WO2018169658A1 - Aiguille pneumatique de biopsie de tissu mou à insertion droite, sans feu frontal et à faible bruit - Google Patents

Aiguille pneumatique de biopsie de tissu mou à insertion droite, sans feu frontal et à faible bruit Download PDF

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Publication number
WO2018169658A1
WO2018169658A1 PCT/US2018/019117 US2018019117W WO2018169658A1 WO 2018169658 A1 WO2018169658 A1 WO 2018169658A1 US 2018019117 W US2018019117 W US 2018019117W WO 2018169658 A1 WO2018169658 A1 WO 2018169658A1
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WO
WIPO (PCT)
Prior art keywords
stylet
barrel
needle
point
biopsy
Prior art date
Application number
PCT/US2018/019117
Other languages
English (en)
Inventor
Dan Stoianovici
Changhan JUN
Doru Petrisor
Misop Han
Original Assignee
The Johns Hopkins University
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 The Johns Hopkins University filed Critical The Johns Hopkins University
Priority to US16/487,236 priority Critical patent/US20210128122A1/en
Publication of WO2018169658A1 publication Critical patent/WO2018169658A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B10/02Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0208Biopsy devices with actuators, e.g. with triggered spring mechanisms

Definitions

  • the present invention relates generally to medical devices. More particularly, the present invention relates to a straight-insertion, forward-less fire, low noise, pneumatic soft tissue biopsy needle.
  • Soft tissue (core) biopsy is a widely used procedure to diagnose various histopathologic conditions that provides tissue samples for examination.
  • Numerous biopsy needles are available commercially. Commonly, biopsy needles are trocar needles with a stylet and a barrel. With few exceptions, these present similar geometry of the needle point, sample loading magazine, and sampling motion sequence. Their performance is commonly less than ideal in several respects, regardless of the manufacturer.
  • a biopsy needle or device commonly includes the needle itself and a needle driver (biopsy firing mechanism, a "gun”).
  • the needle is typically a trocar type needle with an inner stylet and an outer barrel (cannula).
  • FIGS. 1A and IB illustrate needle point geometry and insertion path for a common biopsy needle.
  • FIG. 1A illustrates an asymmetric point and insertion path deflected by rudder effect and
  • FIG. IB illustrates a symmetric point with straighter path.
  • FIGS. 2A-2D illustrate a typical biopsy motion sequence of asymmetric point needles.
  • the firing mechanism is typically spring actuated and manually loaded. Starting with a loaded needle, the following steps are:
  • the needle (stylet and barrel together) is inserted (under various imaging modalities) towards the desired biopsy target.
  • the insertion is stopped short of the target, as shown in FIG. 2A.
  • the distance short of target is typically large, ideally equal to the distance from the center of the magazine slot to the point of the stylet.
  • the stylet bevel plays a critical role in the sample collection mechanism.
  • the forward motion of the barrel in Step 2 plays a role that is just as critical. It is both the bevel and the forward motion that make the point dive. With no forward motion the curvature under the magazine slot would not exist, deteriorating sample loading. As such, most common biopsy needles not only have a bevel point but also forward motion.
  • Step 1 the initial needle insertion (Step 1) must be short of the target. This distance is a known parameter of the needle and the physician can normally account for it. Moreover, most needles do this, so most physicians are used to it. However, while this is combined with the defected insertion path and further dive of the stylet, targeting is difficult.
  • the forward motion of the stylet and barrel are functional requirements of the typical biopsy needles and most needles fire forward.
  • the insertion in FIG. 2B is performed manually. With this, the advancement is actively controlled by the physician and may be monitored, therefore is not less safe than the insertion in FIG. 2A. But with Dual-Fire guns this is a rapid (fire) spring unloading motion. Firing takes a few milliseconds, and could not be stopped in case of an error. If the target is near critical anatomical structures and the Forward-Fire Distance, as illustrated in FIGS. 2A-2D, is misjudged the forward motion may hit the structure. Moreover, if the needle hits a stiff er structure (bone) the point of the needle may bend. This may prevent the stylet from being retracted back into the barrel making the entire needle difficult to retract from the tissues.
  • FIG. 2A illustrates a cross sectional thickness of the sample magazine slot. Therefore, t should be sufficiently large to provide the structural support of the point during insertion.
  • the length of the biopsy slot could also be increased.
  • Core biopsy guns are notoriously noisy when fired, with a typical snapping sound level in excess of lOOdB. This causes patient pain, anxiety, elevated stress and blood pressure levels in patients, and patient motion at biopsy. Studies have shown that the use of noise- canceling headphones and listening to soothing music could make the biopsy experience less painful, and pointed out the need for less noisy biopsy guns.
  • core biopsy guns are spring loaded. When the spring mechanism is released from an original preload, the stylet and/or barrel reach high speeds (on the order of 5 [m/s]) and are quickly stopped into a stopper. The impact at the end of stroke accounts for a predominant part of the firing noise. The use of softer stopper materials provides slight improvement. Manufacturers have not yet found effective ways to substantially reduce or muffle the noise.
  • a biopsy needle that has a straighter insertion path no forward fire, lower noise, and is pneumatic power assisted so that it can be operated with one hand. These features may improve biopsy targeting, provide safer operation for the patient and personnel, reduce patient discomfort, and respectively make optional the help of an assistant at biopsy.
  • a device for biopsy includes a needle assembly having a longitudinal axis, proximal end and a distal end.
  • the device includes a stylet wherein the stylet comprises a point at the distal end, and a magazine for loading the biopsy sample, wherein the magazine has a structurally curved shape.
  • the device includes a barrel, having a proximal end and a distal end, and wherein the barrel can move over the stylet.
  • the device also includes a firing sequence comprising motion of the barrel and the stylet that slices and collects the biopsy sample.
  • the magazine has a striated surface.
  • the distal end of the needle is bent back in an opposite direction of the structurally curved shape of the magazine, such that the distal end of the needle is oriented straight along the longitudinal axis of the needle when the distal end of the barrel is near the stylet point.
  • the barrel and stylet have bevel points.
  • the firing sequence does not advance any needle components past the distal end of the needle.
  • the barrel and stylet rotate relatively to orient the point of the stylet straight along the longitudinal axis of the needle. At least a portion of the stylet point is encased within the barrel at a time of needle insertion.
  • the firing sequence includes retracting the barrel relative to the stylet and then readvancing it.
  • the barrel has a 4- facet sharp point.
  • the stylet has a symmetric point.
  • the stylet can also have a slightly asymmetric point on an opposite side of the barrel point sharpening direction.
  • a device for biopsy includes a needle assembly having a longitudinal axis, proximal end and a distal end.
  • the device includes a stylet, wherein the stylet includes a point at the distal end.
  • the device includes a barrel, having a proximal end and a distal end. The barrel can move relative to the stylet.
  • the device includes a firing mechanism having the relative motion of the barrel and the stylet that slices and collects the biopsy sample. The firing mechanism is configured to reduce firing noise.
  • the stylet includes a magazine with a structurally curved shape.
  • the stylet can have a magazine with a striated surface.
  • the firing mechanism can have a dual action spring, a pneumatic damper, or a pneumatic actuation.
  • the dual action spring can have a compression spring with fixed ends.
  • the pneumatic damper is configured to reduce firing noise.
  • Pneumatic power is provided by a tether connection.
  • the barrel and stylet are mounted on a lateral side of the firing mechanism.
  • FIGS. 1A and IB illustrate needle point geometry and insertion path for a common biopsy needle.
  • FIGS. 2A-2D illustrate typical biopsy motion sequence of asymmetric point needles.
  • FIG. 3 illustrates a cross sectional thickness of the sample magazine slot.
  • FIG. 4 illustrates a side sectional view of a pneumatic biopsy device, according to an embodiment of the present invention.
  • FIG. 5 illustrates a side view of a structural curvature of the magazine slot and back curvature of the symmetric point of the stylet, according to an embodiment of the present invention.
  • FIG. 6A illustrates a side view of a stylet point that is misaligned.
  • FIG. 6B illustrates a side view of a stylet with the point lined up by rotating the barrel with 180°, according to an embodiment of the present invention.
  • FIGS. 7A-7D illustrate a biopsy motion sequence, according to an embodiment of the present invention.
  • FIGS.8A-8C illustrate side and top down views of point geometry and striation of the magazine slot, according to an embodiment of the present invention.
  • FIG. 9 illustrates a side view of a compression and extension spring, according to an embodiment of the present invention.
  • FIGS. lOA-lOC illustrate perspective views of dual action springs. Dual action springs are normally “machined” springs, due to their manufacturing type, according to an embodiment of the present invention.
  • FIGS. 11 A and 1 IB illustrate side views of the pneumatic stopper at the end-of- stroke and the needle in the loaded and fired positions, respectively, according to an embodiment of the present invention.
  • FIGS. 12A-12G illustrate side sectional views of the pneumatic driver and steps of operation, according to an embodiment of the present invention.
  • FIGS. 13A-13C illustrate perspective and side views of the needle biopsy device of the present invention.
  • An embodiment in accordance with the present invention provides a new biopsy needle that may address several problems identified with currently available biopsy needles.
  • the new needle has a straighter insertion path, no forward fire, lower noise, and is pneumatic power-assisted so that it can be operated with one hand.
  • FIG. 4 illustrates a side sectional view of a pneumatic biopsy device according to an embodiment of the present invention.
  • the device 10 includes a needle assembly 12.
  • the needle assembly includes a barrel 14 of the needle assembly and a stylet 16.
  • the stylet 16 is disposed within the barrel 14 of the needle assembly 12.
  • the stylet 16 includes a structurally curved, striated magazine 18 adjacent to its distal end, as illustrated in FIG. 4.
  • the device also includes a body 20, disposed at a proximal end of the needle assembly 12.
  • the body 20 includes a cylindrical housing 22. Inside the cylindrical housing 22 is disposed a piston 24 that actuates a rod 26, that is coupled to the needle assembly 12.
  • the piston 24 is further coupled to a spring 28 and a latch 30 used to actuate the piston 24.
  • the latch 30 is controlled by a button 32.
  • the body 20 also includes a valve 34, pilot 36, and vent 38.
  • a port 40 is also included.
  • the needle design of the present invention includes several novel features which were derived to circumvent the effects that cause operational problems in typical needles, as follows.
  • the curvature of the magazine slot 42 is a critical component of the sample collection mechanism. In the classic design this is achieved at biopsy due to the rudder effect of the asymmetric point of the stylet 16 and its forward motion. But both have side effects.
  • a simple way to circumvent the problem is to make the curvature with a structural bend, as shown in FIG. 5.
  • FIG. 5 illustrates a side view of a structural curvature of the magazine slot and back curvature of the symmetric point of the stylet.
  • the size of the curvature (Ri, ai) depends on multiple factors including the material of the stylet 16, its diameter (d), the thickness (f) of the magazine 18, length of the slot 42, dynamics of biopsy triggering mechanism (gun), targeted types of tissues. Optimal values are determined experimentally based on tissue sampling tests.
  • FIG. 6A illustrates a side view of a stylet point that is misaligned.
  • FIG. 6B illustrates a side view of a stylet with the point lined up by rotating the barrel with 180°. If the length (p) of the point 44 of the stylet 16 in front of the magazine is large, this is sufficiently encased by the barrel 14 when the barrel 14 is advanced over the stylet 16.
  • the length (p) of the point 44 should be maintained as low as possible in order to minimize the overall depth of insertion to target. While (p) is reduced, the point 44 becomes less constrained within the barrel 14, especially if the barrel 14 is sharpened on the opposite side, and the point 44 is not fully aligned, as shown in FIG. 6A. In this case, the back curvature is helpful to align the point 44 of the stylet 16.
  • the size of the back curvature (R2, ai) depends on the point length (p), the geometry of the barrel sharpening, material properties, and the relative location of the stylet and barrel in the fired configuration. Their values are determined experimentally, as small as needed to align the point 44 within the barrel 14.
  • An alternative option is to rotate the barrel 14 (or stylet 16) 180° at the time of needle insertion, so that the longer part of the barrel sharpening straightens the point 44, as shown in FIG. 6B.
  • the rotation would have to be restored at the time of biopsy sampling, so that the barrel point is oriented on the side of the stylet magazine. This option, however, complicates the firing mechanism with the additional rotation.
  • the structural curve of the magazine is straightened up by the barrel advanced over the stylet.
  • the overall shape remains virtually straight since the barrel is substantially stiffer than the small cross section of the stylet at the magazine.
  • the barrel may be structurally curved in the opposite direction, so that the resulting shape is straight.
  • the asymmetric point of the stylet plays a critical role in the classic mechanism of sample collection. Even though this detrimentally curves the path of needle insertion, the point could not be sharpened symmetrically because of the resulting loss of sample size. However, with the new structurally curved magazine, the point may now be sharpened symmetrically, because this uses a different mechanism of sample collection.
  • FIGS. 7A-7D An additional benefit of the structurally curved magazine is that the forward motion of the stylet is no longer required. As shown above, this has been associated with several targeting, safety, and quality problems which may now be corrected.
  • the new biopsy motion sequence associated with the present invention is presented in FIGS. 7A-7D.
  • FIGS. 7A-7D The new biopsy motion sequence associated with the present invention is presented in FIGS. 7A-7D.
  • FIG. 7A-7D illustrate a biopsy motion sequence according to an embodiment of the present invention. This includes the same number but different steps, as follows: 1) The needle 12 (stylet 16 and barrel 14) is inserted all the way to the target 46, so that the target 46 is centered on the magazine slot 42, as shown in FIG. 7A.
  • imaging may now be used to verify targeting, unlike in the classic sequence.
  • the barrel 14 is then retracted exposing the magazine slot 42 (FIG. 7B).
  • the magazine slot 42 bends due to its structural curvature. The degree of bend is in balance with the stiffness of the surrounding tissues. It is interesting to observe that the bend does not necessarily deteriorate targeting, since the target 46 may be displaced by the bend, so that it remains at the magazine slot 42.
  • FIGS. 8A-8C Detail images of the needle point are presented in FIGS. 8A-8C.
  • FIGS.8A-8C illustrate side and top down views of point geometry and striation of the magazine slot.
  • the barrel 14 is fired over the stationary stylet 16.
  • a position during this motion is presented in FIG. 8A.
  • the point 48 of the barrel 14 is oriented on the opposite side of the curvature of the stylet 16.
  • the two create an opening into the cavity of the magazine slot 42 within the barrel 14 that is large relative to the cavity. This large "bite” helps loading the biopsy sample.
  • a series of grooves 50 are also made on the bottom side of the magazine slot 42, as shown in FIG. 8A. These help retain the sample within the magazine slot 42 and fixing it during the slicing motion of the barrel 14, therefore improving sample slicing and loading.
  • the fired position of the needle is shown in FIG. 8B.
  • FIG. 8C An isometric and 2 projection views of the point 48 of the barrel 14 are shown in FIG. 8C.
  • the geometry includes 3 sharpening angles, ui, , and U3 that render 4 facets.
  • Typical barrels have a single slanted surface, a bevel point, such the angle ui alone.
  • the second angle 112 helps reduces the length of the barrel sharpening that in turn reduces the point of the needle in front of the slot (size p in FIG. 5). This creates a longer support of the stylet point within the barrel, as shown in FIG. 8B, and, in addition to the back curvature (R2, a.2 in FIG. 5) helps aligning the needle point.
  • the additional advantage of the angle 112 sharpening is that it allows angle ui to be small (sharp) within a relatively short needle point.
  • the additional bilateral point angle 113 sharpens the point of the barrel further, and is especially useful when ui is small.
  • the stylet point is normally sharpened symmetrically about its axis. This may be done with a classic 3 facet, diamond geometry. The geometry of the stylet point may be slightly offset to compensate the rudder effect of the barrel point geometry, if needed. The stylet may then be sharpened slightly asymmetrically, with a larger facet on the opposite side of the barrel bevel to balance the resulting rudder effect. Note that this solution would not be viable for the classic bevel forward-fire needle because it would still deteriorate sampling, as previously discussed.
  • the length of the magazine slot is not specifically set. With the new motion the stylet is not inserted alone. As shown above, because the stylet is supported by the barrel during insertion, the thickness of the stylet under the magazine (t) may therefore be safely reduced and the length of the magazine may be increased.
  • Biopsy guns typically use compression only springs. The ends of the spring are not fixed to parts of the gun and the spring remains in a compression state (shorter than its free length) throughout all biopsy steps.
  • the spring of the present invention is a compression and extension spring. Its ends are attached to the base (normally fixed relative to the body of the needle device) and the barrel, as shown in FIG. 9.
  • FIG. 9 illustrates a side view of a compression and extension spring, according to an embodiment of the present invention.
  • the stylet 16 is also attached to the base 52. The lengths of the stylet, barrel, and spring are so that when the spring 54 is at the equilibrium position (free length, unstretched), the barrel 14 fully closes the magazine slot 42 and its point 48 is properly located under the point 44 of the stylet 16. This equilibrium position represents the fired position of the barrel. A coordinate axis x originated at this location is used for the barrel displacement.
  • FIGS. lOA-lOC illustrate perspective views of dual action springs. Dual action springs are normally “machined” springs, due to their manufacturing type. Their ends are made so that they can be fixed to other components, as shown in FIG. 10A (one end side).
  • FIGS. 11 A and 1 IB illustrate side views of the pneumatic stopper at the end-of-stroke and the needle in the loaded and fired positions, respectively.
  • a pneumatic piston is attached to the barrel end, that is in fact is the spring-end part.
  • the piston is placed within a cylinder that is fixed on the needle base.
  • the spring 54 is loaded as shown in FIG. 11 A. When released, the spring quickly accelerates the piston-barrel assembly. The air in front of the piston 24 is released to the atmosphere through the vent 38.
  • the vent 38 has a large cross section so that the air does not substantially impede the motion of the piston 24.
  • Pneumatic actuation for loading the spring is a logical choice since the stopper is also pneumatic.
  • the piston and cylinder are readily available.
  • preloading the spring can be done simply by pressurizing the cylinder through the air vent port. This was realized with a piloted valve mechanism, so that the port has a relatively large size, and is either pressurized or opened to the atmosphere.
  • a command lever and a latch mechanism are also use to command the needle respectively retain the preload of the spring.
  • FIGS. 12A-12G illustrate side sectional views of the pneumatic driver and steps of operation, according to an embodiment of the present invention.
  • the overall needle design and the stages of the loading-firing sequence are represented in FIGS. 12 A-12G, as follows: ) LOADED POSITION:
  • FIG. 12A shows the needle in the spring loaded configuration, ready to fire.
  • the barrel is retracted to uncover the sample magazine of the stylet, which is now curved.
  • the stylet is fixed to the base.
  • the barrel is connected to the piston, which is made within a spring-end part.
  • the piston is locked at the compressed spring location by a latch mechanism.
  • the other spring-end is fixed to the base.
  • Firing the barrel is accomplished by pressing the button forward, as shown in FIG.
  • FIRED POSITION The piston bounces back releasing the energy pneumatically over the vent, and soon stops near the zero position, as shown in FIG. 12D. This is the fired, relaxed spring position of the mechanism. Here, the button is relaxed to its central, neutral position.
  • Reloading the spring is performed by pressing the button backwards, as shown in
  • FIG. 12E The lever now raises a valve that allows compressed air to enter the pilot cylinder and pushing the pilot to the right. This closes the air vent, and continues in front of the main piston, causing it to reload the spring. 6)
  • the piston lifts the latch as shown in FIG. 12F.
  • the piston continues to move and the latch is pushed down by its spring within a groove of the piston, as shown in FIG. 12G.
  • the biopsy needle requires one hand operation. Biopsy guns are typically loaded manually, and normally require both hands to reload. Since the biopsy procedure is normally guided by medical imaging, commonly the ultrasound that is also manually held, it is difficult for the physician to reload the gun him or herself. As such, the biopsy procedure is normally done with help form an assistant. The pneumatic loading mechanism of the new needle makes the use of the assistant optional.
  • the present invention represents the first device that uses pneumatics as a source of power to load the biopsy firing mechanism.
  • pneumatics as a source of power to load the biopsy firing mechanism.
  • the use of a motorized mechanism in combination with the impact-less stopper makes it possible to use a substantially suffer spring, that otherwise would be hard to preload manually and would aggravate the noise problem of typical needles.
  • the stuffer spring generates higher force, causing higher barrel accelerations and therefore cutter velocity in order to improve tissue slicing at biopsy.
  • FIGS. 13A-13C illustrate perspective and side views of the needle biopsy device of the present invention. This is the same device presented in cross section in FIGS. 12A-12G. It includes the pneumatic driver 64 and the needle 12. Even though the needle 12 could be placed coaxially with the piston 24 of the pneumatic driver 64, it has been shifted to the side of the driver, so that the needle may be placed close to other medical devices, such as ultrasound probes for image guidance. A pressure port 70 is also included.
  • the stylet 16 attaches with a release tab 66 to the body of the driver.
  • the barrel presents a lateral barrel release tab 68 that clips onto the rod of the piston 24.
  • the firing spring is a dual action spring that is connected to one end to the case of the driver, and at the other to the piston. As such, the rotation of the piston is constrained by the spring. When a helical spring changes its compression state its ends are slightly turning relative to one another. If the needle is not connected to the driver, this will cause the piston rod to rotate slightly when the mechanism is loaded and fired. When the needle is mounted to the driver, the rotation is blocked by the parallel structure formed between the piston rod and the stylet.
  • the piston should be attached to the spring so that the piston rod is properly aligned with the needle when the mechanism is fired. Even though additional constraints could be imposed to prevent the rotation of the piston, these would likely deteriorate dynamical performance while fired, and the one of the needle is adequate.
  • the needle is fired with load/fire button 72
  • the pneumatic driver requires regulated gas pressure as a source of power, supplied through the pressure port.
  • This may be may be compressed air or another gas such as compressed CO2.
  • the pressure may be provided from a supply line such as the compressed air line of the medical facility..
  • Typical biopsy guns are either disposable, in case that the needle is not removable from the device and the entire gun assembly is sterilized for one use, or have a reusable biopsy gun that is cleaned and sterilized after each use and a removable needle that is replaced with a new sterile one.
  • the pneumatic driver of the new device is sufficiently simple to be manufactured as a disposable part.
  • the needle is removable as illustrated in FIGS. 13A-13C, and the driver could be reused.
  • a novel possible solution for single-multiple use and sterilization is to retain the driver for multiple use and provide for single-use the needle and case.
  • the present invention includes a number of novel features.
  • one novel feature is the structurally curved magazine slot geometry.
  • the point of the needle can be back bent or the barrel and stylet rotated 180° in order to align the stylet point within the barrel when the stylet is retracted.
  • a classic needle can also include the feature of the structurally curved magazine slot and/or the back bent point or rotation of the barrel/stylet.
  • Forward-less fire biopsy motion is also novel in the context of magazine defection.
  • the striated magazine slot is novel, as is the 4-facet point geometry. These features would also improve convention biopsy needles.
  • the stylet can have a slightly asymmetric point to compensate for barrel bevel, by balancing the rudder effect.
  • the slot of CI also enables a longer and wider magazine slot.
  • the device can include the use of a dual action spring in the biopsy gun, and a compression spring can be used as a dual action spring. This applies to any mechanism, not only biopsy devices.
  • the device can include a pneumatic stopper and a cylinder with a port that is closed by the piston when the motion is to be stopped. These features may have wider applicability than biopsy devices.
  • a method of reducing firing noise of guns is also included as a feature of the present invention.
  • the device can include a pneumatic piloted mechanism for loading the spring. The pilot opens and closes the air vent, toggling the functionality of the cylinder port between a venting exhaust and pressurized inlet. A latch and valve coordinated by the use of the button lever. A method of supplying pressure to the device from a line is also included.
  • the device can be single or multi-use device with disposable case.
  • Table 1 shows innovative features of the present invention that solve the problems of current devices.

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Abstract

Un mode de réalisation selon la présente invention concerne une nouvelle aiguille de biopsie qui permet de résoudre plusieurs problèmes identifiés avec des aiguilles de biopsie actuellement disponibles. En résumé, la nouvelle aiguille a un trajet d'insertion plus droit, aucun feu frontal, un bruit moindre, et est assistée par énergie pneumatique de telle sorte qu'elle peut être actionnée d'une seule main. Ces caractéristiques améliorent le ciblage de la biopsie, fournissent un fonctionnement plus sûr pour le patient et le personnel, réduisent l'inconfort du patient, et respectivement rendent facultative l'aide d'un assistant à la biopsie.
PCT/US2018/019117 2016-02-18 2018-02-22 Aiguille pneumatique de biopsie de tissu mou à insertion droite, sans feu frontal et à faible bruit WO2018169658A1 (fr)

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US16/487,236 US20210128122A1 (en) 2016-02-18 2018-02-22 Straight-insertion, forward-less fire, low noise, pneumatic soft tissue biopsy needle

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US201762461891P 2017-02-22 2017-02-22
US62/461,891 2017-02-22

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5249582A (en) * 1991-08-30 1993-10-05 Hart Enterprises Oriented biopsy needle assembly
US6273861B1 (en) * 1997-01-30 2001-08-14 Scimed Life Systems, Inc. Pneumatically actuated tissue sampling device
US20120221007A1 (en) * 2010-12-20 2012-08-30 David Batten Articulating tissue removal systems and methods
US20130345710A1 (en) * 2009-09-18 2013-12-26 Jeffrey B. Kleiner Fusion cage with combined biological delivery system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5249582A (en) * 1991-08-30 1993-10-05 Hart Enterprises Oriented biopsy needle assembly
US6273861B1 (en) * 1997-01-30 2001-08-14 Scimed Life Systems, Inc. Pneumatically actuated tissue sampling device
US20130345710A1 (en) * 2009-09-18 2013-12-26 Jeffrey B. Kleiner Fusion cage with combined biological delivery system
US20120221007A1 (en) * 2010-12-20 2012-08-30 David Batten Articulating tissue removal systems and methods

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