Low-Cost Instrument for Endoscopically Guided Operative Procedures

• US 20160174819A1
• Filed: 07/02/2013
• Published: 06/23/2016
• Est. Priority Date: 06/25/2012
• Status: Active Grant

• Current Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Original Assignee: EndoSee Corporation (The Cooper Cos., Inc.)
• Inventors: Ouyang, Xiaolong, Indman, Paul D., Deckman, Robert K., Wang, Shih-Ping
• Granted Patent: US 9,622,646 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 with imaging means A61B90/37, A61B34/20
• 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 for prosthetic joint-implanting tools A61F2/4603
• 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 low-cost hand-held medical instrument for performing an endoscopically-guided operative procedure on a patient'"'"'s uterus, said instrument comprising:

a single-use portion comprising;

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

one or more fluid connection ports formed at the proximal portion of the conduit;

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

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

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

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

a working channel within the conduit including an entry point at the proximal portion and a distal opening at the distal portion, the working channel configured to allow passage of an operative device configured to perform said operative procedure inserted at the entry point;

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 and then detached after a single use, and to be re-used with a second single-use portion without sterilization of the interior surfaces, said multiple-use portion comprising an integral image display that is electrically coupled with said imaging system at least in part by the electrical cable, the display being configured to display images provided by the imaging system for viewing by a user; and

one or more seals configured to prevent fluid in the conduit from contacting the interior surfaces of said multiple-use portion.

2. An instrument according to claim 1 wherein the 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 fourth of said one or more distal openings and the second, third and fourth distal opening being position on a side surface of said conduit.

4. An instrument according to claim 2 wherein the instrument is configured for said operative procedure such that when said distal portion is inserted into the patient'"'"'s uterus to simultaneously provide (a) imaging portions of the uterus by illuminating portions of the uterus with said illumination system, imaging the illuminated portions of the uterus with said imaging system, and delivering fluid flow in a distal direction by introducing fluid under positive pressure into said first fluid connection port, which fluid passes through said first fluid channel and enters the uterus through at least the first distal opening, and (b) 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 operative procedure.

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

6. An instrument according to claim 1 wherein the proximal portion of the conduit includes an outer shell 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 said operative procedure is a tubal sterilization procedure.

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

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

10. An instrument according to claim 9 wherein the proximal portion of said conduit includes an alignment guide member configured to aid in insertion of the injection needle through said 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 needle through at least a portion of the working channel by fixing an orientation of the needle with respect to the alignment guide member.

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

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

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

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

16. An instrument according to claim 1 wherein said operative device is selected from 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 said multiple-use portion further comprises a handle having a low overall off-axis profile configured to facilitate grasping by the user'"'"'s hand and rotation and tilting of the instrument in use, the handle including a plurality of buttons to control a plurality of features of the instrument, wherein when said single-use and multiple-use portions are attached to one another, the display, handle, elongate member and imaging system are mounted in a fixed relationship so as to rotate about a longitudinal axis of the elongate member in rotational alignment.

18. An instrument according to claim 1 wherein said single-use portion further comprises a handle having a low overall off-axis profile configured to facilitate grasping by the user'"'"'s hand and rotation and tilting of the instrument in use.

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

20. A method of performing an operative procedure in a patient'"'"'s uterus with a hand-held, self-contained instrument, said method comprising:

releasably attaching by hand a sterile single-use portion of the instrument to a multiple-use portion of the instrument;

introducing a distal portion of the single-use portion of the instrument into the patient'"'"'s uterus, said single-use portion comprising an elongated conduit including a working channel having an operative device entry point at a proximal portion of the conduit and an operative device distal opening at the distal portion, the conduit further including one or more internal fluid channels in fluid communication with one or more distal openings at said distal portion of the instrument;

illuminating a portion of the patient'"'"'s uterus with an illumination system emitting light at the distal end of the instrument;

imaging the uterus while illuminated with an imaging system located at the distal end of the instrument;

sending live video format images of the uterus from the illumination system through a cable in the conduit;

displaying the live video images on a display that is a part of the multiple-use portion of the instrument to move therewith and is connected to the cable;

performing the operative procedure under guidance of the displayed live video images using an operative device disposed within the working channel of the conduit;

keeping fluid from the conduit from contaminating interior portions of the multiple-use portion through the use of one or more fluid barriers in the instrument;

releasing by hand and removing the single-use portion from the multiple-use portions; and

attaching a new sterile single-use portion to the multiple-use portions to prepare the instrument for performing another operative procedure.

21. A method according to claim 20 further comprising introducing fluid into a first of said one or more fluid channels and causing the fluid to flow into the patient'"'"'s uterus through at least a first of said one or more distal openings.

22. A method according to claim 20 further comprising controlling the illumination and imaging systems with operator-manipulated buttons on at least one of the single-use and multiple-use portions.

23. A method according to claim 22 in which said controlling comprises manipulating buttons on a handle that is a part of the multiple-use portion of the instrument and that the user grasps to manipulate the instrument while performing the operative procedure.

24. A method according to claim 20 further comprising after said releasing and before said attaching a new sterile single-use portion, disinfecting the multiple-use portion in a manner that does not require sterilization.

25. A method according to claim 20 wherein said operative procedure is a tubal sterilization procedure, and the distal portion of the instrument is bent at an angle of between 15 degrees and 35 degrees from a central longitudinal axis of the conduit.

26. A method according to claim 20 wherein said operative procedure is localized drug delivery, and said operative device includes an injection needle.

27. A method according to claim 26 further comprising aligning the injection needle with a portion of said working channel using an alignment guide mounted on the instrument.

28. A method according to claim 20 wherein said operative procedure uses an operative device is selected from group consisting:

of needles;

forceps;

surgical scissors;

clip fixing devices;

ligating devices;

coagulation electrodes;

knives;

catheters;

cleaning devices; and

balloon dilators.