U.S. patent application number 15/462331 was filed with the patent office on 2018-07-26 for handheld surgical endoscope.
The applicant listed for this patent is UroViu Corp.. Invention is credited to Robert K. Deckman, Xiaolong Ouyang, Chih-Yu Ting, Shih-Ping WANG.
Application Number | 20180206707 15/462331 |
Document ID | / |
Family ID | 59239741 |
Filed Date | 2018-07-26 |
United States Patent
Application |
20180206707 |
Kind Code |
A9 |
Ouyang; Xiaolong ; et
al. |
July 26, 2018 |
HANDHELD SURGICAL ENDOSCOPE
Abstract
A handheld surgical endoscope has a disposable, single-use
portion that includes a fluid hub, cannula, distal tip and an
integrated needle and a re-usable portion that includes a handle
and display module. The distal tip includes LED illumination and an
imaging module that feeds live video to the display module that is
rotatable to allow viewing by the operator and others. The
single-use and re-usable portions mate and un-mate with each other
via physically separated mechanical and electrical connectors. The
needle is actuatable to allow for both recessed and extended
positions. The needle delivers liquid from a attached syringe that
can be attached to the handle to move therewith or only connected
to the endoscope by a flexible conduit. The surgical endoscope is
configured for operation by a single clinician in many
procedures.
Inventors: |
Ouyang; Xiaolong; (Bellevue,
WA) ; Deckman; Robert K.; (San Bruno, CA) ;
Ting; Chih-Yu; (New Taipei City, TW) ; WANG;
Shih-Ping; (PALO ALTO, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
UroViu Corp. |
Bellevue |
WA |
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20170188793 A1 |
July 6, 2017 |
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|
Family ID: |
59239741 |
Appl. No.: |
15/462331 |
Filed: |
March 17, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15371858 |
Dec 7, 2016 |
9895048 |
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15462331 |
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PCT/US2016/018670 |
Feb 19, 2016 |
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15371858 |
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14913867 |
Feb 23, 2016 |
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PCT/US2016/018670 |
Feb 19, 2016 |
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15371858 |
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14913867 |
Feb 23, 2016 |
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14913867 |
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PCT/US2016/065396 |
Dec 7, 2016 |
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14913867 |
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14913867 |
Feb 23, 2016 |
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PCT/US2016/065396 |
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PCT/US2016/018670 |
Feb 19, 2016 |
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14913867 |
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PCT/US2016/018670 |
Feb 19, 2016 |
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PCT/US2016/018670 |
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15371858 |
Dec 7, 2016 |
9895048 |
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PCT/US2016/065396 |
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62339810 |
May 21, 2016 |
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62362643 |
Jul 15, 2016 |
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62375814 |
Aug 16, 2016 |
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62405930 |
Oct 9, 2016 |
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62416403 |
Nov 2, 2016 |
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62443769 |
Jan 8, 2017 |
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62449257 |
Jan 23, 2017 |
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62452883 |
Jan 31, 2017 |
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62275222 |
Jan 5, 2016 |
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62275241 |
Jan 6, 2016 |
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62279784 |
Jan 17, 2016 |
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62287901 |
Jan 28, 2016 |
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62299453 |
Feb 24, 2016 |
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62339810 |
May 21, 2016 |
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62362643 |
Jul 15, 2016 |
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62375814 |
Aug 16, 2016 |
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62405930 |
Oct 9, 2016 |
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62416403 |
Nov 2, 2016 |
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62119521 |
Feb 23, 2015 |
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62119521 |
Feb 23, 2015 |
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62139754 |
Mar 29, 2015 |
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62254718 |
Nov 13, 2015 |
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62259991 |
Nov 25, 2015 |
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62275222 |
Jan 5, 2016 |
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62275241 |
Jan 6, 2016 |
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62279784 |
Jan 17, 2016 |
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62287901 |
Jan 28, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/00124 20130101;
A61B 1/018 20130101; A61B 1/0684 20130101; A61B 1/00048 20130101;
A61B 1/00016 20130101; A61M 5/3293 20130101; A61B 1/00108 20130101;
A61B 1/00052 20130101; A61M 5/329 20130101; A61B 1/00087 20130101;
A61B 1/00128 20130101; A61B 1/05 20130101; A61B 1/00034 20130101;
A61B 1/00103 20130101; A61B 1/00119 20130101; A61B 1/015 20130101;
A61B 1/00066 20130101 |
International
Class: |
A61B 1/00 20060101
A61B001/00; A61M 5/32 20060101 A61M005/32; A61B 1/05 20060101
A61B001/05; A61B 1/06 20060101 A61B001/06 |
Claims
1. An endoscope with a disposable distal portion and a reusable
proximal portion, configured to enable a single user to operate the
endoscope both (i) to visualize an internal region of the patient
and (ii) to concurrently inject fluid in or adjacent said region
through an injection needle permanently mounted at a distal part of
the endoscope by jabbing with both portions, comprising: a handle
configured to be grasped by the user's hand and having at least one
button controlling endoscope functions, and an integral video
display screen, wherein both the handle and the screen form a part
of the reusable portion of the endoscope; a cannula forming a part
of the disposable portion of the endoscope and configured with
internal lumena and an injection needle permanently mounted at a
distal part of the cannula for motion between a retracted position
at which it is entirely within the cannula and a releasably locked
protruding position in which it extends distally from the cannula;
a connector at a proximal part of the disposable portion of the
endoscope, configured to releasably mate tool-free with a connector
at the reusable portion of the endoscope thereby releasably
integrating the reusable and disposable portions; a needle
actuation hub at the disposable portion of the endoscope,
intermediate the connector of the disposable portion and the
cannula; an actuation tab mounted to the hub and configured to be
moved by the user's hand between a first position and a second
position; said tab being coupled to the needle to drive it between
its retracted and protruding positions as the user moves the tab
between its first and second positions; an injection fluid port at
the hub, said port being in fluid communication with the injection
needle through the cannula so that fluid introduced in the port can
be injected through the needle; and a light source and an imaging
module with a video camera at a distal portion of the cannula,
coupled with the screen to illuminate the region in the patient and
provide images of the region to the screen under the control of
said buttons on the handle; thereby enabling a single user holding
the handle to use one hand to insert and retract the cannula in and
from the patient, operate said buttons, move the needle from its
retracted position to its protruded position, jab the needle into
tissue, and retract the needle, and to use the same or the other
hand to selectively force fluid into said fluid port.
2. The endoscope of claim 1, further including a source of fluid
and a flexible conduit from the source to the injection fluid port,
wherein the flexible conduit is the sole connection between the
source of fluid and the endoscope, thereby helping to keep motion
of the source of fluid from being mechanically transmitted to the
reusable portion and/or the disposable portion of the endoscope at
least while the needle is in its protruding position.
3. The endoscope of claim 1, further including a fluid source
coupled with the fluid port via a conduit, and an attachment
releasably securing the syringe to the handle to thereby enable the
operator to use a single hand to operate the endoscope both to
visualize a region of the patient, to jab the needle into tissue,
and to inject fluid into the tissue.
4. The endoscope of claim 1, in which said video camera has a field
of view (FOV) and the distal tip of the needle is at a central
region of the FOV when the needle is in its protruding
position.
5. The endoscope of claim 1, in which the tab has a projection
moving with the tab relative to the hub and the hub has stops
configured to releasably engage the projection when the tab is in
its first and second positions and thereby releasably lock the tab
at least at the second tab position and thus the needle at its
protruding position, and the hub further includes a hand-operated
release button acting on said projection to thereby selectively
release the tab and thus the needle from a locked position.
6. The endoscope of claim 1, in which the hub is coupled to the
mechanical connector of the disposable portion of the endoscope
through an angularly sliding coupling enabling rotation of the
cannula relative to the handle when the disposable and reusable
portions are integrated.
7. The endoscope of claim 1, in which the needle is no longer than
the distance from the fluid port to the distal end of the
cannula.
8. The endoscope of claim 1, in which the endoscope is free of
openings at a distal part of the disposable portion for insertion
of an injection needle.
9. The endoscope of claim 1, in which said connector of the
disposable portion of the endoscope comprises a mechanical
connector and an electrical connector spaced proximally from the
mechanical connector, and said connector of the reusable portion
comprises a mechanical connector configured to releasably mate
tool-free with the mechanical connector of the disposable portion
and an electrical connector spaced proximally from the distal end
of the reusable portion and configured to releasably mate tool-free
with the electrical connector of the disposable portion.
10. The endoscope of claim 1, in which the mechanical and
electrical connectors of the disposable portion of the endoscope
are male connectors and the electrical and mechanical connectors of
the reusable portion and female connectors.
11. An endoscope comprising: a disposable portion for a single use
on a patient, comprising a cannula with an injection needle that is
permanently mounted in the cannula for motion between a retracted
position and a releasably locked protruded position; a reusable
portion comprising a handle configured to be grasped by a user's
hand; an electrical connector and a mechanical connector on each of
the disposable portion and the reusable portion, said connectors
releasably mating with each other to integrate the disposable
portion and the reusable portion and to establish electrical
connection between them; wherein each of electrical connectors is
spaced in a proximal direction from each of the mechanical
connectors thereby facilitating prevention of contamination of the
electrical connectors from material in or on the disposable
portion; a needle actuator tab mounted to the disposable portion
and movable by hand between a retracted position and an extended
position, said actuator being coupled with the needle to move the
needle between its retracted and protruded positions as the tab
moves between its retracted and extended position; an injection
fluid port at the disposable portion, coupled with the injection
needle for conveying thereto via the cannula fluid introduced into
the port; an illumination source and an imaging module including a
video camera mounted to a distal part of the cannula, a video
screen mounted to the reusable part to move therewith and to rotate
and/or tilt relative to the reusable part, and controls on the
reusable portion to control video camera; and electrical
connections between the reusable portion and the camera and
illumination source to control the illumination source and the
camera and to convey images from the camera for display on the
screen; wherein when integrated, the endoscope is configured for
selective operation with one hand to move the tab and the needle
between their positions, to control the illumination source and
camera, and to push the needle into tissue by jabbing at least the
disposable portion when the needle is in its protruded
position.
12. The endoscope of claim 11, including a source of fluid and a
flexible conduit connecting the fluid source to said fluid port in
the disposable portion of the endoscope.
13. The endoscope of claim 12, wherein the fluid source is
configured to be out of a mechanical connection with the reusable
portions except through said flexible conduit, and is sufficiently
close to the reusable portion for a single operator to operate the
reusable portion with one hand and the fluid source with the other
hand.
14. The endoscope of claim 12, including an attachment mounting the
fluid source to at least one of the reusable portion and the
disposable portion for operation with a single hand of the
endoscope enabling the user to utilize a single hand (i) to move
the tab to thereby move the needle between its retracted and
protruding positions, (ii) to operate said controls controlling the
video camera, and (iii) to operate the fluid source to inject fluid
therefrom through the needle.
15. The endoscope of claim 14, in which the fluid source comprises
a syringe, and the attachment is secured to the handle and includes
a syringe band into which said syringe can be slipped in and from
which it can be slipped out.
16. The endoscope of claim 15, in which the attachment further
comprise a handle band secured to the handle, and projections on
one of the band and depressions on the other for a releasable
snap-fit of the bands to each other.
17. The endoscope of claim 14, in which the attachment comprises
hook-and-loop patches or bands secured to each of the fluid source
and the handle and adapted to releasably couple with each other
thereby attaching the fluid source to the handle.
18. The endoscope of claim 11, in which the video screen is mounted
to the handle for rotation or tilting about two axes that are
transverse to each other so it can be rotated or tilted relative to
the handle to facilitate selection of the screen orientation
relative to the user before or during a patient procedure.
19. The endoscope of claim 11, further including a flushing fluid
port that is spaced in the distal direction from the injection
fluid port, and the cannula includes at least one flushing fluid
opening at a distal part of the camera and at least one lumen
connecting the flushing fluid port with the at least one flushing
fluid opening.
20. The endoscope of claim 11, in which the video camera has a
field of view and the needle, when in its protruding position, has
a tip that is at a central position in said field of view.
21. The endoscope of claim 11, in which said needle actuator tab is
mounted to the hub for back-and-forth motion in the proximal-distal
direction.
22. The endoscope of claim 11, in which the needle when in its
retracted position is entirely within the cannula.
23. A method of using an endoscope, comprising: removing a
disposable distal portion of an endoscope from sterile packaging
and releasably attaching it tool-free to a reusable portion of the
endoscope to thereby assemble the endoscope; introducing a cannula
that is a part of the distal portion of the endoscope into a
patient until a tip of the cannula reaches a selected region in the
patient; illuminating the selected region with a light source
mounted in the tip of the cannula and visualizing the region with a
video camera mounted in the cannula tip and supplying images to a
video screen mounted to the reusable portion of the endoscope;
operating a tab movably mounted to the reusable portion of the
endoscope to thereby move an injection needle that is permanently
mounted to the cannula tip from a retracted position in which the
needle is entirely within the cannula to a releasably locked
protruding position in which the needle protrudes from the cannula;
jabbing the needle into tissue by moving the reusable and
disposable portions as a unit while the needle is in its protruding
position; and injecting fluid through the needle from a fluid
source that is connected to the endoscope; retracting the needle to
its retracted position by operating the tab and withdrawing the
cannula from the patient; wherein a single user operates the
endoscope to introduce the cannula into the patient, visualize the
region, jab the needle, inject fluid through the needle, and
retract the needle and withdraw the cannula from the patient, using
one or both hands; and and detaching the disposable portion from
the reusable portion by hand, tool-free, and disposing of the
disposable portion.
24. The method of claim 23, in which the user uses a single hand to
operate the endoscope to visualize the region, jab the needle,
inject fluid through the needle, and retract the needle.
25. The method of claim 23, further including attaching a syringe
to the handle in a position in which the same user's hand operating
controls of the camera on the handle reaches the syringe plunger to
inject fluid from the syringe through the needle and into the
patient.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims the benefit of and
incorporates by reference each of the following provisional
applications: [0002] U.S. Prov. Ser. No. 62/339,810 filed May 21,
2016; [0003] U.S. Prov. Ser. No. 62/362,643 filed Jul. 15, 2016;
[0004] U.S. Prov. Ser. No. 62/375,814 filed Aug. 16, 2016; [0005]
U.S. Prov. Ser. No. 62/405,930 filed Oct. 9, 2016; [0006] U.S.
Prov. Ser. No. 62/416,403 filed Nov. 2, 2016; [0007] U.S. Prov.
Ser. No. 62/443,769 filed Jan. 8, 2017; [0008] U.S. Prov. Ser. No.
62/449,257 filed Jan. 23, 2017; and [0009] U.S. Prov. Ser. No.
62/452,883 filed Jan. 31, 2017.
[0010] This patent application is a continuation-in-part of and
incorporates by reference each of the following applications:
[0011] U.S. Ser. No. 14/913,867 filed Feb. 23, 2016; [0012] U.S.
Ser. No. 15/371,858 filed Dec. 7, 2016; [0013] International Patent
Application No. PCT/US16/18670 filed Feb. 19, 2016; and [0014]
International Patent Application No. PCT/US16/65396 filed Dec. 7,
2016.
[0015] This patent application relates to the following provisional
and non-provisional applications that are each incorporated by
reference: [0016] U.S. Prov. Ser. No. 62/119,521 filed Feb. 23,
2015; [0017] U.S. Prov. Ser. No. 62/120,316 filed Feb. 24, 2015;
[0018] U.S. Prov. Ser. No. 62/139,754 filed Mar. 29, 2015; [0019]
U.S. Prov. Ser. No. 62/254,718 filed Nov. 13, 2015; [0020] U.S.
Prov. Ser. No. 62/259,991 filed Nov. 25, 2015; [0021] U.S. Prov.
Ser. No. 62/275,222 filed Jan. 5, 2016; [0022] U.S. Prov. Ser. No.
62/275,241 filed Jan. 6, 2016; [0023] U.S. Prov. Ser. No.
62/279,784 filed Jan. 17, 2016; [0024] U.S. Prov. Ser. No.
62/287,901 filed Jan. 28, 2016; and [0025] U.S. Prov. Ser. No.
62/299,453 filed Feb. 24, 2016.
FIELD
[0026] This patent specification generally relates mainly to a
medical device for use in tissue examinations and endoscopic
surgery such as in urology. More particularly, some embodiments
relate to an integrated, handheld, low-cost surgical endoscope
device having a single-use portion and a multiple-use portion.
BACKGROUND
[0027] Conventional endoscopy, or direct vision used to examine the
interior of a hollow organ or cavity of the body, uses a complex
lens system for transmitting the image from the distal tip of the
endoscope to a viewer. The lens system is typically a relay lens
system in the case of rigid endoscopes or a bundle of fiber optics
or an objective lens system in the case of flexible endoscopes. In
the case of both rigid and flexible conventional endoscopes, the
lens or fiber optic system is relatively expensive and is intended
to be re-used many times. Therefore, stringent decontamination and
disinfection procedures need to be carried out after each use.
[0028] In surgical procedures where a needle is used to inject
fluid such as a drug into the patient's tissues, a long injection
needle is inserted into the working channel of the endoscope. In
such procedures, it is common to use two or more operators to carry
out the surgical procedure: one to operate the endoscope and
another to operate the needle assembly and syringe. It is common
for there to be a physical separation between display screen (e.g.
mounted overhead), the endoscope (into the patient), and/or the
syringe used to administer the drug. In such cases an operator or
clinician has to look up the display screen and cannot
simultaneously view the scope handle and the syringe. Furthermore,
the separate needle assembly which is often long and somewhat
cumbersome needs to be threaded through the working channel of the
endoscope and substantial manual dexterity may be required to
control the jabbing and injection process.
[0029] Disposable endoscopy is an emerging category of endoscopic
instruments. In some cases the manufacture of endoscopes can be
made inexpensive enough to be used on a single patient only.
Disposable or single-use endoscopy lessens the risk of
cross-contamination and hospital acquired diseases. Partially
disposable endoscopy systems for hysteroscopy are discussed in U.S.
Pat. No. 8,460,182, incorporated by reference herein. A
hysteroscope having a disposable probe was offered by Endosee
Corporation of Los Altos, Calif., and is now offered by
CooperSurgical, Inc. of Trumbull, Conn., a company that acquired
EndoSee Corporation.
[0030] The subject matter described or claimed in this patent
specification is not limited to embodiments that solve any specific
disadvantages or that operate only in environments such as those
described above. Rather, the above background is only provided to
illustrate one exemplary technology area where some embodiments
described herein may be practiced.
SUMMARY
[0031] According to some embodiments that are particularly suitable
for fields such as urology and endoscopic surgery rather than
hysteroscopy, a low-cost surgical instrument for examining and
injecting a desired fluid into a patient's tissue comprises an
endoscope with a disposable distal portion and a reusable proximal
portion, configured to enable a single user to operate the
endoscope both (i) to visualize an internal region of the patient
and (ii) to concurrently inject fluid in or adjacent said region
through an injection needle permanently mounted at a distal part of
the endoscope by jabbing with both portions. In this example, the
endoscope comprises a handle configured to be grasped by the user's
hand and having at least one button controlling endoscope
functions, and an integral video display screen, wherein both the
handle and the screen form a part of the reusable portion of the
endoscope; a cannula forming a part of the disposable portion of
the endoscope and configured with internal lumena and an injection
needle permanently mounted at a distal part of the cannula for
motion between a retracted position at which it is entirely within
the cannula and a releasably locked protruding position in which it
extends distally from the cannula; a connector at a proximal part
of the disposable portion of the endoscope, configured to
releasably mate tool-free with a connector at the reusable portion
of the endoscope thereby releasably integrating the reusable and
disposable portions; a needle actuation hub at the disposable
portion of the endoscope, intermediate the connector of the
disposable portion and the cannula; an actuation tab mounted to the
hub and configured to be moved by the user's hand between a first
position and a second position; said tab being coupled to the
needle to drive it between its retracted and protruding positions
as the user moves the tab between its first and second positions;
an injection fluid port at the hub, said port being in fluid
communication with the injection needle through the cannula so that
fluid introduced in the port can be injected through the needle;
and a light source and an imaging module with a video camera at a
distal portion of the cannula, coupled with the screen to
illuminate the region in the patient and provide images of the
region to the screen under the control of said buttons on the
handle. This configuration enables a single user holding the handle
to use one hand to insert and retract the cannula in and from the
patient, operate said buttons, move the needle from its retracted
position to its protruded position, jab the needle into tissue, and
retract the needle, and to use the same or the other hand to
selectively force fluid into said fluid port.
[0032] In some embodiments, the endoscope further includes a source
of fluid and a flexible conduit from the source to the injection
fluid port, wherein the flexible conduit is the sole connection
between the source of fluid and the endoscope, thereby helping to
keep motion of the source of fluid from being mechanically
transmitted to the reusable portion and/or the disposable portion
of the endoscope at least while the needle is in its protruding
position.
[0033] In some embodiments, the endoscope further includies a fluid
source coupled with the fluid port via a conduit, and an attachment
releasably securing the syringe to the handle to thereby enable the
operator to use a single hand to operate the endoscope to visualize
a region of the patient, to jab the needle into tissue, and to
inject fluid into the tissue.
[0034] In some embodiments, the endoscope's video camera has a
field of view (FOV) and the distal tip of the needle is at a
central region of the FOV when the needle is in its protruding
position.
[0035] In some embodiments, the endoscope's tab has a projection
moving with the tab relative to the hub and the hub has stops
configured to releasably engage the projection when the tab is in
its first and second positions and thereby releasably lock the tab
at least at the second tab position and thus the needle at its
protruding position, and the hub further includes a hand-operated
release button acting on said projection to thereby selectively
release the tab and thus the needle from a locked position.
[0036] In some embodiments, the endoscope's hub is coupled to the
mechanical connector of the disposable portion of the endoscope
through an angularly sliding coupling enabling rotation of the
cannula relative to the handle when the disposable and reusable
portions are integrated.
[0037] In some embodiments, the endoscope's needle is no longer
than the distance from the fluid port to the distal end of the
cannula.
[0038] In some embodiments, the endoscope is free of openings at a
distal part of the disposable portion for insertion of an injection
needle.
[0039] In some embodiments, the connector of the disposable portion
of the endoscope comprises a mechanical connector and an electrical
connector spaced proximally from the mechanical connector, and said
connector of the reusable portion comprises a mechanical connector
configured to releasably mate tool-free with the mechanical
connector of the disposable portion and an electrical connector
spaced proximally from the distal end of the reusable portion and
configured to releasably mate tool-free with the electrical
connector of the disposable portion.
[0040] In some embodiments, the mechanical and electrical
connectors of the disposable portion of the endoscope are male
connectors and the electrical and mechanical connectors of the
reusable portion and female connectors.
[0041] In some embodiments, the surgical instruments comprises: a
disposable portion for a single use on a patient, comprising a
cannula with an injection needle that is permanently mounted in the
cannula for motion between a retracted position and a releasably
locked protruded position; a reusable portion comprising a handle
configured to be grasped by a user's hand; an electrical connector
and a mechanical connector on each of the disposable portion and
the reusable portion, said connectors releasably mating with each
other to integrate the disposable portion and the reusable portion
and to establish electrical connection between them; wherein each
of electrical connectors is spaced in a proximal direction from
each of the mechanical connectors thereby facilitating prevention
of contamination of the electrical connectors from material in or
on the disposable portion; a needle actuator tab mounted to the
disposable portion and movable by hand between a retracted position
and an extended position, said actuator being coupled with the
needle to move the needle between its retracted and protruded
positions as the tab moves between its retracted and extended
position; an injection fluid port at the disposable portion,
coupled with the injection needle for conveying thereto via the
cannula fluid introduced into the port; an illumination source and
an imaging module including a video camera mounted to a distal part
of the cannula, a video screen mounted to the reusable part to move
therewith and to rotate and/or tilt relative to the reusable part,
and controls on the reusable portion to control video camera; and
electrical connections between the reusable portion and the camera
and illumination source to control the illumination source and the
camera and to convey images from the camera for display on the
screen. In this configuration, the endoscope, when integrated, is
configured for selective operation with one hand to move the tab
and the needle between their positions, to control the illumination
source and camera, and to push the needle into tissue by jabbing at
least the disposable portion when the needle is in its protruded
position.
[0042] The endoscope can include a source of fluid and a flexible
conduit connecting the fluid source to said fluid port in the
disposable portion of the endoscope. The fluid source can be
configured to be out of a mechanical connection with the reusable
portions except through said flexible conduit, and can be located
sufficiently close to the reusable portion for a single operator to
operate the reusable portion with one hand and the fluid source
with the other hand. In an alternative, the endoscope can be
provided with an attachment mounting the fluid source to at least
one of the reusable portion and the disposable portion for
operation with a single hand of the endoscope enabling the user to
utilize a single hand (i) to move the tab to thereby move the
needle between its retracted and protruding positions, (ii) to
operate said controls controlling the video camera, and (iii) to
operate the fluid source to inject fluid therefrom through the
needle. The fluid source can comprise a syringe, and the attachment
can be secured to the handle and can include a syringe band into
which the syringe can be slipped in and from which it can be
slipped out. The attachment can further comprise a handle band
secured to the handle, and projections on one of the band and
depressions on the other for a releasable snap-fit of the bands to
each other. As an alternative, the attachment can comprise
hook-and-loop patches or bands secured to each of the fluid source
and the handle and adapted to releasably couple with each other
thereby attaching the fluid source to the handle.
[0043] In some embodiments, the video screen is mounted to the
handle for rotation or tilting about two axes that are transverse
to each other so it can be rotated or tilted relative to the handle
to facilitate selection of the screen orientation relative to the
user before or during a patient procedure. The endoscope can
further include a flushing fluid port that is spaced in the distal
direction from the injection fluid port, and the cannula can
include at least one flushing fluid opening at a distal part of the
camera and at least one lumen connecting the flushing fluid port
with the at least one flushing fluid opening. The video camera can
have a field of view and the needle, when in its protruding
position, can have a tip that is at a central position in said
field of view. The needle actuator tab can be mounted to the hub
for back-and-forth motion in the proximal-distal direction. The
needle when in its retracted position can be entirely within the
cannula.
[0044] A method of using the surgical instrument can comprise:
removing a disposable distal portion of an endoscope from sterile
packaging and releasably attaching it tool-free to a reusable
portion of the endoscope to thereby assemble the endoscope;
introducing a cannula that is a part of the distal portion of the
endoscope into a patient until a tip of the cannula reaches a
selected region in the patient; illuminating the selected region
with a light source mounted in the tip of the cannula and
visualizing the region with a video camera mounted in the cannula
tip and supplying images to a video screen mounted to the reusable
portion of the endoscope; operating a tab movably mounted to the
reusable portion of the endoscope to thereby move an injection
needle that is permanently mounted to the cannula tip from a
retracted position in which the needle is entirely within the
cannula to a releasably locked protruding position in which the
needle protrudes from the cannula; jabbing the needle into tissue
by moving the reusable and disposable portions as a unit while the
needle is in its protruding position; and injecting fluid through
the needle from a fluid source that is connected to the endoscope;
retracting the needle to its retracted position by operating the
tab and withdrawing the cannula from the patient. A single user can
operates the endoscope to introduce the cannula into the patient,
visualize the region, jab the needle, inject fluid through the
needle, and retract the needle and withdraw the cannula from the
patient, using one or both hands. The method can include detaching
the disposable portion from the reusable portion by hand,
tool-free, and disposing of the disposable portion.
[0045] In some embodiments of the method, the user can use a single
hand to operate the endoscope to visualize the region, jab the
needle, inject fluid through the needle, and retract the needle. In
some embodiments, the method further includes attaching a syringe
to the handle in a position in which the same user's hand operating
controls of the camera on the handle reaches the syringe plunger to
inject fluid from the syringe through the needle and into the
patient.
[0046] As used herein, the grammatical conjunctions "and", "or" and
"and/or" are all intended to indicate that one or more of the
cases, object or subjects they connect may occur or be present. In
this way, as used herein the term "or" in all cases indicates an
"inclusive or" meaning rather than an "exclusive or" meaning.
[0047] As used herein the terms "surgical" or "surgery" refer to
any physical intervention on a patient's tissues, and does not
necessarily involve cutting a patient's tissues or closure of a
previously sustained wound.
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] To further clarify the above and other advantages and
features of the subject matter of this patent specification,
specific examples of embodiments thereof are illustrated in the
appended drawings. It should be appreciated that these drawings
depict only illustrative embodiments and are therefore not to be
considered limiting of the scope of this patent specification or
the appended claims. The subject matter hereof will be described
and explained with additional specificity and detail through the
use of the accompanying drawings in which:
[0049] FIGS. 1 and 2 are a right side view and a top view,
respectively, of a handheld surgical endoscope, according to some
embodiments;
[0050] FIG. 3 is perspective view showing aspects of attachment and
detachment of single-use and reusable portions of a handheld
surgical endoscope, according to some embodiments;
[0051] FIGS. 4A, 4B and 4C are a side view, perspective view and
cross section of a cannula used on a handheld surgical endoscope,
according to some embodiments;
[0052] FIGS. 5A and 5B are perspective views showing aspects of
needle actuation for a handheld surgical endoscope, according to
some embodiments;
[0053] FIGS. 6A and 6B are perspective views of distal tip 112 and
show aspects of the needle actuation, according to some
embodiments;
[0054] FIGS. 7A and 7B are perspective views of parts of the single
use portion of handheld surgical endoscope, according to some
embodiments;
[0055] FIGS. 8A and 8B are side and cross section views of the
distal tip of a handheld surgical endoscope, according to some
embodiments;
[0056] FIG. 9 is a perspective view of a handheld surgical
endoscope being used to perform a surgical procedure by a single
operator, according to some embodiments;
[0057] FIGS. 10A and 10B are further perspective views of a
handheld surgical endoscope being used to perform a surgical
procedure by a single operator, according to some embodiments;
[0058] FIG. 11 is a perspective view of a handheld surgical
endoscope, according to some embodiments;
[0059] FIG. 12 is a block diagram showing aspects of single
operator carrying out a surgical procedure with a handheld surgical
endoscope, according to some embodiments; and
[0060] FIGS. 13 and 14 are perspective views of a handheld surgical
endoscope having a clip for attaching the syringe to the handle,
according to some embodiments.
DETAILED DESCRIPTION
[0061] A detailed description of examples of preferred embodiments
is provided below. While several embodiments are described, it
should be understood that the new subject matter described in this
patent specification is not limited to any one embodiment or
combination of embodiments described herein, but instead
encompasses numerous alternatives, modifications, and equivalents.
In addition, while numerous specific details are set forth in the
following description in order to provide a thorough understanding,
some embodiments can be practiced without some or all of these
details. Moreover, for the purpose of clarity, certain technical
material that is known in the related art has not been described in
detail in order to avoid unnecessarily obscuring the new subject
matter described herein. It should be clear that individual
features of one or several of the specific embodiments described
herein can be used in combination with features of other described
embodiments or with other features. Further, like reference numbers
and designations in the various drawings indicate like
elements.
[0062] FIGS. 1 and 2 are a right side view and a top view,
respectively, of a handheld surgical endoscope, according to some
embodiments. The surgical endoscope 100 includes an elongated
cannula 120 with a distal tip 112 for inserting into a hollow organ
or cavity of the body. A needle 114 passes trough a dedicated lumen
in cannula 120. The tip of needle 114 can be extended to protrude
distally from distal tip 112 as shown. The needle 114 is hollow and
at needle actuation hub 170 is in fluid communication with fluid
line 172, which in turn is connected to syringe 180 (or other fluid
dispensing device).
[0063] According to some embodiments, a separate tip sub-assembly
110 is attached to the cannula 120 which can be made from an
extruded material. For further details relating to a separate tip
sub-assembly for a handheld endoscope, see co-pending U.S. patent
application Ser. No. 15/371,858 filed Dec. 7, 2016, referred to
hereinafter as "the co-pending '859 application." Sub-assembly 110
includes an imaging module and one or more LED light sources for
viewing the organ or cavity into which it is inserted. The tip
assembly 110 also includes one or more fluid ports. The distal end
of the cannula 120 can also be slightly bent as shown in bent
region 122. According to some embodiments, a bend of about 15
degrees in region 122 has been found to be suitable for many
applications, but using other angles in alternative embodiments is
not excluded.
[0064] According to some embodiments, the cannula 120 includes one
or more fluid channels which are fluidly connected to distal fluid
port 132 at fluid hub and connection assembly 130. Port 132
includes a Luer fitting to facilitate leak-free connection of port
132 with various medical fluid components. The fluid channels or
lumens in cannula 120 are also connected to a distal facing fluid
ports (orifice or ports 616 and 618 shown in FIGS. 6A, and 6B) of
tip assembly 110. According to some embodiments, wires running from
the LED light sources and camera module in tip assembly 110 pass
through a separate channel in cannula 120.
[0065] The endoscope 100 includes a handle portion 140 that is
sized and shaped in a pistol-like fashion for easy grasping by the
endoscope operator (e.g. doctor or other medical professional). A
display module 150 is rotatably mounted on handle 140 via a bearing
which can be a plain bearing made of plastic, and a rubber coated
hinge. Also visible on handle 140 are image capture button 160 and
power button 162. According to some embodiments handle 140 and
display module 150 are configured to be re-usable and make up
reusable portion 102. According to some embodiments, handle 140 is
similar or identical to handle 140 shown and described in the
co-pending '859 application.
[0066] Single-use portion 104 includes the needle actuation hub
170, fluid hub and connection assembly 130, cannula 120 and tip
assembly 110. Single-use portion 104 is made at a relatively
low-cost and is intended to be disposed of after a single-use. By
making the tip, cannula, fluid hub all single-use, stringent
decontamination and disinfection procedures as well as the risk of
cross-contamination and hospital acquired diseases can be
significantly lessened or avoided. According to some embodiments
the disposable, single-use portion (portion 104 shown in FIGS. 1
and 3) is sterilized, for example, during production and is
provided to the user in a sealed sterilized pouch, for ease of
storage and handling. The camera module in the tip assembly can
have a wide angle of view, such as 140 degrees in this example.
According to some embodiments, the fluid line 172 is also included
in single use portion 104 and can be attached to hub 170 and
included in the same sterilized pouch.
[0067] According to some embodiments, the length of needle 114,
including the fluid pathway within needle actuation hub 170 (i.e.
from the distal tip of needle 114 to the needle fluid port 174 is
less than 50 cm, and according to some embodiments is about 37 cm.
This is is contrast to surgical procedures carried out with a
conventional endoscope having a working channel through which is
passed a separate needle assembly. In those cases the separate
needle assembly is operated by a second clinician which
necessitates a longer needle (e.g. between 70 cm to 100 cm) to
allow for enough working space for each clinician. Using a much
shorter needle, according to the embodiments described herein,
allows for less wasted drug fluid remaining within the needle.
[0068] According to some embodiments, the surgical endoscope is
configured to allow cannula 120 to rotate about its longitudinal
axis as shown by the dotted arrow in FIG. 1. For further details of
how to configure the hub 130 to allow rotation of the cannula, see
the co-pending '859 application. According to some embodiments, the
cannula rotation can include a certain amount of friction (e.g.
friction overcome by torque in the range of 0.04 Nm to 0.2 Nm).
This allows for a "rotate and hold" of the cannula that is
desirable for some procedures. For further details of how to
configure such a "frictional fit," see the co-pending '859
application. According to some embodiments, the endoscope can be
configured to detect the rotational position of the cannula 120
relative to the handle 140. The detected rotational position is
then input to a software algorithm configured to reorient the image
displayed on display module 150 such that a correctly oriented
image is displayed to the operator. For further details of such
rotational position detection, see the co-pending '859
application.
[0069] FIG. 3 is perspective view showing aspects of attachment and
detachment of single-use and reusable portions of a handheld
surgical endoscope, according to some embodiments. The single-use
portion 104 and reusable portion 102 attach mechanically primarily
via mating mechanical connectors 320 and 322. Electrical connection
is made via separate mating electrical connectors 310 and 312. In
this example the two portions 102 and 104 are attached via
translation vertically towards each other. Note that the electrical
connector 310 and mechanical connector 320 are both separated from
the fluid hub 130 and from needle actuation hub 170. This
separation allows for easy and effective fluid sealing to prevent
fluid from hubs 170 and 130 from penetrating internally towards
connectors 310 and 320 and also allows some protection against any
exterior fluid, for example from fluid port 132 from reaching and
possibly compromising electrical connectors 310 and 312. Also, the
separation between mechanical connector 320 and hub 130 allows for
a sleeve bearing to allow for rotating of cannula 120 relative to
the proximal portion of hub 130. For further details of this
rotation mechanism, see the co-pending '859 application, for
example FIGS. 8A-8C and 9A-9B and associated text of the co-pending
'859 application. The physical separation of the fluid hub 130 and
the mechanical and electrical connectors 320 and 310 also provide
additional assurance against accidental contamination from fluid
hub 130 to the re-usable portion 102. For further details regarding
the physical separation and associated benefits, see the co-pending
'859 application.
[0070] FIGS. 4A. 4B and 4C are a side view, perspective view and
cross section of a cannula used on a handheld surgical endoscope,
according to some embodiments. The cannula 120 can be extruded and
made of a nylon material such as nylon 12 (e.g. Grilamid.RTM. L25).
The distal end of cannula 120 can include a bent region 122 which
is beneficial for certain applications and can effectively increase
the field of view of the camera fixed to the distal tip when the
endoscope is rotated about its central longitudinal axis. FIGS. 4B
and 4C show a further detail of the internal lumina of cannula 120.
An insulated electrical cable (not shown) is run though the upper
lumen 430. For further details of the insulated cable, which
includes conductors used for sending power to the camera and LEDs
in the distal tip and signals back to electronics in the handle,
see the co-pending '859 application. Fluid lumina 416 and 418 are
used to carry fluid between fluid port 132 (shown in FIGS. 1-3) and
the distal fluid ports (see ports 616 and 618 shown in FIG. 6A). In
this example, lumina 416 and 418 each have a cross sectional area
of about 1.33 mm.sup.2. The needle 114 (shown in FIGS. 1-3, 6A-B
and 8A-B) passes through lumen 470. Dimensions are shown in FIG. 4C
for an example device. In general, the lumen 470 should be
dimensioned to allow passage of the needle 114 which according to
some embodiments is between 26 gauge (0.4636 mm) and 21 gauge
(0.8192 mm). According to some embodiments the needle 114 is 23
gauge (0.6414 mm) or 22 gauge (0.7176 mm). According to some
embodiments, the cannula 120 can be made such that its stiffness is
not constant along its length. For example, it may be useful in
some clinical applications to provide a cannula that is more
flexible towards the distal tip and stiffer towards the handle. In
such cases the cannula 120 can be made from a multi-durometer
tubing such as a multi-duro Pebax.RTM. or Grilamid.RTM..
[0071] According to some embodiments, cannula 120 is rotatable
relative to the handle. The rotation mechanism can be provided in
hub 130 and further details are shown and described in the
co-pending '859 application.
[0072] FIGS. 5A and 5B are perspective views showing aspects of
needle actuation for a handheld surgical endoscope, according to
some embodiments. FIG. 5A shows the needle actuation hub 170 when
the needle is in the retracted position while FIG. 5B shows the hub
170 when the needle is in the extended position. Hub 170 includes
an outer housing 500 through which are formed two windows, proximal
window 532 and distal window 534. A lock release button 530 extends
from the housing 500 and includes a inwardly protruding tab that
aligns with distal window 534. Actuation tab 510 is moveable
relative to the hub housing 500. Moving with tab 510 is fluid port
512 that is in fluid communication with fluid line 172 (not shown),
spring tab 520 and needle 114 (not shown). Further detail of the
movable portions of hub 170 is shown in FIG. 7B.
[0073] FIGS. 6A and 6B are perspective views of distal tip 112 and
show aspects of the needle actuation, according to some
embodiments. FIG. 6A shows tip 112 when the needle 114 in the
retracted position while FIG. 6B shows tip 112 when the needle 114
is in the extended position. Note that while in the retracted
position, the sharp tip of needle 114 is fully recessed within
needle port 614 of tip assembly 110 and there is no risk a sharps
injury from the tip of needle 114. Also visible in FIGS. 6A and 6B
are camera lens dust cover 612, two light-guide lenses 662 and 664
(for LED light sources) and distal fluid ports 616 and 618. The
distal fluid ports 616 and 618 are provided to allow for fluid
communication with fluid lumina 410 and 412 of cannula 120 (shown
in FIGS. 4B and 4C). In this example, each of the fluid ports 616
and 618 have a cross sectional area of about 1.6 mm.sup.2. Note
that port 132, lumina 410 and 412 and distal fluid ports 616 and
618 can be configured to provide fluid in-flow (i.e. flowing fluid
out of the endoscope and into the patient's organ or cavity and/or
fluid out-flow (i.e. flowing fluid out of the patient's organ or
cavity and into the endoscope).
[0074] FIG. 7A and 7B are perspective views of parts of the single
use portion of handheld surgical endoscope, according to some
embodiments. FIG. 7A shows the needle actuation hub 170 from
another perspective in which the needle extension markings 710 and
712 are visible. In this example, marking 710 is a "0" indicating
to the operator that the needle is fully retracted when spring tab
520 protrudes through proximal window 532, and marking 712 is a
"15" indicating that the needle is extended by 15 mm when tab 520
protrudes through distal window 534. According to some embodiments,
the full extension of the needle can be amounts other than 15 mm
(such as values between 10 and 20 mm) and the marking 712 will
reflect that value. FIG. 7B shows carrier 720 which is fixedly
attached to actuation tab 510, spring tab 510 and needle 114.
According to some embodiments carrier 720, spring tab 520 and/or
actuation tab 510 are molded from a single piece of polymer
material. As shown, spring tab 520 has ramp shaped distal edge and
square shaped proximal edge. This shape allows for it move freely
distally but will "lock" when it reaches full extension and
protrudes through the distal window of housing 500. Needle 114 is
glued or bonded into an opening of carrier 720. A fluid-tight
pathway is provided through carrier 720 between fluid port 512 and
the inner lumen of needle 114.
[0075] Referring to FIG. 5A, the actuation tab 510 is shown in the
retracted position where tab 510 it is in its most rearward or
proximal position relative to the hub housing 500. In this
position, spring tab 520 protrudes through proximal window 532 of
housing 500 and the tip of needle 114 is recessed within the needle
port 614 as shown in FIG. 6A. In order to extend the tip of needle
114 so as to penetrate a patient's tissue, the operator moves
actuation tab 510 forward (distally) relative to the housing 500 as
shown by the dotted arrow in FIG. 5A. This causes the carrier 720
(shown in FIG. 7B) to move distally relative to the housing 500,
and needle 114 to translate distally within lumen 470 (shown in
FIGS. 4B and 4c) of cannula 120 and distally relative to tip
assembly 110. As shown in FIG. 7B, spring tab 520 is movable
radially and has ramp shape distal edge and square shaped proximal
edge. Therefore the spring tab 520 is pushed inwards radially by
the proximal edge of the proximal window 532. As the actuation tab
510 is pushed further distally, the top surface of tab 520 moves
across the inner surface of housing 500 and towards distal window
534. When the spring tab 520 reaches the distal window 534 the
radial spring force pushes the tip of tab 520 through the distal
window 534. The square shaped proximal edge of spring tab 520
engages the square shaped proximal edge of window 534 which
effectively "locks" or prevents retraction or proximal movement of
needle 114, carrier 720 and actuation tab 510. This locking
mechanism is useful when using the needle to inject the desired
fluid (such as a drug) into the patient's tissue since the entire
endoscope can be used to push the needle without the needle
retracting back into the cannula. The surgical endoscope with its
needle in a fully extended state is depicted in FIGS. 5B and
6B.
[0076] When the operator wishes to retract the needle, the lock
release button 530 is depressed which forces the spring tab 520
inwards though the window 534. In the depressed state, the spring
tab 520 is no longer "locked" by the distal window 534 and the
actuation tab 510 can then be moved rearwards or proximally
relative to the housing 500 which caused the needle to retract back
within the tip assembly 110 such as shown in FIG. 6A. According to
some embodiments, the spring tab 520 can be shaped with square
edges on both proximal and distal sides which will allow for the
needle to be releasably locked in both the retracted and protruding
positions. In such cases the lock release button 530 is used to
unlock the tab 520 in either position to allow actuation of the
needle.
[0077] FIGS. 8A and 8B are side and cross section views of the
distal tip of a handheld surgical endoscope, according to some
embodiments. The cannula 120 and housing 811 of cannula tip 110 are
held together using a sleeve 820 that is dimensioned to fit around
both the outer surface of the distal end of cannula 120 and the
proximal end 816 of tip housing 811. Tip housing 811 includes an
upper cavity 830 which houses the camera assembly 854 and LEDs 860.
As separate needle cavity 870 is included in tip housing 811 to
allow passage of the needle 114. In the example shown the needle
114 protrudes 15 mm when fully extended, which has been found to be
suitable extension amount for many surgical urology applications.
According to some other embodiments, other extension amounts such
as between 10 and 20 mm can be implemented. According to some
embodiments, the needle 114 is not parallel to the center axis of
the distal tip assembly 110 and housing 811. Rather the needle 114
is angled at about 2-5 degrees upwards (towards the camera), so
that when the needle 114 is in fully protruded position (by 10-20
mm, preferably by 15 mm), its distal tip will roughly reach the
center of the FOV of the camera. This can be accomplished by
appropriate shaping of the needle cavity 870 in housing 811.
According to some embodiments, sleeve 820 is made of stainless
steel, although other material can be used. The three pieces,
cannula 120, sleeve 820 and tip housing 811 can be glued together
using, for example, a U-V cured bonding glue. For further details
of the tip assembly 110 including suitable sensor, lens and LED
components, as well as suitable assembly and bonding techniques,
see the co-pending '859 application. According to some embodiments,
the field of view (FOV) of the camera is configured such that when
extended the tip of needle 114 is plainly and clearly visible by
the sensor and can be displayed as such to the operator. According
to some embodiments, the maximum outer diameter of the tip housing
811 is about 15 fr (or 5 mm) or less, and the other diameter of the
cannula 120 is about 4.8 mm or less. This is in contrast to
conventional rigid endoscopes which often have a outer diameter of
about 7 mm. According to some embodiments, the distal outer edge of
tip housing 811 is rounded to facilitate insertion in/though tissue
passages and alleviate tissue contact issues. For further details
of suitable rounding dimensions and criteria see the co-pending
'859 application.
[0078] FIG. 9 is a perspective view of a handheld surgical
endoscope being used to perform a surgical procedure by a single
operator, according to some embodiments. Unlike conventional
endoscopic surgical procedures that are performed using at least
two skilled operators or clinicians, according to some embodiments,
the surgical endoscope 100 with an integrated needle are configured
for a single operator to perform many surgical procedures. Shown in
FIG. 9 is a single operator, with his/her left hand 910 grasping
the handle 140 (and optionally press the image capture button 160)
and his/her right hand 912 operating the syringe 180 to dispense
the drug (or other fluid) via the extended needle 114. Note that
the patient and patient's tissues are not shown for purposes of
clarity. By integrating the needle assembly with the handheld
endoscope with attached display as shown and described herein, it
has been found that a single operator can both control endoscope
and perform the jabbing with the needle (using the entire
endoscope) and administer the drug fluid in the syringe. Although
the FIG. 9 is shown with the left hand operating handle of
endoscope 100 and right hand operating the syringe, the operator
could easily perform the procedure with his/her hands switched if
desired (i.e. right hand operating the handle and left hand
operating the syringe.
[0079] FIGS. 10A and 10B are further perspective views of a
handheld surgical endoscope being used to perform a surgical
procedure by a single operator, according to some embodiments. It
has been found that for some procedures, an operator may prefer to
manipulate the cannula 120 with one hand while using the other hand
to grasp the handle. FIGS. 10A and 10B illustrate how this can be
performed by a single operator to both manipulate the endoscope and
control the syringe for administering the drug. In particular, the
operator uses his/her left hand 910 to grasp the handle and
optionally press the capture button 160, and his/her right hand 912
to manipulate the cannula 120 (shown in FIG. 10A) and administer
the drug from syringe 180 (shown in FIG. 10B).
[0080] FIG. 11 is a perspective view of a handheld surgical
endoscope, according to some embodiments. As shown, when needle 114
is in the extended position, the camera sensor captures the needle
tip and the display 150 show the needle tip 1115 clearly in the
central portion of the display screen. As is also apparent in FIG.
11, the handheld surgical endoscope 100 is ergonomically configured
to a single operator to view the endoscope, the display screen and
the syringe, which further facilitates carrying out surgical
procedures with a single operator.
[0081] FIG. 12 is a block diagram showing aspects of single
operator carrying out a surgical procedure with a handheld surgical
endoscope, according to some embodiments. In block 1210, the
sterilized packaging containing the single use portion of the
endoscope is opened. As shown in FIGS. 1-3, the single use portion
104 includes the fluid hub 130, cannula 120, tip assembly 110, the
needle actuation hub 170 and fluid line 172. The needle 114 is
pre-installed in a dedicated lumen in cannula 120 in the recessed
(not-extended) position so as to reduce risk of a sharps injury. In
block 1212, the single use portion from the sterilized package is
mated with the multiple use portion. As shown in FIGS. 1-3, the
multiple use portion 102 includes the handle 140 and the display
module 150. In block 1214 a saline solution supply, such as from a
syringe is attached to fluid port 132, and the syringe 180
containing the pharmaceutical is connected to fluid line 172.
[0082] In block 1216, a single operator inserts the distal tip 112
and cannula 120 through the patient's urethra such that the distal
tip 112 is deployed in the patient's bladder. Note that the saline
(or other fluid) supply attached to fluid port 132 can be used in
facilitating insertion of the distal tip as is known. Once in the
bladder, the operator can view the bladder cavity and associated
tissue on the display module 150 using the camera and LED light
sources in the tip 112. In 1218 the needle is actuated from
"retracted" to the "extended" position by manipulating the
actuation tab 510 (shown in FIGS. 5A and 5B) until the sliding
mechanism is distally locked. The extended distal tip of the needle
114 is in or near the center of the field of view of the camera
module and the operator has a good view of the needle tip on the
display module as shown in FIG. 11. In block 1220, the distal end
of needle 114 is inserted or jabbed into the bladder tissue by a
distal motion or jabbing of the entire endoscope 100. This is in
contrast to procedures using a conventional rigid or flexible
endoscope wherein the needle assembly is moved relative to the
scope for each jab. The pharmaceutical liquid in syringe 180 is
dispensed into the tissue. According to some embodiments, the
pharmaceutical liquid is or contains botulinum toxin (botox). In
block 1222 the process of jabbing and dispensing is repeated to
treat as much of the bladder tissue as desired by the operator. In
block 1224, the needle is retracted by depressing the lock release
button 530 and moving the actuation tab 510 proximally. The needle
is thereby retracted back into a recessed position within the tip
assembly 110 of tip 112. In block 1226, the cannula and distal tip
are withdrawn from the patient's bladder and urethra. In block 1228
single use and multiple use portions of the endoscope 100 are
separated from each other. The single use portion can be disposed
of and the multiple use portion can be disinfected.
[0083] According to some embodiments, the portions of the endoscope
that may be come in contact with a patient's tissue, such as the
distal portion of cannula 120 and the tip assembly 110, are
hydrophilic. For further detail relating to hydrophilic treatments,
see the co-pending '859 application.
[0084] FIGS. 13 and 14 are perspective views of a handheld surgical
endoscope having a clip or similar arrangement for attaching the
syringe to the handle, according to some embodiments. In these
examples, the syringe 180 can be temporarily attached to the handle
140 using a clip or band, which has been found to facilitate
performance of the surgical procedure by a single operator in some
applications. In the case of FIG. 13, a clip system 1300 is
provided that includes a band 1310 to hold syringe 180 and a band
1312 which attaches to the body of handle 140. The two bands 1310
and 1312 can be fixed to each other in the orientation shown such
that the syringe 180 is firmly affixed to the handle. With the clip
system 1300 installed, the operator can easily use a single hand
912 to grasp the handle 140 and operate its controls (such as image
capture button 160) as well as push a plunger of syringe 180.
According to some embodiments, the bands 1310 and 1312 are made of
a plastic material and according to other embodiments, one or both
are made of elastic or rubber-like material. In the case one or
both 1310 and 1312 are made of a hard or semi-hard plastic, one or
both of the clips can have an opening to facilitate attachment to
the handle and/or syringe. Bands 1310 and 1312 can be attached to
handle 140 as a unit so that syringe 180 can be slipped in band
1310 and coupled with fluid port 174 via conduit 172 (see FIG. 1).
As an alternative, band 1312 can be wrapped around or otherwise
attached to handle 140, band 1310 can be wrapped around or
otherwise attached to syringe 180, or syringe 180 can be slipped
into band 1310, and bands 1310 and 1312 can then be secured to each
other, for example by one or more buttons on one that snap-fit into
depressions in the other, or by matching hook-and-loop (e.g.,
Velcro) patches secured, for example by gluing, to each band at
appropriate positions. As yet another alternative, a hook-and-loop
band can be wrapped around each of syringe 180 and handle 140, and
the two bands can then be pressed to each other for a hook-and-loop
connection. In this manner, a new syringe can be used for each new
patient, or two or more syringes can be used in succession for a
single patient, and the syringe can be securely attached to the
handle such that the user can operate the syringe and the handle
with a single hand (and still has the option to push the syringe
plunger with the other hand as needed or desired). Syringe 180 can
be attached to the left or the right side of handle 140, and can be
tilted at a desired angle relative to the long axis of cannula
120.
[0085] FIG. 14 shows another example of a clip system or a similar
arrangement for attaching syringe 180 to handle 140. In this case
attachment system 1400 includes bands 1410 and 1412 (similar to
bands 1310 and 1312) to attach the syringe 180 to handle 140. In
the illustrated example, system 1400 is configured to locate the
syringe 180 on the right side of handle 140 and also such that the
plunger of syringe 180 is tilted slightly upwards as shown. Various
other configurations and relative orientations of the positioning
of the syringe 180 and the handle 140 are possible and should be
implemented depending upon operator ergonomics and preferences for
facilitating the particular surgical procedure by a single
operator.
[0086] Although the foregoing has been described in some detail for
purposes of clarity, it will be apparent that certain changes and
modifications may be made without departing from the principles
thereof. It should be noted that there are many alternative ways of
implementing both the processes and apparatuses described herein.
Accordingly, the present embodiments are to be considered as
illustrative and not restrictive, and the body of work described
herein is not to be limited to the details given herein, which may
be modified within the scope and equivalents of the appended
claims.
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