U.S. patent application number 17/144459 was filed with the patent office on 2021-07-15 for extractor cannula securement and processing.
This patent application is currently assigned to Cook Medical Technologies LLC. The applicant listed for this patent is Cook Medical Technologies LLC. Invention is credited to James Andrew Bartholomai, Kristen M. Bunch, Lyle Hundley, Shannon Jones, Carmen Rosporski, Johnny P. Smith.
Application Number | 20210212708 17/144459 |
Document ID | / |
Family ID | 1000005359449 |
Filed Date | 2021-07-15 |
United States Patent
Application |
20210212708 |
Kind Code |
A1 |
Bartholomai; James Andrew ;
et al. |
July 15, 2021 |
EXTRACTOR CANNULA SECUREMENT AND PROCESSING
Abstract
A medical retrieval device for retrieving stones, calculi, and
the like from various organs and passages may comprising an
elongated member, and a first wire and a second wire that forms a
retrieval basket. The wires forming the basket and the elongated
member may be secured by a crimp joint and a second joint.
Processing of the device may include placing all ends of the first
wire and the second wire into an elongated member through a distal
end of the elongated member, moving said elongated member to a
position where the first loop and the second loop start their
curvatures, placing said first and second wires and said elongated
member through a crimping fixture having thru cuts configured for
the interlocked wires, aligning said elongated member in a desired
position, and crimping said first and second wires and said
elongated member.
Inventors: |
Bartholomai; James Andrew;
(Louisville, KY) ; Jones; Shannon; (Greenwood,
IN) ; Smith; Johnny P.; (Worthington, IN) ;
Hundley; Lyle; (Bloomington, IN) ; Bunch; Kristen
M.; (Bloomington, IN) ; Rosporski; Carmen;
(Bloomington, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC |
Bloomington |
IN |
US |
|
|
Assignee: |
Cook Medical Technologies
LLC
Bloomington
IN
|
Family ID: |
1000005359449 |
Appl. No.: |
17/144459 |
Filed: |
January 8, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62960348 |
Jan 13, 2020 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/221 20130101;
A61B 2017/2212 20130101 |
International
Class: |
A61B 17/221 20060101
A61B017/221 |
Claims
1. A method of making a medical device having a first wire, a
second wire, and an elongated member, comprising the steps of:
placing all ends of the first wire and the second wire into an
elongated member through a distal end of the elongated member so
that the first wire forms a first loop and the second wire forms a
second loop; moving said elongated member to a position where the
first loop and the second loop start their curvatures; placing said
first and second wires and said elongated member through an
alignment fixture having thru cuts configured for the wires;
aligning said elongated member in a desired position; and crimping
said first and second wires and said elongated member.
2. The method of claim 1, further comprising: forming a first loop
with a first wire; forming a second loop with a second wire; and
distally interlocking the second wire to said first loop prior to
placing all ends of the first wire and the second wire into an
elongated member through a distal end of the elongated member.
3. The method of claim 2, further comprising configuring said first
wire and said second wire perpendicularly.
4. The method of claim 1, wherein the alignment fixture further has
a longitudinally elongated section that allows the fixture to get
closer to a crimping site.
5. The method of claim 1, further comprising applying a second
securement to the elongated member after placing all ends of the
first wire and the second wire into said elongated member through a
distal end of said elongated member.
6. The method of claim 1, further comprising: placing all ends of
the first wire and the second wire into a heat shrink; moving the
heat shrink to a position where the first loop and the second loop
start their curvatures; heating the heat shrink and all ends of the
wires at a desired distance for a designated time; and cooling the
heat shrink, the first wire, and the second wire prior to placing
all ends of the first wire and the second wire into said elongated
member through the distal end of said member.
7. The method of claim 1, wherein the crimping step includes using
a crimper that crimps the elongated member in a geometric
shape.
8. A medical device comprising: an elongated member having a
proximal end, a distal end, and a hollow passageway longitudinally
positioned therebetween; a first wire having first and second ends
attached to said distal end of said elongated member and forming a
first loop extending longitudinally and distally from said distal
end of said elongated member; and a second wire having first and
second ends attached to said distal end of said elongated member,
forming a second loop extending longitudinally and distally from
said distal end of said elongated member, and interconnected
distally to said first loop; wherein the elongated member and the
first and second wires are secured by a securement joint.
9. The medical device of claim 8, wherein the securement joint is
configured as a crimp joint.
10. The medical device of claim 8, further comprising a second
joint.
11. The medical device of claim 10, wherein the second joint
includes a glue.
12. The medical device of claim 10, wherein the second joint
includes a heat shrink, solder, and/or weld.
13. The medical device of claim 8, wherein the securement joint is,
in cross-section, geometrically shaped.
14. The medical device of claim 13, where geometric shape is
hexagonal or octagonal.
15. The medical device of claim 8, wherein said first wire and said
second wire are interconnected perpendicularly.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 62/960,348, filed Jan. 13, 2020, which is
incorporated herein by reference in its entirety.
BACKGROUND
[0002] Various organs and passages in the body are subject to the
development of stones, calculi, and the like. For example,
gallstones are a common problem in the United States and the most
frequent cause of gallbladder inflammation. Calculi in other parts
of the biliary system and/or the urinary system are also common
places. Medical retrieval devices for capturing and extracting
stones from various organs and passages are well known. Such
devices typically comprise a retrieval basket attached to a distal
end of an elongated member.
[0003] Urological baskets, and other baskets, often utilize a glue
joint to secure the basket formation into the desired orientation.
It is desired to use other methods to construct a stone management
basket such as for the benefits of limiting the cost, both in labor
and in material, to manufacture a stone management basket as well
as for repeatability and other quality control factors.
BRIEF SUMMARY
[0004] Embodiments of the present disclosure relate to, among other
things, securement and processing of medical retrieval devices.
Each of the embodiments disclosed herein may include one or more of
the features described in connection with any of the other
disclosed embodiments.
[0005] One general aspect of the present disclosure includes a
medical retrieval device for retrieving stones, calculi, and the
like, as well as polyps, foreign objects, and/or anatomical
abnormalities from various organs and passages, comprising an
elongated member, and a first wire and a second wire that forms a
retrieval basket. The elongated member has a hollow passageway
longitudinally positioned therebetween, and the first wire having
first and second ends attached to the distal end of the elongated
member and forming a first loop extending longitudinally and
distally from said distal end of the elongated member. The second
wire likewise has its first and second ends attached to the distal
end of the elongated member, forming a second loop extending
longitudinally and distally from the distal end of the elongated
member. The second loop is interconnected distally to said first
loop, which interconnection may include one or more of conjoined
loops, cannula, weld, solder, or other connection means known in
the art for the distal end of wire baskets. The elongated member
and the first and second wires are secured by a crimp joint and a
second joint, where such joints can be secured by a cannula,
welding, and/or soldering in addition to and/or instead of
crimping.
[0006] Another general aspect of the present disclosure includes
processing of the device disclosed above, processing comprising
steps of placing all ends of the first wire and the second wire
into an elongated member through a distal end of the elongated
member, moving said elongated member to a position where the first
loop and the second loop start their curvatures, placing said first
and second wires and said elongated member through an alignment
fixture such as a crimping or other securement fixture having thru
cuts configured for the interlocked wires, aligning said elongated
member in a desired position, and crimping said first and second
wires and said elongated member, where such joints can be secured
by a cannula, welding (including laser welding), glue, and/or
soldering in addition to and/or instead of crimping.
[0007] Other systems, methods, features and advantages of the
invention will be, or will become, apparent to one with skill in
the art upon examination of the following figures and detailed
description. It is intended that all such additional systems,
methods, features, and advantages be within the scope of the
invention, and be encompassed by the following claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present disclosure can be better understood with
reference to the following drawings and description. The components
in the figures are not necessarily to scale, emphasis instead being
placed upon illustrating the principles of the present disclosure.
Moreover, in the figures, like-referenced numerals designate
corresponding parts throughout the different views.
[0009] FIG. 1 is an illustration showing a distal portion of a
retrieval device in accordance with certain non-limiting aspects of
the present disclosure, where alternative basket and/or snare
configurations may be used with the retrieval device.
[0010] FIG. 2 is an illustration showing an elongated member in
accordance with certain aspects of the present disclosure.
[0011] FIG. 3 is an illustration showing a retrieval basket in
accordance with certain aspects of the present disclosure.
[0012] FIGS. 4A-4D are illustrations showing various non-limiting
crimp or other alignment fixture designs for processing of the
device, where other securement means such as a cannula, welding
(including laser welding), glue, and/or soldering in addition to
and/or instead of crimping may be used.
[0013] FIG. 5 is an illustration showing how wires of the device
may interact with, for example, a crimping fixture in accordance
with certain aspects of the present disclosure.
[0014] FIG. 6 is an illustration showing assembly of the device in
accordance with certain aspects of the present disclosure.
[0015] FIGS. 7A-7F are illustrations showing various cross
sectional configurations, taken along line X-X of FIG. 6, near a
crimp joint as described within the scope of the present
disclosure.
DETAILED DESCRIPTION
[0016] Various aspects are described below with reference to the
drawings in which like elements generally are identified by like
numerals. The relationship and functioning of the various elements
of the aspects may better be understood by reference to the
following detailed description. However, aspects are not limited to
those illustrated in the drawings or explicitly described below. It
also should be understood that the drawings are not necessarily to
scale, and in certain instances details may have been omitted that
are not necessary for an understanding of aspects disclosed herein,
such as conventional material, construction, and assembly.
[0017] The terms "proximal" and "distal" are used herein to refer
to the relative positions of the components of an exemplary medical
device. When used herein, "proximal" refers to a position
relatively closer to the exterior of the body or closer to a
medical professional using the medical device. In contrast,
"distal" refers to a position relatively further away from the
medical professional using the medical device, or closer to the
interior of the body.
[0018] Referring to FIG. 1, a retrieval device 10 may comprise an
elongated member 20 (such as, for example, a cannula), a retrieval
basket 30, a crimp joint 50 and an additional/second joint 40. As
illustrated by FIG. 2, the elongated member 20 may generally
comprise a proximal end 22, a distal end 28, and a hollow
passageway 25 longitudinally positioned therebetween. The elongated
member 20 may be made of a metal such as stainless steel. Other
flexible or rigid materials may also be utilized. The retrieval
basket 30 may comprise a plurality of wires 34, 38 attached to the
distal end 28 of the elongated member 20. The basket may include
multiple loops of wires that interact with each other in order to
be used in a stone management clinical setting, or for other
retrieval uses when deployed a patient. The term "loop" should be
understood to encompass a variety of shapes and not merely a
circular or elliptical configuration, but also--by way of
non-limiting example, helical, diamond-shaped, and/or other
wire-shapes capable of defining a central volume to capture and/or
carry a stone or other material. The basket can be preformed into
any desired shape or size for capturing and removing calculi from
the biliary or urinary system. Dimensions should be on scale with
the size of the retrieval device. For example, the diameter of the
device 10 may range from 1.5 Fr to 4.5 Fr. The wires 34, 38 may be
made from a nickel titanium alloy such as nitinol. As illustrated
by FIG. 3, in one embodiment, the basket 30 may comprise two wires
34, 38, each forming loops extending longitudinally and distally
from the distal end of the elongated member 28. In some
embodiments, the wires 34, 38 may be interconnected perpendicularly
relative to each other at the distal end and/or along planes
defined by the respective loop formed by each wire 34, 38. In one
embodiment, the large loop of wire 38 includes a distal-end small
loop 39 that interconnects/links in a chain-like manner with a
distal-end small loop 35 of the wire 34. Alternative embodiments
may include different wire geometries (e.g. pie wire, round,
square, D-shaped, etc.), wire quantities, and/or cannula
geometries.
[0019] In one embodiment, the second joint 40 may be an adhesive
such as glue. The adhesive may temporarily or permanently secure
the wires 34, 38. Ideally, low viscosity cyanoacrylate glue, such
as Loctite 4061, may be used for its strong adhesion to metal,
wicking properties, and fast cure time. Alternative embodiments may
include different glue compositions, and glue properties and
application parameters should be selected to ensure appropriate
adhesive dispersion. When using an adhesive, such as glue, as the
second joint, a notchless cannula design may be advantageous to
provide additional surface area for gluing and crimping.
[0020] In another embodiment, the second joint 40 may be a heat
shrink. Ideally, a heat shrink, which may be activated using a heat
gun, would have a melting temperature lower than the temperature at
which the wires 34, 38 are formed (roughly 400.degree. C.) so that
the wires 34, 38 are not adversely affected during the heat shrink
process. Exemplary heat shrink materials may include PTFE and
PEBAX. One advantage of this embodiment is that the wires 34, 38
are kept in a desired formation throughout the functioning life of
the retrieval device 10. Another advantage of this embodiment is
that it may replace the need to use a metal cannula and give the
retrieval device 10 a higher degree of flexibility when used inside
a scope for a procedure.
[0021] In one embodiment, processing of the retrieval device may
generally include placing all four ends of the wires 34, 38 into
the elongated member 20 through its hollow passageway 25, moving
the elongated member 20 to the bottom of the wires 33, 37 where the
wires 34, 38 end their curvature and go straight. Then, the wires
34, 38 and the elongated member 20 may be placed through an
alignment fixture or other securement fixture such as crimping
fixture 100 having thru cuts configured for the interlocked wires
34, 38 to ensure that the wires 34, 38 are aligned properly. Once
the wires 34, 38 and the elongated member 20 are properly aligned,
they may be crimped to form a crimp joint 50. A second joint 40 may
be formed prior to forming the crimp joint 50.
[0022] In one embodiment, formation of a crimp joint 50 may utilize
a crimping fixture or other alignment fixture 100 to ensure that
the wires 34, 38 hold their desired relationship during the
crimping process. Specifically, crimping fixture or other alignment
fixture 100a, 100b, 200 has a cross-hair thru cut 150, 250 all the
way through the part to allow a distal or proximal end of the
basket 30 to be fed through it before and/or after crimping.
Alternatively, crimping fixture 100a, 100b, 200 may have a blind
cut (not shown in figures) instead of thru cut 150, 200. Referring
to FIGS. 4A-4D, crimping fixture 100a, 100b, 200 may have a thru
cut 150, 250 that slides in the wires 34, 38 interconnected
perpendicularly. Specifically, configurations illustrated in FIGS.
4A-4B have an indented area 110a, 110b in the middle to help the
basket wires 34, 38 slide into the fixture. FIG. 5 illustrates how
wires 34, 38 may interact with crimping fixture 100a. Indented area
110a may help wires 34, 38 to slide all the way into the fixture
100a through the thru cut 150. Other crimping fixtures as
illustrated by FIG. 4B-4B may interact with wires 34, 38 in a
similar manner. More specifically, the fixture of FIG. 4A has
openings 120 on the side to allow assembly with screws (screws not
shown in figures). The fixture of FIG. 4B, the fixture does not
have openings 120 on the side for screw assembly, but instead has
smaller area outside of the indented area 110b. The thru cut 150
should have a tight tolerance to keep the wires 34, 38 in line. For
example, the length and width of thru cuts 150 may be 0.590 inches
and 0.020 inches, respectively. As illustrated by FIGS. 4C and 4D,
in another embodiment, crimping fixture 200 may comprise a base
section 210 and an elongated section 230 to help get the fixture
200 closer to the crimping site. Specifically, the diameter of the
base section 210 may be greater than the diameter of the elongated
section 230. For example, the diameter of the base section 210 may
be 0.750 inches while the diameter of the elongated section 250 may
be 0.375 inches. Further, the thickness of base section 210 may be
0.157 inches. The thickness of the elongated section 250 may range
from 0.079 inches to 0.154 inches. The crimping fixture 200 may
also have the thru cut 250. As with alternative embodiment
described above, the thru cut 250 should have a tight tolerance to
keep the wires 34, 38 in line. Specific dimensions should be on
scale with the size of the retrieval device 10, thus may vary.
[0023] Referring to FIG. 6, processing of a device with a glue 40a
or other secondary securement means (such as, by way of
non-limiting example, weld or solder) 40a as part of a second joint
40 may include steps of aligning the wires 34, 38 inside an
elongated member 20 to ensure that the wires 34, 38 are shaped
correctly to form a basket of a desired configuration. Aligning may
include pulling the wires 34, 38 into an alignment sheath (not
shown) to assure a proper alignment and then removing the alignment
sheath while maintaining the alignment. After removing the
alignment sheath, the glue may be applied to the distal end 28 of
the elongated member 20 or elsewhere within the elongated member
20. Once the glue 40a cures, a sheath 46 may be pulled over the
elongated member 20 before or after the act of crimping. As shown
in the drawings, the proximal half of the elongated member 20,
where no glue 40a presents, may be crimped with the wires 34, 38.
But, this crimp 50 and/or additional crimp joints 50 may be placed
as needed or desired, proximal and/or distal of the glue or other
secondary securement means in embodiments were such secondary
securement means are present.
[0024] Processing an embodiment using a heat shrink as an elongated
body 20 may comprise steps of placing all ends of the wires 34, 38
in a heat shrink, moving the heat shrink (20) to the wires' bottom
portions 33, 37 where the wires 34, 38 end their curvature and go
straight or substantially straight as compared to the loop
portions. Further, processing may include turning a heat gun to a
desired temperature, placing all ends of the wires 34, 38 and the
heat shrink at a desired distance from the heat gun for a
designated time. Once the heat shrink and the wires 34, 38 cool
down and an inspection confirms a proper alignment, which may be
perpendicular, one may proceed to further process the device
10.
[0025] In another embodiment, a short crimper that can crimp down
to 0.010'' at a force greater than 100 lbs. may be used to form a
crimp joint 50. It is important to ensure that the pressure setting
for the crimping fixture is set to the correct final outside
diameter and that the pressure is high enough. The area of crimp
joint 50 after crimping with a short crimper may have a hexagonally
shaped cross-section, or another geometric shape (e.g., octagonal,
circular, elliptical, or other shape, depending upon the shape of
the crimping mechanism/surface contacting the crimp joint 50 during
formation thereof, with reference to non-limiting examples in FIGS.
7A-7F, where "geometric" is defined as "utilizing rectilinear or
simple curvilinear motifs or outlines that bear little resemblance
to natural/organic forms"). In some embodiments, as illustrated by
FIGS. 7A-7F, the region near and/or including the crimp joint 50
may have different cross-sectional configurations (as viewed along
line X-X of FIG. 6) after the wires are aligned and secured
together. Certain embodiments, such as FIGS. 7A, 7D, 7E, and 7F,
may advantageously include a pie-shaped wire, also called "delta
wire", because the added angles may help keep the wires 34, 38 in
the perpendicular relationship.
[0026] Although some preferred embodiments of the disclosure have
been described, it should be understood that the disclosure is not
so limited and modifications may be made without departing from the
disclosure. The scope of the invention is defined by the appended
claims, and all devices that come within the meaning of the claims,
either literally or by equivalence, are intended to be embraced
therein.
* * * * *