U.S. patent application number 12/499908 was filed with the patent office on 2009-10-29 for device for assisting the positioning of medical devices.
This patent application is currently assigned to SonoSite, Inc.. Invention is credited to Steven Bunce, Jared Floyd.
Application Number | 20090270722 12/499908 |
Document ID | / |
Family ID | 34657244 |
Filed Date | 2009-10-29 |
United States Patent
Application |
20090270722 |
Kind Code |
A1 |
Floyd; Jared ; et
al. |
October 29, 2009 |
DEVICE FOR ASSISTING THE POSITIONING OF MEDICAL DEVICES
Abstract
In one embodiment, a needle guide is attached to the end of an
ultrasonic probe in a manner such that the needle will follow a
known trajectory under control of the needle guide. The surgeon
then positions the needle guide by looking at the ultrasound image
formed from the ultrasound radiated from the probe. In one
embodiment, the needle guide has a release mechanism that allows
the needle (or other medical device) that had been positioned in
the guide to remain in the patient when the probe is removed. In
one embodiment, the needle guide is designed to be releasably
mounted to a bracket which, in turn, is releasably mounted to the
end of the probe.
Inventors: |
Floyd; Jared; (Lynnwood,
WA) ; Bunce; Steven; (Sedro Woolley, WA) |
Correspondence
Address: |
FULBRIGHT & JAWORSKI L.L.P
2200 ROSS AVENUE, SUITE 2800
DALLAS
TX
75201-2784
US
|
Assignee: |
SonoSite, Inc.
Bothel
WA
|
Family ID: |
34657244 |
Appl. No.: |
12/499908 |
Filed: |
July 9, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10766707 |
Jan 28, 2004 |
7588541 |
|
|
12499908 |
|
|
|
|
60528505 |
Dec 10, 2003 |
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Current U.S.
Class: |
600/424 |
Current CPC
Class: |
A61B 2017/3413 20130101;
A61B 17/3403 20130101; A61B 2017/347 20130101; A61M 25/02
20130101 |
Class at
Publication: |
600/424 |
International
Class: |
A61B 8/00 20060101
A61B008/00 |
Claims
1. An apparatus for positioning a medical device for insertion
within a body; said apparatus comprising: a bracket configured to
attach to the body of an imaging probe; and a plurality of medical
device supports, said plurality of medical device supports being
configured to individually attach to said bracket, one or more of
said plurality of medical device supports configured to create a
different angle of attack than another of said plurality of medical
device supports, said plurality of device supports including a
latch configured to hold a medical device at a predetermined angle
with respect to said probe such that images produced as a result of
radiation from said probe serve to position said medical device for
insertion within said body.
2. The apparatus of claim 1 wherein said bracket comprises: slots
for fitting over the proximal end of said image probe without
interference with said radiation from said probe.
3. The apparatus of claim 2 wherein said latch comprises: at least
one tab for maintaining said medical device at said predetermined
angle.
4. The apparatus of claim 1 wherein the first medical device
support of said plurality of medical device supports is configured
to be pivotably coupled to said bracket.
5. The apparatus of claim 1 further comprising: means for
controlling the release of said medical device after positioning
within said body.
6. The apparatus of claim 5 wherein said controlling means
comprises: a latch for sliding over a surface of said medical
device.
7. The apparatus of claim 5 wherein said controlling means
comprises: a latch for pivoting over a surface of said medical
device.
8. The apparatus of claim 1 wherein said medical device is selected
from the list of: a needle, a catheter, a drill bit, a cutting
blade.
9. The apparatus of claim 1 wherein said latch is a slide
configured to traverse perpendicularly over said medical device
when said medical device is seated in one of said plurality of
medical device supports.
10. A method of releasably attaching a medical device to a probe,
said method comprising: releasably connecting a bracket to the
proximal end of said probe; releasably connecting a guide to said
bracket, so that the longitudinal axis of said guide falls along
the longitudinal axis of said probe, said guide being selected from
a plurality of guides which are adapted to form different angles of
attack for said medical device; positioning said medical device
along said longitudinal axis of said guide; and releasably clamping
said positioned medical device within said guide so that an angle
of attack of the selected medical device remains constant with
respect to the proximal end of said probe.
11. The method of claim 10 further comprising: generating at least
one image of structures below the surface of an object over which
said proximal end of said probe moves, said image generation
resulting at least in part from signals emitted from said proximate
end of said probe; sliding a proximal end of said clamped medical
device toward said surface of said object along a trajectory
predictable as a result of said generated image; continuing to
slide said proximal end of said clamped medical device along said
trajectory to a position below said surface of said object; and
releasing said clamped positioned medical device from said probe
while said proximal end of said medical device remains positioned
below said surface of said object.
12. The method of claim 11 wherein said guide is configured to
define a closing angle with respect to said proximal end of said
probe and wherein said trajectory is predictable at least in part
by said closing angle.
13. The method of claim 12 wherein said closing angle corresponds
to a target depth of said positioned medical device below said
surface of said object.
14. The method of claim 10 wherein said releasably clamping is
controlled at least in part by a slide operating transverse
perpendicular to said longitudinal axis.
15. The method of claim 14 wherein at least a portion of said slide
contains a ramp.
16. The method of claim 10 wherein said plurality of guides are
configured to accept medical devices having different
diameters.
17. A device comprising: a releasable guide configured to mate with
said proximate end of an imaging probe; a channel configured to
accept the longitudinal axis of an elongated medical device, said
channel lying along a longitudinal axis of said probe when said
guide is mated with said probe, said channel defining a
pre-established closing angle with respect to a location below a
surface of an object in proximity to said proximate end of said
probe; and a slide configured to traverse perpendicularly over said
channel, said slide applying controlled clamping force on an
accepted elongated medical device.
18. The device of claim 17 wherein said slide further comprises: at
least one tab configured to maintain said applied controlled
clamping force.
19. The device of claim 18 wherein said controlled clamping force
allows the proximal end of said clamped elongated medical device to
slide toward said surface of said object under control of a
user.
20. The device of claim 17 wherein said releasable guide comprises:
a bracket releasably affixed to both said guide and said proximate
end of said probe.
21. A device for securing a medical implement at a pre-determined
angle, said device comprising: a guide defining said pre-determined
angle, said guide further defining a longitudinal channel
configured to accept said medical implement; a latching mechanism
configured to secure said medical implement in longitudinal channel
of said guide, said latching mechanism including a flexible portion
configured compress in order to insert said latching mechanism into
said guide and further configured to expand and provide a secure
latch when inserted into said guide and when said latching
mechanism is in a closed position.
22. The device of claim 21 wherein said latching mechanism
comprises a lower portion configured to be placed below said
channel and an upper portion configured to be placed above said
medical implement.
23. The device of claim 22 wherein said lower portion comprises a
sloped surface keyed to a diameter of said medical implement.
24. The device of claim 21 wherein said flexible portion comprises
a tab.
25. The device of claim 21 wherein said flexible portion is
configured to be depressed when said latching mechanism is in a
closed position in order to release said latching mechanism.
26. The device of claim 21 wherein said latching mechanism is
slidably coupled to said guide.
27. The device of claim 26 wherein said latching mechanism is
configured to slide perpendicularly across said longitudinal
channel to secure said medical implement.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of, and claims priority
to U.S. patent application Ser. No. 10/766,707 filed Jan. 28, 2004,
entitled SYSTEMS AND METHODS FOR ASSISTING IN POSITIONING OF
MEDICAL DEVICES. Which claims priority to U.S. Provisional Patent
Application No. 60/528,505 filed Dec. 10, 2003, entitled DEVICE FOR
ASSISTING THE POSITIONING OF MEDICAL DEVICES, and, the disclosures
of which are hereby incorporated by reference in their
entirety.
TECHNICAL FIELD
[0002] This invention relates to medical positioning devices and
more particularly to systems and methods for using imaging
equipment, such as ultrasound, for assisting in the placement of a
medical device.
BACKGROUND
[0003] Proper positioning of medical devices, such as needles,
catheters, drills, saws and even scalpels, is critical in the
proper performance of certain medical procedures. Often the surgeon
must look at a screen while trying to manually position a medical
device, and thus can not look directly at the device. This is
difficult at best and sometimes results in improper angles of
attack and could result in improper placement of the medical
device.
SUMMARY
[0004] In one embodiment, a needle guide is attached to the end of
an ultrasonic probe in a manner such that the needle will follow a
known trajectory under control of the needle guide. The surgeon
then positions the needle guide by looking at the ultrasound image
formed from the ultrasound radiated from the probe.
[0005] In one embodiment, the needle guide has a release mechanism
that allows the needle (or other medical device) that had been
positioned in the guide to remain in the patient when the probe is
removed.
[0006] The foregoing has outlined rather broadly the features and
technical advantages of the present invention in order that the
detailed description of the invention that follows may be better
understood. Additional features and advantages of the invention
will be described hereinafter which form the subject of the claims
of the invention. It should be appreciated that the conception and
specific embodiment disclosed may be readily utilized as a basis
for modifying or designing other structures for carrying out the
same purposes of the present invention. It should also be realized
that such equivalent constructions do not depart from the invention
as set forth in the appended claims. The novel features which are
believed to be characteristic of the invention, both as to its
organization and method of operation, together with further objects
and advantages will be better understood from the following
description when considered in connection with the accompanying
figures. It is to be expressly understood, however, that each of
the figures is provided for the purpose of illustration and
description only and is not intended as a definition of the limits
of the present invention.
DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 shows one embodiment of a probe having a medical
device positioning guide mounted thereon;
[0008] FIG. 2 shows a view of the positioning guide of FIG. 1;
[0009] FIG. 3 shows one embodiment of a medical device guide and
release mechanism based on the embodiment of FIG. 1;
[0010] FIG. 4 shows one embodiment of a needle held by the medical
device guide;
[0011] FIG. 5 shows details of one embodiment of the release
mechanism based on the embodiment of FIG. 1;
[0012] FIG. 6 illustrates how the release mechanism of FIG. 5
releasably mates with the device guide of FIG. 1;
[0013] FIGS. 7A, 7B and 7C illustrate the releaseable mating of the
device bracket with the probe;
[0014] FIGS. 8A, 8B and 8C illustrate the releaseable mating of the
device guide with the device bracket;
[0015] FIGS. 9A, 9B, 9C and 9D show dimensional relationships of
embodiments of the illustrated device guide;
[0016] FIGS. 10A, 10B and 10C show dimensional relationships of
embodiment of the illustrated release mechanism; and
[0017] FIG. 11 shows one embodiment of packaging a plurality of
device guides; and
[0018] FIGS. 12 and 13 show alternate embodiments of the medical
device guides.
DETAILED DESCRIPTION
[0019] FIG. 1 shows one embodiment of probe 10 having bracket 12
releasably attached thereto. This attachment, for example, is by
fitting a first side 71 of the bracket over protrusion 13 on probe
10, as shown in FIG. 7A. The other side 72 of the bracket fits over
the other side 15 of probe 10 as shown in FIG. 7B, and locks
between protrusions 73 and 74 up against slot 14 of probe 10 again,
as shown in FIG. 7C. Slot 702 snaps over protrusion 13 to hold
bracket 12 from swinging open. Probe 10, in the embodiment of FIG.
1, can be an ultrasound probe.
[0020] In operation, probe 10 (FIG. 1) sends ultrasound signals
into the body and these signals then provide images of organs,
fluids, etc which are otherwise hidden from view. When the probe is
positioned properly, as determined by the images sent back by the
ultrasound, the surgeon can then insert a needle, such as needle
41, (or other surgical instrument), knowing the instrument's
trajectory based upon the received images. The trajectory is a
preset by the selection of the device guide. The device guide
establishes an angle of attack with respect to the proximal end of
the probe. By extension, this angle of attack extends below the
skin of the patient. In some cases, the image may contain a
projection of the needle trajectory as an aide to the surgeon.
[0021] When the needle, or other device to be inserted, is
positioned properly, the needle is slid forward so that its
proximal end moves toward the patient and enters the patient. When
the desired depth is reached, mechanism 50 is operated to release
the needle thereby allowing probe 10, bracket 12 and needle guide
20 to be removed, leaving the needle (or other device) within the
patient's body.
[0022] FIG. 2 shows bracket 12 having medical device guide 20
mounted thereon. Note that device 20 and device 12 can be a single
structure if desired. Device 20 in the embodiment shown, is a
device for holding a needle (shown in FIG. 4) within groove 22.
Release control portion 50 holds the needle in position, while end
portion 51 serves to release the needle when the needle has been
properly positioned. If device 20 and device 12 are separate
structures, they can be releasably mated as shown in FIGS. 8A and
8B. As shown in FIG. 8A, one end of device 20 is mated via pins 82
(shown in FIG. 8C) being inserted into bracket 82. Once pin 83 is
positioned in bracket 82, guide 20 is rotated toward probe 10 and
snaps in position under control of tab 81 of bracket 12 releaseably
locking on edge 21 of device 20.
[0023] As shown in FIG. 3, device guide 30 consists of two parts:
namely, guide 20 and release mechanism 50. Guide 30 snaps into
bracket 12, as discussed above, attached to an ultrasound
transducer. The device guide is manufactured to control the
placement of devices, such as catheter and needles, to multiple
depths, by changing the angle of attack at which the needle (or
catheter) is presented to the transducer. The device guide is also
manufactured to handle multiple gauges to accommodate specific
diameter medical devices.
[0024] As shown in FIG. 4, guide 20 has lead-in 43 to make
insertion of the needle (such as needle 41) into the guide easier.
Needle 41 then rests in channel 44 along the longitudinal axis of
probe 10 so that the needle is positioned in a specific trajectory
with respect to the surface to be probed. In effect, the medical
device (which typically would be an elogated device (needle) with a
substantially round cross-section forms a closing angle with the
proximal end of the guide (and the probe) so that when the probe is
properly placed, the proximal end, when moved down the channel,
will be positioned a given distance below the skin of the patient.
This trajectory intersects the patient at the target depth (such as
1.5 cm.) as indicated on the needle guide. Various angles and
respective depths for 1.5, 2.5, 3.5 and 4.5 cms are shown in FIG.
9A-9D.
[0025] FIG. 4 shows mechanism 50 (discussed in more detail with
respect to FIGS. 6 and 7) mounted in slot 45 of guide 20. Release
portion 52 is positioned over needle 41 and exerts pressure on
needle 41 within groove 44. The pressure from portion 52 on the
needle guide keeps the needle in proper orientation, but allows the
user to slide the clamped needle toward the patient. The needle can
then be positioned below the skin of the patient at the desired
depth.
[0026] FIG. 5 shows mechanism 50 having flexible tab 55 to maintain
a closed position and to prevent accidental opening. The geometry
of mechanism 50, including dimension D, provides a specific amount
of needle drag friction between the inserted needle and groove 44.
Once the needle has been oriented into the desired position, tab 55
is flexed inward allowing mechanism 50 (and particularly overhang
52) to move away from groove 44, thereby allowing needle 41 to
release from the device guide. This, then, allows needle 41 to
remain in the patient when the probe is removed.
[0027] FIG. 6 shows a top schematic view of mechanism 50 inserted
in guide 20 with tab 55 locking against edge 42 of guide 20 prior
to release of mechanism 50 from guide 20. Tab 55 flexes into slot
53 formed by opening 54.
[0028] FIGS. 9A-9D show dimensional relationships of embodiments of
a device guide. FIG. 9A shows a top view of guide 20. FIG. 9B is an
end view of guide 20 and FIG. 9C is a section 9C-9C taken through
device 20 in FIG. 9B. FIG. 9D shows typical illustrative dimensions
(keyed to FIG. 9C) for different depth guides.
[0029] FIG. 10A shows a top view of mechanism 50. FIG. 10B shows
the end view of mechanism 50 and FIG. 10C is a section 10C-10C
taken through mechanism 50 in FIG. 10B. Dimension D is keyed to the
diameter of the device to be held within the guide. For 18 gauge
needles, this dimension would be 0.070 in for the embodiment shown,
and dimension D1 would be 0.096 in. A typical length for mechanism
50 would be 0.564 in. If desired, portion 501 (FIG. 10C) can be
tapered to better wedge needle 41 when in seating portion 44 of the
guide.
[0030] FIG. 11 shows one embodiment 1100 of the packaging for a
plurality of needle guides, 50, 1110, 1111 and 1112. Each of the
needle guides can have different target depths, or they can all
have the same depth. Center holder 1101 has limbs 1102 for holding
each guide. Any number of limbs can be used.
[0031] FIG. 12 shows one alternate device guide 1200 with latch
1201 in the open position. As shown, latch 1202 will engage
protrusion 1203 for latching purposes.
[0032] FIG. 13 shows guide 1200 in the latched position clamping
needle 41 in position.
[0033] Although the present invention and its advantages have been
described in detail, it should be understood that various changes,
substitutions and alterations can be made herein without departing
from the invention as defined by the appended claims. Moreover, the
scope of the present application is not intended to be limited to
the particular embodiments of the process, machine, manufacture,
composition of matter, means, methods and steps described in the
specification. As one will readily appreciate from the disclosure,
processes, machines, manufacture, compositions of matter, means,
methods, or steps, presently existing or later to be developed that
perform substantially the same function or achieve substantially
the same result as the corresponding embodiments described herein
may be utilized. Accordingly, the appended claims are intended to
include within their scope such processes, machines, manufacture,
compositions of matter, means, methods, or steps.
* * * * *