Biopsy device with multiple air paths for ventilation
By designing coaxially arranged cutter cannulas, vacuum cannulas, and core needle cannulas in the biopsy equipment, and utilizing the coordination of multiple air paths and vacuum sources, the problem of low efficiency in tissue sample cutting and transmission in biopsy devices was solved, achieving efficient sample collection.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BARD PERIPHERAL VASCULAR INC
- Filing Date
- 2022-01-06
- Publication Date
- 2026-06-05
AI Technical Summary
Existing biopsy devices are inefficient in cutting and transporting tissue samples, making it difficult to effectively transfer tissue samples to the sample collection container.
Design a biopsy device including a cutter cannula, a vacuum cannula, and a needle cannula arranged coaxially. By designing a seal, multiple air paths are established at different positions to achieve fluid communication between the vacuum cannula and the needle cannula. In conjunction with a vacuum source and mechanical movement, the tissue sample is cut and transported.
It improves the efficiency of tissue sample cutting and transfer, ensuring that samples can be effectively moved from the cutter sleeve to the vacuum sleeve, thus achieving efficient sample collection.
Smart Images
Figure CN116782833B_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application claims the benefit of co-pending U.S. Provisional Patent Application No. 63 / 135256, filed January 8, 2021, entitled “Biopsy Device with Multiple Air Pathways for Ventilation,” the entire contents of which are incorporated herein by reference. Technical Field
[0003] This disclosure relates to biopsy devices, and more particularly to single-insertion multi-sample biopsy equipment. Background Technology
[0004] Biopsies can be performed on patients to help determine whether tissue in an area of interest contains cancer cells. For example, one biopsy technique for evaluating breast tissue involves inserting a biopsy probe into an area of interest in the breast tissue to capture one or more tissue samples from that area. Such biopsy techniques typically utilize a vacuum to pull the tissue to be sampled into the sample notch of the biopsy probe, then the tissue is cut and collected. Efforts in the art have been made to improve the ability of biopsy devices to cut tissue samples and transfer the cut tissue samples to a sample collection container.
[0005] What is needed in the art is a biopsy device that facilitates the efficient cutting of tissue samples and the efficient transfer of tissue samples to a sample collection container. Summary of the Invention
[0006] In one embodiment, a biopsy device includes a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a needle cannula coaxially arranged along a longitudinal axis. The vacuum cannula is positioned within the needle cannula to define a first intermediate lumen therebetween. The needle cannula is positioned within the cutter cannula to define a second intermediate lumen therebetween. The vacuum cannula has a vacuum lumen. The needle cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position. The needle cannula has a plurality of vents, the plurality of vents including at least one longitudinal vent groove. The biopsy device also includes a seal having a proximal sealing portion and a distal sealing portion, the distal sealing portion having a distal sealing lip positioned to radially engage the outer diameter of the cutter cannula, and the proximal sealing portion having a proximal sealing lip positioned to radially engage the outer diameter of the needle cannula. As the mandrel sleeve moves from the first extended position toward the first retracted position, the at least one longitudinal vent groove is longitudinally positioned below the proximal sealing lip of the proximal sealing portion of the seal, thereby opening a sealing bypass path within the longitudinal extension range of the proximal sealing lip of the proximal sealing portion of the seal. This establishes a first air path in the first intermediate cavity between the outer diameter of the vacuum sleeve and the inner diameter of the mandrel sleeve, and a second air path in the second intermediate cavity between the inner diameter of the cutter sleeve and the outer diameter of the mandrel sleeve. The first and second air paths are in fluid communication with the region located proximal to the seal.
[0007] In another embodiment, a method includes applying a vacuum to the lumen of the biopsy device's needle sheath via a vacuum sleeve at a sample notch in the needle sheath. The biopsy device's cutter sleeve, vacuum sleeve, and needle sheath are coaxially arranged along a longitudinal axis. The vacuum sleeve is positioned inside the needle sheath to define a first intermediate lumen therebetween, the needle sheath is positioned inside the cutter sleeve to define a second intermediate lumen therebetween, and the vacuum sleeve has a vacuum lumen. The needle sheath is movable relative to the vacuum sleeve and the cutter sleeve between a first extended position and a first retracted position. The needle sheath has a plurality of vents, the plurality of vents including at least one longitudinal vent groove. The biopsy device includes a seal having a proximal sealing portion and a distal sealing portion, the distal sealing portion having a distal sealing lip positioned to radially engage the outer diameter of the cutter sleeve, and the proximal sealing portion having a proximal sealing lip positioned to radially engage the outer diameter of the needle sheath. The method further includes moving the core needle sleeve toward a first retracted position to move the cut tissue sample into the vacuum sleeve. As the core needle sleeve moves toward the first retracted position, the at least one longitudinal vent groove is longitudinally positioned below the proximal sealing lip of the proximal sealing portion of the seal to open a sealing bypass path within the longitudinal extension of the proximal sealing lip of the proximal sealing portion of the seal, thereby establishing a first air path sleeve at a first intermediate cavity between the outer diameter of the vacuum sleeve and the inner diameter of the core needle sleeve, and establishing a second air path at a second intermediate cavity between the inner diameter of the cutter sleeve and the outer diameter of the core needle sleeve. The first and second air paths are in fluid communication with a region located proximal to the seal.
[0008] These and additional features provided by the embodiments described herein will be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings. Attached Figure Description
[0009] The above and other features and advantages of this disclosure, as well as the ways in which they are obtained, will become more apparent and the disclosure will be better understood by referring to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:
[0010] Figure 1 This is a perspective view of a biopsy device constructed according to embodiments of the present disclosure, wherein a biopsy probe assembly is attached to a biopsy driver assembly;
[0011] Figure 2 yes Figure 1 A perspective view of the biopsy device, in which the biopsy probe assembly is removed from the biopsy driver assembly and the top cover of the biopsy driver assembly is removed to expose the puncture module of the biopsy driver assembly;
[0012] Figure 2A yes Figure 2A bottom view of the biopsy driver assembly, wherein the biopsy driver assembly is... Figure 2 The orientation shown is reversed;
[0013] Figure 3 yes Figure 1 A block diagram representation of the biopsy driver assembly;
[0014] Figure 4 yes Figure 1 An exploded view of the biopsy probe assembly;
[0015] Figure 5A yes Figure 1 The biopsy probe assembly along Figure 2 A sectional view taken from line 5A-5A;
[0016] Figure 5B yes Figure 5A The amplified portion of the vacuum sleeve is shown.
[0017] Figure 5C yes Figure 5A The enlarged portion of the needle sleeve shown;
[0018] Figure 6A The relative positions of the vacuum sleeve, core needle sleeve, and cutter sleeve are shown before, during, and immediately after the piercing shot;
[0019] Figure 6B The relative positions of the vacuum sleeve, the core needle sleeve, and the cutter sleeve are shown, with the cutter sleeve retracted to expose the sample notch of the core needle sleeve.
[0020] Figure 6C The relative positions of the vacuum sleeve, the core needle sleeve, and the cutter sleeve are shown, and the wobbling of the sample notch caused by alternating a small distance in the proximal and distal directions of the core needle sleeve is depicted.
[0021] Figure 6D The relative positions of the vacuum cannula, the core needle cannula, and the cutter cannula are shown, wherein the cutter cannula is rotated and translated in a distal direction to cut the tissue sample from the tissue received in the sample notch.
[0022] Figure 6E The relative positions of the vacuum cannula, the core needle cannula, and the cutter cannula are shown, wherein the core needle cannula moves proximally within the cutter cannula to mechanically assist in moving the tissue sample into the flared portion of the vacuum cannula.
[0023] Figure 6F The relative positions of the vacuum sleeve, the mandrel sleeve, and the cutter sleeve are shown, wherein the mandrel sleeve moves distally within the cutter sleeve to disengage the protruding member from the flared portion of the vacuum sleeve.
[0024] Figure 6G The relative positions of the vacuum sleeve, the mandrel sleeve, and the cutter sleeve are shown, wherein the mandrel sleeve moves again proximally within the cutter sleeve, causing the protruding member to re-engage the flared portion of the vacuum sleeve.
[0025] Figure 6H The relative positions of the vacuum sleeve, the mandrel sleeve, and the cutter sleeve are shown, wherein the mandrel sleeve moves again in the distal direction within the cutter sleeve to disengage the protruding member from the flared portion of the vacuum sleeve and return to the extended position.
[0026] Figure 7 It is a vacuum / time graph (standardized), depicting, for example... Figures 6A-6H The baseline vacuum pressure is shown at multiple different locations during tissue sample cutting and transport sequences;
[0027] Figure 8 This is a perspective view of the core needle sleeve, showing one of two longitudinal vent slots that are opposite each other in diameter.
[0028] Figure 8A It is along Figure 8 The cross-sectional view of the core needle sleeve taken from line 8A-8A depicts the arrangement of the vent structure including two longitudinal vent grooves opposite each other in diameter and multiple circular vent holes.
[0029] Figure 9 It includes the injector sleeve. Figure 2 A side view of the biopsy probe assembly, in which the core cannula is essentially as shown. Figure 6D Positioning shown;
[0030] Figure 10 It is along Figure 9 An enlarged cross-sectional view of a portion of the biopsy probe assembly, taken from line 10-10;
[0031] Figure 11 yes Figure 10 A further enlarged portion of the cross-sectional view depicts the first and second air paths;
[0032] Figure 12 It includes the injector sleeve. Figure 2 A side view of the biopsy probe assembly, in which the core cannula is essentially as shown. Figure 6E Positioning shown;
[0033] Figure 13 It is along Figure 12 An enlarged cross-sectional view of a portion of the biopsy probe assembly, taken from line 13-13;
[0034] Figure 14 yes Figure 13 A further enlarged portion of the cross-sectional view depicts the first and second air paths; and
[0035] Figure 15 yes Figure 2 A cross-sectional view of a portion of a biopsy probe assembly, wherein the protruding member of the puncture tip of the core needle cannula is positioned at... Figure 6E The retracted position is shown slightly to the side, and the combined airflow formed by the combination of airflows from the first and second air paths is depicted.
[0036] The corresponding reference numerals in the accompanying drawings indicate the corresponding parts in multiple views. The examples described herein illustrate at least one embodiment of this disclosure, and such examples should not be construed as limiting the scope of this application in any way. Detailed Implementation
[0037] Now refer to the attached diagram, and more specifically to... Figure 1 and Figure 2 The image shows a biopsy device 10, which generally includes a non-invasive, e.g., non-disposable biopsy driver assembly 12 and an invasive, e.g., disposable biopsy probe assembly 14. As used herein, the term "non-disposable" is used to refer to a device intended for use on multiple patients during the device's lifespan, and the term "disposable" is used to refer to a device to be discarded after use on a single patient. The biopsy driver assembly 12 includes a driver housing 16 that is constructed and ergonomically designed for user grip.
[0038] refer to Figure 2 and 3 The biopsy driver assembly 12, housed within the driver housing 16, includes a controller circuitry 18, an electromechanical power source 20, a vacuum source 22, a vacuum sensor 24, and a battery 26 (or an alternative AC adapter). User interface 28 (see...) Figure 1 For example, a small keyboard is positioned to be mounted in the drive housing 16 and is accessible to the user from the outside relative to the drive housing 16. Battery 26 may be, for example, a rechargeable battery, which can be charged via an inductive charging device connected to inductor coil 29, or alternatively via an electrical connection connected to a power supply. Battery 26 is electrically connected to controller circuitry 18, electromechanical power source 20, vacuum source 22, and user interface 28.
[0039] refer to Figure 3The user interface 28 may include control buttons and visual / auditory indicators, wherein the control buttons provide the user with control over various functions of the biopsy device 10, and the visual / auditory indicators provide visual / auditory feedback on the status and / or position of one or more components of the biopsy device 10. The control buttons may include a sample button 28-1 and a main / puncture button 28-2. The visual indicators may include a display screen 28-3 and / or one or more light-emitting diodes (LEDs) 28-4. The auditory indicators may include a buzzer 28-5. The control buttons may include tactile feedback to the user when activated.
[0040] The controller circuit 18 is electrically and communicatively connected, for example, to the electromechanical power source 20, the vacuum source 22, the vacuum sensor 24, and the user interface 28 via one or more wires or circuit traces. The controller circuit 18 may be mounted on a circuit board and includes, for example, a processor circuit 18-1 and a memory circuit 18-2.
[0041] Processor circuit 18-1 has one or more programmable microprocessors and associated circuitry, such as input / output interfaces, clocks, buffers, and memories. Memory circuit 18-2 may be communicatively connected to processor circuit 18-1, for example, via a bus circuit, and is a non-transient electronic memory, which may include volatile memory circuitry, such as random access memory (RAM), and non-volatile memory circuitry, such as read-only memory (ROM), electronically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc. Controller circuit 18 may be configured as one or more application-specific integrated circuits (ASICs).
[0042] The controller circuit 18 is configured via software and / or firmware residing in the memory circuit 18-2 to execute program instructions to perform functions associated with the retrieval of biopsy tissue samples, such as controlling and / or monitoring one or more components of the electromechanical power source 20, vacuum source 22, and vacuum sensor 24.
[0043] The electromechanical power source 20 may include, for example, a cutter module 30, a transmission module 32, and a piercing module 34, all of which are electrically connected to the battery 26. Each of the cutter module 30, the transmission module 32, and the piercing module 34 is electrically and controllably connected to the controller circuitry 18 via one or more electrical conductors (e.g., wires or circuit traces).
[0044] The cutter module 30 may include an electric motor 30-1 with a shaft to which a drive gear 30-2 is attached. The transmission module 32 may include an electric motor 32-1 with a shaft to which a drive gear 32-2 is attached. The piercing module 34 may include an electric motor 34-1, a drive spindle 34-2, and a piercing shot actuator 34-3. Each electric motor 30-1, 32-1, 34-1 may be, for example, a direct current (DC) motor or a stepper motor. As an alternative to the above arrangement, each of the cutter module 30, transmission module 32, and piercing module 34 may include one or more gears, gear trains, conveyor belt / pulley arrangements, etc., between the respective motor and drive gear or drive spindle.
[0045] The piercing module 34 is configured such that activation of the electric motor 34-1 and the drive spindle 34-2 causes the piercing firing actuator 34-3 to move proximally 36-1 to compress the firing spring, such as one or more coil springs, and locks the piercing firing actuator 34-3 in the ready position. When the main / piercing button 28-2 of the user interface 28 is actuated, the piercing firing actuator 34-3 is advanced distally 36-2, i.e., fired (see [link to relevant documentation]). Figure 2 ).
[0046] Vacuum source 22 is electrically and controllably connected to battery 26 via one or more electrical conductors (e.g., wires or circuit traces). Vacuum source 22 may include, for example, an electric motor 22-1 that drives vacuum pump 22-2. Vacuum source 22 has a vacuum source port 22-3 connected to vacuum pump 22-2 for establishing a vacuum in biopsy probe assembly 14. Electric motor 22-1 may be, for example, a rotary, linear, or vibratory DC motor. Vacuum pump 22-2 may be, for example, a peristaltic pump or a diaphragm pump, or one or more pumps connected in series or parallel, respectively.
[0047] Vacuum sensor 24 is electrically connected to controller circuitry 18 via one or more electrical conductors (e.g., wires or circuit traces). Vacuum sensor 24 may be a differential pressure sensor that provides a vacuum (negative pressure) feedback signal to controller circuitry 18. In some embodiments, vacuum sensor 24 may be incorporated into vacuum source 22.
[0048] refer to Figure 1 and 2 The biopsy probe assembly 14 is configured to be releasably attached to the biopsy driver assembly 12. As used herein, the term “releasably attached” refers to a configuration that facilitates a intended temporary connection followed by selective disassembly, involving manipulation of the disposable biopsy probe assembly 14 relative to the biopsy driver assembly 12 without the need for tools.
[0049] refer to Figure 4An exploded view shows that the biopsy probe assembly 14 includes a probe housing 40, a probe sub-housing 42, a vacuum sleeve 44, a core needle sleeve 46, a core needle gear-spindle assembly 48 for linear translation of the core needle, a cutter sleeve 50, a cutter gear-spindle assembly 52 for rotating and linearly translating the cutter, a sample manifold 54, and a sample cup 56.
[0050] refer to Figure 2 , 4 In 5A, the probe housing 40 is formed as an L-shaped structure having an elongated portion 40-1 and a front plate 40-2. When the biopsy probe assembly 14 is attached to the biopsy driver assembly 12, the front plate 40-2 is positioned distally adjacent to the entire front surface 16-1 of the driver housing 16, i.e., to shield the entire front surface 16-1 of the non-disposable driver assembly from contact with the patient.
[0051] Vacuum sleeve 44, needle sleeve 46, and cutter sleeve 50 are coaxially arranged in a nested tube arrangement along the longitudinal axis 58, wherein vacuum sleeve 44 is the innermost tube, cutter sleeve 50 is the outermost tube, and needle sleeve 46 is an intermediate tube between vacuum sleeve 44 and cutter sleeve 50. In other words, vacuum sleeve 44 is located inside needle sleeve 46, and needle sleeve 46 is located inside cutter sleeve 50.
[0052] The vacuum sleeve 44 is mounted in a fixed position relative to the probe sub-housing 42. The vacuum sleeve 44 is fluidly connected to the vacuum source 22 via the sample manifold 54.
[0053] refer to Figure 4 , 5A Like 5B, the vacuum sleeve 44 includes an elongated portion 44-1, a flared portion 44-2 extending distally from the elongated portion 44-1, and a vacuum lumen 44-3. The elongated portion 44-1 has a first outer diameter D1. The flared portion 44-2 flares from the elongated portion 44-1 into two stages, namely a first flared stage 45-1 and a second flared stage 45-2. The first flared stage 45-1 diverges from the elongated portion 44-1 at a first acute angle A1, and the second flared stage 45-2 diverges from the first flared stage 45-1 relative to the elongated portion 44-1 at a second acute angle A2, wherein acute angle A2 is greater than acute angle A1. The distal outer diameter D2 of the second flared stage 45-2 is selected to be received within and in sliding contact with the lumen 46-4 of the core needle sleeve 46. Each of the first flaring stage 45-1 and the second flaring stage 45-2 of the flared portion 44-2 has a diameter that gradually increases distally, which is larger than the diameter D1 of the elongated portion 44-1.
[0054] refer to Figure 4 and 5AThe mandrel sleeve 46 includes a proximal portion 46-1 and a distal portion 46-2. The distal portion 46-2 includes a sample notch 60. A piercing tip 62 is attached to the distal portion 46-2, which in turn forms part of the mandrel sleeve 46. A mandrel gear-spindle assembly 48 engages with the external thread of a transmission spindle 46-5, which is fixedly attached (e.g., glued, welded, or riveted) to the proximal portion 46-1 of the mandrel sleeve 46. The mandrel gear-spindle assembly 48 is an integral gear with a driven gear 48-1 fixedly attached to the threaded spindle 48-2, and can be formed as a single molded part. By activating the transmission module 32 of the biopsy probe assembly 14, the needle cannula 46 retracts or extends along the longitudinal axis 58, wherein the drive gear 32-2 of the transmission module 32 of the biopsy driver assembly 12 engages with the driven gear 48-1 of the needle gear-spindle assembly 48.
[0055] Also refer to Figure 5C , 6A In addition to 6B, the sample notch 60 is formed as an elongated opening in the sidewall 46-3 of the mandrel cannula 46 to facilitate the reception of tissue 66 into the lumen 46-4 of the mandrel cannula 46. The sample notch 60 has a longitudinal extension 60-1 extending along the longitudinal axis 58. The sample notch 60 does not extend below the centerline of the diameter of the mandrel cannula 46 in the sidewall 46-3 and may include a cutting edge around the periphery of the opening formed by the sample notch 60, wherein the cutting edges of the elongated (linear) portion of the sample notch 60 all have a cutting edge that diverges from the cutting edge along the sidewall 46-3 to the centerline at the diameter of the mandrel cannula 46.
[0056] The piercing tip 62 has a tip portion 62-1, a mounting portion 62-2, and a protruding member 62-3. The piercing tip 62 is inserted into the lumen 46-4 of the mandrel cannula 46 at its distal portion 46-2, wherein the mounting portion 62-2 is attached to the distal portion 46-2 of the mandrel cannula 46, for example, by adhesive or welding. Thus, the tip portion 62-1 extends distally from the distal portion 46-2 of the mandrel cannula 46, and the protruding member 62-3 extends proximally (i.e., in the proximal direction 36-1) within the lumen 46-4 along a portion of the longitudinal extension 60-1 of the sample notch 60. Therefore, as... Figure 6E and 6G As shown, when the core needle sleeve 46 is fully retracted in the proximal direction 36-1, the protruding member 62-3 is received into the flared portion 44-2 of the vacuum sleeve 44. At least the proximal tip portion of the protruding member 62-3 has a diameter that decreases proximally.
[0057] Refer again Figure 4The cutter sleeve 50 includes a proximal portion 50-1 and a distal portion 50-2. The distal portion 50-2 includes an annular cutting blade 64. A cutter gear-spindle assembly 52 is fixedly attached (e.g., glued, welded, or riveted) to the proximal portion 50-1 of the cutter sleeve 50. The cutter gear-spindle assembly 52 is an integral gear having a driven gear 52-1 fixedly attached to a threaded spindle 52-2, and can be formed as a single molded part. By activating the cutter module 30 of the biopsy probe assembly 14, the cutter sleeve 50 retracts or extends along the longitudinal axis 58, wherein the drive gear 30-2 of the cutter module 30 of the biopsy actuator assembly 12 engages with the driven gear 52-1 of the cutter gear-spindle assembly 52. Thus, the cutter sleeve 50 has a rotary cutting motion and axial translation along the longitudinal axis 58. The thread pitch of the threaded spindle 52-2 determines the number of revolutions required for each axial distance (in millimeters (mm)) of axial movement of the cutter sleeve 50.
[0058] refer to Figure 4 and 5A The sample manifold 54 is configured in an L-shape having a vacuum chamber portion 54-1 and a collection chamber portion 54-2. The vacuum chamber portion 54-1 includes a vacuum input port 54-3, which is arranged to hermetically engage with the vacuum source port 22-3 of the vacuum source 22 of the biopsy driver assembly 12 when the biopsy probe assembly 14 is attached to the biopsy driver assembly 12. The vacuum chamber portion 54-1 is fluidly connected to the collection chamber portion 54-2. The proximal end of the elongated portion 44-1 of the vacuum sleeve 44 passes through the vacuum chamber portion 54-1 and is in direct fluid communication with the collection chamber portion 54-2. The collection chamber portion 54-2 has a cavity sized and arranged to removably receive a sample cup 56, such that the sample cup 56 is in direct fluid communication with the elongated portion 44-1 of the vacuum sleeve 44, and also with the vacuum input port 54-3 of the vacuum chamber portion 54-1. In the vacuum chamber section 54-1, ink-absorbing paper is placed in the area between the vacuum input port 54-3 and the collection chamber section 54-2.
[0059] Therefore, the tissue sample cut by the cutter sleeve 50 at the sample notch 60 of the core needle sleeve 46 can be transferred by the vacuum source 22 at the sample cup 56, through the vacuum sleeve 44 and into the sample cup 56.
[0060] Refer again Figure 2 , 4Like 5A, the probe sub-housing 42, such as a probe carrier, is a sub-housing slidably connected to the probe housing 40, for example using a guide rail / slot arrangement. The probe sub-housing 42 includes a proximal threaded portion 42-1 and a distal threaded portion 42-2. Furthermore, the probe sub-housing 42 is configured to be drivably connected to the puncture module 34. In other words, when the biopsy driver assembly 12 is connected to the biopsy probe assembly 14 to form the biopsy device 10, the puncture module 34 is drivably connected to the probe sub-housing 42.
[0061] The probe sub-housing 42 includes one or more piercing module engagement openings, such as slots. In this embodiment, reference... Figure 2 and 2A The probe sub-housing 42 includes a piercing module engagement opening 42-3 and a piercing module engagement opening 42-4, each of which is configured, for example, in size and shape to receive a corresponding drive protrusion 34-5, 34-6 of the piercing firing actuator 34-3 of the piercing module 34, so as to achieve longitudinal movement of the probe sub-housing 42 in accordance with the longitudinal movement of the piercing firing actuator 34-3 during a piercing firing (firing) operation. For example, each of the piercing module engagement openings 42-3 and 42-4 may be a corresponding rectangular slot. While this embodiment includes two piercing module engagement openings for symmetry and / or redundancy, alternative embodiments may have, for example, only one piercing module engagement opening, such as piercing module engagement opening 42-3.
[0062] The proximal threaded portion 42-1 in the probe sub-housing 42 has a threaded hole that threadably receives the threaded spindle 48-2 of the core needle gear-spindle assembly 48, such that rotation of the driven gear 48-1 of the core needle gear-spindle assembly 48 causes linear translation of the core needle sleeve 46 along the longitudinal axis 58, wherein the direction of rotation is related to the direction of translation of the core needle sleeve 46 toward either the proximal direction 36-1 or the distal direction 36-2. When the biopsy probe assembly 14 is attached to the biopsy actuator assembly 12 (see...) Figure 1 The driven gear 48-1 of the core pin gear-spindle assembly 48 engages with the drive gear 32-2 of the transmission module 32.
[0063] Similarly, the distal threaded portion 42-2 of the probe sub-housing 42 has a threaded hole that threadably receives the threaded spindle 52-2 of the cutter gear-spindle assembly 52, such that rotation of the driven gear 52-1 of the cutter gear-spindle assembly 52 causes a combined rotation and linear translation of the cutter sleeve 50 along the longitudinal axis 58, wherein the direction of rotation is related to the direction of translation of the cutter sleeve 50. When the biopsy probe assembly 14 is attached to the biopsy actuator assembly 12 (see...) Figure 1 The driven gear 52-1 of the cutter gear-spindle assembly 52 engages with the drive gear 30-2 of the cutter module 30.
[0064] Similarly, when the biopsy probe assembly 14 is attached to the biopsy driver assembly 12, reference is also made. Figure 2 and 3 The probe sub-housing 42 is connected to the puncture firing actuator 34-3 of the puncture module 34. Therefore, upon the first actuation of the master / puncture button 28-2, the probe sub-housing 42 and the puncture firing actuator 34-3 are translated in a proximal direction 36-1 to position the puncture firing actuator 34-3 and the probe sub-housing 42 carrying the core needle cannula 46 and the cutter cannula 50 in the ready position, i.e., the tilted position. Upon the second actuation of the master / puncture button 28-2 to initiate the puncture firing, the probe sub-housing 42 and the puncture firing actuator 34-3 are rapidly and uniformly advanced in a distal direction 36-2 to position the core needle cannula 46 and the cutter cannula 50 at the most distal position of the combined element, for example, inside a patient.
[0065] Figures 6A-6H Together they represent the tissue sample cutting and transmission sequence. Figure 6E and 6G The needle sleeve 46 is shown in its retracted position 68-1. Figure 6A , 6B Figure 6H shows the needle sleeve 46 in its extended position 68-2 (sometimes also called the zero position). Figure 6C , 6D Figures 6F and 6F show the mandrel sleeve 46 in different positions between the retracted position 68-1 and the extended position 68-2. Figure 6B and 6C The cutter sleeve 50 is shown in its retracted position 70-1, and when the mandrel sleeve 46 is in or near its extended position 68-2, the cutter sleeve exposes the sample notch 60 of the mandrel sleeve 46. Figure 6A and 6D -6H shows the cutter sleeve 50 in its extended position 70-2 (sometimes also referred to as the zero position), where the cutter sleeve 50 covers the sample notch 60 of the mandrel sleeve 46.
[0066] To achieve the movement of the needle sleeve 46, the controller circuit 18 executes program instructions and sends corresponding control signals to the transmission module 32 of the biopsy driver assembly 12, which in turn transmits the movement to the needle gear-spindle assembly 48 of the biopsy probe assembly 14. Similarly, to achieve the movement of the cutter sleeve 50, the controller circuit 18 executes program instructions and sends corresponding control signals to the cutter module 30 of the biopsy driver assembly 12, which in turn transmits the movement to the cutter gear-spindle assembly 52 of the biopsy probe assembly 14. The controller circuit 18 can determine the axial position of each of the needle sleeve 46 and the cutter sleeve 50 relative to the corresponding zero position by counting the number of corresponding motor drive pulses or, alternatively, counting the number of corresponding motor shaft rotations.
[0067] Figure 6A The relative positions of the vacuum sleeve 44, the mandrel sleeve 46, and the cutter sleeve 50 are shown before, during, and immediately after the piercing shot performed by the piercing module 34. As shown, the distal portion 50-2 of the cutter sleeve 50 extends over the sample notch 60.
[0068] exist Figure 6B In the illustrated sequence of steps, vacuum source 22 is actuated to deliver vacuum via vacuum sleeve 44 to the lumen 46-4 of the mandrel sleeve 46 at the sample notch 60, and cutter sleeve 50 is retracted by actuation of cutter module 30 to expose sample notch 60, thereby allowing tissue 66 to be aspirated through sample notch 60 into lumen 46-4 of mandrel sleeve 46. In this embodiment, to expose sample notch 60, cutter sleeve 50 is rotated counterclockwise to achieve a linear translation of cutter sleeve 50 in the proximal direction 36-1 by approximately 23 mm, thereby defining the opening length of sample notch 60. As used herein, the relative term “approximately” refers to a base value (if any) plus or minus 5%, unless otherwise stated. The actual aperture size at the sample notch 60 (corresponding to the desired sample size) can be selected by the user at the user interface 28, wherein the distance the cutter sleeve 50 retracts from the extended position 70-2 toward the retracted position 70-1 is controlled by the controller circuit 18 to correspond to the sample size selected by the user.
[0069] Figure 6C and 6D The cutting sequence is shown.
[0070] exist Figure 6CIn the sequence steps shown, to increase the size of the tissue sample to be collected, the mandrel cannula 46 can be moved alternately a short distance, for example, 2 to 5 mm, in the proximal direction 36-1 and the distal direction 36-2, to agitate the sample notch 60, thereby increasing the amount of tissue 66 passing through the sample notch 60 and into the lumen 46-4 of the mandrel cannula 46. The last movement of the agitation is defined as follows: Figure 6A Compared to the zero position of the core needle sleeve 46 shown, the sample notch 60 is held in a retracted position of 1 mm (see...). Figure 6C This is to ensure that the cutter sleeve 50 is in the cutting sequence (see...). Figure 6D During this period, the sample incision is closed at 60°, and a further 1mm incision is made, thereby ensuring that the connective tissue or string is intact. Figure 6D The cutting sequence shown is completely cut during the steps.
[0071] exist Figure 6D In the cutting sequence steps shown, the cutter sleeve 50 rotates and translates distally 36-2 to cut tissue sample 66-1 from tissue 66. In this embodiment, the cutter sleeve 50 rotates clockwise to achieve a linear translation of the cutter sleeve distally 36-2 by approximately 23 mm to cut the tissue and return to the zero position.
[0072] Figure 6E-6H The tissue sample transfer sequence is shown.
[0073] exist Figure 6E In the illustrated sequence of steps, a vacuum is applied by the vacuum sleeve 44, and the core needle sleeve 46 moves proximally 36-1 within the cutter sleeve 50 to mechanically assist in moving the tissue sample 66-1 into the flared portion 44-2 of the vacuum sleeve 44. More specifically, as the core needle sleeve 46 moves proximally 36-1 within the cutter sleeve 50, the protruding member 62-3 of the puncture tip 62 engages with the tissue sample 66-1 to facilitate its entry into the vacuum sleeve 44. The protruding member 62-3 then engages with the flared portion 44-2 of the vacuum sleeve 44 to prevent air from flowing into the flared portion 44-2 of the vacuum sleeve 44.
[0074] exist Figure 6F In the sequence of steps shown, a vacuum is applied using a vacuum sleeve 44, and a core needle sleeve 46 moves distally 36-2 within a cutter sleeve 50 to disengage the protruding member 62-3 from the flared portion 44-2 of the vacuum sleeve 44, thereby causing a sudden change in the airflow entering the vacuum sleeve 44, which helps to transfer the tissue sample 66-1 through the vacuum sleeve 44 under vacuum.
[0075] Figure 6G and 6HThe sequence steps shown are essentially a repetition of sequence steps 6E and 6F.
[0076] exist Figure 6G In the sequence steps shown, a vacuum is applied to the vacuum sleeve 44 by the vacuum source 22, and the core needle sleeve 46 moves again in the proximal direction 36-1 within the cutter sleeve 50, so that the protruding member 62-3 of the piercing tip 62 re-engages the flared portion 44-2 of the vacuum sleeve 44 to prevent air from flowing into the flared portion 44-2 of the vacuum sleeve 44 again.
[0077] exist Figure 6H In the sequence steps shown, vacuum source 22 applies a vacuum to vacuum sleeve 44, and core needle sleeve 46 moves distally 36-2 within cutter sleeve 50 to disengage protrusion 62-3 from the flared portion 44-2 of vacuum sleeve 44, thereby causing a sudden change in the airflow entering vacuum sleeve 44, which helps to remove tissue sample 66-1 (if it has not yet passed through) Figure 6E and 6F If the sequence steps are to be transported, vacuum transmission is carried out through vacuum sleeve 44. Figure 6H At the end of the sequence, the core cannula 46 is repositioned at the tissue receiving position, i.e., extension position 68-2, also known as the zero position, and is ready to receive tissue for the next tissue sample. Figures 6A-6H The sequence steps will be repeated.
[0078] It is noted that Figure 6E and 6F The sample transfer sequence shown can be repeated multiple times as needed to complete the vacuum transfer of tissue sample 66-1 through vacuum cannula 44. Furthermore, the rearward movement of the protruding member 62-3 of the piercing tip 62 of the mandrel cannula 46 in the proximal direction 36-1 can be implemented as incremental steps, alternating between rearward movement and subsequent forward movement (forward distance less than rearward distance) until the final position (retracted position 68-1) is reached, as shown. Figure 6E and 6G As shown.
[0079] Figure 7 It is a standardized vacuum curve, depicting the vacuum curve at... Figures 6A-6H The baseline vacuum pressure at different locations during the tissue sample cutting and transport sequence is shown.
[0080] refer to Figure 7 The vacuum curve shows that, Figures 6A-6H A vacuum is applied throughout the entire sequence shown. At time T0, vacuum source 22 is activated, and a vacuum (negative pressure) is established in vacuum sleeve 44. At time T1, the maximum vacuum is achieved, which corresponds to... Figure 6D The shown cutting sequence steps have ended. At time T2, Figure 6E-6F The tissue filling sequence begins, and the vacuum pressure suddenly drops momentarily due to the unrestricted vent 80 in the mandrel cannula 46. Before time T3, the vacuum begins to build up and is maximized when the protruding member 62-3 of the puncture tip 62 approaches the flared portion 44-2 of the vacuum cannula 44. Figure 6E The first padding sequence shown ends. At time T3, due to... Figure 6F As shown, the protruding member 62-3 of the piercing tip 62 moves away from the flared portion 44-2, and the vacuum pressure suddenly drops. In some cases, tissue sample 66-1 can be transported to sample cup 56. At time T4, Figure 6G and 6H The second padding sequence begins as shown. Time T5 corresponds to... Figure 6G The second padding sequence shown ends. At time T6, due to... Figure 6H The protruding member 62-3 that pierces the tip 62 moves away from the flared portion 44-2 again, the vacuum pressure drops, and it returns to the tissue receiving (zero) position.
[0081] Through Figures 6A-6H The different stages of the tissue cutting and transport sequence shown will be compared with the actual vacuum pressure. Figure 7 By comparing the baseline vacuum curves shown, abnormalities in cutting or tissue transfer can be identified, and corrective actions can be attempted.
[0082] According to one aspect of this disclosure, vacuum sensor 24 provides a vacuum pressure feedback signal to controller circuit 18, and controller circuit 18 executes program instructions to determine whether the actual vacuum pressure provided by vacuum sensor 24 at a corresponding point in the tissue cutting and transfer sequence deviates from the specified value. Figure 7 The baseline pressure of the vacuum curve exceeds a predetermined amount. This predetermined amount can be, for example, the baseline vacuum pressure plus or minus 10%. If the deviation is outside an acceptable range, corrective action can be taken based on when an anomaly occurs in the tissue cutting and transport sequence.
[0083] For example, if the vacuum pressure drops below the baseline by more than an allowable deviation during the time interval between time T1 and T2, this could be an indication of incomplete cutoff, thus allowing the controller circuit 18 to repeat the process without user intervention. Figure 6C and Figure 6D The cutting sequence is shown, instead of immediately entering an error state. Similarly, if the vacuum pressure rises above the baseline by more than an allowable deviation between times T3 and T5, this can be an indication of incomplete tissue transfer through the vacuum sleeve 44, so the controller circuit 18 can increase the number of iterations of sequence steps 6E and 6F without user intervention.
[0084] Refer again Figure 5A Combination Figure 10 and 13 A vacuum is maintained within the biopsy probe assembly 14 by a series of seals. Seal 72 (e.g., a sleeve seal) is positioned to provide a seal between the cutter sleeve 50 and the needle sleeve 46. Seal 74 (e.g., an O-ring) is positioned to provide a seal between the needle sleeve 46 and the vacuum sleeve 44. Seal 76 (e.g., a sleeve seal or O-ring arrangement) is positioned to provide a seal between the vacuum sleeve 44 and the vacuum chamber portion 54-1 of the sample manifold 54. Additionally, seal 78 may be positioned within the collection chamber portion 54-2 of the sample manifold 54 and the sample cup 56. Finally, a seal is placed at the vacuum input port 54-3 at the vacuum interface between the biopsy probe assembly 14 and the biopsy driver assembly 12.
[0085] During operation, the vacuum pump 22-2 of vacuum source 22 establishes a vacuum (negative pressure) within the vacuum container formed by sample manifold 54 and sample cup 56. More specifically, the volume of sample cup 56 and sample manifold 54 defines the intensity of the "vacuum pressurization" and also defines the cycle time of vacuum pump 22-2 of vacuum source 22. In this embodiment, for example, the volume is approximately 25 ml.
[0086] Regarding "vacuum pressurization," the core needle cannula 46 has one or more vents 80 longitudinally separated from the sample notch 60. The vents 80 may be arranged annularly at a predetermined distance proximal to the sample notch 60 and the tip portion 62-1, and when the core needle cannula 46 is retracted to the retracted position 68-1 (see...). Figure 6E and 6G These vents are 80 (see...) Figure 4 The system will be exposed to the atmosphere, with the vent 80 sliding beneath the seal 72 between the cutter sleeve 50 and the core needle sleeve 46. Once these vents 80 are exposed to the atmosphere, the system is “open,” and the established vacuum pressure will be equal to the ambient pressure in addition to the continuous flow supplied by the vacuum pump 22-2 of the vacuum source 22, thus creating a vacuum boosting effect.
[0087] Also refer to Figure 8 and Figure 8A In this embodiment, the vent 80 in the needle sleeve 46 includes at least one longitudinal vent groove 82, and in this embodiment, it may include multiple longitudinal vent grooves 84 (e.g., longitudinal vent grooves 82 and longitudinal vent grooves 86) and multiple circular vent holes 88, such as two or more circular vent holes. In this embodiment, the longitudinal vent grooves 82 and 86 are diametrically opposed. Furthermore, in this embodiment, the proximal ends of the multiple longitudinal vent grooves 84, such as the proximal end 82-1 of the longitudinal vent groove 82 and the proximal end 86-1 of the longitudinal vent groove 86 (see also...) Figure 11 () and the multiple circular vent holes 88 are aligned longitudinally.
[0088] Especially for reference Figure 11 and 14 The seal 72 includes a proximal sealing portion 90 and a distal sealing portion 92. The distal sealing portion 92 of the seal 72 includes a distal sealing lip 92-1, which is positioned to radially engage with the outer diameter (OD) of the cutter sleeve 50. The proximal sealing portion 90 of the seal 72 includes a proximal sealing lip 90-1, which is positioned to radially engage with the outer diameter (OD) of the mandrel sleeve 46.
[0089] Each longitudinal vent groove, such as a plurality of longitudinal vent grooves 84, of the core needle cannula 46 is configured in size and shape to promote an increased airflow to the vacuum lumen 44-3 of the vacuum cannula 44 compared to the airflow through a corresponding number of circular vent holes, thereby aiding in the movement of the severed tissue sample 66-1 in a proximal direction 36-1 (see also...). Figure 6E-6G For example, in this embodiment, each of the multiple longitudinal venting slots 82, 86 of the core needle sleeve 46 may have a longitudinal length of 21 mm and a width of 0.75 mm.
[0090] More specifically, reference Figure 9-14 When the cannula 46 is retracted towards the proximal direction 36-1 towards the retracted position 68-1 (see...) Figure 6D-6E Each of the plurality of longitudinal vent grooves 84 of the core needle sleeve 46 opens a sealing bypass path 94 within the longitudinal extension of the proximal sealing lip 90-1 of the proximal sealing portion 90 of the seal 72 (see...). Figure 11 and 14 This is to establish a first air path 94-1 at intermediate lumen 96 between the outer diameter (OD) of vacuum sleeve 44 and the inner diameter (ID) of mandrel sleeve 46, and a second air path 94-2 at intermediate lumen 98 between the ID of cutter sleeve 50 and the OD of mandrel sleeve 46. When the sealed bypass path 94 is established (i.e., by positioning at least one longitudinal vent groove of mandrel sleeve 46, such as longitudinal vent groove 82 and / or longitudinal vent groove 86, to longitudinally bridge the proximal sealing lip 90-1 of the proximal sealing portion 90 of seal 72), each of the first air path 94-1 and the second air path 94-2 is in fluid communication with the atmosphere in the region proximal to seal 72.
[0091] Further reference Figure 15The first air path 94-1 and the second air path 94-2 converge at the sample notch 60 of the core needle sleeve 46 to establish a combined airflow 100 from the first air path 94-1 and the second air path 94-2 to the vacuum cavity 44-3 of the vacuum sleeve 44. This promotes an increase in airflow to the vacuum cavity 44-3 of the vacuum sleeve 44 compared to the airflow using multiple circular vents 88 (e.g., 6) without using longitudinal vent slots. In other words, Figure 15 The illustration shows the use of at least one longitudinal venting slot 82, and in this embodiment, multiple longitudinal venting slots 84. More air flows through and out of both intermediate lumens 96 and 98, where the combined airflow 100 reaches the tissue sample 66-1. Then, due to the additional (second) air path 94-2, more air can move into the vacuum lumen 44-3 of the vacuum sleeve 44, thereby moving the tissue sample 66-1 through the vacuum lumen 44-3 of the vacuum sleeve 44, thus allowing pressure equalization to occur more quickly and strongly. Without at least one longitudinal slot 82 and / or longitudinal venting slot 86 of the mandrel sleeve 46, the additional (second) air path 94-2 would not be possible with the component arrangement of this embodiment.
[0092] The following items are also covered by this disclosure:
[0093] A biopsy device, comprising:
[0094] A drive assembly with an electromechanical power source and a vacuum source; and
[0095] A biopsy probe assembly releasably attached to a driver assembly, the biopsy probe assembly having a cutter sleeve, a vacuum sleeve, and a needle sleeve coaxially arranged along a longitudinal axis, the vacuum sleeve being positioned inside the needle sleeve to define a first intermediate lumen therebetween, the needle sleeve being positioned inside the cutter sleeve to define a second intermediate lumen therebetween, and the vacuum sleeve having a vacuum lumen.
[0096] The vacuum chamber of the vacuum sleeve is fluidly connected to the vacuum source.
[0097] The core needle cannula is connected in a drive-through manner to an electromechanical power source. The core needle cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position. The core needle cannula has a proximal portion and a distal portion, the distal portion having a sample notch.
[0098] The core needle cannula has multiple vents arranged near the sample recess, each vent including at least one longitudinal vent groove; and
[0099] A seal having a proximal sealing portion and a distal sealing portion, the distal sealing portion having a distal sealing lip positioned to radially engage with the outer diameter of the cutter sleeve, and the proximal sealing portion having a proximal sealing lip positioned to radially engage with the outer diameter of the mandrel sleeve.
[0100] The biopsy device is configured such that, as the mandrel cannula moves from a first extended position toward a first retracted position, the at least one longitudinal vent groove is longitudinally positioned below the proximal sealing lip of the proximal sealing portion of the seal, to open a sealing bypass path within the longitudinal extension range of the proximal sealing lip of the proximal sealing portion of the seal, thereby establishing a first air path in the first intermediate cavity between the outer diameter of the vacuum cannula and the inner diameter of the mandrel cannula, and a second air path in the intermediate cavity between the inner diameter of the cutter cannula and the outer diameter of the mandrel cannula. The first and second air paths are in fluid communication with a region located proximal to the seal.
[0101] The cutter sleeve is connected in a drive-through manner to an electromechanical power source and is movable relative to the mandrel sleeve between a second extended position covering the sample notch and a second retracted position exposing the sample notch when the mandrel sleeve is in the first extended position.
[0102] The following numerical terms can be used to describe the various embodiments:
[0103] 1. A biopsy device, comprising: a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a needle cannula coaxially arranged along a longitudinal axis, the vacuum cannula being positioned inside the needle cannula to define a first intermediate lumen therebetween, the needle cannula being positioned inside the cutter cannula to define a second intermediate lumen therebetween, and the vacuum cannula having a vacuum lumen, wherein: the needle cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position; and the needle cannula has a plurality of vents, the plurality of vents including at least one longitudinal vent groove; and a seal having a proximal sealing portion and a distal sealing portion, the distal sealing portion having a distal sealing lip, the distal sealing lip being positioned to radially engage with the outer diameter of the cutter cannula, and the proximal sealing portion having a ... The side sealing portion has a proximal sealing lip positioned to radially engage with the outer diameter of the mandrel sleeve, wherein: when the mandrel sleeve moves from the first extended position toward the first retracted position, the at least one longitudinal vent groove is longitudinally positioned below the proximal sealing lip of the proximal sealing portion of the seal to open a sealing bypass path within the longitudinal extension range of the proximal sealing lip of the proximal sealing portion of the seal, thereby establishing a first air path in the first intermediate cavity between the outer diameter of the vacuum sleeve and the inner diameter of the mandrel sleeve and establishing a second air path in the second intermediate cavity between the inner diameter of the cutter sleeve and the outer diameter of the mandrel sleeve, the first air path and the second air path being in fluid communication with a region located proximal to the seal.
[0104] 2. The biopsy device as described in Clause 1 further includes a driver assembly having an electromechanical power source and a vacuum source, wherein the biopsy probe assembly is releasably attached to the driver assembly.
[0105] 3. The biopsy device as described in any of the preceding clauses further includes a driver assembly having an electromechanical power source and a vacuum source, wherein the vacuum cavity of the vacuum sleeve is fluidly connected to the vacuum source.
[0106] 4. The biopsy device as described in any of the preceding clauses further includes a driver assembly having an electromechanical power source and a vacuum source, wherein the needle sheath is driven and connected in communication with the electromechanical power source.
[0107] 5. The biopsy device as described in any of the preceding clauses further includes a driver assembly having an electromechanical power source and a vacuum source, wherein the cutter sleeve is driven and connected in communication with the electromechanical power source.
[0108] 6. The biopsy device as described in any of the preceding clauses, wherein the cutter cannula is movable relative to the needle cannula between a second extended position covering the sample notch of the needle cannula and a second retracted position exposing the sample notch when the needle cannula is in the first extended position.
[0109] 7. The biopsy device as described in any of the preceding clauses, wherein the needle cannula has a proximal portion and a distal portion, the distal portion defining a sample notch.
[0110] 8. The biopsy device as described in any of the preceding clauses, wherein the plurality of air vents are arranged near the sample recess.
[0111] 9. The biopsy device as described in any of the preceding clauses, wherein the first air path and the second air path converge at the sample notch.
[0112] 10. The biopsy device as described in any of the preceding clauses, wherein the plurality of vents includes at least two longitudinal vent slots.
[0113] 11. The biopsy device as described in any of the preceding clauses, wherein the first longitudinal ventilation slot and the second longitudinal ventilation slot are opposite each other in diameter.
[0114] 12. The biopsy device as described in any of the preceding clauses, wherein the plurality of vents includes at least one circular vent hole.
[0115] 13. The biopsy device as described in any of the preceding clauses, wherein the proximal end of the at least one longitudinal ventilation slot is aligned with the at least one circular ventilation hole.
[0116] 14. A method comprising: applying a vacuum to a lumen of a needle sleeve of a biopsy apparatus at a sample notch in the needle sleeve of the biopsy apparatus via a vacuum sleeve of the apparatus, wherein: the cutting sleeve, the vacuum sleeve, and the needle sleeve of the biopsy apparatus are coaxially arranged along a longitudinal axis; the vacuum sleeve is positioned inside the needle sleeve to define a first intermediate lumen therebetween; the needle sleeve is positioned inside the cutting sleeve to define a second intermediate lumen therebetween; and the vacuum sleeve has a vacuum lumen; the needle sleeve is movable relative to the vacuum sleeve and the cutting sleeve between the first extended position and the first retracted position; the needle sleeve has a plurality of vents, the plurality of vents including at least one longitudinal vent groove; and the biopsy apparatus includes a seal having a proximal sealing portion and a distal sealing portion, the distal sealing portion having a distal sealing lip positioned relative to the outer diameter of the cutting sleeve. The seal is radially engaged, and the proximal sealing portion has a proximal sealing lip positioned to radially engage with the outer diameter of the mandrel sleeve; and the mandrel sleeve is moved toward the first retracted position to move a cut tissue sample into the vacuum sleeve, wherein: as the mandrel sleeve moves toward the first retracted position, at least one longitudinal vent groove is longitudinally positioned below the proximal sealing lip of the proximal sealing portion of the seal to open a sealing bypass path within the longitudinal extension of the proximal sealing lip of the proximal sealing portion of the seal, thereby establishing a first air path in the first intermediate cavity between the outer diameter of the vacuum sleeve and the inner diameter of the mandrel sleeve and a second air path in the second intermediate cavity between the inner diameter of the cutter sleeve and the outer diameter of the mandrel sleeve, the first air path and the second air path being in fluid communication with a region located proximal to the seal.
[0117] 15. The method of Clause 14, wherein the cutter sleeve is movable relative to the mandrel sleeve between a second extended position covering the sample notch and a second retracted position exposing the sample notch when the mandrel sleeve is in the first extended position.
[0118] 16. The method of any one of the preceding clauses further comprises: moving the needle cannula toward the first extended position to puncture tissue with the needle cannula; and moving the cutter cannula toward the second retracted position to expose a sample notch in the needle cannula, wherein: a vacuum is applied via the vacuum cannula to aspirate the tissue through the sample notch into the lumen of the needle cannula.
[0119] 17. The method as described in any of the preceding clauses further comprises: moving the cutter cannula to the second extended position to cut the severed tissue sample from the tissue.
[0120] 18. The method of any one of the preceding clauses, wherein the first air path and the second air path converge at the sample notch.
[0121] 19. The method as described in any of the preceding clauses further includes applying a vacuum via the vacuum sleeve while moving the core cannula toward the first retracted position to move the severed tissue sample into the vacuum sleeve.
[0122] 20. The method as described in any of the preceding clauses, wherein the plurality of vents includes at least two longitudinal vent slots, wherein the first longitudinal vent slot and the second longitudinal vent slot are diametrically opposed.
[0123] As used herein, “basically,” “slightly,” “approximately,” and other degree words are relative modifiers used to indicate permissible variations from the feature that is so modified. They are not intended to be limited to the absolute value or feature they modify, but rather to have more physical or functional characteristics than their counterparts, and to be close to or approximate such physical or functional characteristics.
[0124] Furthermore, as used herein, the term “link” and its derivatives are intended to include any operational functional connection, i.e., a direct or indirect connection.
[0125] Although this application has been described with respect to at least one embodiment, further modifications can be made to this application within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the claimed subject matter using its general principles.
Claims
1. A biopsy device, comprising: A biopsy probe assembly has a cutter sleeve, a vacuum sleeve, and a core needle sleeve arranged coaxially along a longitudinal axis. The vacuum sleeve is positioned inside the core needle sleeve to define a first intermediate lumen therebetween. The core needle sleeve is positioned inside the cutter sleeve to define a second intermediate lumen therebetween. The vacuum sleeve has a vacuum lumen, wherein: The core needle sleeve is movable relative to the vacuum sleeve and the cutter sleeve between a first extended position and a first retracted position; and The core needle sleeve has multiple vents, each vent including at least one longitudinal vent groove; and A seal has a proximal sealing portion and a distal sealing portion, the distal sealing portion having a distal sealing lip positioned to radially engage with the outer diameter of the cutter sleeve, and the proximal sealing portion having a proximal sealing lip positioned to radially engage with the outer diameter of the mandrel sleeve, wherein: As the mandrel sleeve moves from the first extended position toward the first retracted position, the at least one longitudinal vent groove is longitudinally positioned below the proximal sealing lip of the proximal sealing portion of the seal, so as to open a sealing bypass path within the longitudinal extension range of the proximal sealing lip of the proximal sealing portion of the seal, thereby establishing a first air path in the first intermediate cavity between the outer diameter of the vacuum sleeve and the inner diameter of the mandrel sleeve and establishing a second air path in the second intermediate cavity between the inner diameter of the cutter sleeve and the outer diameter of the mandrel sleeve, the first air path and the second air path being in fluid communication with the region located proximal to the seal.
2. The biopsy device as claimed in claim 1 further includes a driver assembly having an electromechanical power source and a vacuum source, wherein, The biopsy probe assembly is releasably attached to the driver assembly.
3. The biopsy device as claimed in claim 1 further includes a driver assembly having an electromechanical power source and a vacuum source, wherein, The vacuum chamber of the vacuum sleeve is fluidly connected to the vacuum source.
4. The biopsy device of claim 1 further includes a driver assembly having an electromechanical power source and a vacuum source, wherein, The core needle sleeve is connected in a driving communication with the electromechanical power source.
5. The biopsy device of claim 1, further comprising a driver assembly having an electromechanical power source and a vacuum source, wherein, The cutter sleeve is connected in a driving communication with the electromechanical power source.
6. The biopsy device as described in claim 1, wherein, The cutter sleeve is movable relative to the mandrel sleeve between a second extended position covering the sample notch of the mandrel sleeve and a second retracted position exposing the sample notch when the mandrel sleeve is in the first extended position.
7. The biopsy device as described in claim 1, wherein, The core needle cannula has a proximal portion and a distal portion, the distal portion defining a sample notch.
8. The biopsy device as described in claim 7, wherein, The plurality of vents are arranged at a position near the sample recess.
9. The biopsy device as described in claim 7, wherein, The first air path and the second air path converge at the notch of the sample.
10. The biopsy device as claimed in claim 1, wherein, The plurality of vents includes at least two longitudinal vent slots.
11. The biopsy device as claimed in claim 10, wherein, The first longitudinal ventilation slot and the second longitudinal ventilation slot are opposite each other in diameter.
12. The biopsy device as claimed in claim 1, wherein, The plurality of vents includes at least one circular vent hole.
13. The biopsy device as claimed in claim 12, wherein, The proximal end of the at least one longitudinal ventilation slot is aligned with the at least one circular ventilation hole.