Mounting shaft 7, 7.1 Tissue support 8, 8.1 Head 9, 9.1 Narrow side 10, 10.1 Recess 11, 11.1 Edge 12 Narrow side 13 Recess 14 piercing tip 15 Bottom 16 sample carriers 17 support bodies 18 Top layer 19 Top layer 20,20.1 Tissue sample 21 volumes 22 Release G Tissue sample recess W Wall QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] WO 2009 / 144202 A2 [0005, 0008, 0012] DE 20 2009 013 353 U1

[0006] WO 2002 / 059571 A2

[0007] WO 2011 / 140374 A1

[0007] US 9,733,167 B2

[0007] EP 3 058 877 B1

[0007]

Claims

[1] Tissue sample fixator comprising a base body (2) with a tissue sample recess (G) for receiving an edge section of a tissue sample (20, 20.1), at least one fixation needle (5) extending into or through the tissue sample recess (G) and a mounting shaft (6) arranged adjacent to the tissue sample recess (G) for fastening the tissue sample fixator (1, 1.1) on a sample carrier (16), characterized by that the base body (2) further comprises a tissue support (7, 7.1) projecting therefrom in a direction opposite to the tip of the fixing needle (5) and having at least one retaining structure (11, 11.1) on its side facing a tissue sample (20, 20.1) to be fixed, for holding in position the part of the tissue sample (20, 20.1) caught thereon with respect to its distance from the base body (2). [2] Tissue sample fixator according to claim 1, characterized bythat the fabric support (7, 7.1) is strip-shaped. [3] Tissue sample fixer according to claim 1 or 2, characterized by that the at least one retaining structure is provided by a contour of the fabric support (7, 7.1) forming an edge (11, 11.1). [4] Tissue sample fixator according to claim 3, characterized by that the contour forming the edge (11, 11.1) is provided by a recess (10, 10.1) made in the fabric support (7, 7.1). [5] Tissue sample fixator according to claim 4, characterized by that the recess (10, 10.1) is designed in the manner of a notch, the longitudinal axis of which is inclined relative to the longitudinal axis of the fabric support (7, 7.1) in the direction of the base body (2). [6] Tissue sample fixator according to claim 5, characterized by that the recess (10.1) designed in the manner of a notch has a release (22) on its side opposite the flank forming the edge (11.1). [7] Tissue sample fixer according to one of claims 1 to 6, characterized by that the fabric support (7, 7.1) has several retaining structures arranged at different distances from the base body (2). [8] Tissue sample fixer according to one of claims 1 to 7, characterized by that the fabric support (7, 7.1) has at least one, preferably several, traction means guides arranged at different distances from the base body (2) on its side opposite the at least one retaining structure. [9] Tissue sample fixator according to claim 8, characterized by that the at least one traction means guide is designed as a recess (13) in the manner of a notch. [10] Tissue sample fixer according to one of claims 1 to 9, characterized by that the fabric support (7, 7.1) carries, at its end opposite the base body (2), a head (8, 8.1) projecting on at least one side beyond the cross-sectional area of ​​the fabric support (7, 7.1). [11] Tissue sample fixer according to one of claims 1 to 10, characterized by in that the base body (2) has a fixing needle holding leg (3) and a mounting shaft leg (4) which delimits an insertion amount of the mounting shaft (6) in a sample carrier (16), wherein the two legs (3, 4) are offset from one another and spaced from one another in the direction of the longitudinal extent of the tissue sample fixer (1, 1.1) and are connected to one another by a wall (W) which delimits the tissue sample recess (G) in the direction of the mounting shaft leg (4). [12] Tissue sample fixer according to one of claims 1 to 11, characterized by that the mounting shaft (14) has a piercing tip (14) and at least one undercut acting opposite to its piercing direction for fastening the tissue sample fixator (1, 1.1) to a sample carrier (16). [13] Tissue sample fixer according to one of claims 1 to 12, characterized bythat the longitudinal axis of the at least one fixing needle (5) and that of the mounting shaft (6) are arranged parallel to one another. [14] Arrangement comprising at least one tissue sample fixator (1, 1.1) according to one of claims 1 to 13 and at least one sample carrier (16), characterized by in that the sample carrier (16) is constructed in at least two layers and has a cover layer (18) with an upper side provided for positioning the tissue sample (20, 20.1) and a support body (17) connected to the underside of the cover layer (18), wherein the support body (17) of the sample carrier (16) counteracts a lower penetration counterpressure at least in the region of an intended fastening of a tissue sample fixator (1, 1.1) than when the cover layer (18) is pierced by the mounting shaft (6) of the at least one tissue sample fixator (1, 1.1) when it is fastened to the sample carrier (16). [15] Arrangement according to claim 14, characterized bythat several tissue sample fixators (1, 1.1) are arranged around a tissue sample (20, 20.1) with their at least one retaining structure facing the tissue sample (20, 20.1). [16] Arrangement according to claim 14 or 15, characterized by that the cover layer (18) is a preferably plastic-coated cellulose cardboard layer. [17] Arrangement according to one of claims 14 to 16, characterized by that the support body (17) of the sample carrier (16) is a material-homogeneous support layer, preferably a rigid foam layer. [18] Arrangement according to one of claims 14 to 17, characterized by that the support body (17) has a second cover layer (19) on its side opposite the cover layer (18) and is thus designed as a sandwich panel.

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