U.S. patent application number 14/942029 was filed with the patent office on 2016-05-12 for method and device for loading medical appliance with medicaments and/or polymers.
The applicant listed for this patent is SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.. Invention is credited to Qiyi Luo, Zhirong Tang, Changsheng Wu, Bo Yi, Jie Zhang.
Application Number | 20160128848 14/942029 |
Document ID | / |
Family ID | 44263911 |
Filed Date | 2016-05-12 |
United States Patent
Application |
20160128848 |
Kind Code |
A1 |
Zhang; Jie ; et al. |
May 12, 2016 |
METHOD AND DEVICE FOR LOADING MEDICAL APPLIANCE WITH MEDICAMENTS
AND/OR POLYMERS
Abstract
A method and a device for loading a medical appliance with a
medicament and/or polymer includes capturing images of a plurality
of grooves or holes of the medical appliance using an image
capturing device; performing digital image processing on the image
of each of the grooves or holes to obtain a pattern of each of the
grooves or holes; calculating a central position of the pattern of
each of the grooves or holes, and determining a loading position of
each of the grooves or holes based on the central position; and
adjusting a relative position between a loading device and the
medical appliance to align an outlet of the loading device with the
loading position of the medical appliance, and loading each of the
grooves or holes with the medicament and/or polymer. The method and
device can load the medical appliance with the medicament and/or
polymer fast and efficiently.
Inventors: |
Zhang; Jie; (Shanghai,
CN) ; Yi; Bo; (Shanghai, CN) ; Wu;
Changsheng; (Shanghai, CN) ; Tang; Zhirong;
(Shanghai, CN) ; Luo; Qiyi; (Shanghai,
CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD. |
SHANGHAI |
|
CN |
|
|
Family ID: |
44263911 |
Appl. No.: |
14/942029 |
Filed: |
November 16, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13522819 |
Jul 18, 2012 |
9205180 |
|
|
PCT/CN11/00215 |
Jan 19, 2011 |
|
|
|
14942029 |
|
|
|
|
Current U.S.
Class: |
118/713 |
Current CPC
Class: |
A61L 2300/416 20130101;
A61F 2/91 20130101; A61F 2240/001 20130101; A61F 2/82 20130101;
A61L 31/06 20130101; A61F 2250/0068 20130101; C08L 67/04 20130101;
B05C 21/00 20130101; A61L 31/16 20130101; A61L 31/06 20130101 |
International
Class: |
A61F 2/82 20060101
A61F002/82; B05C 21/00 20060101 B05C021/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 19, 2010 |
CN |
201010022937.0 |
Claims
1. A device for loading a medial appliance with a medicament and/or
polymer, the medical appliance containing a plurality of grooves or
holes, characterized in comprising: a platform for placing the
medical appliance; an image capturing device disposed above the
platform for capturing images of the grooves or holes of the
medical appliance; an image processing unit connected with the
image capturing device for performing digital image processing on
the images of the grooves or holes captured by the image capturing
device; a position calculating unit connected with the image
processing unit for calculating a desired relative position based
on a result processed by the image processing unit; a memory unit
connected with the position calculating unit for recording a
relative position calculated by the position calculating unit; a
first position adjustment device connected with the memory unit and
with the platform for moving the platform based on the relative
position in the memory unit to adjust a relative position relation
between the medical appliance and the image capturing device and/or
the loading device; and a loading device disposed above the
platform for loading the grooves or holes of the medical appliance
with the medicament and/or polymer, characterized in that the image
processing unit comprises: an image converting sub-unit for
converting the image of the groove or hole into a set of pixel
points; an image pre-processing sub-unit for performing a filter
processing on the set of pixel points to remove image noise; and an
image processing sub-unit for processing the pre-processed image
with a binary method to obtain the pattern of each of the grooves
or holes, and characterized in that the image processing sub-unit
assigns a value to each of the pixel points with the binary method
based on a gray value of each of the pre-processed pixel points,
designates a pixel point conforming with a preset value or a value
range as a target pixel point or a background pixel point, and
connects all the pixel points designated as the target pixel points
or the background pixel points to obtain the patterns of the
grooves or holes.
2. The device according to claim 1, characterized in further
comprising a position calibration device connected with the memory
unit for calibrating a spatial position relation between a central
position of the image capturing device and an outlet of the loading
device, and the platform comprises a rotation platform and a stent
shaft, the stent shaft fixed in and penetrated through the middle
of the rotation platform, and the medical appliance disposed on the
stent shaft.
3. The device according to claim 2, characterized in further
comprising: a second position adjustment device connected with the
memory unit and with the image capturing device for driving the
image capturing device to move in a horizontal coordinate plane
based on the relative position in the memory unit; and a third
position adjustment device connected with the memory unit and with
the loading device for driving the loading device to move in a
horizontal plane based on the relative position in the memory unit,
wherein an axes of the image capturing device and an axis of the
loading device are disposed in the same vertical plane.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 13/522,819, filed Jul. 18, 2012, which is a national stage
filing under 35 U.S.C. 371 of International Application No.
PCT/CN2011/000215 filed Jan. 19, 2011, which claims foreign
priority benefits to Chinese Patent Application No. 201010022937.0
filed Jan. 19, 2010. These applications are incorporated herein by
reference in their entirety.
TECHNICAL FIELD
[0002] The present invention relates to the field of a medical
instrument, and particularly to a method and a device for loading a
medical appliance with a medicament and/or polymer.
BACKGROUND
[0003] A medicament eluting stent is a new technology for treating
coronary heart diseases that is developed in recent years. A
medicament eluting stent can be also called as a medicament
releasing stent that carries a medicament via a polymer coated on a
surface of the medicament eluting stent. When the stent is
implanted into a lesion site within a blood vessel, the medicament
releases controllably in a manner of eluting from the polymer
coating into the cardiovascular wall tissue to exert the biological
effect.
[0004] A single-sided coating manner is a newest manner of coating
a medicament on a stent surface at present. Specifically, in the
single-sided coating manner, a large amount of ever-indeformable
small apertures capable of storing a medicament, which are called
grooves or holes that may provide a medicament elution, are
processed on the surface of a medicament eluting stent. The grooves
or holes on the medicament elution stent are in a magnitude order
of micron, so it is necessary to load a medicament and/or polymer
with a dedicated method and device for loading.
[0005] In a process of carrying out the present application, the
inventor found out that in the existing technology only one image
of the storage grooves or holes can be obtained every time the
medicament eluting stent performs the medicament and/or polymer
loading, and the grooves or holes on the image are loaded after
calculating a central position of the storage grooves or holes in
the image. The aforesaid method for loading has the defects of a
low loading speed and a low loading efficiency when performing
loading.
SUMMARY OF INVENTION
[0006] In order to solve the aforesaid technical problem, the
embodiment of the present application provides a method and device
for loading a medical appliance with a medicament and/or polymer to
load grooves or holes with the medicament and/or polymer fast and
efficiently. The technical solution is as follows:
[0007] A method for loading a medial appliance with a medicament or
polymer, wherein the medical appliance contains a plurality of
grooves or holes for being loaded with the medicament and/or
polymer, characterized in comprising: [0008] capturing images of
the grooves or holes of the medical appliance for multiple times
using an image capturing device, each image containing a pattern of
at least one entire the groove or hole; [0009] performing digital
image processing on the image of each of the grooves or holes to
obtain the pattern of each of the grooves or holes; [0010]
calculating a central position of the pattern of each of the
grooves or holes based on the pattern of each of the grooves or
holes, and determining a loading position of each of the grooves or
holes based on the central position; and [0011] adjusting a
relative position between a loading device and the medical
appliance to align an outlet of the loading device with the loading
position of each of the grooves or holes, and loading each of the
grooves or holes with the medicament and/or polymer.
[0012] Preferably, the image processing is embodied as: [0013]
image converting that converts the image of each of the grooves or
holes into a set of pixel points; [0014] image pre-processing that
performs a filter processing on the set of pixel points to remove
image noise; and [0015] image processing that processes the
pre-processed image with a binary method to obtain the pattern of
each of the grooves or holes.
[0016] Preferably, the processing with the binary method is
embodied as: [0017] assigning a value to each of the pixel points
with the binary method based on a gray value of each of the
pre-processed pixel points, designating a pixel point conforming
with a preset value or value range as a target pixel point or a
background pixel point, and connecting all the pixel points
designated as the target pixel points or the background pixel
points to obtain the pattern of each of the grooves or holes.
[0018] Preferably, the calculating the central position of the
pattern of each of the grooves or holes and determining the loading
position of each of the grooves or holes based on the central
position is embodied as: [0019] calculating a spatial coordinate of
a central pixel point of the pattern of each of the grooves or
holes based on a spatial coordinate of each of the pixel points of
the pattern of each of the grooves or holes; [0020] determining a
spatial coordinate of a geometrical center of the image of each of
the grooves or holes; [0021] calculating a coordinate difference
value in the x direction and/or in the y direction between the
spatial coordinate of the central pixel point of the pattern of
each of the grooves or holes and the spatial coordinate of the
geometrical center of the image of each of the grooves or holes,
and [0022] recording it as a first relative position; and recording
the first relative position corresponding to each of the grooves or
holes as a first array.
[0023] Preferably, the determining the spatial coordinate of the
geometrical center of the image of each of the grooves or holes is
embodied as: [0024] obtaining spatial coordinates of four apexes of
the image of each of the grooves or holes; and [0025] calculating
the spatial coordinate of the geometrical center of the image of
each of the grooves or holes based on the spatial coordinates of
the four apexes.
[0026] Preferably, the calculating the central position of the
pattern of each of the grooves or holes, and determining the
loading position of each of the grooves or holes based on the
central position is embodied as: [0027] calculating a pixel
coordinate of the central pixel point of the pattern of each of the
grooves or holes based on a pixel coordinate of each of the pixel
points in the pattern of each of the grooves or holes; [0028]
determining a pixel coordinate of the pixel point of the
geometrical center of the image of each of the grooves or holes;
[0029] calculating a coordinate difference value between the pixel
coordinate of the central pixel point of the pattern of each of the
grooves or holes and the pixel coordinate of the pixel point of the
geometrical center of the image of each of the grooves or holes,
converting the coordinate difference value between the two pixels
points into a spatial coordinate difference value, and recording it
as a first relative position; and [0030] recording the first
relative position corresponding to each of the grooves or holes as
a first array.
[0031] Preferably, the determining the pixel coordinate of the
pixel point of the geometrical center of the image of each of the
grooves or holes is embodied as: [0032] obtaining pixel coordinates
of four apexes of the image of each of the grooves or holes; and
[0033] calculating the pixel coordinate of the geometrical center
of the image of each of the grooves or holes based on the pixel
coordinates of the four apexes.
[0034] Preferably, the calculating the pixel coordinate of the
geometrical center of the image of each of the grooves or holes is
embodied as: [0035] obtaining a medium value of the pixel point
respectively in an x direction and/or in a y direction based on a
resolution of the image of each of the grooves or holes, the medium
value being the pixel coordinate of the geometrical center of the
image of each of the grooves or holes.
[0036] Preferably, the adjusting the relative position between the
loading device and the medical appliance to align the outlet of the
loading device with the loading position of the medical appliance
is embodied as: [0037] determining a relative position of the
loading device to the image capturing device, and recording it as a
second relative position; and [0038] adjusting a relative position
between the loading device and the medical appliance based on the
first relative position and the second relative position to cause
the outlet of the loading device and the central position of the
pattern of each of the grooves or holes to be in the same
longitudinal axis.
[0039] Preferably, the determining the relative position of the
loading device to the image capturing device, and recording it as
the second relative position is embodied as: [0040] obtaining a
spatial coordinate of the center of the image capturing device;
[0041] obtaining a spatial coordinate of the outlet of the loading
device; [0042] calculating a coordinate difference value in a x
direction and/or in a y direction between the spatial coordinate of
the center of the image capturing device and the spatial coordinate
of the outlet of the loading device, and recording it as a second
relative position.
[0043] Preferably, the adjusting the relative position between the
loading device and the medical appliance based on the first
relative position and the second relative position is embodied as:
[0044] moving the medical appliance in the x direction and/or in
the y direction based on the first relative position and the second
relative position to cause outlet of the loading device and the
central position of the pattern of each of the grooves or holes to
be in the same longitudinal axis.
[0045] Preferably, the adjusting the relative position between the
loading device and the medical appliance based on the first
relative position and the second relative position is embodied as:
[0046] moving the medical appliance in the x direction and/or in
the y direction based on the first relative position to cause the
central position of the pattern of each of the grooves or holes and
the geometrical center of the image to be in the same longitudinal
axis; and [0047] moving the loading device in the x direction
and/or in the y direction based on the second relative position to
cause the outlet of the loading device and the central position of
the pattern of each of the grooves or holes to be in the same
longitudinal axis.
[0048] Preferably, the adjusting the relative position between the
loading device and the medical appliance to align the outlet of the
loading device with the loading position of the medical appliance
is embodied as: [0049] moving the image capturing device in the x
direction and/or in the y direction based on the first relative
position in the first array to cause the central position of the
pattern of each of the grooves or holes and the geometrical center
of the image of each of the grooves or holes to be in the same
longitudinal axis; [0050] determining a relative position of the
loading device to the image capturing device, recording it as a
second relative position, recording the second relative position
corresponding to each of the grooves or holes as a second array;
and [0051] adjusting a relative position between the loading device
and the medical appliance based on the second relative position in
the second array to cause the outlet of the loading device and the
central position of the pattern of each of the grooves or holes to
be in the same longitudinal axis.
[0052] Preferably, the determining the relative position of the
loading device to the image capturing device, recording it as the
second relative position is embodied as: [0053] obtaining a spatial
coordinate of a center of the image capturing device; [0054]
obtaining a spatial coordinate of an outlet of the loading device;
[0055] calculating a coordinate different value in the x direction
and/or in the y direction between the spatial coordinate of the
center of the image capturing device and the spatial coordinate of
the outlet of the loading device, and recording it as a second
relative position; and [0056] recording the second relative
position corresponding to each of the grooves or holes as a second
array.
[0057] Preferably, adjusting the relative position between the
loading device and the medical appliance based on the second
relative position is embodied as: [0058] moving the medical
appliance in the x direction and/or in the y direction based on the
second relative position in the second array to cause the outlet of
loading device and the central position of the pattern of each of
the grooves or holes to be in the same longitudinal axis.
[0059] Preferably, the adjusting the relative position between the
loading device and the medical appliance based on the second
relative position is embodied as: [0060] moving the loading device
in the x direction and/or in the y direction based on the second
relative position in the second array to cause the outlet of
loading device and the central position of the pattern of each of
the grooves or holes to be in the same longitudinal axis.
[0061] Preferably, the loading each of the grooves or holes with
the medicament or polymer is embodied as: [0062] after causing the
outlet of loading device and the central position of the pattern of
each of the grooves or holes to be in the same longitudinal axis,
opening the outlet of the loading device to load the grooves or
holes with the medicament and/or polymer; and [0063] loading each
of the grooves or holes with the medicament and/or polymer.
[0064] Preferably, the loading each of the grooves or holes with
the medicament and/or polymer is repeated for multiple times based
on a desired dose of the medicament and/or polymer.
[0065] Preferably, the method further comprises adjusting the
position between the medical appliance and the image capturing
device to cause other grooves or holes of the medical appliance to
be located at an image capture position of the image capturing
device.
[0066] Preferably, the width of the grooves or holes is within
0.5-200 microns.
[0067] Preferably, the width of the grooves or holes is within
20-80 microns.
[0068] Preferably, the medical appliance is a human body
endoluminal stent.
[0069] Preferably, the human body endoluminal stent is a blood
vessel stent.
[0070] Preferably, the medicament is selected from a chemical
medicament and/or a bioactive sub stance.
[0071] Preferably, the chemical medicament is selected from an
immunosuppressant and/or an anticancer medicament.
[0072] Preferably, the immunosuppressant is selected from rapamycin
and derivatives thereof, and that the anticancer medicament is
selected from paclitaxel and derivatives thereof.
[0073] Preferably, the bioactive substance includes protein,
polypeptide, DNA, RNA and/or microRNA.
[0074] Preferably, the polymer is a biodegradable polymer.
[0075] Preferably, the biodegradable polymer is one or more
selected from homopolymers and copolymers of C.sub.2-C.sub.6
acyclic hydroxycarboxylic acid composed of C, H, and O.
[0076] Preferably, the biodegradable polymer is:
(1) one or more of homopolymers of D-lactic acid, L-lactic acid,
glycolic acid or .epsilon.-caprolactone; and/or (2) one or more of
copolymers formed by more than any two from D-lactic acid, L-lactic
acid, glycolic acid and .epsilon.-caprolactone as monomers.
[0077] Preferably, the biodegradable polymer is one or more
selected from poly D, L-lactide, poly D-lactide, poly L-lactide,
polyglycolide, poly(glycolide-lactide) and poly
.epsilon.-caprolactone.
[0078] A device for loading a medial appliance with a medicament
and/or polymer, the medical appliance containing a plurality of
grooves or holes, characterized in comprising: [0079] a platform
for placing the medical appliance; [0080] an image capturing device
disposed above the platform for capturing images of the grooves or
holes of the medical appliance; [0081] an image processing unit
connected with the image capturing device for performing digital
image processing on the images of the grooves or holes captured by
the image capturing device; [0082] a position calculating unit
connected with the image processing unit for calculating a desired
relative position based on a result processed by the image
processing unit; [0083] a memory unit connected with the position
calculating unit for recording a relative position calculated by
the position calculating unit; [0084] a first position adjustment
device connected with the memory unit and with the platform for
moving the platform based on the relative position in the memory
unit to adjust a relative position relation between the medical
appliance and the image capturing device and/or the loading device;
and [0085] a loading device disposed above the platform for loading
the grooves or holes of the medical appliance with the medicament
and/or polymer.
[0086] Preferably, the device further comprises a position
calibration device connected with the memory unit for calibrating a
spatial position relation between a central position of the image
capturing device and an outlet of the loading device.
[0087] Preferably, the platform comprises a rotation platform and a
stent shaft, the stent shaft fixed in and penetrated through the
middle of the rotation platform, and the medical appliance disposed
on the stent shaft.
[0088] Preferably, the image capturing device is a camera or video
camera.
[0089] Preferably, the image capturing device is an industrial
camera or video camera.
[0090] Preferably, the image processing unit comprises: [0091] an
image converting sub-unit for converting the image of the groove or
hole into a set of pixel points; [0092] an image pre-processing
sub-unit for performing a filter processing on the set of pixel
points to remove image noise; and [0093] an image processing
sub-unit for processing the pre-processed image with a binary
method to obtain the pattern of each of the grooves or holes.
[0094] Preferably, the image processing sub-unit assigns a value to
each of the pixel points with the binary method based on a gray
value of each of the pre-processed pixel points, designates a pixel
point conforming with a preset value or a value range as a target
pixel point or a background pixel point, and connects all the pixel
points designated as the target pixel points or the background
pixel points to obtain the patterns of the grooves or holes.
[0095] Preferably, the device further comprises: [0096] a second
position adjustment device connected with the memory unit and with
the image capturing device for driving the image capturing device
to move on a horizontal coordinate plane based on the relative
position in the memory unit.
[0097] Preferably, the device further comprises: [0098] a third
position adjustment device connected with the memory unit and with
the loading device for driving the loading device to move in a
horizontal plane based on the relative position in the memory
unit.
[0099] Preferably, an axis of the image capturing device and an
axis of the loading device are disposed in the same vertical
plane.
[0100] Preferably, the width of the grooves or holes of the medical
appliance is within 0.5-200 microns.
[0101] Preferably, the width of the grooves or holes of the medical
appliance is within 20-80 microns.
[0102] Preferably, the medical appliance is a human body
endoluminal stent.
[0103] Preferably, the human body endoluminal stent is a blood
vessel stent.
[0104] Preferably, the medicament includes a chemical medicament
and/or a bioactive substance.
[0105] Preferably, the chemical medicament is selected from an
immunosuppressant and/or an anticancer medicament.
[0106] Preferably, the immunosuppressant is selected from rapamycin
and derivatives thereof, and that the anticancer medicament is
selected from paclitaxel and derivatives thereof.
[0107] Preferably, the bioactive substance is selected from
protein, polypeptide, DNA, RNA and/or microRNA.
[0108] Preferably, the polymer is a biodegradable polymer.
[0109] Preferably, the biodegradable polymer is one or more
selected from homopolymers and copolymers of C.sub.2-C.sub.6
acyclic hydroxycarboxylic acid composed of C, H, and O.
[0110] Preferably, the biodegradable polymer is:
(1) one or more of homopolymers of D-lactic acid, L-lactic acid,
glycolic acid or .epsilon.-caprolactone; and/or (2) one or more of
copolymers formed by more than any two from D-lactic acid, L-lactic
acid, glycolic acid and .epsilon.-caprolactone as monomers.
[0111] Preferably, the biodegradable polymer is one or more
selected from poly D,L-lactide, poly D-lactide, poly L-lactide,
polyglycolide, poly(glycolide-lactide) and poly
.epsilon.-caprolactone.
[0112] In the embodiments of the present application, the images of
the grooves or holes of the medical appliance containing a
plurality of grooves or holes are captured for multiple times, the
image of each of the grooves or holes is processed, and then each
of the grooves or holes is loaded concentratively, reducing the
displacement movement route during the process of loading,
shortening the loading time, and improving the loading speed and
efficiency.
[0113] Besides, the embodiments of the present application search a
groove core or a hole core using a machine visual theory, precisely
locate each of the grooves or holes of the medical appliance,
provide a precise coordinate for loading a medicament and/or
polymer, and ensure the loading accuracy while loading rapidly.
[0114] Furthermore, the embodiments of the present application
employ the intermittent loading manner, reduce the time waiting for
evaporation of the medicament and/or polymer, not only shorten the
loading time, but also make the loaded medicament and/or polymer
more even, and improve the quality of loading the medicament and/or
polymer.
DESCRIPTION OF DRAWINGS
[0115] In order to explain the embodiments of the present
application or the technical solutions in the existing technologies
more clearly, the drawings to be referred to in depictions of the
embodiments and the existing technologies are briefly introduced
below. Obviously, the drawings depicted below are only some
embodiments disclosed in the present application. An ordinary
skilled person in the art can obtain other drawings without
inventive efforts.
[0116] FIGS. 1A and 1B are structural drawings of the blood vessel
stent having grooves or holes used in the present application and a
drawing of a partial enlargement thereof;
[0117] FIG. 2 is a flow chart of one method for loading a medical
appliance with a medicament and/or polymer provided by the
embodiments of the present invention;
[0118] FIG. 3 is a flow chart of another method for loading a
medical appliance with a medicament and/or polymer provided by the
embodiments of the present invention;
[0119] FIG. 4 is the image of the grooves or holes captured by the
image capturing device according to the embodiments of the present
application; and
[0120] FIG. 5 is a schematic diagram of the structure of a device
for loading a medical appliance with a medicament and/or
polymer;
[0121] FIG. 6 is a schematic diagram of the structure of the image
processing unit according to the embodiments of the present
application.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0122] In order to enable those skilled in the art to better
understand the technical solution of the present application, the
technical solutions in the embodiments of the present application
will be depicted clearly and completely with reference to the
drawings in the embodiments of the present application. Obviously,
the depicted embodiments are only a part of the embodiments of the
present application rather than all the embodiments. Based on the
embodiments of the present application, all the other embodiments
that can be obtained by an ordinary skilled in the art without
inventive efforts shall fall into the scope claimed in the present
application.
[0123] FIG. 1 is the blood vessel stent having grooves or holes
used in the present application and a drawing of a partial
enlargement thereof.
[0124] FIG. 1 (a) shows a blood vessel stent that is formed by
cutting a metal circular tube roughcast with a laser cutter,
wherein on an outer surface of the stent grooves or holes having a
depth of 30 microns, a width of 50 microns, and a length of 500
microns are etched, and on each stent there are a plurality of
rings. I shows the drawing of the partial enlargement of one ring.
As shown in FIG. 1(b), 1 is a strut, and 2 is a groove or hole.
There are a plurality of struts on every ring, and there is one
groove or hole on each strut.
[0125] A medicament and/or polymer is loaded within the groove or
hole, and the loaded medicament may be a chemical medicament and/or
bioactive substance. The chemical medicament includes an
immunosuppressant selected from rapamycin and derivatives thereof
and/or an anticancer medicament selected from paclitaxel and
derivatives thereof. The bioactive substance includes protein,
polypeptide, DNA, RNA and/or microRNA.
[0126] The loaded polymer may be a biodegradable polymer. The
biodegradable polymer is one or more selected from homopolymers and
copolymers of C.sub.2-C.sub.6 acyclic hydroxycarboxylic acid
composed of C, H, and O.
[0127] Alternatively, the above-mentioned biodegradable polymer
is:
(1) one or more of homopolymers of D-lactic acid, L-lactic acid,
glycolic acid or .epsilon.-caprolactone; and/or (2) one or more of
copolymers formed by more than any two from D-lactic acid, L-lactic
acid, glycolic acid and .epsilon.-caprolactone as monomers.
[0128] Alternatively, the above-mentioned biodegradable polymer is
one or more selected from poly D,L-lactide, poly D-lactide, poly
L-lactide, polyglycolide, poly(glycolide-lactide) and poly
.epsilon.-caprolactone.
Embodiment 1 of the Method
[0129] In the present embodiment, the medical appliance is
specifically a blood vessel stent. The embodiment of the present
application provides a method for loading a medical appliance with
a medicament or polymer, comprising the following steps as shown in
FIG. 2:
[0130] In step 210, images of the blood vessel stent are captured
for multiple times using an image capturing device, each image
containing a pattern of at least one entire the groove or hole.
[0131] When the blood vessel stent is relatively long, the grooves
or holes on one or more rings of the blood vessel stent may be
photographed for multiple times at one time. When the blood vessel
stent is relatively short, the grooves or holes on all the rings of
the blood vessel stent can be photographed at one time. The
captured images of the grooves or holes can be recorded as one set
of images, of which each image contains one groove or hole in one
strut. Assume that there are m images in the set of images, then
there are m grooves or holes all together.
[0132] In step 220, digital image processing is performed on the
image of each of the grooves or holes of the blood vessel stent to
obtain the pattern of each of the grooves or holes.
[0133] Firstly, the image of each of the grooves or holes is
converted into a set of pixel points. After the image is converted
into the set of pixel points, the set of pixel points is filtering
processed to remove disturbing noise of the image.
[0134] Secondly, image processing is performed on the pre-processed
image. Mainly, the pre-processed image is processed with a binary
method, in which values are assigned to the pixel points based on a
gray value of each of the pixel points, a pixel point conforming
with a preset value or value range is designated as a target pixel
point or a background pixel point, and all the pixel points
designated as the target pixel points or the background pixel
points are connected to form a target pixel body, i.e., the pattern
of the groove or hole of the blood vessel stent, to obtain the
images of m grooves or holes.
[0135] In step 230, a central position of the pattern of each of
the grooves or holes of the blood vessel stent is calculated based
on the captured pattern of each of the grooves or holes of the
blood vessel stent, and a loading position of each of the grooves
or holes of the blood vessel stent is determined based on the
central position.
[0136] Firstly, a spatial coordinate of a central pixel point of
the pattern of each of the grooves or holes of the blood vessel
stent is calculated.
[0137] Based on the pattern of the m grooves or holes obtained in
step 220, as shown in FIG. 3, the central pixel point P is the
central position of the pattern of each of the grooves or holes.
The pixel coordinate of the central pixel point P is obtained, and
then is converted to obtain the spatial coordinate (A, B) of the
central pixel point P.
[0138] Secondly, a spatial coordinate of a geometrical center of
the image of each of the grooves or holes of the blood vessel stent
is determined.
[0139] Spatial coordinates of four apexes of the image are obtained
based on the image of the groove or hole, the spatial coordinate
(A', B') of the geometrical center of the image of each of the
grooves or holes of the blood vessel stent, i.e., the central
position of the image capturing device, is calculated based on the
spatial coordinates of the four apexes.
[0140] Finally, a difference value between the spatial coordinate
(A, B) of the central pixel point and the spatial coordinate (A',
B') of the geometrical center is calculated, and represented in a
form of a coordinate (A-A', B-B'). That is, it is necessary to
adjust the distances A-A' and B-B' respectively in the x direction
and/or in the y direction so that the spatial coordinate (A, B) of
the central position of the pattern of the groove or hole and the
spatial coordinate (A', B') of the geometrical center of the image
are in the same longitudinal axis.
[0141] The m grooves or holes are subject to the aforesaid
calculation. The difference values (A-A', B-B') between the
coordinates corresponding to m grooves or holes are recorded as a
first array.
[0142] In step 240, a relative position of the loading device to
the blood vessel stent is adjusted so that the outlet of the
loading device is aligned with the loading position of the storage
grooves or holes of the blood vessel stent for loading the grooves
or holes of the blood vessel stent with the medicament and/or
polymer. The step includes the following steps:
[0143] In step 241, a relative position of the loading device to
the image capturing device is determined and recoded as a second
relative position.
[0144] The spatial coordinate of the center of the image capturing
device and the spatial coordinate of the outlet of the loading
device are obtained. A coordinate difference value between the
spatial coordinate of the center of the image capturing device and
the spatial coordinate of the outlet of the loading device in the x
direction and/or in the y direction is calculated. If the
coordinate difference value between the aforesaid two spatial
coordinates in the x direction and/or in the y direction is set as
(M, N), then (M, N) is recorded as a second relative position.
[0145] If the image capturing device and the loading device are
fixed, the second relative position can be calculated in advance.
If either of the aforesaid two devices exist relative displacement,
it is necessary to calculate the second relative position in step
241.
[0146] In step 242, the blood vessel stent is moved based on the
first relative position in the first array taking the central
position of each image capturing device as the reference so that
the central position of the pattern of each of the grooves or holes
and the geometrical center of the image are in the same
longitudinal axis.
[0147] A first element is selected from the array, the blood vessel
stent is adjusted by moving in the x direction by A-A' and moving
in the y direction by B-B' based on the recorded value of the first
relative position (A-A', B-B') and taking the spatial coordinate
(A', B') of the central position of the image as the reference so
that the central position of the pattern of each of the grooves or
holes and the center of the image capturing device are in the same
longitudinal axis. That is, the loading position of the groove or
hole superposes the center of the image capturing device in the
vertical direction, and the loading position of the groove or hole
is found.
[0148] In step 243, the blood vessel stent is moved taking the
outlet of the loading device as the reference and based on the
second relative position so that the loading position of each of
the grooves or holes and the outlet of the loading device are in
the same longitudinal axis.
[0149] The blood vessel stent is moved in the x direction and/or in
the y direction respectively by M and N so that the loading
position of the grooves or holes of the blood vessel stent and the
outlet of the loading device are in the same longitudinal axis. The
outlet of the loading device is opened so that the medicament
and/or polymer pre-loaded into the device is dispensed via the
outlet thereof into the groove or hole 2 of the blood vessel stent.
The same operation is repeated to each of the grooves or holes to
load it with the medicament and/or polymer.
[0150] The aforesaid step 242 and step 243 are moving the blood
vessel stent respectively based on the first relative position and
based on the second relative position, so the aforesaid two steps
can be combined into one step.
[0151] As shown in FIG. 4, after the completion of loading in step
240, step 250 may be further included, in which the relative
position of the blood vessel stent to the image capturing device is
adjusted so that the other medicament grooves of the blood vessel
stent are at the photographing position of the image capturing
device.
[0152] Steps 210 to 240 can realize loading a plurality of
medicament grooves of the blood vessel stent. Where it is necessary
to load all the grooves of the entire blood vessel stent, after
completion of one loading, firstly the blood vessel stent is moved
back within a photographing range of the image capturing device,
secondly the blood vessel stent is rotated by a certain angle
and/or translated by a certain distance so that other grooves or
holes of the blood vessel stent move to the photographing position
of the image capturing device. Thus, after the completion of
loading a plurality of grooves or holes at one time, it is feasible
to circularly load the other grooves or holes of the blood vessel
stent, thereby completing loading the entire blood vessel
stent.
[0153] It is known to those skilled in the art that the medical
appliance in practical use may also be a biliary stent, an
esophageal stent, a ureteral stent, or other human body endoluminal
stents. Although the medical appliance in the present embodiment is
a blood vessel stent, it shall not constitute a restriction on the
present application.
[0154] Besides, depending on the desired dose of the medicament
and/or polymer to be loaded, step 240 may be repeated for multiple
times to avoid an excessive loading amount at one time from
influencing the adhering effect of the medicament and/or polymer.
Loading for multiple times can leave time for the medicament and/or
polymer evaporating so that the loading is more even and the
quality of loading the medicament and/or polymer is improved.
Embodiment 2 of the Method
[0155] In Embodiment 1 of the present invention, in step 230, the
loading position of each of the grooves or holes of the blood
vessel stent can be determined based on the pixel coordinate, which
is specifically realized by the following steps:
[0156] Firstly, the pixel coordinate of the central pixel point of
the pattern of each of the grooves or holes of the blood vessel
stent is calculated.
[0157] According to the images of the m grooves or holes obtained
in step 220, as shown in FIG. 3, the central pixel point P is the
central position of the pattern of each of the grooves or holes.
The pixel coordinate value (a, b) of the central pixel point P is
obtained.
[0158] Secondly, the pixel coordinate of the geometrical center of
the image of each of the grooves or holes of the blood vessel stent
is determined.
[0159] Pixel coordinates of four apexes of the image are obtained
based on the photographed image of the groove or hole. The medium
value of the pixel point in the x direction and/or in the y
direction is obtained respectively based on the pixel coordinates
of the four apexes and the resolution of each of the grooves or
holes. The medium value is the pixel coordinate (a', b') of the
geometrical center of the image of each of the grooves or holes of
the blood vessel stent, and is also the center of the image
capturing device.
[0160] Finally, the difference value between the pixel coordinate
(a, b) of the central pixel point and the pixel coordinate (a', b')
of the geometrical center. Likewise, the difference value is
represented in the form of a coordinate (a-a', b-b'). That is, it
is necessary to adjust the distances a-a' and b-b' respectively in
the x direction and/or in the y direction so that the pixel
coordinate (a, b) of the central position of the pattern of the
groove or hole superposes the pixel coordinate (a', b') of the
geometrical center of the image. That is, the central position of
the pattern of the groove or hole superposes the center of the
image capturing device, and the loading position of the groove or
hole is found.
Embodiment 3 of the Method
[0161] In Embodiment 1 and/or Embodiment 2 of the present
invention, in step 241, the image capturing device may be moved
taking the central position of the pattern of each of the grooves
or holes as the reference, and the step is as follows:
[0162] In step 242, the image capturing device is moved according
to the first relative position in the first array taking the
central position of each of the grooves or holes as the reference
so that the central position of the pattern of each of the grooves
or holes and the geometrical center of the image are in the same
longitudinal axis.
[0163] A first element is selected from the array, the blood vessel
stent is adjusted by moving in the x direction and/or in the y
direction based on the recorded value of the first relative
position and taking the spatial coordinate of the central position
of each of the grooves or holes as the reference so that the center
of the image capturing device and the central position of the
pattern of each of the grooves or holes are in the same
longitudinal axis. That is, the loading position of the groove or
hole superposes the center of the image capturing device in the
vertical direction, and the loading position of the groove or hole
is found.
Embodiment 4 of the Method
[0164] In Embodiment 1, Embodiment 2, and/or Embodiment 3 of the
present invention, in step 243, the loading device may also be
moved taking the central position of the pattern of each of the
grooves or holes as the reference, the step is as follows:
[0165] In step 243, the loading device is moved taking the central
position of each of the grooves or holes as the reference and based
on the second relative position so that the loading position of
each of the grooves or holes and the outlet of the loading device
are in the same longitudinal axis.
[0166] The loading device is moved in the x direction and/or in the
y direction respectively by -M and -N so that the outlet of the
loading device and the loading position of the grooves or holes of
the blood vessel stent are in the same longitudinal axis. The
outlet of the loading device is opened so that the medicament
and/or polymer pre-loaded into the device is dispensed via the
outlet thereof into the groove or hole 2 of the blood vessel stent.
The same operation is repeated to each of the grooves or holes to
load it with the medicament and/or polymer.
[0167] Corresponding to the above embodiments of the method, the
present application further provides a device for loading a medical
appliance with a medicament and/or polymer.
Embodiment 1 of the Device
[0168] As shown in FIG. 5, the device comprises a platform, an
image capturing device 52, an image processing unit 53 (not shown
in the drawings), a position calculating unit 54 (not shown in the
drawings), a first position adjustment device (not shown in the
drawings), a memory unit (not shown in the drawings), a loading
device 56, a gantry 57, and a base 58.
[0169] The platform comprises a rotation platform 511 and a stent
shaft 512. The stent shaft 512 is through the middle of the
rotation platform 511 and perpendicular to it, and fixed to the
rotation platform 511. The rotation platform 511 may be of a circle
or of another geometrical shape, and can rotate freely in a
vertical plane.
[0170] The gantry 57 and the base 58 serve the purpose of fixing
and supporting. The gantry 57 is disposed on the base 58, and is
perpendicular to the base 58.
[0171] The image capturing device 52 is fixed on a beam of the
gantry 57 and perpendicular to the beam of the gantry 57. The image
processing unit 53 is connected to the image capturing device 52.
The image capturing device 52 uses an industrial camera or video
camera in practical use. When photographing a blood vessel stent,
it is necessary to illuminate the blood vessel stent for making the
photographed image clear. The present embodiment of the application
employs two 12V brightness-adjustable power sources respectively
for controlling a point light source and an annular light source
for providing a required illumination.
[0172] The image processing unit 53 receives and processes the
image photographed by the image capturing device 52 and sends the
processed image data to the position calculating unit 54.
[0173] As shown in FIG. 6, the image processing unit 53 comprises:
[0174] an image converting sub-unit 61 for converting the image of
each of the grooves or holes captured by the image capturing device
52 into a set of pixel points; [0175] an image pre-processing
sub-unit 62 for performing a filter processing on the set of pixel
points to remove image noise; [0176] an image processing sub-unit
63 for processing the pre-processed image with a binary method to
obtain the pattern of each of the grooves or holes; [0177] a
position calculating unit 54 for calculating based on the image
data to obtain relative position data and sending the relative
position data to the a memory unit; and [0178] a memory unit for
storing the relative position data calculated by the position
calculating unit 54, sending the recorded relative position data to
a position adjustment device or to an externally visible part for
an operator to proceed with a next operation.
[0179] The first position adjustment device comprises a control
chip (not shown in the drawings) and a mobile device 551. The
control chip receives relative position data in the memory unit to
generate control instructions so as to control the mobile device
551 to move respectively in the x direction and/or in the y
direction. The mobile device 551 is disposed in the gantry, and
below the image capturing device 52. The platform is fixed on the
mobile device 551, and the mobile device 551 moves in the x
direction and/or in the y direction and can drive the platform to
make a corresponding movement.
[0180] The loading device 56 is also fixed on a beam of the gantry
57, and also perpendicular to the beam of the gantry 57. The
loading device 56 is pre-loaded with a desired medicament and/or
polymer. The outlet of the loading device is 561.
[0181] In the embodiment of the present invention, in the process
of loading, the first position adjustment device controls the
mobile device 551 to move based on relative position data of the
unit so as to drive the blood vessel stent on the platform to move.
Firstly, the blood vessel stent is moved so that the central
position of the groove or hole of the blood vessel stent and the
central position of the image capturing device 52 are in the same
longitudinal axis. Secondly, the blood vessel stent is moved again
so that the central position of the groove or hole of the blood
vessel stent and the outlet 561 of the loading device are in the
same longitudinal axis. Finally, the outlet of the loading device
is opened to perform the loading. During the aforesaid process of
loading, it is only necessary to move the blood vessel stent so as
to fulfill the loading, and the positions of the image capturing
device 52 and the loading device 56 are constant.
[0182] During the process of loading, the first position adjustment
device can control the mobile device 551 to move directly based on
the first relative position data of the first relative position and
the second relative position of the unit to move the blood vessel
stent so that the central position of the groove or hole of the
blood vessel stent and the outlet 561 of the loading device are in
the same longitudinal axis. Then the outlet of the loading device
is opened to perform the loading.
Embodiment 2 of the Device
[0183] In the embodiment of the present invention, the device
further comprises: [0184] a position calibration device for
calibrating a spatial position relation between a central position
of the image capturing device and an outlet of the loading device;
and [0185] a second position adjustment device connected with the
memory unit and with the image capturing device for driving the
image capturing device to move in a horizontal coordinate
plane.
[0186] In the embodiment of the present invention, during the
process of loading, firstly, the image capturing device is moved so
that the central position of the groove or hole of the blood vessel
stent and the central position of the image capturing device are in
the same longitudinal axis. Secondly, the blood vessel stent is
moved so that the central position of the groove or hole of the
blood vessel stent and the outlet of the loading device are in the
same longitudinal axis. Finally, the outlet of the loading device
is opened to perform the loading. During the aforesaid process of
loading, not only the blood vessel stent but also the image
capturing device are moved, and the loading device remains
static.
Embodiment 3 of the Device
[0187] In the embodiment of the present invention, the device
further comprises: [0188] a position calibration device for
calibrating a spatial position relation between a central position
of the image capturing device and an outlet of the loading device;
and [0189] a third position adjustment device connected with the
memory unit and with the loading device for driving the loading
device to move in a horizontal coordinate plane.
[0190] In the embodiments of the present application, the images of
the grooves or holes of the medical appliance containing a
plurality of grooves or holes are captured for multiple times, the
image of each of the grooves or holes is processed, and then each
of the grooves or holes is loaded concentratively, reducing the
displacement movement route during the process of loading,
shortening the loading time, and improving the loading speed and
efficiency.
[0191] Besides, the embodiments of the present application search a
groove core or a hole core using a machine visual theory, precisely
locate each of the grooves or holes of the medical appliance,
provide a precise coordinate for loading a medicament and/or
polymer, and ensure the loading accuracy while loading rapidly.
[0192] Furthermore, the embodiments of the present application
employ the intermittent loading manner, reduce the time waiting for
evaporation of the medicament and/or polymer, not only shorten the
loading time, but also make the loaded medicament and/or polymer
more even, and improve the quality of loading the medicament and/or
polymer.
[0193] For convenience of description, the aforesaid devices are
divided into various units as per functions to be depicted
respectively during the depiction. Surely, while the present
application is carried out, it is feasible to realize the functions
of every unit in the same one or multiple software and/or
hardware.
[0194] As can be seen from the depictions of the aforesaid
embodiments, those skilled in the art may clearly understand that
the present application can be realized by means of software plus
necessary universal hardware platform. Based on such understanding,
the technical solution of the present application substantively or
the portion that makes contribution to the existing technologies
can be reflected in the form of a software product. The computer
software product can be stored in a storage medium, such as a
ROM/RAM, a disk, a Compact Disc and so on, and include a plurality
of instructions for enabling a computer device (which may be a
personal computer, a server, or a network device and so on) to
execute the methods depicted in the embodiments of the present
application or in some parts of the embodiments.
[0195] The above are only the specific means of carrying out the
present invention. It shall be pointed out that under the premise
of not deviating from the principle of the present application, an
ordinary skilled person in the concerned technical field can make a
plurality of improvements and modifications, which shall also be
deemed to be the protection scope of the present application.
* * * * *