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NL2034141B1 - Improvements to biopsy devices - Google Patents

Improvements to biopsy devices Download PDF

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Publication number
NL2034141B1
NL2034141B1 NL2034141A NL2034141A NL2034141B1 NL 2034141 B1 NL2034141 B1 NL 2034141B1 NL 2034141 A NL2034141 A NL 2034141A NL 2034141 A NL2034141 A NL 2034141A NL 2034141 B1 NL2034141 B1 NL 2034141B1
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Netherlands
Prior art keywords
collection
vessel
needle
sheath
biopsy
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NL2034141A
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Dutch (nl)
Inventor
Jan Breemhaar Jonathan
Gerardus Johannes Dohmen Richard
Augusto Da Silva Moura Miguel
Original Assignee
Mosa Meat B V
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Publication date
Application filed by Mosa Meat B V filed Critical Mosa Meat B V
Priority to NL2034141A priority Critical patent/NL2034141B1/en
Priority to PCT/EP2024/053373 priority patent/WO2024170445A1/en
Application granted granted Critical
Publication of NL2034141B1 publication Critical patent/NL2034141B1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

The invention relates to improvements to biopsy devices. The current device allows for obtaining a biopsy sample directly into a cell culture medium or other liquid containing vessel, without an external transfer step.

Description

DESCRIPTION
TITLE: IMPROVEMENTS TO BIOPSY DEVICES
TECHNICAL FIELD
The invention is in the field of biopsy devices, specifically in the field of biopsy devices for obtaining live animal cell samples. The improvements to traditional biopsy devices disclosed herein allow for a sample obtained by biopsy to be immersed in a cell culture medium without the need of an intermediate step of biopsy material transfer from the biopsy device to an external medium containing vessel.
BACKGROUND OF THE INVENTION
Biopsy devices, also known in certain configurations as biopsy guns, are well known in the art as a straightforward way to obtain biological samples. Biopsy guns in particular improve biopsy conditions by allowing for better automated handling of biopsy needles (which may always be used without a biopsy gun in more traditional devices). Most biopsy devices work by having a protruding needle that is inserted into the area of tissue of the animal where a sample is to be collected from, this needle being adapted to retrieve a sample by having a sampling cavity and a sheath, basically a second needle of larger diameter than the needle, concentric with the needle and surrounding it, that can retract to expose the sampling cavity and, by a mechanical action on the biopsy device (for example pushing a trigger on a biopsy gun) usually by means of a pre-loaded spring or similar mechanism, can advance over the needle towards the needle tip and over the sampling cavity, cutting the tissue by means of a sharpened distal edge and at the same time sealing the sampling cavity. The needle, covered by the sheath, is then removed from the tissue being sampled and the sample is collected by retracting the sheath and exposing the sample in the sampling cavity, usually either by removing the needle from the gun for posterior collection of the sample, or expelling the sample from the needle whilst still attached to the gun, making use of a mechanism on the gun adapted to do so. A good example of this state of the art can be found in Fig. 4 of WO 2011/034046
Al. The type of sampling cavity in this prior art document is called a “side notch”. Other types of biopsy device exist in the prior art, using different solutions from the needle/sheath combination. Another common type of biopsy device are ones that present with a simple hollow needle, collecting a “full core” sample.
When there is a need to prevent the cells in a sample from dying, culture medium must be provided to the same. This is done by transferring the sample from the collection cavity or whatever equivalent means the specific biopsy device uses, and posterior immersion in culture medium present in an external vessel, implying a biopsy sample material transfer step involving risk of contamination. Also, it may not be critical to maintain the cells in the sample alive, but to simply transfer them to a liquid medium other than cell culture medium to fulfil any sort of processing need. As long as this needs to be done in a sterile fashion, the state of the art does not provide an adequate solution. Also, the state of the art does not provide a solution to carrying out the sterile transfer operation within the biopsy device itself, without recourse to an external vessel.
There is thus a need to ameliorate these problems, as disclosed in the present invention.
SUMMARY OF THE INVENTION
The inventors describe a new biopsy device with an inline collection vessel.
The preferred embodiments of the invention are as follows:
In a preferred embodiment, a biopsy device comprising an inline collection vessel (10) and a collection needle.
In another preferred embodiment, a biopsy device wherein the collection vessel is mounted on the collection needle, the collection needle traversing the collection vessel in a straight line.
In another preferred embodiment, a biopsy device wherein the collection vessel comprises an internal cavity adapted to receive a biological sample and/or a liquid.
In another preferred embodiment, a biopsy device wherein the collection vessel comprises two perforable seals (11), the perforable seals optionally containing two pre-made orifices.
In another preferred embodiment, a biopsy device wherein the collection needle comprises an internal needle (12) with a collection cavity (13) and a monolithic (20) or notched (21) sheath, concentric to and on the outside of the internal needle (12).
In another preferred embodiment, a biopsy device wherein the notched (21) sheath comprises a notch (22) of a size not smaller than required to expose the collection cavity (13)
when this is aligned with the notch and wherein the notched sheath may optionally display alignment markings to determine the position of the collection vessel (10) in relation to the notch (22).
In another preferred embodiment, a biopsy device wherein the collection vessel is 5S contained within the body of a biopsy gun, configured to be able to open and close to insert and remove the collection vessel.
In another preferred embodiment, a biopsy device wherein the collection needle is supported by mechanical supports built on the body of the gun, the mechanical supports built in line with the collection vessel seals (11) to allow guiding the collection needle through the seals.
In an alternative preferred embodiment, a process to operate a biopsy device with an inline collection vessel (10) comprising the steps of: a. Providing a sealed collection vessel (10) with two seals (11) containing a liquid, such as cell culture medium; b. Traversing the body of the collection vessel with a collection needle inserted through the seals; c. Inserting the distal end of the collection needle in an animal tissue to be biopsied, d. Exposing the collection cavity (13) to the animal tissue; e. Cutting the animal tissue by causing an opposing movement between the internal needle and the sheath. tf. Retracting the internal needle until the collection cavity is contained inside the collection vessel; g. Releasing the sample inside the collection vessel; h. Fully removing the collection needle from the collection vessel allowing the self-sealing seals (11) to seal the collection vessel.
In another preferred embodiment, a process, wherein between steps f) and g) there is a step of retracting the monolithic (20) sheath and exposing the collection cavity to the inner medium of the collection vessel.
In another preferred embodiment, a process wherein between steps b) and c¢) the notch (22) of a notched sheath (21) is aligned until contained inside the collection vessel (10) and between steps f) and g) there is a step of aligning the collection cavity with the notched (21) sheath notch (22), exposing the collection cavity to the inner medium of the collection vessel.
In an alternative preferred embodiment, a biological sample inline collection vessel for a biopsy device, comprising two seals on opposite sides, able to be traversed by a biopsy collection needle.
In another preferred embodiment, a vessel wherein the seals comprise a screwed or forced in plug or membrane.
In another preferred embodiment, a vessel wherein the plug or membrane optionally comprises a premade orifice of a dimension that allows self-sealing.
In another preferred embodiment, a vessel wherein the vessel is opaque or transparent, wherein the vessel is preferably made of metal, glass or polymeric material and wherein the polymeric material is preferably an elastomer, such as silicone or polyurethane rubber.
In another preferred embodiment, a vessel wherein the vessel comprises securing means to the collection needle, such as mechanical anchors.
DESCRIPTION OF THE DRAWINGS
Fig. 1 — Collection vessel.
Fig. 2a — Collection vessel and monolithic sheath combination ready to use.
Fig. 2b — Collection vessel and monolithic sheath combination after collection of a sample.
Fig. 2c — Collection vessel and monolithic sheath combination after emptying of collection cavity.
Fig. 3a — Collection vessel and notched sheath combination ready to use
Fig. 3b — Collection vessel and notched sheath combination after collection and sample release into vessel.
Fig. 4 — Mid section cut view of a collection vessel with plugs and optional preformed orifice.
Reference signs: 10 — Collection vessel, 11 — Vessel seal, showing optional preformed orifice; 12 — Internal needle; 13 — Collection cavity on internal needle; 14 — Sample obtained by biopsy; 20 — Monolithic sheath; 21 — Notched sheath; 22 — Notch on notched sheath; 23 — Skin of the animal to be biopsied;
DETAILED DESCRIPTION OF THE INVENTION
The invention described herein aims primarily to solve the problem of transferring biological samples biopsied from the sampling area of an animal, using a biopsy device, into a liquid, preferably a culture medium solution, in a sterile fashion.
A culture medium is a solution used to maintain cells alive, preferably in cell culture conditions. Cell cultures consist of animal cells, isolated from their original living organism (the animal), subject to artificial conditions that replicate the biological processes that allow them to proliferate or differentiate. These artificial conditions may comprise placing the cells in an appropriate bioreactor, petri dish or any other industrial or laboratory equipment adequate for the culture of cells. The cells are mostly surrounded by, or immersed in, a cultivation medium appropriate for culturing the specific cell type. This medium can be specifically tailored to promote proliferation, differentiation, or both.
Several pre-formulated media for cell culture are available in the market. These can be “basal media”, usually based on salt solutions with several compounds added to allow for the culture of specific cells or “complex media”, that support a wide range of mammalian cells.
Examples of well-known basal media are MEM (Minimum Essential Medium) or DMEM (Dulbecco’s Modified Eagle Medium), amongst many other types.
Culture medium can be used as a temporary solution to keep the cells healthy (i.e. alive) between the moment of biopsy and posterior transfer to an appropriate cell culture device, including any intermediate steps required, such as dissociation of individual cells from the collected tissue.
An example of cells that can be cultured are cells obtained from a biopsy of an animal tissue, in vivo. For example, in the area of cellular agriculture, cells normally used for human consumption, such as primary cells like Fibro Adipogenic Precursors (FAPs) or Satellite Cells (SCs), also known as myosatellite cells are obtained by biopsy from animals usually consumed by humans, for example mammals such as bovines, ovines or porcines among others.
Specifically in the field of cellular agriculture, but also for the broader biotechnology field, sterility of the biopsied sample is of the utmost importance to prevent contamination of the cell samples. Contamination may lead to, for example, unsuccessful cell cultures or misleading analysis results.
By providing, with this invention, a solution to obtain biological samples immersed in aliquid with no transfer steps external to the biopsy device, the inventors solve at least three important problems: maintaining the samples in a liquid, be it medium or any other liquid necessary for any process downstream of the biopsy without contamination, maintain the biopsied cells alive, when using cell culture medium or any other appropriate solution for this end and; allow the biopsy device to replace the step of transfer of a sample to an external vessel by its own novel internal functions, fully eliminating this step from the process.
Biopsy device with a collection vessel
The inventors propose providing a biopsy device with a collection vessel (10), filled with a liquid, preferably a cell culture medium. The collection vessel is mounted on the biopsy needle, the biopsy needle traversing the collection vessel. Due to this type of assembly, the collection vessel may be said to be inline with the collection needle of the biopsy device. The term inline will be used to signify this alignment in this specification. Whether the term is written down or not, and many times, for brevity, it won’t, whenever the “collection vessel” is referenced, it is to be assumed this is taken to mean an “inline collection vessel”.
Preferably, the inline collection vessel is shaped as a hollow cylinder, mounted in a concentric fashion on the collection needle. The collection needle may comprise an internal needle (12) and a sheath (20 or 21). Both the internal needle and the sheath can be movable.
The collection may be done by a side notch type of biopsy or by obtaining a full core. The side notch option is preferred due to sterility concerns. The internal needle may present with a sampling cavity (side-notch) or be hollow (full core).
The collection vessel needs to be removable from the biopsy device to allow for transport of biopsy samples. This is accomplished by providing means to slide it over the collection needle and closing the two openings (11) previously occupied by the needle. This closure may be accomplished by providing self-sealing means, such as post-puncture, self- sealing membranes or plugs. In general, this description will refer to these structures as the vessel seals.
The inline collection vessels may be seen as consumables, provided filled with a liquid, such as cell culture medium, and presenting with two seals on opposite sides that can be perforated by the collection needle before the biopsy operation is performed. The needle should traverse the vessel from one seal to the other. Optionally the collection vessels and/or the collection needle may present with anchoring means to maintain their relative positions.
One surface of the collection vessel may be openable (screwed on, for example) to allow for the later discharge of its contents — preferably this may be one of the two bases of a cylindrically shaped vessel. Optionally, this discharge can be done by removing the seals, if these are optionally removable.
In operation, the biopsy device is first loaded with a (preferably sterilized) collection needle. A collection vessel filled with the desired liquid is loaded on the collection needle. The distal end of the collection needle (the end further from the operator) is inserted into the animal from which a sample is to be taken. In the side notch version, the collection needle slides into the animal with the sheath covering the collection cavity present on the internal needle. At this stage, when perforation of the skin of the animal happens, the side notch version of the internal needle is preferred since the side notch allows for the tip of the needle to be solid and as such for the sheath to keep the collection cavity closed during insertion. This further prevents contamination of the sampling cavity with material not from the area to be biopsied.
After inserting the needle in the animal (23) and reaching the desired depth/position, the internal needle may be pushed forward from within the sheath, allowing biological material to fill the collection cavity. A relative opposing movement between the sheath and the internal needle is then caused. The sheath may be extended forward over the collection cavity, cutting the sample and enclosing it within the collection cavity. Optionally, the sheath may retract over the internal needle exposing the collection cavity to the biological material and later extend again over the collection cavity. These movements of the internal needle and/or the sheath may be performed by manual handling of the devices, for example by having handling means, such as, for example, plungers or handles, in the proximal (closest to the operator) end of the collection needle or automatically by the use of triggers, for example operated by a combination of trigger(s) and spring(s). These means are outside the scope of the invention but could be any such as traditionally used in biopsy guns. The provision of these means together with the collection needle as disclosed in this invention would transform the novel biopsy device into a novel biopsy gun. This is a preferred presentation for the invention, considering how biopsy guns facilitate the handling of biopsy devices. It is also possible to provide the collection vessel inside the biopsy gun itself. In this case, the biopsy gun would present with opening means to allow insertion or removal of the collection vessel.
After the biological sample (14) is contained within the collection cavity, the collection needle may be pulled through the collection vessel in the distal-proximal direction, or the internal needle only may be retracted in the same direction. When the sample within the collection cavity reaches a position where it is completely inside the collection vessel, the sample is released from the collection cavity. This may happen by retracting the sheath over the internal needle, thus exposing the sample to the medium or by having an opening (22) on the sheath, located inside the collection vessel, that will expose the sample to the medium as the internal needles slides past it. In case the collection vessel is located inside a biopsy gun, the biopsy gun may have built in guiding elements to help support the collection needle and guarantee a linear movement inside the vessel, preventing lateral forces that could damage the seals from arising, as could eventually happen when manually supporting the vessel outside of a biopsy gun. It may be necessary to provide manual agitation to the biopsy device to dislodge the sample (i.e., shaking) and preferably the operation is done in such a way as to maintain the distal seal opening of the vessel against the skin of the animal (i.e. the outer surface of the area being sampled) during the retraction step. This will further help prevent any contamination of the collection needle as it is pulled through the vessel. The skin/outer surface is assumed to be disinfected as part of the preparation steps for a biopsy. The collection needle may optionally be coated in an antiseptic solution to avoid pulling/pushing biological contaminants into the vessel. The seal should completely surround the collection needle while it slides in it, pushing any contaminants from the outer surface of the collection needle as it slides along it, keeping the contaminants on the outer surface of the needle.
In every step where the sheath is moving (except in the final separation of the collection vessel from the collection needle for transport of the sample), it may be advantageous to have the collection vessel move concurrently with the sheath instead of allowing the sheath to move inside the vessel. This prevents the introduction of possible pathogens and provides for the maintenance of a better seal around the collection needle. Several different options are obviously possible.
The collection vessel, now containing a sample, can be transported and processed in a laboratory or any other appropriate facility by opening the openable surface, for example a screw-on base of a cylindrically shaped vessel, or by removing or re-perforating the seals provided on the openings.
Exemplary Embodiments of the Invention
Collection vessel and monolithic sheath combination.
In this embodiment, exemplified in Fig. 2, the collection vessel (10), provided with cell culture medium or another liquid, is mounted on the collection needle by perforating it through the openings (11) and sliding it over the collection needle as previously described. The perforated surfaces of the collection vessel are thus in contact with the sheath (20). The internal needle (12) comprises a side-notch as a collection cavity (13). The sheath is of monolithic construction, 1.e., no special opening is created on its surface to allow access to the collection cavity on the internal needle. After these operations the biopsy device is considered primed to obtain a sample (Fig. 2a). After a biological sample (14) is collected in the collection cavity
(13), by any combination of movements of the internal needle or the sheath, the collecting needle, presenting with the sheath covering the collection cavity, is retracted through the collection vessel up to a point where the collection cavity (13) and thus the sample (14) is fully contained within the collection vessel (fig. 2b). At this point, the sheath is retracted (fig. 2c) exposing the collection cavity to the internal liquid environment of the collection vessel.
Mechanical agitation (shaking of the biopsy device) may be required to dislodge the biological sample from the collection cavity. The collection needle is then removed fully from the collection vessel, preferably with the sheath having moved to a position covering the collection cavity, to prevent leaks.
Collection vessel and notched sheath combination.
In this embodiment, exemplified in Fig. 3, the collection vessel (10), provided with cell culture medium or another liquid, is mounted on the collection needle by perforating it through the openings (11) and sliding it over the collection needle as previously described. The perforated surfaces of the collection vessel are thus in contact with the sheath (20). The internal needle (12) comprises a side-notch as a collection cavity (13). The sheath (21) includes an opening (22), with dimensions appropriate to expose the collection cavity (13). When inserting the collection needle in the collection vessel, this opening is to be fully contained within the vessel (Fig. 3a). This can be done by visual inspection of the sheath through a transparent vessel or by using visual markings on the sheath (on a version where a biopsy gun is used, non-alignment should be impossible due to the body of the gun fixing the relative positions of all elements).
After a biological sample is collected in the collection cavity, by any combination of movements of the internal needle or the sheath the collecting needle, presenting with the distal end of the sheath covering the collection cavity, is retracted through the collection vessel up to a point where the collection cavity (13) and thus the sample (14) are inside the collection vessel (10), concurrent with the sheath opening (22) (fig. 3b). Mechanical agitation (shaking of the biopsy device) may be required to dislodge the biological sample from the collection cavity.
The collection needle is then removed fully from the collection vessel, preferably with the internal needle having moved to a position where both the sheath opening and the collection cavity are closed, to prevent leaks.
Manual vs biopsy gun version
Both previous embodiments may present as a biopsy gun. This would be an automated version when compared to a manual version of the biopsy device. By manual version it is meant that all the operation, including extending or retracting either the sheath or the internal needle, in any combination, is done by direct manual manipulation of these. By biopsy gun version, it is meant that some of these operations may be automated or semi-automated by mechanical means typically found in biopsy guns, such using manual triggers and springs to create per determined movements of certain parts.
In a biopsy gun version of the biopsy device, it 1s possible that the collection vessel is contained within the body of the biopsy gun, which may open to allow the insertion or removal of the collection vessel. Another advantage of a biopsy gun with internal collection vessel version of the invention is that the collection needle, both when being inserted or removed from the vessel, may be guided with the aid of mechanical supports built on the body of the gun. This will help prevent unforeseen movements away from linearity which could damage the vessel or it’s openings.
When using a notched sheath, the gun may allow for an easier positioning of the notch inside the vessel, by limiting position of the several elements due to its construction.
The collection vessel
The inline collection vessel is, in its most basic form, a container for a liquid that presents with two perforable surfaces in a straight line when taken through the liquid containing cavity.
Ideally, this vessel is of a mostly cylindrical shape, for ease of handling, maximizing the internal volume and possibility of mass manufacturing. As an example, the vessel may be a plastic, metal or glass cylinder (other suitable materials may be possible) with both ends open.
A seal, for example a plug (best exemplified in fig. 4) or membrane (best exemplified in fig. 1), may be pushed onto or screwed to the open cylinder by means of a screwable seal holder.
The plug or membrane of the seal may be as thick as required to guarantee self-sealing properties as the collection needle slides in and out of it. The plug or membrane may be deformable to better accompany any movements of the collection needle and push contaminants along the outside of the needle, keeping them from entering the vessel.
The seal may preferably have a preformed through orifice, with a diameter that allows maintaining the self-sealing properties of the seal material, to help guide the initial insertion of the collection needle and diminish the force necessary to perforate it. The orifice also has the advantage of minimizing the probability of the internal needle or sheath shaving off any of the plug or membrane material during insertion. Shaving off is also prevented by presenting the solid conical tip protruding from the sheath during insertion.
The membrane or plug may be made from natural or synthetic materials, preferably polymers, preferably elastomers, such as silicone or polyurethane rubber.
With manual loading of the vessel on the collection needle, the vessel is preferably transparent, preferably a transparent plastic, so the collection needle can be guided visually during insertion and removal. In a biopsy gun version with automated functioning, the vessel may be opaque, since the operator will rely on guides and mechanisms to determine the perforation orientation and movement distances at any stage.
The vessel may be filled with culture medium or another liquid before the last seal is applied.
This can/should be done in a sterile, contaminant free fashion. To empty the vessel after removal from the collection needle, for example in a laboratory, the seal may be pulled out or removed by unscrewing, depending on the actual construction, or the vessel itself may be breakable, similarly to a breakable ampoule. The removal of the seal is preferred to a breakable version of the vessel.
The vessel may be provided with anchoring means to the collecting needle.
Obviously, several different equivalents to all these vessel features may be thought of without recourse to further inventive activity, as long as the basic principle of the vessel being able to be traversed by a collection needle whilst keeping its watertightness is upheld.

Claims (16)

ConclusiesConclusions 1. Een biopsiesysteem omvattende een in lijn opvangvat (10) en een opvangnaald.1. A biopsy system comprising an in-line collection vessel (10) and a collection needle. 2. Een biopsiesysteem volgens conclusie 1 waarbij het opvangvat op de opvangnaald is gemonteerd, de opvangnaald beweegt in een rechte lijn door het opvangvat.2. A biopsy system according to claim 1, wherein the collection vessel is mounted on the collection needle, the collection needle moves in a straight line through the collection vessel. 3. Een biopsiesysteem volgens conclusie 2 waarbij het opvangvat een interne holte omvat die is aangepast om een biologisch sample en/ of een vloeistof te ontvangen.3. A biopsy system according to claim 2 wherein the collection vessel comprises an internal cavity adapted to receive a biological sample and/or a fluid. 4. Een biopsiesysteem volgens conclusie 3 waarbij het opvangvat twee perforeerbare afdichtingen (11) omvat, optioneel bevatten de perforeerbare afdichtingen twee vooraf gemaakte openingen.4. A biopsy system according to claim 3 wherein the collection vessel comprises two perforatable seals (11), optionally the perforatable seals comprise two pre-made openings. 5. Een biopsiesysteem volgens conclusie 4 waarbij de opvangnaald een interne naald (12) met een opvangholte (13) en een monolitische (20) of ingekeepte (21) schede omvat, concentrisch met en aan de buitenkant van de interne naald (12).5. A biopsy system according to claim 4 wherein the collection needle comprises an internal needle (12) having a collection lumen (13) and a monolithic (20) or notched (21) sheath concentric with and external to the internal needle (12). 6. Een biopsiesysteem volgens conclusie 5 waarbij de ingekeepte (21) schede een inkeping omvat met een afmeting die niet kleiner dan nodig is om de opvangholte (13) bloot te leggen wanneer deze wordt uitgelijnd met de inkeping en waarin de ingekeepte schede optioneel markingen om de positie van het opvangvat (10) ten opzichte van de inkepingen (22) te bepalen.6. A biopsy system as claimed in claim 5 wherein the notched (21) sheath comprises a notch having a dimension no smaller than necessary to expose the collection cavity (13) when aligned with the notch and wherein the notched sheath optionally includes markings to determine the position of the collection vessel (10) relative to the notches (22). 7. Een biopsiesysteem volgens conclusie 6 waarbij het opvangvat zich bevindt in de kern van een biopsiepistool, geconfigureerd om te kunnen openen en sluiten om het opvangvat in te brengen en te verwijderen.7. A biopsy system as claimed in claim 6 wherein the collection vessel is located in the core of a biopsy gun configured to open and close to insert and remove the collection vessel. 8. Een biopsiesysteem volgens conclusie 7 waarbij de opvangnaald wordt ondersteund door mechanische ondersteuningen gebouwd op het omhulsel van het pistool, de mechanische ondersteuningen in lijn met de opvangvat afdichtingen (11) zijn gebouwd om de opvangnaald door de afdichtingen te geleiden.8. A biopsy system as claimed in claim 7 wherein the collection needle is supported by mechanical supports built onto the gun body, the mechanical supports being built in alignment with the collection barrel seals (11) to guide the collection needle through the seals. 9. Een process voor het bedienen van een biopsiesysteem met een in lijn opvangvat (10) omvattende de stappen:9. A process for operating a biopsy system having an in-line collection vessel (10) comprising the steps of: a. Het verschaffen van een afgesloten opvangvat (10) met twee afdichtingen (11) dat een vloeistof bevat, zoals een celkweekmedium;a. Providing a closed holding vessel (10) having two seals (11) containing a liquid, such as a cell culture medium; b. Het beweegt door de kern van het opvangvat met een opvangnaald welke door de afdichtingen is gestoken;b. It moves through the core of the collection vessel with a collection needle inserted through the seals; c. Het inbrengen van het distale uiteinde van de opvangnaald in een te biopteren dierlijk weefsel;c. Inserting the distal end of the collection needle into an animal tissue to be biopsied; d. Het blootstellen van de opvangholte (13) aan het dierlijk weefsel,d. Exposing the collection cavity (13) to the animal tissue, e. Het snijden van het dierlijk weefsel door een tegengestelde beweging tussen de interne naald en de schede te veroorzaken; f Het terugtrekken van de interne naald totdat de opvangholte zich in het opvangvat bevindt;e. Cutting the animal tissue by causing an opposing movement between the internal needle and the sheath; f. Withdrawing the internal needle until the collecting cavity is in the collecting vessel; g. Het vrijgeven van het sample in het opvangvat;g. Releasing the sample into the collection vessel; h. Het volledig verwijderen van de opvangnaald van het opvangvat zodat de zelfsluitende afdichtingen (11) het opvangvat afsluiten.h. Completely remove the collection needle from the collection vessel so that the self-closing seals (11) close the collection vessel. 10. Een process volgens conclusie 9 waarbij er tussen stappen f) en g) een stap is van het terugtrekken van de monolitische (20) schede en het blootstellen van de opvangholte aan het interne medium van het opvangvat.10. A process according to claim 9 wherein between steps f) and g) there is a step of withdrawing the monolithic (20) sheath and exposing the collection cavity to the internal medium of the collection vessel. 11. Een process volgens conclusie 9 waarbij er tussen stappen b) en c) de inkeping (22) van een ingekeepte schede (21) wordt uitgelijnd todat deze zich in het opvangvat (10) bevindt en tussen stappen f) en g) een stap is van het uitlijnen van de opvangholte met de inkeping (22) van de ingekeepte (21) schede, waardoor de opvangholte wordt blootgesteld aan het interne medium van het opvangvat.A process according to claim 9 wherein between steps b) and c) there is a step of aligning the notch (22) of a notched sheath (21) until it is within the collection vessel (10) and between steps f) and g) there is a step of aligning the collection cavity with the notch (22) of the notched sheath (21), thereby exposing the collection cavity to the internal medium of the collection vessel. 12. Een in lijn opvangvat voor een biologisch sample voor een biopsiesysteem omvattende twee afdichtingen aan weerszijde, waar een biopsieopvangnaald doorheen kan bewegen.12. An in-line biological sample collection vessel for a biopsy system comprising two seals on either side through which a biopsy collection needle can pass. 13. Een vat volgens conclusie 12 waarbij de afdichten een geschroefde of ingeperste plug of membraan omvatten.13. A vessel according to claim 12 wherein the seals comprise a screwed or pressed-in plug or membrane. 14. Een vat volgens conclusie 13 waarbij de plug of membraan optioneel een vooraf gemaakte opening omvat van een afineting die zelfdichting mogelijk maakt.14. A vessel according to claim 13 wherein the plug or membrane optionally comprises a pre-made opening of a size which allows for self-sealing. 15. Een vat volgens conclusie 14 waarbij het vat ondoorzichtig of transparant is, waarbij het vat bij voorkeur is gemaakt van metaal, glas of polymerisch materiaal en waarbij het polymerisch materiaal bij voorkeur is gemaakt van een elastomeer, zoals silicone of polyurethaan rubber.15. A vessel according to claim 14 wherein the vessel is opaque or transparent, preferably the vessel is made of metal, glass or polymeric material and preferably the polymeric material is made of an elastomer, such as silicone or polyurethane rubber. 16. Een vat volgens conclusie 15 waarbij het vat bevestigingsmiddelen omvat aan de opvangnaald, zoals mechanische ankers.16. A vessel according to claim 15 wherein the vessel comprises attachment means to the collection needle, such as mechanical anchors.
NL2034141A 2023-02-14 2023-02-14 Improvements to biopsy devices NL2034141B1 (en)

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