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JP-7857454-B2 - Real-time sampling system

JP7857454B2JP 7857454 B2JP7857454 B2JP 7857454B2JP-7857454-B2

Inventors

  • ジェイソン・ティー・パンゼンベック
  • デイヴィッド・エー・ヘリン
  • クリストファー・アール・ラルフ

Assignees

  • ジャイラス エーシーエムアイ インク ディー／ビー／エー オリンパス サージカル テクノロジーズ アメリカ

Dates

Publication Date
20260512
Application Date
20250206
Priority Date
20190827

Claims (15)

  1. It is a device, A sheath comprising a first lumen and a second lumen, It comprises a handle, and the handle is A connector that can be connected to the proximal end of the endoscope, A shaft portion rotatably connected to the proximal end of the connector, The manifold is slidably received by the shaft portion, and the manifold is A distal end connectable to the sheath, the distal end comprising a first manifold lumen aligned with the longitudinal axis of the handle and connectable to the first lumen, and a second manifold lumen aligned with the longitudinal axis and connectable to the second lumen, A probe port connected to the proximal end of the lumen of the first manifold, configured to receive an ultrasonic probe, An angled port, angled with respect to the longitudinal axis and connected to the proximal end of the lumen of the second manifold, is configured to receive a sampling needle and guide the sampling needle into the lumen of the second manifold, A device comprising: a safety mechanism disposed within the angled port, configured to prevent distal movement of the medical instrument handle shaft below a predetermined threshold.
  2. The device according to claim 1, wherein the safety mechanism includes a keying mechanism connected to the angled port, and the keying mechanism secures a medical instrument actuator within the handle.
  3. The device according to claim 2 , wherein the safety mechanism includes a first keyway connectable to the angled port.
  4. The device according to claim 3, wherein the safety mechanism includes a second keyway disposed within the inner radius of the proximal end of the angled port and within the first keyway.
  5. The device according to claim 4, wherein the second keyway is rotationally offset from the first keyway.
  6. The device according to claim 2 , wherein the safety mechanism is configured to receive a keying pin disposed at the distal end of the medical instrument actuator.
  7. The device according to claim 6, wherein the safety mechanism receives the keying pin through a first keyway in a first rotational orientation and receives the keying pin through a second keyway in a second rotational orientation.
  8. The device according to claim 4, wherein the safety mechanism includes a divided O-ring disposed between the first keyway and the second keyway, and is configured to provide feedback upon complete insertion of the medical instrument actuator into the angled port.
  9. A manifold device, wherein the manifold device is configured to connect to an endoscope instrument and enable the introduction of an imaging probe and a sampling needle, and the manifold device is A probe port connected to the proximal end of the lumen of the first manifold, configured to receive the imaging probe, An angled port, which is angled with respect to a longitudinal axis aligned with the lumen of the first manifold and connected to the proximal end of the lumen of the second manifold, is configured to receive the sampling needle and guide the sampling needle into the lumen of the second manifold, A manifold device comprising: a safety mechanism disposed within the angled port, configured to prevent distal movement of the sampling needle actuator shaft below a predetermined threshold; and a safety mechanism.
  10. The manifold device according to claim 9, wherein the safety mechanism includes a first keyway connectable to the angled port.
  11. The manifold device according to claim 10, wherein the safety mechanism includes a second keyway disposed within the inner radius of the proximal end of the angled port and within the first keyway.
  12. The manifold device according to claim 11, wherein the second keyway is offset in the rotational direction with respect to the first keyway.
  13. The manifold device according to claim 11, wherein the safety mechanism is configured to receive a keying pin disposed at the distal end of the sampling needle actuator.
  14. The manifold device according to claim 13, wherein the safety mechanism is configured to receive the keying pin through the first keyway in a first rotational orientation and to receive the keying pin through the second keyway in a second rotational orientation.
  15. The manifold apparatus according to claim 11, wherein the safety mechanism includes a divided O-ring disposed between the first keyway and the second keyway, and is configured to provide feedback when the sampling needle actuator is fully inserted into the angled port.

Description

The descriptions in this section may not constitute prior art, but merely provide background information relating to this disclosure. The tools currently available for ultrasound visualization and sampling of peripheral lung tumors have limited range of motion and diagnostic capabilities. Typically, during peripheral sampling, the guide sheath is advanced through the bronchoscope and extends beyond its reach, making the distal end of the guide sheath invisible. A radial endobronchial ultrasound (EBUS) miniprobe is initially threaded through the guide sheath and used to measure the approximate location of the tumor. Unfortunately, peripheral tumors located away from the airway (as opposed to tumors primarily surrounding the airway) have a substantially low diagnostic rate, partly due to the limitations of current radial EBUS technology. This means that while the operator can perceive the depth from the probe, they cannot perceive the direction of the tumor. The sampling needle must extend out-of-axis from the length of the catheter, and therefore, knowledge of the rotational orientation of the needle and the target of sampling is required. Radial ultrasound probes do not indicate the orientation of the needle relative to the lesion. While radial ultrasound images are 360° images that allow the user to see the lesion, the user cannot determine whether the needle is pointing to the lesion or not. This invention provides a device for enabling real-time observation of a patient's tissue sample or drug delivery procedure beyond the field of view of an endoscope that may be used to transport the device. An exemplary device includes a sheath and a handle having at least two lumens. The handle includes a connector that connects to the proximal end of an endoscope, a shaft portion that rotatably connects to the proximal end of the connector, and a manifold that is slidably received by the shaft portion. The manifold includes a distal end that connects to the sheath. The distal end includes at least two lumens, each lumen having a longitudinal axis aligned with one of the at least two lumens of the connected sheath. The manifold also includes a first proximal port having a longitudinal axis coinciding with the longitudinal axis of one of the distal end's longitudinal axes, and a second proximal port having a longitudinal axis angularly related to the longitudinal axis of the second lumen of the two lumens of the distal end. The first proximal port receives a radial ultrasound probe, and the second proximal port receives a medical instrument. The second proximal port allows the medical instrument to pass through the second lumen of the two lumens of the distal end. In one embodiment, the medical device includes a needle. The actuator includes a distal end connected to the proximal end of the needle and a proximal end connected to a suction source. In another embodiment, the shaft portion includes a buckling prevention device that limits buckling of at least one of the sheaths or medical instruments within the shaft portion, and the manifold includes a buckling prevention device that limits buckling of the medical instruments within the manifold. The buckling prevention device may include nesting tubes. In yet another embodiment, the sheath includes a distal end having a distal support member, a proximal support member, and at least two longitudinal support members connected between the distal and proximal support members. The distal support member, the proximal support member, and the at least two longitudinal support members are formed from a machined, punched, or laser-cut hypotube. The distal and proximal support members are ring-shaped. In another embodiment, the distal end includes an inclined surface that allows the distal end of the medical instrument to deflect as the medical instrument is advanced distally. The proximal support member includes a support that provides support to the inclined surface. In yet another embodiment, the second proximal port receives the medical device in a predetermined orientation such that, when the medical device is received into the second proximal port, the distal end of the medical device is oriented in a predetermined orientation with respect to the inclined surface. Further features, advantages, and application areas will become apparent from the descriptions provided herein. Please understand that the descriptions and specific examples are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. The drawings described herein are for illustrative purposes only and are not intended to limit the scope of this disclosure. The elements in the drawings are not necessarily to a specific scale and are primarily intended to illustrate the principles of the invention. The drawings include: This figure shows a real-time system (RTS) and an endoscope.This is a side view of the RTS.Figure 2 is a cross-sectional view of the sheath of the RTS comp