Low-cost instrument for endoscopically guided operative procedures

• US 9,622,646 B2
• Filed: 07/02/2013
• Issued: 04/18/2017
• Est. Priority Date: 06/25/2012
• Status: Active Grant

• Current Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Original Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Inventors: Ouyang, Xiaolong, Indman, Paul D., Deckman, Robert K., Wang, Shih-Ping
• Primary Examiner(s): NEAL, TIMOTHY JAY
• Application Number:
  US14/409,281
• Publication Number:
  US 20160174819A1
• Time in Patent Office: 1,386 Days
• CPC Class Codes: A61B 1/00052 positioned at proximal end of the endoscope body
• CPC Class Codes: A61B 1/00066 Proximal part of endoscope body, e.g. handles A61B1/0052 takes precedence
• CPC Class Codes: A61B 1/00098 Deflecting means for inserted tools
• CPC Class Codes: A61B 1/00103 designed for single use
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/0011 Manufacturing of endoscope parts
• CPC Class Codes: A61B 1/00128 mechanical, e.g. for tubes or pipes
• CPC Class Codes: A61B 1/00133 Drive units for endoscopic tools inserted through or with the endoscope
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/0034 : adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61B 2017/0046 : with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00738 : part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
• CPC Class Codes: A61B 2017/4216 : Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2017/4233 : Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/0807 : Indication means
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61M 5/00 : Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

Installments and methods are described for performing endoscopically guided operative procedures. According to some embodiments, a re-usable portion of the instrument includes a handle, electronics and an integrated display screen while a fluid hub and a cannula which includes a CMOS imaging module and LED lighting, form a single use portion of the instrument. The cannula includes a working channel configured to accept an operative device for performing the operative procedures.

Claims

1. A hand-held medical instrument for performing an endoscopically-guided operative procedure on a uterus of a patient, the instrument comprising:

a single-use portion comprising;

an elongated conduit having a distal portion configured and dimensioned for insertion into the uterus through a cervix of the patient and having a proximal portion;

a fluid hub connected to the proximal portion of the elongated conduit;

one or more fluid connection ports formed in the fluid hub;

one or more distal openings at the distal portion of the elongated conduit configured to provide fluid from the elongated conduit and into the uterus;

an imaging system at the distal portion of the elongated conduit configured to image the uterus and provide video signals;

an illumination system at the distal portion of the elongated conduit configured to illuminate the uterus at an illumination field viewed by the imaging system;

an electrical cable extending from the proximal portion of the elongated conduit to the imaging system and configured to carry video signals and control signals;

a sliding connector attached to a proximal end of the fluid hub that isolates fluid to the single-use portion, the sliding connector comprising;

an outer shell, and

a fluid barrier disposed within the outer shell and surrounding the electrical cable, wherein the outer shell and the fluid barrier together form a first seal at a proximal end of the outer shell, wherein the fluid barrier and the electrical cable together form a second seal at a distal end of the fluid barrier, and wherein the fluid barrier and the electrical cable together form a third seal located proximal to the second seal and along a radial projection of the electrical cable that seats within a radial recess of the fluid barrier; and

a working channel within the elongated conduit including an entry point formed in the fluid hub and a distal opening at the distal portion of the elongated conduit, the working channel configured to allow passage of an operative device configured to perform the endoscopically-guided operative procedure and configured to be inserted at the entry point; and

a multiple-use portion having interior and exterior surfaces, the multiple-use portion being configured to be attached to the single-use portion for a single use, detached after the single use, and re-used with a second single-use portion without sterilization of the interior surfaces, the multiple-use portion comprising;

a handle by which a user can grasp the hand-held medical instrument, the handle coupled to the proximal end of the outer shell of the sliding connector and being located proximal to the sliding connector and to the fluid hub such that the handle, the sliding connector, the fluid hub, and the elongated conduit are arranged in an in-line configuration; and

an integral image display that is electrically coupled with the imaging system at least in part by the electrical cable, the integral image display being located proximal to the handle and configured to display images provided by the imaging system for viewing by the user.

2. An instrument according to claim 1 wherein the elongated conduit comprises:

a first fluid channel in fluid communication with at least a first of the one or more distal openings and with a first fluid connection port of the one or more fluid connection ports; and

a second fluid channel in fluid communication with at least a second of the one more distal opening and with a second fluid connection port of the one or more fluid connection ports, wherein the first fluid channel is configured to deliver fluid into the patient from the first distal opening and the second fluid channel is configured to withdraw fluid from the patient into the second distal opening.

3. An instrument according to claim 2 wherein the first distal opening is positioned on a distal end surface close to the imaging system and is configured to aid in imaging by at least in part flowing clear liquid in a vicinity of the imaging system, the second fluid channel being in further fluid communication with a third and a fourth of the one or more distal openings, and the second, third, and fourth distal openings being positioned position on a side surface of the elongated conduit.

4. An instrument according to claim 2 wherein the instrument is configured for the endoscopically-guided operative procedure such that when the distal portion is inserted into the uterus of the patient to simultaneously provide (a) imaging portions of the uterus by illuminating portions of the uterus with the illumination system, imaging the illuminated portions of the uterus with the imaging system, and delivering fluid flow in a distal direction by introducing fluid under positive pressure into the first fluid connection port, which fluid passes through the first fluid channel and enters the uterus through at least the first distal opening, and (b) for displaying live video images from the imaging system to an operator on the integral image display of the imaged portions of the uterus, the live video images aiding the operator in performing the endoscopically-guided operative procedure.

5. An instrument according to claim 1 wherein at least one of the first, second, and third seals is at least partially formed by one or more ultrasonic bonding processes during manufacture.

6. An instrument according to claim 1 wherein the outer shell is fabricated as two pieces that are bonded together using one or more ultrasonic bonding processes during manufacture.

7. An instrument according to claim 1 wherein the endoscopically-guided operative procedure is a tubal sterilization procedure.

8. An instrument according to claim 7, wherein a distal portion of the elongated conduit is bent at an angle of between 15 degrees and 35 degrees from a central longitudinal axis of the elongated conduit.

9. An instrument according to claim 1 wherein the endoscopically-guided operative procedure is localized drug delivery, and the operative device includes an injection needle.

10. An instrument according to claim 9 wherein the proximal portion of the elongated conduit includes an alignment guide member configured to aid in insertion of the injection needle through the entry point of the working channel.

11. An instrument according to claim 10 wherein the operative device includes a locking device configured to facilitate passage of the injection needle through at least a portion of the working channel by fixing an orientation of the injection needle with respect to the alignment guide member.

12. An instrument according to claim 9 wherein the injection needle includes one or more markings on the exterior of the injection needle configured to visually aid an operator in controlling a depth of deployment of the injection needle.

13. An instrument according to claim 9 wherein a distal tip of the injection needle includes a beveled portion shaped so as to facilitate passage of the injection needle through the working channel.

14. An instrument according to claim 1 wherein the working channel includes a valve configured to inhibit backflow of fluid from the patient through the working channel and out of the entry point of the working channel.

15. An instrument according to claim 1 wherein at least a portion of an internal surface of the working channel is made of a non-wetting fluoropolymer material.

16. An instrument according to claim 1 wherein the operative device is selected from a group consisting:

of needles;

forceps;

surgical scissors;

clip fixing devices;

ligating devices;

electrosurgical electrodes, fibers or cables for delivery of microwave, laser, and/or other energy sources;

knives;

catheters;

cleaning devices; and

balloon dilators.

17. An instrument according to claim 1 wherein the handle includes a plurality of buttons to control a plurality of features of the instrument, wherein when the single-use and multiple-use portions are attached to one another, the display, the handle, the elongated conduit, and the imaging system are mounted in a fixed relationship so as to rotate about a longitudinal axis defined by the elongated conduit in rotational alignment.

18. An instrument according to claim 1 in which the illumination system comprises at least one LED device at the distal portion of the elongated conduit.

19. The instrument according to claim 1 wherein the integral image display is pivotable with respect to a longitudinal axis defined by the elongated conduit.

20. The instrument according to claim 1 wherein the fluid hub surrounds the proximal portion of the elongated conduit.

21. The instrument according to claim 20 wherein the fluid hub surrounds a central longitudinal axis defined by the elongated conduit along an entire length of the fluid hub.

22. The instrument according to claim 1 wherein the handle seats within the proximal end of the outer shell of the sliding connector.