EP4164504A1 - Système d'aiguilles de biopsie - Google Patents

Système d'aiguilles de biopsie

Info

Publication number
EP4164504A1
EP4164504A1 EP21734319.3A EP21734319A EP4164504A1 EP 4164504 A1 EP4164504 A1 EP 4164504A1 EP 21734319 A EP21734319 A EP 21734319A EP 4164504 A1 EP4164504 A1 EP 4164504A1
Authority
EP
European Patent Office
Prior art keywords
biopsy needle
needle device
housing
biopsy
finger grip
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21734319.3A
Other languages
German (de)
English (en)
Inventor
Juan Sebastián SÁNCHEZ LÓPEZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Inline Med GmbH
Original Assignee
Inline Med GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Inline Med GmbH filed Critical Inline Med GmbH
Publication of EP4164504A1 publication Critical patent/EP4164504A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • A61B2017/00438—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping connectable to a finger

Definitions

  • the invention relates to a biopsy needle device having at least one hollow outer needle, an inner needle guided in the outer needle such that it can move longitudinally, and a housing. With such a biopsy needle device, a biopsy can be carried out on a living organism.
  • Such a biopsy needle device is known, for example, from DE 19848513 A1.
  • the invention has for its object to raise a further improved Biopsienadelvor device.
  • the biopsy needle device has at least one manually operable trigger element for triggering a relative movement between the outer needle and the inner needle.
  • the biopsy needle device can be operated by the user through such a release element.
  • the biopsy needle device can be designed as a purely manual biopsy needle device or as a semiautomatic biopsy needle device.
  • the user himself has to manually perform the complete relative movement between the outer needle and the inner needle, as required for performing the biopsy, by means of the manually operable trigger element.
  • the semi-automatic embodiment the user only has to trigger a pretensioned movement mechanism by means of the trigger element and only have to carry out a comparatively small movement himself.
  • the further required relative movement between the outer needle and the needle for performing the biopsy is then automatically carried out by the movement mechanism, for example by a pretensioned Auslbaumfe.
  • the trigger element can accordingly serve in particular to trigger a semiautomatic relative movement between the outer needle and the inner needle.
  • the biopsy needle device has at least one finger grip element for holding and / or for operating the biopsy needle device by means of at least one finger of the user.
  • the finger grip element can in particular be designed as a finger grip element that can only accommodate one finger of a user or that can only be operated by one finger of the user.
  • the finger grip element can be designed in the shape of a ring with an inner recess which is so large that it can accommodate a finger of a user, but is not suitable for accommodating several fingers.
  • the biopsy needle device can also be gripped or held by its housing by the user.
  • the housing itself is not considered a finger grip element in the sense of the present application.
  • the housing can, e.g. on the side, have a notch or indentation that serves as a finger grip element.
  • the inner needle is immovably connected to the trigger element in the longitudinal direction.
  • the trigger element can, for example, be part of a sliding element of the biopsy needle device.
  • the outer needle can be attached to an outer needle holder so that it cannot move in the longitudinal direction.
  • the biopsy needle device has only one finger grip element.
  • the one finger grip element can be present in addition to the trigger element and, for example, be arranged at a distance from the trigger element.
  • the biopsy needle device can be designed to be very compact and small, so that it can be used with little space requirement.
  • One finger grip element can be used, for example, to hold the middle finger of the user.
  • the trigger element can, for example, with the Forefinger operated.
  • the triggering element can be actuated with the user's thumb, which allows the biopsy needle device to be held particularly precisely.
  • the biopsy needle device has one or more finger grip elements which are arranged asymmetrically to a longitudinal axis of the outer needle. This can also improve the operability and ergonomics of the biopsy needle device. In addition, this also enables particularly compact designs of the biopsy needle device.
  • a trigger element can be present in addition to the finger grip elements, or the trigger element can be formed by one or more finger grip elements.
  • the biopsy needle device has at least one finger grip element on the proximal end of the housing.
  • the proximal end of the housing is the end facing the user and accordingly the end of the housing facing away from the patient when the biopsy needle device is used on the patient to perform a biopsy. Accordingly, the distal end of the housing is the end facing the patient.
  • the biopsy needle device has exactly three finger grip elements. In this way, too, the operability of the biopsy needle device can be further improved. In particular, one-handed operability with a three-finger operating technique is supported both during the initial initialization movement and during the triggering movement for performing the biopsy. In the case of a semiautomatic biopsy needle device, the initialization movement is used to pretension the movement mechanism or its release spring.
  • the biopsy needle device has at least one pretensioning control element, by means of which a relative movement between the outer needle and the inner needle can be executed in a tensioning direction against the force of a release spring of the biopsy needle device.
  • the release spring can be a tension spring or a compression spring, depending on the design of the movement mechanism.
  • the release spring can be designed as a spiral spring, torsion spring or other resilient element, e.g. as a block made of an elastic material.
  • the release spring can be a single spring or an arrangement of several Fe countries.
  • the biopsy needle device is designed in such a way that at least one finger grip element or an arrangement of at least two finger grip elements is mounted displaceably in the direction of the longitudinal axis of the outer needle relative to the housing of the biopsy needle device.
  • the displaceable finger grip element or the displaceable arrangement of at least two finger grip elements can be used for improved operation of the biopsy needle device, e.g. as a trigger element and / or as a preload control element.
  • the biopsy needle device can in particular be designed in such a way that the entire length does not increase when the release spring is pretensioned. This is made possible in that the displaceably mounted finger grip element or the displaceably mounted arrangement of at least two finger grip elements can only be displaced within the housing. This also enables operating advantages for the user to be realized.
  • the manually actuatable trigger element can be actuated in an actuation direction which is arranged transversely to the longitudinal axis of the outer needle. In this way, the release movement can take place sideways, so to speak. gen. This also allows different types of operation of the Biopsy needle device.
  • the remote release of the release element means that the user does not have to keep his / her position in the X-ray area.
  • the biopsy needle device can optionally be designed with or without a finger grip element or finger grip elements.
  • a finger-grip element can be completely dispensed with.
  • the biopsy needle device has a guide, e.g. in the housing of the biopsy needle device, in which the release element is guided.
  • a direction of movement of the Ausleriaele element is set transversely to the longitudinal axis of the outer needle during the release process.
  • a right angle between the direction of movement of the trigger element and the longitudinal axis of the outer needle can be set by the guide.
  • the biopsy needle device can have at least one manually actuatable trigger element for triggering a relative movement between the outer needle and the inner needle.
  • At least one finger grip element or an arrangement of at least two finger grip elements can advantageously be designed as such a trigger element at the same time.
  • the aforementioned displaceably mounted finger grip element or the displaceably mounted arrangement of at least two finger grip elements can form such a trigger element.
  • the biopsy needle device can be designed without a separate trigger element, whereby the structure is simplified.
  • the trigger element can also serve as a pretensioning control element, i.e. as a manual operating element for pretensioning the semiautomatic movement mechanism. In this way, the biopsy needle device can be operated with one hand.
  • the trigger element is used to trigger a relative movement between the outer needle and the inner needle that is opposite to the tensioning direction and is brought about by the force of the pretensioned release spring.
  • the inner needle can be designed as a solid needle without an inner cavity.
  • the inner needle can advantageously have a recess shortly before its distal end which serves as a tissue receiving pocket.
  • the biopsy needle device in addition to the preload control element, has a release element for releasing a relative movement between the outer needle and the inner needle caused by the force of the preloaded release spring, opposite to the tensioning direction.
  • a semiautomatic biopsy needle device can be brought into a biased state, in which it can then be triggered by the separate manually operated trigger element to automatically carry out the further required relative movement between the outer needle and the inner needle for carrying out the biopsy removal.
  • the trigger element can in particular be arranged at a distance from the pre-tensioning control element, so that no unintentional actuation occurs.
  • the biopsy needle device can also have more than one trigger element.
  • the biopsy needle device has a holding mechanism through which the biasing control element or a component connected to it when the release spring is pretensioned in at least one holding position, in particular in at least two different holding positions, against the force of the pretensioned Release spring is held.
  • the holding mechanism can be designed as a latching mechanism, for example.
  • one, several or all finger grip elements have a ring shape, wherein the ring shape can be designed as a ring that is completely closed on the circumference or a ring that is open at one point. This allows a finger to be securely received in a finger grip element.
  • the ring shape can be circular, oval or any other ergonomically suitable ring shape. If the biopsy needle device has a plurality of finger grip elements, these can be of identical or different design.
  • the finger grip element can be designed as a notch or indentation on the housing.
  • one, several or all finger grip elements are designed as a separate component that is rigidly or movably coupled to the housing. This simplifies the manufacture of the biopsy needle device. In particular, comparatively simple injection molding tools can be used to manufacture the components.
  • only one finger grip element of the biopsy needle device is arranged on the housing, laterally offset to the longitudinal axis of the outer needle.
  • the finger grip element can in particular be arranged offset to the longitudinal axis of the outer needle on the housing to such an extent that the longitudinal axis does not intersect the only one finger grip element.
  • the distance between the finger grip element arranged at the proximal end of the housing and the distal end of the housing cannot be changed. This allows a particularly ergonomic design of the biopsy needle device for one-handed operation.
  • the housing area of the biopsy needle device has a constant length, which the user can calculate from the outset and which does not change during operation of the biopsy needle device.
  • This is advantageous, for example, when the space for movement of the biopsy needle device is limited, for example in a CT tube.
  • the arranged at the proximal end of the housing fin gergriffelement can be immovably connected to the housing.
  • the finger grip element arranged at the proximal end of the housing can protrude from the housing in a direction pointing away from the distal (near the patient) end of the housing.
  • the distance between the finger grip element arranged at the proximal end of the housing and other finger grip elements of the biopsy needle device in each operating state of the biopsy needle device is at least 2 cm or at least 50% of the housing length of the biopsy needle device.
  • the distance can also be at least 3 cm.
  • the finger grip element arranged at the proximal end of the housing is ergonomically arranged in a particularly pleasant manner compared to the length of the housing.
  • the distance between the distal and the proximal end of the housing is regarded as the housing length.
  • a docking holder for holding an external actuator is arranged on the housing of the biopsy needle device, with which the triggering element can be operated by the user by remote triggering.
  • the external actuator can protect the user of the biopsy needle device, for example during an x-ray examination, from holding his hand in the area of the x-ray radiation to actuate the trigger element. It is thus possible to trigger the release element remotely.
  • the docking holder can in particular allow a form-fitting coupling of the external actuator to the housing of the biopsy needle device (in the sense of “docking”).
  • the invention also relates to a set of a
  • Biopsy needle device having at least one hollow outer needle, an inner needle guided longitudinally movably in the outer needle and a housing, the biopsy needle device having at least one manually actuatable trigger element for triggering a relative movement between the outer needle and the inner needle, and an external actuator with which the user can
  • the trigger element of the biopsy needle device can be operated by remote triggering.
  • the advantages explained above can also be realized in this way.
  • the previously mentioned advantageous remote triggering of the biopsy needle device can be carried out so that the user can be protected from unnecessary radiation exposure during an X-ray examination or other examinations.
  • the external actuator has at least one fastening element with which the external actuator can be fastened to the biopsy needle device in a form-fitting and / or force-fitting manner.
  • the fastening element can be designed as a counterpart to the aforementioned docking bracket.
  • the biopsy needle device can, however, also be designed without a docking bracket.
  • the fastening element of the external actuator can be designed in such a way that it encompasses or overlaps a certain area of the housing of the biopsy needle device. In this way, the user can couple the external actuator to the biopsy needle device with little effort.
  • the external actuator has an actuating plunger for remote actuation of the triggering element of the biopsy needle device.
  • the actuating plunger is longitudinally movable in a direction which runs transversely to the longitudinal axis of the outer needle.
  • the actuating plunger can be longitudinally movable in a direction which is essentially perpendicular to the longitudinal axis of the outer needle. In this way, the biopsy needle device can be triggered from the side, so to speak, by the external actuator or its actuating plunger. This allows space-saving and ergonomic handling of the biopsy needle device with the external actuator attached to it, even in confined spaces, for example in a CT tube.
  • a pistol grip is arranged on one end area of the external actuator. This has the advantage that the pistol grip represents an ergonomically adapted handle for the user, so that the force required is minimized and the precision of the intervention can be increased at the same time. Furthermore, improved grip and stability in the guidance and alignment of the biopsy needle device is achieved.
  • Figure 1 shows the components of a biopsy needle device in a first embodiment in an exploded view
  • FIG. 2 shows the biopsy needle device according to FIG. 1 in side view and FIG. 3 shows a detailed view of the biopsy needle device according to FIG. 2 and FIG. 4 shows a perspective view of a displacement element and FIG. 5 shows a perspective view of an outer needle holder and FIG. 6 shows a side view of a housing part and FIG Figure 6 and Figure 8 the housing part according to Figure 6 in a side view from the opposite side and
  • FIG. 9 shows a sectional view of the housing part according to FIG. 8 in the section plane A-A and drawn therein
  • FIG. 10 shows a side view of a further housing part with a finger grip element shown in perspective
  • FIG. 11 shows a second embodiment of a biopsy needle device in an exploded view
  • FIG. 12 shows a third embodiment of a biopsy needle device in an exploded view
  • FIG. 13 shows the biopsy needle device according to FIG. 12 in a top view and FIG. 14 shows the biopsy needle device according to FIG. 12 in a side view and FIG. 15 shows a housing part of the biopsy needle device according to FIG Representation and
  • FIG. 17 shows a fourth embodiment of a biopsy needle device in an exploded view
  • FIG. 18 shows an embodiment of an external actuator in an exploded view
  • FIG. 19 shows a fifth embodiment of a biopsy needle device in an exploded view
  • FIG. 20 shows a biopsy needle device according to FIG. 19 in a sectional side view.
  • FIG. 1 shows a biopsy needle device with a housing 1, 2, which has two housing parts.
  • the housing parts 1, 2 can be designed, for example, in the shape of a half-shell.
  • the biopsy needle device has only one finger grip element 8, which can be designed as a separate component and is fastened to the housing parts 1, 2.
  • the finger grip element 8 can also be designed as a common component with the housing.
  • the biopsy needle device also has a hollow outer needle 3 and an inner needle 4 guided in a longitudinally movable manner in the outer needle 3.
  • a penetration depth marker 30 is arranged on the outside, by means of which the insertion depth of the outer needle 3 can be read during a biopsy.
  • the inner needle 4 has a tissue window 40 for receiving the Ge tissue sample during a biopsy.
  • the biopsy needle device has an outer needle holder 6, a displacement element 5 and a Release spring 7 on.
  • the outer needle holder 6 is arranged in an elongated interior space 51 of the displacement element 5.
  • the sliding element 5 is arranged within the housing 1, 2 in the area in which the outer needle holder 6 is arranged in the interior space 51.
  • the displacement element 5 protrudes from the housing 1, 2 with a manual operating element, which in this case is designed at the same time as a triggering element 50 and as a pretensioning operating element.
  • the release spring 7 is clamped between the outer needle holder 6 and a spring bearing 19, which serves as a counter bearing fixed to the housing.
  • the spring bearing 19 can be formed on one or on both housing parts 1, 2.
  • the proximal end of the outer needle 3 is firmly connected to the outer needle holder 6, for example there is also glued.
  • the inner needle 4 is guided through an inner flea space of the outer needle 3.
  • FIG. 2 shows the biopsy needle device according to FIG. 1 in the assembled state in a side view. It can be seen that the displacement element 5 with the release element 50 protrudes from the housing 1, 2 at the proximal end 10 of the housing 1, 2.
  • the distal area of the biopsy needle device with the tissue window 40 formed on the inner needle 4 can be seen.
  • This distal region is shown as an enlarged detail B in FIG. 3.
  • the fabric window 40 is designed as an elongated recess, i.e. the cross-sectional area of the inner needle 4 is reduced in this area.
  • FIG. 4 shows the displacement element 5 in an enlarged detailed view. It can be seen that the displacement element 5 has two spaced apart longitudinal struts 52, 53. At the proximal end, the longitudinal struts 52, 53 open into the manual release element 50. At the distal end, the longitudinal struts 52, 53 open into a cross strut 57. In the cross strut 57 there is a through hole that forms an outer needle guide 56 through which the outer needle 3 is slidably passed through. On the trigger element 50 or in the vicinity of the trigger element 50, there may be an opening on the sliding element 5, which serves as an inner needle receptacle 59. The inner needle 4 can be attached to this inner needle receptacle 59.
  • the sliding element 5 serves as a tensioning device for tensioning the semiauto matic movement mechanism of the biopsy needle device.
  • the release element 50 is gripped by the user and pulled out of the housing 1, 2 in the proximal direction, whereby parts of the longitudinal struts 52, 53 emerge from the housing 1, 2 and become visible.
  • the user can observe the cut length markings 54 attached to the displacement element 5, for example on a longitudinal strut 52, and use these cut length markings 54 to choose from one of several pretensioning positions, for example two different pretensioning positions.
  • the outer needle holder 6 arranged in the interior space 51 is carried along by the cross strut 57 and is pressed against the release spring 7, which is fixedly mounted on the spring bearing 19 on the housing.
  • the release spring 7 is compressed in this way and receives a greater preload voltage.
  • a latching release element 55 can also be arranged on the displacement element 5, for example on a longitudinal strut 53. With a release movement of the semiautomatic movement mechanism, the locking of the outer needle holder 6 that was previously carried out during tensioning can be released by the locking release element 55.
  • the manual operating element of the displacement element 5 serves as a pretensioning operating element during tensioning and then as a manually operable trigger element 50 when triggered.
  • FIG. 5 shows the outer needle holder 6 in an enlarged view.
  • the reconnectenna delhalter 6 is guided in the housing 1, 2 in linear guide elements.
  • the outer needle holder 6 has its own guide element 62, which is guided in at least one linear guide element of the housing 1, 2.
  • the outer needle holder 6 has a receiving opening which forms an outer needle seat 60 for receiving and fastening the outer needle 3.
  • at least one first latching element 61 is arranged on the outer needle holder 6.
  • there are two first latching elements 61 which correspond to two different latching positions during the pretensioning movement according to the cut length markings 54.
  • FIG. 6 shows the first housing part 1 in a side view.
  • a second latching element 12 is also arranged on the housing part 1, for example in the form of an elastically deflectable latching tab, which can be implemented, for example, by making a U-shaped cutout on the housing part 1 in which the latching tab is formed as the remaining material.
  • the second Ras telement 12 cooperates with the first locking elements 61 of the outer needle holder 6 for fixing the outer needle holder 6 in the desired locking positions.
  • FIG. 7 shows the first housing part 1 in a front view, i.e. in a plan view of the distal end of the housing 1, 2.
  • FIG. 8 shows the first housing part 1 from the opposite side compared to FIG. 6, i.e. looking towards the inside.
  • the second latching element 12 can be seen again, at the free end of which a latching contour 13 is formed.
  • the locking contour 13 interacts with the first Ras tiatan 61 of the outer needle holder 6 to form a locking.
  • the first latching element 61 is described as a rigid part on the outer needle holder 6, and the second latching element 12 as an elastically deflectable part.
  • the assignment can also be reversed, i.e. the first latching element 61 can be elastically deflectable and the second latching element 12 can be arranged rigidly.
  • the first and the second latching element 12, 61 can also each be elastically deflectable.
  • the latching contour 13 is shown and described in the exemplary embodiments as a latching projection.
  • the latching contour 13 can also be designed differently, e.g. as a latching recess, latching recess or some type of latching edge.
  • receiving elements 15 in which receiving pins of the finger grip element 8 can be received in order to connect it to the housing parts 1, 2 in a form-fitting manner.
  • FIG. 10 illustrates the attachment of the finger grip element 8 to the housing parts, here using the example of the housing part 2 shown in a side view.
  • the housing part 2 also has the receiving elements 15.
  • the finger grip element 8 has an annular finger receptacle 80 with an inner recess 81.
  • the inner recess 81 is dimensioned such that only one finger of a user can be placed there.
  • the finger grip element On the side facing the connection point 14, the finger grip element has receiving pins 82 which are designed for insertion into the receiving elements 15 of the housing parts 1, 2.
  • the biopsy needle device can be used as follows. First, the biopsy needle device is to be pretensioned in one of the pretensioning positions 1 or 2 according to the cutting length markings 54 by pulling out the sliding element 5 on the manual control element, i.e. on the release element 50. Here, one of the first latching elements 61 latches with the second latching element 12. If the tissue sample is to be removed as part of the biopsy, the triggering element 50 is pressed manually. As a result, the displacement element 5 is already displaced somewhat in the distal direction. Here, the second latching element 12 is slightly deflected by the latching release element 55, as a result of which the latching of the latching contour 13 with the first latching element 61 of the outer needle holder 6 is released.
  • the outer needle holder 6 Due to the release of this latching, the outer needle holder 6 is automatically moved further in the distal direction by the release spring 7 from this point in time. In this way, the outer needle 3 is pushed over the area of the tissue window 40 of the inner needle 4. In this case, the desired tissue sample is separated by the outer needle 3 and stored in the area of the Ge tissue window 40 that is then located within the outer needle 3. The biopsy needle device can then be removed from the patient.
  • FIG. 11 shows an embodiment of a biopsy needle device in which the housing parts 1, 2, the outer needle 3, the inner needle 4, the displacement element 5, the outer needle holder 6 and the release spring 7 are essentially the same as the biopsy needle device described above with reference to FIGS can be formed.
  • further elements are provided which enable an external, that is to say a spaced-apart, triggering of the pretensioned biopsy needle device by means of an external actuator 9.
  • the biopsy needle device can optionally be designed with or without a finger grip element.
  • a docking bracket 16 is formed on the housing 1, 2 and is designed to hold the external actuator 9.
  • the external actuator 9 has fastening elements 90 with which it can be fastened to the docking bracket 16, for example in a form-fitting manner.
  • a second trigger element 27 can be arranged within the docking holder 16, which is mounted displaceably in a direction transverse to the longitudinal axis of the outer needle 3. By applying a compressive force to the end of the second trigger element 27 remote from the slide element 5, the slide element 5 can be moved by means of the second trigger element 27 in the same distal direction as by direct manual pressure actuation of the trigger element 50 of the slide element 5 27 can be actuated remotely, an actuating plunger 92 is guided through the actuator 9.
  • the actuating plunger 92 can be actuated manually at an end region 91 of the external actuator 9, at which the latter can also be held manually by the user.
  • a bevel can be formed on the second trigger element 27, similar to a ramp, which enables the direction of movement to be implemented.
  • FIG. 12 shows a further embodiment of a biopsy needle device in an exploded view.
  • the biopsy needle device has a housing 1, 2 with a first housing part 1 and a second housing part 2.
  • a finger grip element 8 which is immovably connected to the housing 1, 2, is arranged at the proximal end 10.
  • the finger grip element 8 can, for example, be integrally formed on one or both of the housing parts 1, 2.
  • the biopsy needle device also has a semi-automatic movement mechanism, which is largely in terms of structure and functionality corresponds to the previously described movement mechanism of the othermonysfor men.
  • a displacement element 5 an outer needle holder 6 and a release spring 7, of course also the outer needle 3 and the inner needle 4.
  • the outer needle holder 6 is used to hold the outer needle 3, which is immovably fixed thereon.
  • the outer needle holder 6 is in turn guided with at least a partial area in an interior space 51 of the displacement element 5.
  • the release spring 7 is in turn clamped between the outer needle holder 6 and a spring bearing 19 fixed to the housing.
  • the displacement element 5 cannot be operated manually by the user at the proximal end of the biopsy needle device, but on the side of the housing 1, 2.
  • a or two finger grip elements 58 formed on or connected to it.
  • the side finger grip elements 58 protrude laterally from the housing 1, 2 when the components are assembled.
  • the sliding element 5 is only moved back and forth in the region of the longitudinal extent of the housing 1, 2, but it does not protrude with different dimensions at the proximal end of the housing 1, 2 depending on the preload position, as in the case of the previous ones described embodiments. In this way, the total length of the housing area of the biopsy needle device always remains the same during use, regardless of the clamping state.
  • the biopsy needle device explained with reference to FIG. 12 is additionally shown in FIG. 13 in a top view and in FIG. 14 in a side view.
  • FIG. 13 it can be seen that here, too, different pretensioning positions, which can be read from the cutting length markings 20, can be set.
  • the cut length markings 20 can be placed on one of the housing parts 1, 2, for example.
  • the finger grip element 8 in turn has an annular finger receptacle 80 with an inner recess 81.
  • the inner recess 81 is dimensioned in such a way that only one finger of a user can be accommodated in it.
  • the biopsy needle device is constructed in a manner comparable to that of the embodiments described with reference to FIGS.
  • FIG. 15 illustrates the structure of the displacement element 5 with its manual operating area with the finger grip elements 58 which, in combination, form a trigger element 50 and a pretensioning operating element.
  • the finger grip elements 58 can be designed in a manner comparable to that of the finger grip element 8 in terms of design and dimensions.
  • This interior space 51 is surrounded by longitudinal struts 52, 53 which are connected by a cross strut 57 at the distal end.
  • the cross strut 57 has an outer needle guide 56 for passing the outer needle 3 through.
  • the spring bearing 19 fixed to the housing for the triggering spring 7 can be seen.
  • the longitudinal struts 52, 53 are guided past the spring bearing 19 laterally.
  • the housing part 1 has a second latching element 12, for example an elastically deflectable latching tab, on which a latching contour 13, for example a latching projection, is arranged.
  • the locking contour 13 is used to lock the outer needle holder 6 in the respective desired locking position.
  • a detent release element 55 is arranged on the sliding element 5, for example on one or both longitudinal struts 52, 53, which comes into contact with a release contour 18 of the second detent element 12 during a release process and thereby deflects the second detent element 12 downward and in this way engages the latching contour 13 with first latching elements 61 of the outer needle holder 6 releases.
  • the detent release element 55 can be located on the sliding element 5 at the very rear, below each side of the outer needle receptacle 59.
  • FIG. 16 shows the outer needle holder 6 in a view in which its first ras tiata 61 can be seen. In this case, these are formed on an extended loading area on the underside so that they can come into contact with the latching contour 13 on the housing part 1.
  • the outer needle holder 6 has a longitudinal guide or two guide element 62 which is guided in the longitudinal strut 53 of the sliding element 5 / are.
  • the function and operation of the biopsy needle device in this embodiment largely corresponds to the type of operation already described above.
  • the clamping process takes place here via the manual operating area facing the finger grip elements 58, i.e. a different type of gripping and finger holding is possible than in the first embodiment.
  • the biopsy needle device described here can be gripped with three fingers and operated with one hand in this way, both during pretensioning and during the triggering movement.
  • the finger grip elements 58 thus also serve as a trigger element 50 for triggering the movement of the outer needle 3 with respect to the inner needle 4 supported by the trigger spring.
  • FIG. 17 shows an embodiment of a biopsy needle device and an external actuator 9 which is used to remotely trigger the trigger element 50 of the biopsy needle device.
  • the biopsy needle device according to FIG. 17, in contrast to the embodiment of FIG. 11, for example, does not have a docking holder 16 for docking the external actuator 9.
  • the external actuator 9 is designed by its fastening element 90 so that it is still, for example, by a form fit and / or force fit at the proximal end 10 of the housing 1,
  • the external actuator 9 with the fastening element 90 can simply be slipped over the proximal end 10 of the biopsy needle device.
  • the biopsy needle device must first be pre-tensioned into a desired pre-tensioned position.
  • the triggering element 50 is then triggered, similar to the embodiment of FIG. 11, by an actuating plunger 92 which can be moved at the end of the external actuator (by pressing).
  • the actuating plunger 92 acts mechanically directly on the release element 50.
  • no separate second trigger element 27 is required.
  • the biopsy needle device according to FIG. 17 can be designed in a manner comparable to one of the biopsy needle devices as described above.
  • FIG. 17 A further special feature of the biopsy needle device is shown in FIG. 17, namely the embodiment of a finger grip element 8 as a notch or indentation arranged on the side of the housing 1, 2. This is also advantageous for ergonomic operability of the biopsy needle device.
  • FIG. 18 shows an embodiment of an external actuator 9 in an exploded view.
  • the external actuator 9 according to FIG. 18 has a fastening element 90, it being possible for the external actuator 9 to be fastened to the proximal end of a housing of a biopsy needle device, as described above, by a form fit and / or force fit.
  • the external actuator 9 has a pistol grip in its end region 91, the actuating plunger 92 being effected by advancing the external actuator 9.
  • the actuating tappet 91 can be actuated manually, for example by pressing.
  • the pistol grip has the advantage that it represents an ergonomically adapted fland grip for the user, so that the force to be used can be minimized and the precision of the intervention can be increased at the same time. Furthermore, an improved grip and stability in the guidance and alignment of the biopsy needle device is achieved.
  • the pistol grip is arranged laterally on the end region 91 of the external actuator 9. But it is also conceivable that the pistol handle is arranged from above or below.
  • the external actuator 9 according to FIG. 18 can be designed in a manner comparable to one of the external actuators 9, as described above.
  • FIG. 19 shows an embodiment of a biopsy needle device in an exploded view.
  • the first latching elements 61 are therefore no longer accessible from the outside, the housing parts 1, 2 being formed in themselves closed off in the assembled state.
  • the second latching elements 12 can be designed, for example, as elastically deflectable webs, the second latching elements 12 interacting with the first latching elements 61 of the outer needle holder 6 to fix the outer needle holder 6 in the desired latching positions.
  • FIG. 20 shows the biopsy needle device according to FIG. 19 in a sectional side view. It becomes clear that there are two second latching elements 12 in the illustrated embodiment, which are arranged on opposite sides of the housing parts 1, 2. These two second latching elements 12 are arranged at different positions in the longitudinal direction of the housing parts 1, 2, so that the outer needle holder 6 can be fixed in two different positions by at least one of the first latching elements 61 latching with the corresponding second latching element 12.
  • the two second latching elements 12 are only arranged on one of the housing parts 1, 2 at different positions in the direction of longitudinal extension of the corresponding housing part 1, 2.
  • housing parts 1, 2 are closed in the assembled state. This means that the second latching elements 12 are no longer accessible from the outside. In this way, external influences on the latching can be reduced or avoided.
  • biopsy needle device according to FIGS. 19 and 20 can be designed in a manner comparable to one of the biopsy needle devices as described above. List of reference symbols

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système d'aiguilles de biopsie comprenant au moins une aiguille externe creuse (3), une aiguille interne (4) guidée de manière mobile longitudinalement dans l'aiguille externe (3) et une enveloppe (1, 2). Un tel système d'aiguilles de biopsie apporte une meilleure ergonomie pour la réalisation d'une biopsie sur un être vivant.
EP21734319.3A 2020-06-16 2021-06-16 Système d'aiguilles de biopsie Pending EP4164504A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020115846.7A DE102020115846A1 (de) 2020-06-16 2020-06-16 Biopsienadelvorrichtung
PCT/EP2021/066194 WO2021255072A1 (fr) 2020-06-16 2021-06-16 Système d'aiguilles de biopsie

Publications (1)

Publication Number Publication Date
EP4164504A1 true EP4164504A1 (fr) 2023-04-19

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Application Number Title Priority Date Filing Date
EP21734319.3A Pending EP4164504A1 (fr) 2020-06-16 2021-06-16 Système d'aiguilles de biopsie

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US (1) US20230218279A1 (fr)
EP (1) EP4164504A1 (fr)
JP (1) JP2023531626A (fr)
DE (1) DE102020115846A1 (fr)
WO (1) WO2021255072A1 (fr)

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4776346A (en) 1984-02-10 1988-10-11 Dan Beraha Biopsy instrument
US5611352A (en) 1995-09-14 1997-03-18 Kobren; Myles S. Cervical biopsy device
CA2275249C (fr) 1997-01-30 2004-03-23 Boston Scientific Corporation Dispositif pneumatique d'echantillonnage de tissus
DE19848513A1 (de) 1998-10-21 2000-08-10 Daum Gmbh Biopsiegunsystem
EP1889572A3 (fr) * 2003-05-30 2008-06-18 William R. Krause Biopsie et dispositif d'administration
US8192369B2 (en) * 2008-05-30 2012-06-05 Inrad, Inc. Apparatus for cocking a biopsy device
US8162850B2 (en) * 2008-12-16 2012-04-24 Devicor Medical Products, Inc. Hand actuated tetherless biopsy device with scissors grip
US8517955B2 (en) 2009-05-08 2013-08-27 Broncus Medical Inc. Tissue sampling devices, systems and methods
US20110004121A1 (en) 2009-05-28 2011-01-06 Angiotech Pharmaceuticals Inc. Biopsy device handle
US9968337B2 (en) 2010-12-20 2018-05-15 Cook Medical Technologies Llc Coring tissue biopsy needle and method of use
US9668718B2 (en) * 2011-06-03 2017-06-06 Theragenics Corporation Methods and apparatus for tissue removal
US8882681B2 (en) 2011-06-29 2014-11-11 Cook Medical Technologies Llc Through-cradle soft tissue biopsy device
US20130023790A1 (en) * 2011-07-19 2013-01-24 Schaeffer Jeremy R Biopsy device
US11793498B2 (en) 2017-05-19 2023-10-24 Merit Medical Systems, Inc. Biopsy needle devices and methods of use

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JP2023531626A (ja) 2023-07-25
US20230218279A1 (en) 2023-07-13
DE102020115846A1 (de) 2021-12-16
WO2021255072A1 (fr) 2021-12-23

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