Patent Application
20200022685
This application claims the benefit of European Patent Application No. 18183972.1, filed Jul. 17, 2018, and European Patent Application No. 19179101.1, filed Jun. 7, 2019, the contents of which are incorporated herein by reference as if fully rewritten herein.
The invention relates to a biopsy instrument.
From publication DE 10 2007 020 582 A1, a cryosurgical instrument and method for severing a tissue sample have been known, said instrument comprising a probe with a probe head for solid-freezing of a sample, as well as a support device, in which the probe is guided. By means of the support device, it is possible to support the surrounding tissue while the tissue is being severed. When the frozen-solid tissue sample is torn off, the probe head can be retracted into the support device so that, as a result, the tissue sample is safely accommodated in the support device.
From publication DE 10 2008 026 635 A1 a cryobiopsy probe has been known, which probe can be guided through a support hose. The support hose and the probe can be accelerated relative to each other in order to tear off the tissue sample with a defined tearing force.
During the flexible endoscopic tissue sample removal, (e.g., tissue sample from the pancreas) with the aid of a cryobiopsy probe through an organ wall (e.g., stomach wall), it is possible for parts of the sample or the entire sample to be lost on the entire recovery path or, specifically, while it is pulled through the organ wall. This may result in the transfer of germs or cross-contamination.
For the recovery of tissue samples it has been known to provide a recovery tube having a recovery section, wherein the probe with the tissue sample is pulled into the recovery region. The probe and the recovery tube are removed simultaneously. However, the recovery tube of the cryopuncture probe cannot be moved through the affected organ wall. The reason being that the recovery tube has too large a diameter and thus too great a force is required for moving the recovery tube forward. The risk of stripping the sample on the organ wall thus continues to exist. The tissue sample (e.g., tumor tissue) is pulled through healthy tissue (e.g., the stomach wall) before the sample has been retracted into the recovery tube. In doing so, tumor cells may be transferred. A loss of the tissue samples by stripping on the stomach wall, for example, may occur.
Furthermore, the punch biopsy has been known from prior art, wherein, by means of special types of needles (e.g., TruCut), a cylindrical biopsate can be harvested. However, the latter is frequently tainted with artifacts and the amount of biopsate is too small for an evaluation.
Furthermore, the fine needle biopsy has been known from prior art, wherein an injection needle is inserted into the tissue site from which a sample is to be removed and the cells are aspirated by the injection needle. Therefore, it cannot be used for harvesting larger biopsates.
The object of the invention is to state an improved concept for harvesting a biopsate.
This object is achieved with a biopsate recovery device and a biopsy instrument as described herein:
The biopsate recovery device according to the invention comprises a recovery element to be fastened to or adjacent to a working tip of a biopsy instrument (hereinafter also referred to as instrument). The working tip is disposed to hold the biopsate. The working tip may also be referred to as the head or probe head. The biopsate may adhere, for example, to the outside of the working tip, in particular be frozen thereto, and/or be received in the working tip. The working tip may be disposed to be guided through an opening, in particular in a tissue wall, to a removal site, for example an additional tissue wall behind said tissue wall. For example, the working tip may be disposed to be guided through a stomach wall in order to extract a biopsate from an organ, e.g., the pancreas, that is adjacent to the stomach. The working tip is disposed to be retracted through an opening, e.g., through an opening in a wall of tissue, an organ wall, or through an opening of a working channel of an endoscope or bronchoscope. The recovery element is disposed to be folded over the biopsate during the retraction of the working tip in order to enclose the biopsate during the retraction of the working tip through the opening, for example the organ wall, in order to separate the biopsate during the retraction through the opening from the environment—in particular transverse to the recovery direction, in particular from the wall around the opening. In particular, the biopsate can be held by means of the recovery element during the retraction of the biopsate through the opening, in particular through the opening of the tissue wall, separated from the edge of the opening or from the tissue wall or the tissue, i.e., at a distance from or separate from the edge of the opening or the tissue wall or the tissue, in order to not contaminate the biopsate, for example. Additionally or alternatively, the recovery device may be disposed to separate the tissue around the opening from the biopsate which may contain germs or degenerated cells, i.e., to hold the biopsate at a distance from or separate from the tissue in order to not transfer the germs or degenerated cells, for example.
While being retracted, the recovery element is preferably folded over from a first position (orientation) into a second position (orientation) in order to enclose the biopsate. Preferably, the recovery element has a first surface which, during recovery when the recovery element separates the biopsate, faces the biopsate and a second surface which, during recovery when the recovery element separates the biopsate, faces away from the biopsate. While folding over from the first position into the second position for enclosing the biopsate, the first surface, which is facing outward in the first position, faces inward due to being folded over in order to be facing the biopsate. Accordingly, the second surface is moved outward while being folded over.
By means of the recovery element it is possible to protect the biopsate and/or the tissue around the opening not only from a germ or cell transfer, but the biopsate can be protected, by means of the recovery element, against being mechanically stripped off while it is being pulled through the opening. This is in particular of importance for embodiments of the biopsy instruments according to the invention which are used for harvesting biopsates that have a transverse dimension, e.g., diameter, that is greater than the transverse dimension of the working tip and/or a puncture channel formed with the working tip in the target tissue and/or an opening made with the working tip in an organ wall.
Furthermore, a biopsy instrument is stated which comprises a biopsate recovery device according to the invention.
The biopsate recovery device and/or the biopsy instrument according to the invention may be developed further with one or more of the following features:
When the recovery element is folded over the biopsate in order to circumferentially enclose the biopsate, the biopsate may experience a mechanical protection from the recovery element, for example, against being stripped off the working tip. The recovery element may be disposed to circumferentially enclose the biopsate, in particular along the circumference of the shaft on which the working tip is arranged, along a circumference around the working tip and/or around the biopsate, in order to fluidically separate the biopsate from the tissue. When the biopsate is fluidically separated from the tissue by means of the recovery element in transverse direction, in particular perpendicularly to retracting direction, from the environment, the biopsate and the tissue can be particularly reliably protected against mutual contamination. The section of the recovery element that encloses the biopsate is preferably fluid-tight, in particular consist of a fluid-tight material. The section may be of plastic material, for example, silicone or polytetrafluorethylene. If the recovery element is disposed to form a fluid-tight shield or sheath for the biopsate, the recovery element can particularly effectively shield the biopsate against contamination due to fluid, in particular when the biopsate is being extracted through a tight opening in a tissue wall, which tissue wall would potentially directly contact the opening around the biopsate without recovery element during recovery.
The recovery element—in elastically undeformed state—may be disposed to enclose the biopsate at a distance transverse to the retracting direction or recovering direction or transverse to the longitudinal extension direction of the shaft and/or the working tip. The recovery chamber that the folded-over recovery element provides for the biopsate may have—in its elastically non deformed state transverse to the recovery direction—an inside diameter that is greater than the diameter of the biopsate.
Referring to the embodiments, a section of the recovery element for enclosing the biopsate may be resilient in such a manner that the section, when said section—while the working tip is pulled out of the body of the patient—is pressed against the biopsate and adapts to the form of the biopsate and remains in intimate contact therewith until the working tip is pulled out of the body.
The ratio of the diameter of the shaft—measured at a location at or in the recovery element—to the greatest outside diameter of the recovery element is preferably at most 1:1 to at least 1:6, particularly preferably at most 1:3 to at least 1:5. A ratio of 1:1 is possible if the greatest diameter of the working tip in its region for adhesion of biopsate is smaller than the diameter of the shaft.
The length of the section of the instrument which is disposed for receiving, in particular for the adhesion of, a biopsate and along which extends the part of the recovery element when enclosing the biopsate and thus separates the section, preferably corresponds to 2 to 20 times, in particular preferably to 4 to 10 times, the diameter of the shaft measured at a location at or in the recovery element.
While the folded-over recovery element preferably circumferentially (along a circumference around the biopsate) encloses the biopsate in such a manner that no fluid and/or aerosol and/or gas transverse to the recovery direction and/or radially to the working tip can reach the biopsate or move from the biopsate into the environment, the recovery element may be open in the direction counter the recovery direction, in particular in the direction in which the working tip is pointing.
The recovery element can completely enclose the biopsate, i.e. not only in circumferential direction, but a section of the recovery element folded around the biopsate may also be arranged in distal direction or in longitudinal extension direction of the working tip and/or the instrument between the distal end and the environment. When the biopsate is completely enclosed by the folded-over recovery element, the transfer of germs can be prevented in a particularly effective manner.
The recovery element may be provided with a structure that—when the working tip is being retracted—is disposed to come into engagement with the opening, the opening edge and/or the wall around the opening in order to aid the folding-over of the recovery element around the biopsate. During retraction, the structure comes into engagement with the wall, the opening edge and/or the opening wall and may temporarily be hung up there due to positive-locking or frictional locking, so that the folding-over of the recovery element is promoted by the retraction until the structured section of the recovery element is pulled through the opening. The structure may consist of a rough surface, for example; or the interior surface structure may comprise at least one structure element or several structure elements such as scales and/or nubs. A structure disposed for promoting the folding-over may be provided, for example, on one side of a part of the recovery element that faces outward during retraction of the recovery element when being folded over; and/or a specific structure for promoting the folding-over may be provided, for example, on one side of a part of the recovery element that is folded inward when the recovery element is being retracted.
The embodiments of the biopsate recovery device may comprise, for example, recovery elements that comprise a support element. Said support element is preferably elastically deformable transverse to the retracting direction and is disposed to support itself on the wall at the opening, preferably around the opening, during retraction in order to promote the folding-over. When guided through the opening in the direction to the site where the biopsate is to be removed, the support element is elastically deformed and, after passage through the opening, which can be expanded by passing the instrument, in particular the recovery element, is inclined—upon elimination of the outside force outside the opening—to assume again a greater diameter transverse to the opening direction or recovery direction (retracting direction). The support element that, due to elastic resetting forces, has again assumed a greater diameter—preferably a diameter greater than the opening—supports itself during the retraction against the wall that contains the opening, and thus remains temporarily hang up in order to promote the folding-over. Preferably, the support element supports itself around the opening during retraction.
During retraction, the support element preferably supports itself at least until the recovery element is folded over.
For example, the support element may be an elastically deformable ring. Preferably, the support element is arranged on the end of the recovery element that, during passage through the opening in the direction for receiving a biopsate with the working tip, is last to leave the opening.
The recovery element may consist of a material or have a coating, said material or coating being disposed to prevent an adhesion and/or freezing of the recovery element to the instrument, for example a cryobiopsy probe, in particular its working tip and/or its shaft, and/or to prevent a freezing and/or adhesion of the biopsate to the recovery element. For example, the recovery element may consist of a material or have a coating, said material or coating being disposed to prevent an adhesion and/or freezing of the recovery element to a biopsy instrument for harvesting a biopsate, said biopsy instrument being equipped with a biopsate recovery device according to the invention, and in particular prevent an adhesion and/or freezing to its working tip and/or its shaft.
When the recovery element is used with a cryobiopsy probe, it is possible, additionally or alternatively, for the recovery element to be preferably made of a material whose elasticity is not affected by the cooling of the working tip and/or the shaft. In particular, the elasticity of the part of the recovery element that is folded over, is preferably temperature-independent in those temperature ranges in which the part that can be folded over can assume a temperature, during the extraction of the biopsate by means of a cryobiopsy probe, in sections of the part.
The recovery element can comprise—in particular adjacent to or near a fastening location on the biopsy instrument, or adjacent to a fastening section of the recovery element that is affixed to the biopsy instrument—a subsection having an outside diameter that widens along a longitudinal section of the biopsy instrument. Between the subsection and the biopsy instrument in folded-over condition, the subsection can delimit a region of a recovery chamber. The outside diameter of the subsection can widen for moving the biopsy instrument through an opening in a wall in a direction that is counter to the direction (passage direction) in which the biopsy instrument is moved for passage, or narrow in passage direction in order to simplify moving through the opening. Preferably, the outside diameter of the subsection tapers—in the first position assumed by the recovery element in the direction of movement of the instrument toward the location where the biopsate is to be harvested, and/or the outside diameter of the subsection tapers—with the recovery element in the second, folded-over position—in the recovery direction, i.e., in the direction in which the biopsy instrument is removed from the location where the biopsate was taken for removal of the working tip with the biopsate. In this manner, the passage of the recovery element through the opening may be simplified. For example, the subsection may taper conically. Preferably the subsection is elastically deformable in radial direction and in a direction transverse to the recovery direction, respectively. In doing so, the passage of the recovery element through the opening in puncturing direction and/or the retraction of the recovery element through the opening through the opening may be particularly simplified.
The subsection which connects the section for enclosing the biopsate with the fastening section can have, in the transition to the fastening section of the recovery element, an outside diameter which, with respect to the outside diameter in the transition to the section for enclosing the biopsate, is in a ratio of at most 1:1 to at least 1:6; preferably at most 1:3 to at least 1:5, when the recovery element is not elastically deformed transversely to the longitudinal extension direction of the shaft. The stated ratio may refer to a position in which the free end of the recovery element points in the proximal direction and/or to a position in which the free end of the recovery element points in distal direction.
Preferably, the material or materials of the recovery element have a hardness of at least 20 to at most 80 Shore A, preferably at least 40 to at most 60 Shore A. In the exemplary embodiments, the recovery element may be composed of material which display different hardnesses, for example in Shore A. For example, the recovery element may be of a harder material in the fastening section than in the section (connecting section) of the recovery element adjacent in the direction toward the free end of the recovery element, which connects the section of the recovery element for enclosing the biopsate to the fastening section. Alternatively or additionally, the material of the connecting section may be harder than the material of the section of the recovery element for enclosing the biopsate. The difference in hardness between the materials may be, for example, at least 5 Shore A. For example, in the exemplary embodiments, the hardness of the sections may increase linearly, progressively or degressively from the section for enclosing being the least hard section, via the connecting section, to the fastening section being the hardest of the three sections.
The recovery element may have a opening up structure which comprises elongated elements and/or sections extending away from a base section or base element and being at a distance from each other in circumferential direction, which sections—due to the stiffness of the connection of the base section element or element with the elements from this path and/or section—attempt, when an outside force is removed, to resume their original orientation relative to the base section or base element and thus widen the mounting structure after, for example, the base element has been moved through a narrow opening into a wider region. The elongated elements or sections that are at a distance from each other in circumferential direction ensure that the subsection can be compressed radially in a controlled manner when the subsection is pushed through an opening in a tissue wall, and the connection with the base element or base section ensures that the subsection will particularly reliably open again due to the elastic resetting forces to assume its original form. For example, the recovery element many have elongated sections in the form of a wall thickness that increases and decreases in an alternating manner along the circumference and/or elongated reinforce element sections that may consist of another material than the subsection, e.g. of metal or another polymer.
When the recovery element in exemplary embodiments comprises, in longitudinal direction, adjacent different materials that form the sections of the recovery element, the sections may be configured with differing radial stiffnesses. In the exemplary embodiments, a connecting section may consist of a different material than a section for enclosing the biopsate. In doing so, exemplary embodiments of the recovery element according to the invention can be provided, wherein the connecting section displays another, e.g. greater, radial stiffness than the section for enclosing the biopsate.
Alternatively or additionally, in embodiments of the recovery elements, the greatest wall thickness of the section of the recovery element for enclosing the biopsate may be smaller than the greatest wall thickness of the connecting section of the recovery element that connects the section for enclosing the recovery element to the fastening section. In embodiments with a connecting section whose wall thickness alternately increases or decreases along the circumference, e.g. to form a mounting structure, the wall thickness—compared to the wall thickness of the section for enclosing the biopsate—can be measured at a location of the greatest wall thickness or at a location of the lowest wall thickness. Due to the wall thickness that continuously changes over sections of the recovery element in the direction toward the free end of the recovery element, in particular steadily and preferably monotonously (e.g., linearly) in the direction toward the free end of decreasing wall thickness, sections having a stiffness decreasing in the direction of the free end against radial deformation can be reliably provided which supports positioning variability and the ability of the recovery element to be reliably folded over the biopsate.
The wall of the recovery element preferably has a thickness of including 0.005 mm to 2 mm. Preferably, the wall has a thickness of <0.5 mm. The passage through an organ wall, in particular a stomach wall, is facilitated as a result of this.
When the recovery element is moved through the opening while the instrument is advanced to the location where the biopsate is to be extracted, the recovery element can be compressed and can be drawn lengthwise and in particular be expanded because the rear sections of the recovery element pass through the opening more slowly than the front sections which have already passed the opening due to the advance motion of the instrument. In doing so, preferably, the recovery element is elastically expanded at most to five times the unexpanded length, particularly preferably to at most 1.5 times the unexpanded length of the recovery element. The length is preferably measured in longitudinal extension direction of the biopsy element and/or the working tip. If this prevents an excessive lengthwise pulling of the retraction element when pulling or pushing through the recovery element through the stomach wall, for example, it is also possible to perform tissue biopsies directly behind the stomach wall, without having to dispense with enclosing the biopsate with the recovery element during the retraction through the opening.
Preferably, the recovery element has a first surface and/or a second surface to which cells and/or tissue will not adhere. The first surface and/or the second surface can display their non-adhesive (greatly inhibited adhesion) property, for example, due to micro-structuring and/or plasma treatment. Alternatively or additionally, the surface of the recovery element, for example the first surface and/or the second surface, may have an anti-adhesion coating against the adhesion of cells and/or tissue. For example, the surface may be coated with a fluoropolymer. For example, the surface—due to the coating and/or processing—may display a contact angle greater than or equal to 90°, particularly preferably greater than or equal to 110°. In doing so, it can be prevented that the cells are transferred by the recovery element.
The embodiments of the biopsy instruments according to the invention may be cryobiopsy probes, in particular. When the sections of the working tip of the cryobiopsy probe are cooled, tissue may freeze to it. A frozen biopsate may be harvested by being torn off. The low temperatures at the working tip can be achieved, for example, by utilizing the Joule-Thomson effect, as stated in prior art cited hereinabove.
Whereas the biopsy instrument preferably is a cryobiopsy probe, the biopsate recovery device according to the invention may also be used in other biopsy probes in order to separate a biopsate during removal from the environment in order to protect the environment and/or the biopsate and/or prevent a loss of the biopsate. For example, the biopsate recovery device can also be used on a biopsy probe with which a biopsate is punched out of tissue.
Preferably, the working tip is disposed for puncturing an organ wall with said working tip, i.e., the opening in the organ wall can be produced by means of the working tip.
For example, the recovery element can be manufactured by injection-molding around a working tip and/or a shaft of a biopsy instrument, in particular a cryobiopsy probe, and, in doing so, be connected to the biopsy instrument.
Preferred are instruments with at least one recovery element that can be interchanged in order to be able to dispose of the recovery element—in particular after the first use—and to be able to use the instrument with another recovery element.
For positioning the biopsy instrument for severing the sample from the tissue, the section of the recovery element for enclosing the biopsate can be received in a section of the recovery element, in particular, inserted, rolled in and/or folded in, said section connecting the section for enclosing the biopsate with the biopsy instrument. In one state of the embodiments of the instrument according to the invention, the section of the recovery element for enclosing the biopsate is received in a section of the recovery element, in particular inserted, rolled in and/or folded in, said section connecting the section for enclosing the biopsate with the biopsy instrument.
The biopsy instrument may comprise a securing element which is disposed to prevent an unwanted folding-over during the positioning of the working tip for severing the sample. The securing element can be deactivated before the retraction of the biopsy instrument for removal of the sample, so that a folding-over is possible during retraction.
Additional advantageous features with which the recovery device according to the invention or the biopsy instrument according to the invention can be further developed, or preferred embodiments of the recovery device according to the invention or the biopsy instrument according to the invention can be inferred from the description and the figures hereinafter. They show schematically and in an exemplary manner:
The instrument according to the invention is an instrument for harvesting a biopsate. Harvesting of a biopsate by means of the instrument according to the invention may involve the separation by punching, the aspiration of tissue or the cutting-off and holding with a clamp. However, preferably, the biopsy instrument is a cryobiopsy instrument or a cryobiopsy probe. In the case of these, the working tip of the instrument can be cooled, for example by utilizing the Joule-Thomson effect inside the working tip, as has been amply disclosed by prior art. The working tip is pressed against the tissue at the site where the biopsate is to be removed, or pressed or punctured into the tissue. By strongly cooling the working tip, the tissue adjacent the working tip can be frozen solid. By removing the working tip from the site where the tissue has frozen to the working tip, in particular by an abrupt movement, the frozen tissue can be torn out of the tissue bond and be recovered for examination.
Exemplary embodiments of biopsy instruments 10 according to the invention, as are depicted, for example, by
In
The part 19 for enclosing the biopsate 20 can be folded over from this position or orientation into a second position or orientation. In doing so, the open, free end 27 of the recovery element 17 is moved around the shaft 11 and the working tip 13 beyond the fastening section 18 in the direction of the working tip 13 or the distal end 15 of the instrument 10. In doing so, the fastening section 18 remains preferably fixed in place, so as to be immovable relative to the shaft 11 and/or the working tip 13 on the shaft 11 and/or the working tip 13. During the movement of the end 27 and the folding-over of the part 19 of the recovery element 17, the second surface 26, which when not folded over faced inward, is at least partially oriented outward, and the first surface 25, which was faced outward when not folded over, is at least partially oriented inward, in order to be facing the shaft 11 and/or the working tip 13 and/or the biopsate 20.
The subsection 30 of the part 19 of the recovery element 17 for enclosing the biopsate 20 adjoining the fastening section 18 may be elastically deformable (transversely relative to the shaft 11 and/or relative to the working tip 13 and/or the biopsate 20) in radial direction. The subsection 30 may have the form of a cone or be conical. An adjoining additional subsection 31 for enclosing the biopsate 20—with the recovery element 17 folded-over, said subsection being arranged between the free end 27 and the subsection 30—can be deformed but not elastically deformed. Whereas the elastically deformable subsection attempts to return into its original form upon the removal of a deforming force, this cannot or only to a minimal decree apply to the non-elastically deformable additional subsection 31. The additional subsection 31 adjoining the elastically deformable subsection 30, however, may also be elastically deformable.
To do so, as depicted by
The instrument 10 is further advanced through the thusly made opening 46 in the stomach wall 41, in which case also the part 19 of the recovery element for enclosing the biopsate 20 is pushed forward through the opening 46. When the recovery element 17 passes through the opening 46, it is radially squeezed together. The wall of the recovery element 17, in particular the wall 19 for enclosing the biopsate 20, has a thickness including 0.005 mm to including 2 mm. The wall, in particular the wall of the part 19 for enclosing the biopsate 20 preferably has a thickness of <0.5 mm. In particular when the maximum thickness of the wall of the recovery element 17 or at least the maximum thickness of the part 19 that encloses the biopsate 20 is between including 0.005 mm to including 2 mm or smaller, the passage through an organ wall—like in this example the stomach wall 41—is facilitated as a result of this.
When, as also in the embodiment according to
The subsection 30 that connects the section 31 for enclosing the biopsate 20 to the fastening section 18 can comprise—at the transition to the fastening section 18 of the recovery element 17 an outside diameter da1 (see, for example,
Preferably, the subsection 30 is not directly connected by means of the shaft 11 or the working tip 13 to the instrument 10, but via the fastening section 18. The subsection 30 is radially elastically deformable or transversely with respect to the retracting direction ZR and/or the puncturing direction VR. When the subsection 30 between the stomach wall and the pancreas has moved out through the opening 46, said subsection may again assume its original form due to its elasticity.
When the recovery element 17, while the instrument 10 is being advanced to the site on the pancreas 45 where the biopsate 20 is to be harvested, is moved through the opening 46, the recovery element 17—as it is being pulled through or pushed through—can be pulled lengthwise, and in particular elongated, because the rear sections of the part 19 of the recovery element 17 move through the opening 46 more slowly than the front sections that have already passed through the opening 46. Preferably, the recovery element 17 and/or a part 19 of the recovery element that adjoins the fastening section 18 is elastically extended at most up to five times the non-extended length, particularly preferably to at most 1.5 times of the non-elongated length of the recovery element 17 or the part 19. The length is preferably measured in longitudinal extension direction of the biopsy instrument 10 and/or the working tip 13. If, due to that, an excessive lengthwise elongation of the recovery element 17 is prevented while, for example, the stomach wall 14 is being punctured, it is also possible to obtain tissue biopsies directly behind the stomach wall 14, without having to dispense with the enclosing of the biopsate 20 by the recovery element 17 during the retraction through the opening 46.
The instrument 10 is pushed further through the opening 46 and when the recovery element 17 has left the opening 46 between the stomach wall 41 and the pancreas 45, the elastic sections 30—to the extent that they exist—of the recovery element 17 can again assume the original form due to radial expansion. The instrument 10 is moved forward until the working tip 13 presses against the tissue of the pancreas 45 or punctures the tissue of the pancreas 45 (
The working tip 13 is cooled and, as a result of this, the tissue is frozen to the working tip 13. The tissue is released from the pancreas 45 by abrupt retraction of the instrument 10 in recovery direction ZR (arrow in
The working tip 13 is pulled out through the opening 46 from the intermediate space between the pancreas 45 and the stomach wall 41. In doing so, the recovery element 17 first comes into abutment and/or engagement with the stomach wall 41 and, by the retracting movement of the shaft 11 and abutment against the stomach wall 41 or the engagement with the stomach wall, is folded over the working tip 13 or over the biopsate 20 in order to—as illustrated by the arrows P in
The recovery element 17 may be disposed to enclose the biopsate 20 circumferentially along a circumference around the working tip 13 in a closed manner in order to fluidically separate the biopsate 20 from the tissue, in particular the stomach wall tissue, in radial direction. When the biopsate 20 is fluidically separated from the tissue by means of the retraction element 17 transversely—in particular perpendicularly to the retracting direction (RZ)—from the environment, the biopsate 20 and the tissue can be particularly reliably protected against mutual contamination. The section of the recovery element that encloses the biopsate, accordingly, is preferably fluid-tight in particular of fluid-tight material. When the recovery element 17 forms a fluid-tight sheath or shield transversely to the retracting direction ZR, this can shield the biopsate 20, in particular while being pulled through the opening 46 (
The folded-over recovery element 17 can also protect the biopsate 20 from unwanted stripping on the distal end 37 of the endoscope 36 or in the working channel 35 of the endoscope when the working tip 13 with the biopsate 20 is pulled back into the working channel 35 of the endoscope 36, for example, in order to recover the biopsate 20 through the working channel 35.
The recovery element can completely enclose the biopsate, i.e., not only circumferentially, but the folded-over recovery element, optionally together with the instrument, can enclose the biopsate on all sides. In particular, a region of the part of the folded-over retraction element for enclosing the biopsate can also be arranged distally between the distal end of the working tip and the environment. To do so, the recovery element is preferably long enough that the folded-over recovery element reaches beyond the distal end of the working tip and/or beyond the distal end of the biopsate. When the recovery element is being retracted, in particular the subsection of the part of the retraction element for enclosing the biopsate, said subsection projecting distally over the working tip and/or the biopsate, can be squeezed together, and opposite sections of the first surface can be brought into abutment and be held together by adhesive forces. This is shown, for example, by
The fastening section 18 may be glued or clamped, for example, to the shaft of the instrument 10. The recovery element 17 is preferably fastened to the instrument 10 in a fluid-tight manner. Adjoining the fastening section 18, there is provided—at a connecting site 50—the part 19 of the recovery element 17 which is folded over and which radially shields the biopsate 20. In the exemplary embodiment according to
As shown by
Whereas the biopsy instrument preferably is a biopsy probe, the biopsate recovery device can also be used with other biopsy probes in order to separate a biopsate from the environment while it is being removed, in order to protect the environment or the biopsate, or to prevent a loss of the biopsate. For example, the biopsate recovery device can also be used on a biopsy probe with which a biopsate is punched out of the tissue.
Whereas the recovery element is essentially made as a one-piece part or flexible sheath, in particular as a seamless one-piece part, the recovery element may also consist of several parts which are connected to each other so as to be movable relative to another to form a mechanical element. For example, the recovery element may be designed similarly to a folding bellows. In particular considering embodiments in which the recovery element is a one-piece part, the dimensioning of the recovery element and/or different materials for the different sections of the recovery element can affect the stiffness of the different sections of the recovery element in a targeted manner.
With reference to a further exemplary embodiment,
The material or materials of the recovery element in the exemplary embodiments may display hardnesses of at least 20 to at most 80 Shore A, preferably at least 40 to at most 60 Shore A. In the exemplary embodiments, the recovery element may be composed of materials such as, e.g., different silicones, that display different hardnesses. The hardness may decrease in longitudinal direction L of the recovery element in the direction toward the free end 27 of the recovery element 17, for example be greater in the connecting section 30 than in the section 31 for enclosing the biopsate 20.
With reference to an exemplary embodiment,
In the embodiments, the section 31 of the recovery element 17 for enclosing the biopsate 20 can—for the puncturing by the biopsy instrument—be received in the connecting section 30 of the recovery element 17 for positioning said instrument. Preferably, the section 30 for enclosing the biopsate 20 can be rolled and/or folded into the connecting section 30.
Biopsy instruments 10 according to the invention may comprise a securing element 68 which is disposed to prevent an unwanted folding-over of the recovery element 17 while the working tip 13 is being positioned for severing the biopsate 20. For retracting the biopsy instrument 10 for removal of the biopsate, it is possible to deactivate the securing element 65, so that a folding-over is possible during retraction. The securing element 65 can be pulled off the recovery element 17 in order to allow the folding-over. Preferably, the securing element 65 encloses a proximally facing edge 66 of the recovery element 17, which edge may be formed by the free end 27 or, for example, by a ring formed by rolling-in and/or folding-in, as described in conjunction with the exemplary embodiment according to
With reference to an exemplary embodiment, a recovery element 17 according to the invention having a wall thickness decreasing in the direction toward the free end 27 of the recovery element is shown by
The features of the embodiments described herein may be combined with each other as desired. For example, features described in conjunction with
Features such as different wall thickness, material displaying different hardnesses and/or a mounting structure 65 are examples of features which can be used to form embodiments that display a stiffness of the recovery element against radial deformation decreasing toward the free end 27. For example, the connecting section 30 may be stiffer against radial deformation than the section 31 for enclosing the biopsate 20, at least when it is rolled out and/or unfolded.
A biopsate recovery device 16 for recovering a biopsate 20 through an opening 46 with a recovery element 17 for fastening to or adjacent to a working tip 13 of a biopsy instrument 10 is disclosed, wherein the recovery element 17 is set up to—while the working tip 13 is being retracted through the opening 46—be folded over the biopsate 20 in order to enclose the biopsate during the retraction of the working tip 13 through the opening 46 in order to separate the biopsate 20 from the environment during retraction through the opening 46. As a result of this, the biopsate 20 and/or the environment can be protected against contamination and/or cell transfer and/or germ transfer, and/or the biopsate 20 can be protected against being inadvertently stripped off at the opening 46.
| Number | Date | Country | Kind |
|---|---|---|---|
| 18183972.1 | Jul 2018 | EP | regional |
| 19179101.1 | Jun 2019 | EP | regional |
