U.S. patent application number 17/011026 was filed with the patent office on 2020-12-24 for medicant delivery device.
This patent application is currently assigned to Gyrus ACMI, Inc.. The applicant listed for this patent is Gyrus ACMI, Inc.. Invention is credited to Hugo X. Gonzalez, Madeline C. Graham, Jason T. Panzenbeck.
Application Number | 20200397459 17/011026 |
Document ID | / |
Family ID | 1000005066424 |
Filed Date | 2020-12-24 |
![](/patent/app/20200397459/US20200397459A1-20201224-D00000.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00001.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00002.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00003.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00004.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00005.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00006.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00007.png)
![](/patent/app/20200397459/US20200397459A1-20201224-D00008.png)
United States Patent
Application |
20200397459 |
Kind Code |
A1 |
Graham; Madeline C. ; et
al. |
December 24, 2020 |
MEDICANT DELIVERY DEVICE
Abstract
An example medical instrument for creating tracks within target
tissue. Medicants could be injected into these tracks for diffusion
into the surrounding tissue. An exemplary medical device includes a
first tissue penetrating device, a second tissue penetrating device
and a handle. The handle includes a first component connected to
the first tissue penetrating device and a second component
connected to the second tissue penetrating device. When the second
component is at a first position relative to the first component,
the second tissue penetrating device is in a non-track creation
configuration. When the second component is at a second position
relative to the first component, the second tissue penetrating
device is in a track creation configuration. The second tissue
penetrating device is slidably received within the first tissue
penetrating device.
Inventors: |
Graham; Madeline C.;
(Redmond, WA) ; Gonzalez; Hugo X.; (Woodinville,
WA) ; Panzenbeck; Jason T.; (Seattle, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Gyrus ACMI, Inc. |
Southborough |
MA |
US |
|
|
Assignee: |
Gyrus ACMI, Inc.
Southborough
MA
|
Family ID: |
1000005066424 |
Appl. No.: |
17/011026 |
Filed: |
September 3, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16184231 |
Nov 8, 2018 |
|
|
|
17011026 |
|
|
|
|
62895337 |
Sep 3, 2019 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/2676 20130101;
A61B 17/320016 20130101; A61B 17/3205 20130101 |
International
Class: |
A61B 17/3205 20060101
A61B017/3205; A61B 17/32 20060101 A61B017/32; A61B 1/267 20060101
A61B001/267 |
Claims
1. A medical device comprising: a first tissue penetrating device;
a second tissue penetrating device configured to extend from the
first penetrating device, in an extended state the second tissue
penetrating device forms a coil, in a retracted state the second
tissue penetrating device conforms to the first tissue penetrating
device; and a handle comprising: a first component connected to the
first tissue penetrating device; a second component connected to
the second tissue penetrating device; and a fluid delivery
component configured to allow fluid to pass into the first tissue
penetrating device, wherein when the second component is at a first
position relative to the first component, the second tissue
penetrating device is in an undeployed configuration, wherein when
the second component is at a second position relative to the first
component, the second tissue penetrating device is in a deployed
configuration.
2. The medical device of claim 1, wherein the first and second
tissue penetrating devices are configured to repeatedly allow the
second tissue penetrating device to extend from and retract into
the first tissue penetrating device.
3. A method comprising: a) inserting a hollow needle into a target;
b) deploying a coil from within the hollow needle; c) retracting
the coil back into the hollow needle; and d) advancing medicant
solution through the hollow needle to the target.
4. The method of claim 3, further comprising: before d) performing
the following one or more times; at least one of retracting or
advancing the hollow needle into a different location of the
target; and repeating b) and c).
5. The method of claim 3, wherein the coil is in a non-coiled
configuration when within the hollow needle.
Description
PRIORITY CLAIM
[0001] This application claims the benefit of U.S. Provisional
Application No. 62/895,337 filed 3 Sep. 2019, the contents of which
are hereby incorporated by reference.
[0002] This application is a continuation of U.S. application Ser.
No. 16/184,231 filed 8 Nov. 2018, the contents of which are hereby
incorporated by reference.
BACKGROUND
[0003] There are several medical situations where it is desired to
deliver substances by injection to a relatively large volume of
tissue. If a substance is delivered by a single point injection,
the problems that may arise are (a) the substance cannot spread
throughout the volume in sufficient time; (b) too much dilution may
occur during the spreading; (c) the distribution of the substance
within the volume may be very inhomogeneous; and (d) unwanted
spreading to regions away from the target volume may occur. One
solution to this problem is to give smaller injections at several
sites within the target volume. This approach has at least a few
disadvantages: (a) multiple needle stab wounds are created; (b)
accuracy of placement is limited; and (c) the time for the
procedure may be increased.
SUMMARY
[0004] The embodiments shown relate to an improved hypodermic
needle and fluid injection device.
[0005] The embodiments shown an example medical instrument for
creating tracks within target tissue. Medicants could be injected
into these tracks for diffusion into the surrounding tissue.
[0006] Further features, advantages, and areas of applicability
will become apparent from the description provided herein. It
should be understood that the description and specific examples are
intended for purposes of illustration only and are not intended to
limit the scope of the present disclosure.
DRAWINGS
[0007] The drawings described herein are for illustration purposes
only and are not intended to limit the scope of the present
disclosure in any way. The components in the figures are not
necessarily to scale, emphasis instead being placed upon
illustrating the principles of the embodiments. In the
drawings:
[0008] FIG. 1 is a side view of external components of an injection
system formed in accordance with an embodiment;
[0009] FIG. 2 is an x-ray view of a distal end of a component of
the injection system of FIG. 1;
[0010] FIG. 3 is a side, x-ray view of the distal end of the
component of FIG. 2 in a first configuration;
[0011] FIG. 4 is a side x-ray view of the distal end of the
component of FIG. 2 in a second configuration;
[0012] FIG. 5 is a perspective view of a handle associated with the
component of FIG. 2;
[0013] FIG. 6-1 is an x-ray view of a distal end of an injection
component formed in accordance with an embodiment;
[0014] FIG. 6-2 is an x-ray view of the injection component of FIG.
6-1 in a different operational state;
[0015] FIG. 6-3 is a side view of a stylet device used in the
injection component of FIGS. 6-1 and 6-2 having a first pattern of
injection;
[0016] FIG. 6-4 is a side view of a stylet device used in the
injection component of FIGS. 6-1 and 6-2 having a second pattern of
injection;
[0017] FIG. 7-1 is an x-ray view of the injection component in a
first operational state;
[0018] FIG. 7-2 is an x-ray view of the injection component of FIG.
7-1 in a second operational state;
[0019] FIG. 8-1 is an x-ray view of a distal end of an injection
component formed in accordance with an embodiment;
[0020] FIG. 8-2 is an x-ray view of the injection component of FIG.
8-1 in a first operational state;
[0021] FIG. 9-1 is a partial cross-sectional view of a distal end
of an injection component formed in accordance with an
embodiment;
[0022] FIG. 9-2 is a partial cross-sectional view of the stylet
component of FIG. 9-1 in a first operational state;
[0023] FIG. 10 is a side view of stylet device formed in accordance
with an embodiment;
[0024] FIG. 11-1 is a side view of a distal end of an injection
component formed in accordance with an embodiment;
[0025] FIG. 11-2 is side view of a stylet of the injection
component of FIG. 11-1; and
[0026] FIG. 11-3 is an x-ray view of a distal end of the injection
component of FIG. 11-1.
DETAILED DESCRIPTION
[0027] The following description is merely exemplary in nature and
is not intended to limit the present disclosure, application, or
uses.
[0028] FIG. 1 shows an exemplary system 10 for injecting fluid or
medicants into target tissue. The system 10 includes an injection
device 20 that is received through a handle 16 and an insertion
tube 14 of an endoscope 12 (e.g., bronchoscope). The injection
device 20 may or may not be used with a sheath. If the injection
device 20 is used with the sheath (not shown), a handle of the
injection device 20 includes a base component 22 connected to the
sheath, an actuator component 24 connected to a needle device (not
shown) slidably received within the sheath and a stylet handle
component 26 connected to a stylet (not shown) slidably received
within the needle device.
[0029] The actuator component 24 allows a user to extend a distal
end of the needle distally from a distal end of the sheath. Force
applied by the user to the actuator component 24 translates into a
force at the distal end of the needle, thus allowing for
penetration of the needle into target tissue (e.g., lesion or
tumor).
[0030] A stylet extension mechanism (shown by example in FIG. 5)
allows for extension of at least a portion of the stylet from a
distal section of the needle. The stylet extension mechanism may
include components located in the actuator component 24 and/or the
stylet handle component 26. Examples of the stylet extension
mechanism are shown and/or described below.
[0031] As shown in FIG. 2, a needle 40 of the injection device 20
(FIG. 1) includes a trocar or occluded tip 44. The needle 40
includes one or more slots 48 proximal from the tip 44. The slots
48 expose a lumen of the needle 40 to the exterior of the needle
40. A proximal end of a stylet 50 is connected to the stylet handle
component 26. A distal end of the stylet 50 is split into multiple
flexible prongs 52 at a distal section. The distal ends of the
prongs 52 are connected to each other at a distal plug 54. The
stylet 50 and the prongs 52 may be manufactured by laser cutting a
hypotube or rod.
[0032] Once the needle 40 has been positioned adjacent to
previously identified target tissue with the help of the endoscope
12, the actuator component 24 is advanced distally causing the
needle 40 to penetrate the target tissue 70 (FIG. 3). Next, the
user applies a distal force to the stylet handle component 26. When
pressure/force is applied to the stylet handle component 26, the
distal plug 54 makes contact with the distal end of the lumen of
the needle 40 or inside of the tip 44. This causes the prongs 52 of
the stylet 50 bend outward from a longitudinal axis of the needle
40, thus passing through the slots 48. The prongs 52 protruding
from the slots 48 penetrate or apply pressure to the surrounding
target tissue 70 (FIG. 4). Then the needle 40, if desired, could be
rotated, allowing the prongs 52 to cut the tissue and subsequently
create more or larger pockets within the target tissue for fluid,
such as a medicant, to flow. Once the distal force is released, the
prongs 52 retract within the needle 40 and return to the
predeployed position. Then fluid could be injected through the
needle lumen and out of the slots 48 at the tip of the needle 40.
The stylet 52 would be thin enough that there would be room within
the needle lumen for fluid to flow.
[0033] In one embodiment, the prongs 52 have edges sharp enough to
cut tissue. Thus, when the needle 40 is rotated, the sharp edges of
any protruding prongs 52 will cut surrounding tissue.
[0034] In one embodiment, the distal plug 54 and the tip 44 are
configured such that when the distal plug 54 is forced against the
interior of the tip 44, the distal plug 54 rotates into proper
alignment so that the prongs 52 rotate to align with the slots 48.
This is considered a clocking mechanism. Other clocking mechanisms
can be used.
[0035] In one embodiment, as shown in FIG. 5, a stylet handle
component 20-1 includes a screw/twist knob 60 that mates to a luer
62 at the proximal end of an actuator handle component 64. If the
stylet twist knob 60 is not connected to the luer 62, but simply
rests on top of it, then a distal end of a stylet 66 will sit in
the middle of a bevel cut of the distal end of a needle. The prongs
52 will not be forced to expand out of the needle slots 48. By
connecting the stylet knob 60 and luer 62, the stylet 66 compresses
against the tip 44 of the needle, thus causing the prongs 52 to
protrude through the slots 48. How far the prongs 52 protrude
depends on how far the knob 60 is twisted onto the luer 62.
[0036] In one embodiment, a stylet knob includes a counterbore with
a spring. When the knob rests on the luer at the proximal end of
the device, a distal tip of the stylet attached to the knob lies
within the distal end of the needle. When the spring is compressed
by a distal force applied by a user to the stylet knob, the distal
force causes the prongs of the stylet to extend out of slots at the
distal end of the needle.
[0037] In one embodiment, as shown in FIGS. 7-1 and 7-2, a needle
100 attached to a handle (not shown) is advanced into target tissue
106 is a guide device, such as a bronchoscope. A coil 102 is
initially located within a lumen of the needle 100 and advances
with the needle 100. The coil 102 is attached to a component of the
handle distinct from the handle component that connects to the
needle 100. Once the needle 100 has been advanced into the target
tissue 106 as identified by some imaging system, the coil 102
extended to beyond the distal end of the needle 100. As the coil
102 extends beyond the distal end of the needle 100, the coil 102
changes from a shape that conforms to the needle 100 to its
predefined shape, which is a coil or helical configuration. The
coil 102 may be formed of a shape-memory metal. The coil 102 is
then retracted back into the needle 100. After coil retraction has
occurred, a treatment solution device is attached to the handle and
the medicant solution device forces a treatment solution through
the handle and into the needle 100 and out the distal end of the
needle 100 into the target tissue 106.
[0038] In another embodiment, the steps of deploying the coil 102
and retracting the coil 102 into the target tissue 106 is repeated
one or more times before the deployment of the treatment solution
with the needle 100 being at a different position within the target
tissue 106. The device shown in FIGS. 7-1 and 7-2 creates one or
more tracks within the target tissue that allows for flow of the
treatment solution.
[0039] The description is merely exemplary in nature and variations
that do not depart from the gist of the embodiments are intended to
be within the scope of the invention. Such variations are not to be
regarded as a departure from the spirit and scope of the
invention.
* * * * *