U.S. patent application number 11/026647 was filed with the patent office on 2006-07-06 for apparatus and method for automatic catheter threader.
Invention is credited to Rafael Fernandez-Sein.
Application Number | 20060144982 11/026647 |
Document ID | / |
Family ID | 36639264 |
Filed Date | 2006-07-06 |
United States Patent
Application |
20060144982 |
Kind Code |
A1 |
Fernandez-Sein; Rafael |
July 6, 2006 |
Apparatus and method for automatic catheter threader
Abstract
A system for the automated threading of catheters with cables,
wires or fluid conductors during their manufacture is presented.
The system provides for a vacuum catheter sheath clamping and
enlarging mechanism that facilitates the treading of catheters
within very tight confines. The system also provides for rotating
needle and or conductor pushing and pulling mechanisms to allow the
rapid threading of the catheters with carefully controlled
parameters. These pushing and pulling mechanisms are monitored
through force, torque, and position sensors so that materials are
not damaged during manufacture.
Inventors: |
Fernandez-Sein; Rafael; (San
German, PR) |
Correspondence
Address: |
Eugenio J. Torres;Ferramar Building
Suite 1
1060 Ashford Avenue
San Juan
PR
00907
US
|
Family ID: |
36639264 |
Appl. No.: |
11/026647 |
Filed: |
December 31, 2004 |
Current U.S.
Class: |
242/364 ;
156/349 |
Current CPC
Class: |
A61M 25/0009 20130101;
B29L 2031/7542 20130101; B29C 63/18 20130101 |
Class at
Publication: |
242/364 ;
156/349 |
International
Class: |
B65H 51/20 20060101
B65H051/20 |
Claims
1. An apparatus for the automated threading of a catheter,
comprising: a) A clamping and enlarging means; b) A needle or
conductor pusher and puller assembly having a plurality of electric
motors, a plurality of rollers connected to said motors, a
plurality of sensors to ascertain the progress of the manufacturing
step, and opening and closing means for gripping of materials; c) a
plurality of opening and closing means for gripping threading
needles or conductors within said rollers; d) a camera disposed to
overlook the workspace; e) an image processor means; f) a plurality
of electric motor controllers; g) an industrial computer, wherein
said image processor means feeds the visual information captured by
said camera to the industrial computer to monitor the progress of
the manufacturing step and wherein said computer schedules movement
of the different parts of the apparatus through the plurality of
motor controlling means; and h) A computer based controller with
stored program means to control the entire apparatus assembly and
the sequence of operations.
2. The apparatus for the threading of catheters of claim 1, wherein
said sensors comprise: a) position sensors to detect the position
of the threading needle and or conductors entering and emerging
from the sheath to be threaded; b) a sensor to measure the gap
between the slider plates.
3. The apparatus for the threading of catheters of claim 1, said
pusher and puller assembly further comprising: a) a slider stage
having a base provided with a two section screw and being driven by
a motor having control wires; wherein one half of said two section
screw is right handed and the other half of said two section screw
is left handed; b) a plurality of slider plates said two section
screw being connected to said slider plates such that when the
screw turns in one direction the slider plates are drawn apart, and
when the screw turns in the opposite direction the slider plates
come together; c) a plurality of L-shaped brackets fixedly
connected to the slider plates; d) Force plates having sensor wires
and being affixed to the L-shaped brackets; e) A C-shaped bracket
attached to each of the L-shaped brackets so that the assembly may
slide relative to the L-shaped brackets and transmit any forces
applied to the force placed in between the L and C-shaped brackets;
f) Controllable motors having control wires and being mounted on
each of the C-shaped brackets; g) A rotary encoder and a torque
sensor to monitor the operation so that if high torque is measured
with no movement this indicates an obstruction and proper action
must be taken; h) A plurality of rubberized wheels in contact with
the needle and tubing making it advance or retract; i) A plurality
of shafts for sustaining the vertical rotating assemblies; j)
Stiffening brackets for maintaining the rotary encoder and torque
sensor in position;
4. The apparatus for the threading of catheters of claim 1, wherein
said clamping and enlarging means is supplied with vacuum means for
straightening and facilitating the threading of cables, wires, or
fluid conductors through the catheter sheath.
5. The apparatus for the threading of catheters of claim 4,
wherein: a) said clampling and enlarging means is a hinged vacuum
clamp, having a lower part, and upper part, a distal end, and a
proximal end; said distal end and said proximal end each having a
protrusion through which a needle may be inserted; b) said vacuum
clamp is disposed so as to be able to encase and enlarge a catheter
sheath device.
6. A method of using the apparatus for the threading of catheter of
claim 1, comprising the steps of: a) Clamping and enlarging the
catheter sheath with the vacuum clamping means; b) Passing a
threading needle through the sheath by using the pusher and puller
assembly; c) Monitoring the pushing torque, rotational movement,
and pinching forces with a supervisory and control microcomputer;
d) Monitoring the status of the manufacturing step with said
supervisory and control computer and making decisions based on the
information gathered by the sensors.
7. A clamp device for clamping and enlarging a catheter sheath,
comprising: a) A hinged clamp having a lower part, an upper part, a
distal end, and a proximal end; said distal end and said proximal
end each having a protrusion through which a needle may be inserted
said clamp having vacuum means for straightening and facilitating
the threading of cables, wires, or fluid conductors through the
catheter sheath a hinged vacuum clamp; and b) said clamp being
disposed so as to be able to encase and enlarge a catheter sheath
device.
8. The clamp device of claim 7, wherein said vacuum clamp includes
connected striations visible in both the lower part and the upper
part.
Description
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND
DEVELOPMENT
[0001] N/A
RELATED APPLICATIONS
[0002] N/A
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The present invention relates generally to the manufacture
and assembly of catheters for use or as a part of medical devices.
More specifically, the present invention relates to an apparatus
and method by which some of the manufacturing procedures of
catheters may be considerably sped up and made safer by automated
operations.
[0005] 2. Discussion of the Background
[0006] Catheters are flexible medical devices that are inserted
into a human or animal body to perform different procedures, such
as exploration, sampling, surgery, expansion, and connection of
devices. Catheters must perform under conflicting considerations:
they must be flexible enough to pass through veins and arteries,
but stiff enough not to collapse under pressure. Catheters may also
contain wires and fluid conductors that must be isolated from the
subject body.
[0007] At present, very skilled persons in a very time consuming
and costly process perform most catheter manufacture manually. Some
of the operations performed on tubing and other flexible materials
may be dangerous or hazardous to the persons, such as when a worker
must present tubing to a clamping device that may nab the person's
fingers. The present invention presents an apparatus and method by
which some of the manufacturing procedures may be considerably sped
up and made safer by automated operations.
[0008] Catheters, tubing, cables, wires, and filamentary materials
are notoriously difficult to handle, and have been the focus of
much research. See for example Robot Manipulation of Deformable
Objects, Dominik Henrich and Heinz Worn editors, ISBN 1-85233-250-6
Springer Verlag London Limited 2000; and Mechanics of Robotic
Manipulation by Matthew T. Mason, ISBN 0-262-13396-2, The MIT
Press, Cambridge, Mass. 2001. However, no systematic solution to
the problem of threading catheters has been found in the
literature. Some methods related to the problem at hand are found
in the following patents, which are incorporated herein by
reference: [0009] A. U.S. Pat. No. 6,544,367, to Katzutoshi
Fujimoto, and Lloyd Miller ('367); [0010] B. U.S. Pat. No.
6,357,994, to Douglas L. St. Onge ('994); [0011] C. U.S. Pat. No.
6,021,244 to Ronald O. Simpson ('244); and [0012] D. U.S. Pat. No.
5,811,951 to Kar-Keung and David Young ('951).
[0013] U.S. Patent '244 teaches the process and apparatus to
assemble fiber optic strands into sign components. This patent
attacks the problem of handling fiber by maintaining the bulk of
the fiber in roll and then inserting the individual strands into a
holder. A specialized needle is used to insert the fiber strands
into the holder.
[0014] U.S. Patent '367 describes an end-effector for applying tape
materials to bundles of fibers. However, the patent does not teach
how the fibers themselves are handled.
[0015] U.S. Patent '994 presents a multi purpose end-effector for a
robotic arm that moves a workpiece through a multi station
manufacturing operation. In this case the operation involves
several steps in the manufacture of gears.
[0016] The following patents are pertinent to the topic of speeding
up and making safer the manufacturing procedures of catheters by
automated operations and are incorporated herein by reference:
[0017] A. U.S. Pat. No. 5,022,952 ('952).
[0018] B. U.S. Pat. No. 6,736,156 ('156)
[0019] B. U.S. Pat. No. 5,354,518 ('518)
[0020] C. U.S. Pat. No. 6,591,472 ('472).
[0021] Patent '952 to Milo M. Vaniglia presents a FIBER
PLACEMENT-MACHINE for the placement of one or several rows of
filamentary fiber material for the purpose of reinforcing composite
materials.
[0022] Patent '156 to Scott A. Beals and Ronald D. Hammer for a
METHOD FOR INSTALLING CABLE IN PRESSURIZED PIPELINES teaches the
use of rollers and conveyors to introduce long sections of
communications fiber optic cable into pressurized pipelines.
[0023] Patent '518 to Yosuke Okada and Yumiko Suzuki, for a METHOD
FOR MANUFACURING A FIBERCOPIC CATHETER teaches the method of
threading a catheter by heating expanding the catheter sheath by
injecting internally a fluid under pressure.
[0024] Patent '472 to Michael S. Noone et al. for MULTIPLE SEGMENT
CATHETER AND METHOD OF FABRICATION teaches how a cathether may be
formed from extruding several layers of material over a
mandrel.
[0025] While the aforementioned devices or methods in the prior art
fulfill their respective, particular objectives and requirements,
none of them, however, teach neither the apparatus nor methods by
which to automate the threading of a catheter sheath with the
wires, optical fibers or fluid conductors required for the
operation of the catheter while in production. Thus, it can be
appreciated that there is a continuing need for a new and improved
method and apparatus for the threading of catheter sheaths that
overcomes the deficiencies already noted in the prior art. In this
regard, the present invention substantially fulfills this need.
[0026] In addition, none of the existing art, taken either simply
or in combination teaches the use of the very principle of the
automated threading of catheter sheaths. In this respect, the
device according to the present invention substantially departs
from the conventional concepts and designs of the prior art to
fulfill the aforementioned needs.
SUMMARY OF THE INVENTION
[0027] It is an object of the present invention to provide a device
to grasp a section of tubing material with rotating and force
controlled means that will form the sheath or envelope of a
catheter.
[0028] It is a further object of the present invention to provide
the means to grasp a needle like object with rotating and force
controlled means to accomplish the movement of said needle by
pushing or pulling mechanisms.
[0029] It is another object of the present invention to measure the
amount of rotation or movement of the grasping means for the tubing
sheath and for the needle.
[0030] Another object of this invention is to provide the means to
measure the rotational torque impressed to the shafts of both the
grasping sections for the tubing sheaths and for the needle.
[0031] Another object of the present invention is to provide
devices that will measure the force with which the tubing sheath
and the needle are being grasped or pinched.
[0032] A further object of the present invention is to teach the
method by which the grasping assemblies can be used to accomplish
the object of this invention. Once the assembly already described
grasps the tubing sheath, the mechanism grasping the needle is
rotated, making the needle advance into the open sheath. The
rotation of the advancement shaft is measured and monitored at all
times. If a point is reached when maximum torque is being applied
but not no substantial rotation is observed, indicating an
obstruction, needle advancement is stopped. At this moment, the
sheath grasp is slightly released, and the motor is reversed in
direction. Insertion of the needle into the sheath is then
re-attempted in order to complete the insertion.
[0033] In still another aspect of the present invention, an
apparatus is provided to clamp, hold in place, and enlarge the
diameter of a catheter sheath during manufacture.
[0034] It is a further object of the present invention to provide
the means to control all the actions of the different mechanisms
and actuators by means of an electronic microcomputer such that all
the operations may be supervised and executed at the proper moment
and sequence, and to the corresponding degree.
[0035] When the word "invention" is used in this specification, the
word "invention" includes "inventions", that is, the plural of
"invention". By stating "invention", the Applicant does not in any
way admit that the present application does not include more than
one patentable and non-obviously distinct invention and Applicant
maintains that the present application may include more than one
patentable and non-obviously distinct invention.
[0036] Further, the purpose of the accompanying abstract is to
enable the U.S. Patent and Trademark Office and the public
generally, and especially the scientists, engineers, and
practitioners in the art who are not familiar with patent or legal
terms or phraseology, to determine quickly from a cursory
inspection the nature and essence of the technical disclosure of
the application. The abstract is neither intended to define the
invention of the application, which is measured by the claims, nor
is it intended to be limiting as to the scope of the invention in
any way.
DESCRIPTION OF THE DRAWINGS
[0037] FIG. 1 shows a perspective of the apparatus of the present
invention.
[0038] FIG. 2 is an end view of the puller or pusher mechanism.
[0039] FIG. 3 shows a view of the clamping and enlarging mechanism
in its open position.
[0040] FIG. 4 presents an end view of the clamping and enlarging
mechanism prior to pulling vacuum.
[0041] FIG. 5 is an end view of the clamping and enlarging
mechanism after vacuum has been established and the catheter sheath
is enlarged.
[0042] FIG. 6 shows details and how L-shaped bracket with force
plate and C-shaped bracket are assembled.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0043] Referring now to the drawings, wherein like reference
numerals designate the corresponding structure, part, or element,
as the case may be, throughout the views, and particularly to FIGS.
1 and 5, the present invention, comprises a hinged vacuum clamp 34,
having a lower part 32, and an upper part 33, a distal end, and a
proximal end, wherein said vacuum clamp 34 encases a catheter
sheath 23, and a needle 24 protrudes from the distal end of said
vacuum clamp 34.
[0044] In the preferred embodiment of this invention, wires 31 to
be threaded through the catheter sheath 23 are hooked on the needle
24. The apparatus of this invention further comprises a pusher
assembly and puller assembly. The pusher and puller assembly is
fully explained in FIG. 2.
[0045] In the preferred embodiment, the position of the needle 24
as to the vacuum clamp 34 is monitored by a laser light curtain
transmitter 36 and receiver 37. A camera 38 is used to overlook the
workspace. An Image processor 39 feeds the visual information
captured by said camera 38 to an industrial computer 40, which then
schedules movement through a plurality of motor controlling means
41. A sensor processor module 42 receives data from a plurality of
position, rotation, force, and torque sensors, to ascertain the
progress of the manufacturing step.
[0046] FIG. 2 shows an assembly of parts that are used to push or
pull the needle 24 through the catheter sheath 23. Said pusher and
puller assembly comprising a slider stage, having a base 10
provided with a two section screw 30, wherein one half of said two
section screw is right handed, and the other half of said two
section screw is left handed. The two-section screw is connected to
slider plates 11 such that when the screw turns in one direction
the slider plates 11 are drawn apart, and when the screw turns in
the opposite direction the slider plates 11 come together. A sensor
12 measures the gap between the slider plates 11. The slider stage
is driven by a motor 18 having control wires 25. L-shaped brackets
13 are fixedly connected to the slider plates 11. Force plates 14
having sensor wires 27 are affixed to the L-shaped brackets. A
C-shaped bracket 15 is attached to each of the L-shaped brackets so
that the assembly may slide relative to the L-shaped brackets and
transmit any forces applied to the force plates 14 placed in
between the L and C shape brackets. Controllable motors 19 having
control wires 26 are mounted on each of the C-shaped brackets. A
Rotary encoder 21 and a torque sensor 22 monitor the operation so
that if high torque is measured with no movement, this indicates an
obstruction and proper action must be taken. A plurality of
rubberized wheels 20 come into contact with the needle 24 and
tubing making it advance or retract. Shafts 17 sustain the vertical
rotating assemblies. Stiffening brackets 35 maintain the rotary
encoder 21 and torque sensor 22 in position.
[0047] FIG. 3 shows the vacuum clamp in the open position, with
connected striations visible in both the lower part 32 and the
upper part 33.
[0048] FIG. 4 shows an end view of the vacuum clamp in the closed
position with catheter sheath 23 prior to the establishment of a
vacuum through connections 34.
[0049] FIG. 5 is another end view of the vacuum clamp, this time
after the establishment of a vacuum, pulling on the catheter sheath
walls and enlarging its diameter to facilitate the insertion of the
needle 24 and wires 31.
[0050] FIG. 6 shows details of how the L-shaped brackets and the
C-shaped brackets come together with force measurement plates 14
sandwiched in between. Wires 27 protrude from the force plate.
[0051] Thus, there has been shown and described a catheter threader
which fulfills all the objects and advantages sought therefor. The
invention is not limited to the precise configuration described
above. While the invention has been described as having a preferred
design, it is understood that many changes, modifications,
variations and other uses and applications of the subject invention
will, however, become apparent to those skilled in the art without
materially departing from the novel teachings and advantages of
this invention after considering this specification together with
the accompanying drawings. For example, the particular shapes and
proportions of the elements of the invention may be varied as
desired. Accordingly, all such changes, modifications, variations
and other uses and applications which do not depart from the spirit
and scope of the invention are deemed to be covered by this
invention as defined in the following claims.
[0052] All of the patents recited herein, and in the Declaration
attached hereto, if any, are hereby incorporated by reference as if
set forth in their entirety herein. The details in such patents may
be considered to be incorporable at Applicant's option, into the
claims during prosecution as further limitations in the claims to
patentably distinguish any amended claims from any applied prior
art. The components disclosed in the various patents, patent
applications, and publications, disclosed or incorporated by
reference herein may be used in the embodiments of the present
invention, as well as equivalents thereof.
[0053] All, or substantially all, of the components and methods of
the various embodiments may be used with at least one embodiment or
all of the embodiments, if more than one embodiment is described
herein.
[0054] In the claims, means-plus-function clauses, if any, are
intended to cover the structures described herein as performing the
recited function and not only structural equivalents but also
equivalent structures.
* * * * *