Search

EP-4736797-A1 - FULLY AUTOMATIC BIOPSY NEEDLE WITH HEMOSTASIS FUNCTION

EP4736797A1EP 4736797 A1EP4736797 A1EP 4736797A1EP-4736797-A1

Abstract

Disclosed is a biopsy needle with hemostasis function, which includes: a sampling needle; a cutting needle assembly including a cutting needle and an inner insulating layer covering a periphery of the cutting needle, where the cutting needle is fitted over a periphery of the sampling needle, with the distal end of the cutting needle exposed beyond the inner insulating layer to form a first electrode with the distal end of the sampling needle; a cannula assembly including a cannula and an outer insulating layer, an outer insulating layer, and a cannula plug, where the outer insulating layer covers a periphery of a cannula, with a distal end of the cannula exposed beyond the outer insulating layer to form a second electrode, the cannula assembly is configured to be detachably connected to a handle of the biopsy needle via the cannula plug, allowing the cannula to be coaxially fitted over the periphery of the cutting needle; the proximal ends of the sampling needle and the cannula plug are respectively electrically connected to a power supply device to enable the insertion of the sampling needle and the cutting needle assembly into the cannula after sample tissue extraction, and the application of electrical energy to perform hemostasis operation on the needle tract using the first electrode and the second electrode.

Inventors

  • CHEN, QIANG
  • ZHANG, Yao
  • ZHANG, ZHIQING

Assignees

  • CURAWAY MEDICAL TECHNOLOGY CO., LTD.

Dates

Publication Date
20260506
Application Date
20251023

Claims (10)

  1. A fully automatic biopsy needle with hemostasis function, characterized by comprising: a sampling needle (1) having a sampling groove (1001) provided at a distal end thereof; a cutting needle assembly comprising a cutting needle and an inner insulating layer (3) covering a periphery of the cutting needle, wherein a cutting edge that matches the sampling groove (1001) is provided at a distal end of the cutting needle, the cutting needle is fitted over a periphery of the sampling needle (1), with the distal end of the cutting needle exposed beyond the inner insulating layer (3) to form a first electrode (001) with the distal end of the sampling needle (1); a cannula assembly comprising a cannula (4), an outer insulating layer (5), and a cannula plug (6), wherein the outer insulating layer (5) covers a periphery of a cannula (4), with a distal end of the cannula (4) exposed beyond the outer insulating layer (5) to form a second electrode, the cannula assembly is configured to be detachably connected to a handle (7) of the biopsy needle via the cannula plug (6), allowing the cannula (4) to be coaxially fitted over the periphery of the cutting needle and detachable; and the proximal ends of the sampling needle (1) and the cannula plug (6) are respectively electrically connected to a power supply device (10) to disassemble the cannula assembly from the handle (7) after biopsy sampling, leaving the cannula assembly in a needle tract, and then insert the sampling needle (1) and the cutting needle assembly into the cannula (4) after removing a sample tissue from the sampling groove (1001), and apply electrical energy to perform hemostasis operation on the needle tract using the first electrode (001) and the second electrode (002) .
  2. The fully automatic biopsy needle with hemostasis function according to claim 1, characterized in that the biopsy needle further comprises a distance adjusting block (8), which is slidably connected to the handle (7), with a distal end of the distance adjusting block (8) fixedly connected to the cannula plug (6), after inserting the sampling needle (1) and the cutting needle assembly into the cannula (4), the biopsy needle is configured to at least comprise a sampling configuration and a hemostasis configuration; in the sampling configuration, when the sampling needle (1) and the cutting needle complete sampling, a proximal end of the sampling groove (1001) extends beyond the distal end of the cannula (4); and in the hemostasis configuration, when the sampling needle (1) and the cutting needle maintain the completed sampling, the distance adjusting block (8) and the cannula assembly are adjusted a preset distance distally along a length of a needle body.
  3. The fully automatic biopsy needle with hemostasis function according to claim 2, characterized in that a cross-section of the distance adjusting block (8) matches that of the handle (7), with sliding buckles (81) provided on two sides of an inner wall of the distance adjusting block (8) extending along the length, an outer surface of the handle (7) is provided with chutes (71) that match the sliding buckles (81), the distance adjusting block (8) is configured to be slidably connected to the handle (7) via the sliding buckles (81) and the chutes (71) to enable distance adjustment along the length, after adjusting the distance adjusting block (8) to a predetermined position, a position of the distance adjusting block (8) is locked by a locking structure.
  4. The fully automatic biopsy needle with hemostasis function according to claim 3, characterized in that the locking structure comprises a plurality of locking holes (83) penetrating a surface of the distance adjusting block (8) and an elastic arm locking button (92) with one end fixedly arranged on the handle (7), a protrusion on a free end of the elastic arm locking button (92) is engaged with one of the locking holes (83) to lock axial relative positions of the first electrode (001) and the second electrode (002).
  5. The fully automatic biopsy needle with hemostasis function according to claim 2, characterized in that the biopsy needle further comprises an energy transmission socket (9), which is fixedly connected to the proximal end of the handle (7), with the distal end being a free end, an elastic arm locking button (92) for locking the axial relative positions of the first electrode (001) and the second electrode (002) is arranged on the free end of the energy transmission socket (9), and two electrical connection ends on the energy transmission socket (9) are respectively electrically connected to the cannula plug (6) and the proximal end of the sampling needle (1).
  6. The fully automatic biopsy needle with hemostasis function according to claim 5, characterized in that a first wiring groove (82) is provided at the inner wall of the distance adjusting block (8), and a second wiring groove (91) connected to the first wiring groove (82) is provided at an inner wall of the energy transmission socket (9), conducting wires connecting the cannula plug (6) to the energy transmission socket (9) and the sampling needle (1) to the energy transmission socket (9) extend along the first and/or second wiring grooves (91).
  7. The fully automatic biopsy needle with hemostasis function according to claim 5, characterized by further comprising a portable power supply device (10), which is electrically connected to the energy transmission socket (9) through an electrical pin, wherein the portable power supply device (10) comprises a lithium battery, a DCDC module, an MCU controller, an H-bridge module, and a step-up transformer, the lithium battery supplies power to the MCU controller through the DCDC module, the lithium battery is electrically connected to the H-bridge module, and the MCU controller outputs a driving signal to drive the H-bridge module to output current to the first electrode (001) and the second electrode (002) through the step-up transformer for tissue hemostasis.
  8. The fully automatic biopsy needle with hemostasis function according to claim 7, characterized in that the portable power supply device (10) is detachably connected to the proximal end of the handle (7), a first magnetic attraction piece (101) is provided inside a distal end of the portable power supply device (10), and a second magnetic attraction piece (72) is provided inside the proximal end of the handle (7), the distal end of the portable power supply device (10) is provided with elastic arms with convex clamping points on two sides of a circumference, and the proximal end of the handle (7) is provided with concave clamping points that match the convex clamping points.
  9. The fully automatic biopsy needle with hemostasis function according to claim 1, characterized in that the biopsy needle is configured to detect impedance in real-time via a control system during hemostasis operation, when the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance and the hemostasis operation is repeated until the biopsy needle completely exits the needle tract.
  10. A biopsy needle with hemostasis function, characterized by comprising: a sampling needle (1) having a sampling groove (1001) provided at a distal end thereof; a cutting needle assembly comprising a cutting needle and an inner insulating layer (3) covering a periphery of the cutting needle, wherein a cutting edge that matches the sampling groove (1001) is provided at a distal end of the cutting needle, the cutting needle is fitted over a periphery of the sampling needle (1), with the distal end of the cutting needle exposed beyond the inner insulating layer (3) to form a first electrode (001) with the distal end of the sampling needle (1); a cannula assembly comprising a cannula (4), an outer insulating layer (5), and a cannula plug (6), wherein the outer insulating layer (5) covers a periphery of a cannula (4), with a distal end of the cannula (4) exposed beyond the outer insulating layer (5) to form a second electrode (002), the cannula assembly is configured to be detachably connected to a handle (7) of the biopsy needle via the cannula plug (6), allowing the cannula (4) to be coaxially fitted over the periphery of the cutting needle and detachable; and the proximal ends of the sampling needle (1) and the cannula plug (6) are respectively electrically connected to a power supply device (10) to disassemble the cannula assembly from the handle (7) after biopsy sampling, leaving the cannula assembly in a needle tract, and then insert the sampling needle (1) and the cutting needle assembly into the cannula (4) after removing a sample tissue from the sampling groove (1001), and apply electrical energy to perform hemostasis operation on the needle tract using the first electrode (001) and the second electrode (002).

Description

Technical Field The invention relates to the technical field of medical device, particularly to a fully automatic biopsy needle with hemostasis function and a biopsy needle. Background Art Biopsy is an important means for tumor diagnosis. With an increasing incidence of tumors, the demand for biopsy procedures has been growing annually. According to statistics, the global market size for biopsy needles reached billions of dollars in 2020 and is expected to maintain rapid growth in the coming years. Biopsy procedures are often accompanied by bleeding, necessitating the use of products with hemostasis functions to reduce bleeding risks. With the growth of the biopsy market, the invention also possesses significant technical advantages and market prospects. At present, there are some ablation needles with hemostasis functions on the market, but they often have the following shortcomings: Bulky size and complex operation: They require connection to external radiofrequency or microwave hosts, which increases the difficulty and risks of surgical procedures.High cost: Radiofrequency or microwave hosts are expensive, leading to increased surgical costs.Inadequate hemostatic effect: Some products have ablation-based hemostatic functions but cannot precisely target the biopsy needle tract. This results in poor hemostasis or may cause secondary puncture injuries or bleeding (e.g., the high-temperature carbonization and adhesion of the needle tip can tear other tissues during needle withdrawal, leading to secondary bleeding). Summary of the Invention An objective of the invention is to provide a fully automatic biopsy needle with hemostasis function and a biopsy needle that can promptly perform hemostasis on the needle tract after tissue biopsy,.It features simple operation, low cost, and high safety, eliminating the need for expensive emergency medical resources. This provides precise diagnosis and treatment for tumor patients with high bleeding risks or coagulation disorders, while avoiding excessive consumption of emergency medical resources and promoting the efficient utilization of healthcare resources. The technical solution provided by the invention is: a fully automatic biopsy needle with hemostasis function, which includes: a sampling needle having a sampling groove provided at a distal end thereof;a cutting needle assembly including a cutting needle and an inner insulating layer covering a periphery of the cutting needle, where a cutting edge that matches the sampling groove is provided at a distal end of the cutting needle, the cutting needle is fitted over a periphery of the sampling needle, with the distal end of the cutting needle exposed beyond the inner insulating layer to form a first electrode with the distal end of the sampling needle; the cutting needle includes a cutting part at the distal end and a conveying part connected to a proximal end of the cutting part, with an outer diameter of the conveying part being smaller than that of the cutting part, and the inner insulating layer covers the conveying part;a cannula assembly including a cannula, an outer insulating layer, and a cannula plug, where the outer insulating layer covers a periphery of a cannula, with a distal end of the cannula exposed beyond the outer insulating layer to form a second electrode, the cannula assembly is configured to be detachably connected to a handle of the biopsy needle via the cannula plug, allowing the cannula to be coaxially fitted over the periphery of the cutting needle and detachable; andthe proximal ends of the sampling needle and the cannula plug are respectively electrically connected to a power supply device to disassemble the cannula assembly from the handle after biopsy sampling, leaving the cannula assembly in a needle tract, and then insert the sampling needle and the cutting needle assembly into the cannula after removing a sample tissue from the sampling groove, and apply electrical energy to perform hemostasis operation on the needle tract using the first electrode and the second electrode. Preferably, the biopsy needle further includes a distance adjusting block, which is slidably connected to the handle, with a distal end of the distance adjusting block fixedly connected to the cannula plug, after inserting the sampling needle and the cutting needle assembly into the cannula, the biopsy needle is configured to at least include a sampling configuration and a hemostasis configuration; in the sampling configuration, when the sampling needle and the cutting needle complete sampling, a proximal end of the sampling groove extends beyond the distal end of the cannula; andin the hemostasis configuration, when the sampling needle and the cutting needle maintain the completed sampling, the distance adjusting block and the cannula assembly are adjusted a preset distance distally along a length of a needle body. Preferably, a cross-section of the distance adjusting block matches that of the handle, with sliding