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US011033412B2

( 12 ) United States Patent ( 10) Patent No .: US 11,033,412 B2


Carroux (45 ) Date of Patent : Jun . 15 , 2021

( 54 ) SOLID WIRE URETERAL STENT ( 56 ) References Cited

U.S. PATENT DOCUMENTS


( 71 ) Applicant: Gyrus ACMI , Inc. , Southborough, MA
(US ) 4,713,049 A 12/1987 Carter 604/8
5,295,954 A 3/1994 Sachse 604/8
( 72 ) Inventor: Alexander Carroux , Waltham , MA 5,647,843 A 7/1997 Mesrobian et al . 604/8
5,681,274 A 10/1997 Perkins et al . 604/8
( US ) 5,791,036 A * 8/1998 Goodin A61M 25/0014
29/423
( 73 ) Assignee: Gyrus Acmi, Inc. , Westborough , MA 6,395,021 B1 5/2002 Hart et al . 623 / 1.15
(US) 6,569,150 B2 5/2003 Teague et al. 604/524
6,887,215 B2 5/2005 McWeeney 604/9
7,169,139 B2 1/2007 Teague et al. 604/524
( * ) Notice: Subject to any disclaimer, the term of this 7,972,292 B2 7/2011 Behl et al . 604/8
patent is extended or adjusted under 35 8,512,272 B2 8/2013 Ostrovsky et al . 604/8
U.S.C. 154 ( b ) by 41 days. 2003/0130683 A1 * 7/2003 Andreas A61F 2/88
606/200

(21 ) Appl . No .: 15 /235,245 (Continued )


FOREIGN PATENT DOCUMENTS
(22) Filed : Aug. 12 , 2016
EP 0789602 A1 8/1997
EP 3281668 A1 2/2018
( 65 ) Prior Publication Data
US 2018/0042741 A1 Feb. 15 , 2018 OTHER PUBLICATIONS

( 51 ) Int . Cl . " Resonance Metallic Ureteral Stent ” , Cook Medical, 2014 , www .
cookmedical.com , 2 pgs .
A61F 2/94 ( 2013.01 )
A61M 27/00 ( 2006.01 ) (Continued )
A61M 25/01 (2006.01 ) Primary Examiner Yashita Sharma
A61F 2/844 ( 2013.01 ) ( 74 ) Attorney, Agent, or Firm - Schwegman Lundberg &
A61F 2/962 ( 2013.01 ) Woessner, P.A.
A61F 2/848 (2013.01 ) (57 ) ABSTRACT
( 52 ) U.S. CI .
Disclosed herein is an apparatus. The apparatus includes a
CPC A61F 2/94 ( 2013.01 ) ; A61F 2/844 solid wire and a delivery catheter. The solid wire being
(2013.01 ) ; A61F 2/962 ( 2013.01 ) ; A61M provided with one or more retention mechanisms at a
25/01 ( 2013.01 ) ; A61M 27/008 ( 2013.01 ) ; proximal end , a distal end, or both . The delivery catheter
A61F 2002/8486 ( 2013.01 ) ; A61F 2210/0014 being capable of maintaining the one or more retention
( 2013.01 ) ; A61F 2220/0008 (2013.01 ) mechanisms in a delivery configuration . The one or more
( 58 ) Field of Classification Search retention mechanisms are configured to expand to a
CPC A61F 2002/048 ; A61F 2/962 ; A61F 2/966 deployed configuration upon removal of the delivery cath
USPC 623/ 23.65–23.7 eter.
See application file for complete search history. 19 Claims , 2 Drawing Sheets

10

20 16

-14

12

18

-22
US 11,033,412 B2
Page 2

( 56 ) References Cited
U.S. PATENT DOCUMENTS

2003/0191450 A1 10/2003 Teague et al . 604/524


2004/0138644 A1 * 7/2004 DiCarlo A61L 29/085
604/524
2004/0193092 Al 9/2004 Deal 604/8
2005/0240141 A1 10/2005 Aliski et al . 604/8
2005/0240278 A1 10/2005 Aliski et al. 623 / 23.7
2007/0032880 A1 * 2/2007 Maeda A61M 27/008
623 / 23.7
2011/0172678 A1 7/2011 Behl et al . 606/127
2011/0230950 A1 9/2011 Knapp 623 / 1.11
2011/0320008 A1 * 12/2011 Teague A61M 27/008
623 /23.65
2013/0173016 Al 7/2013 Devereux 623 /23.66
2014/0172118 Al 6/2014 Pendleton et al . 623 / 23.66
2017/0202688 A1 * 7/2017 Caldwell A61F 2/04

OTHER PUBLICATIONS

“ European Application Serial No. 17179427.4 , Extended European


Search Report dated Nov. 16 , 2018 " , 7 pgs .
“ European Application Serial No. 17179427.4 , Response filed Aug.
3 , 2018 to Extended European Search Report dated Jan. 16 , 2018 ” ,
17 pgs.
* cited by examiner
U.S. Patent Jun . 15 , 2021 Sheet 1 of 2 US 11,033,412 B2

10

16 10
20

10
20 16

12
14
HI 16 14
20

12

14
24

18 -22 18 th

FIG.1
22
-18
FIG.3
22

FIG.2
U.S. Patent Jun . 15 , 2021 Sheet 2 of 2 US 11,033,412 B2

26

12
16

30

28

18

FIG.4
US 11,033,412 B2
1 2
SOLID WIRE URETERAL STENT includes one or more retention mechanisms at a proximal
end, a distal end, or both . The delivery catheter is configured
BACKGROUND to maintain the one or more retention mechanisms in a
delivery configuration .
Field of the Invention 5
BRIEF DESCRIPTION OF THE DRAWINGS
The invention relates to an apparatus and method for
stenting a passageway of a human or animal body, and more The foregoing aspects and other features of the invention
specifically relates to an apparatus and method for a ureteral are explained in the following description, taken in connec
stent. 10 tion with the accompanying drawings, wherein :
FIG . 1 is a perspective view of a ureteral stent ( in a
Brief Description of Prior Developments delivery configuration ) incorporating features of the inven
tion ;
A ureter is a tubular passageway in the body that conveys FIG . 2 is a perspective view of the ureteral stent shown in
urine from a kidney to a bladder. Ureteral stents are used to 15 FIG . 1 in a transition from the delivery configuration to a
facilitate urinary drainage from the kidney to the bladder in deployed configuration ;
patients have a ureteral obstruction or injury, or to protect FIG . 3 is a perspective view of another example of a
the integrity of the ureter in a variety of surgical manipula- ureteral stent incorporating features of the invention ; and
tions . Ureteral stents are typically about 30 cm long , hollow FIG . 4 is a perspective view of the ureteral stent shown in
catheter - like devices made from a polymer and placed 20 FIG . 1 deployed within a bladder, a ureter, and a kidney.
within the ureter with the distal end residing in the kidney
and the proximal end residing in the bladder . One or both DETAILED DESCRIPTION
ends of a ureteral stent may be coiled in a pigtail shape to
prevent the upward and / or downward migration of the stent Referring to FIG . 1 , there is shown a perspective view of
due to patient movement. For example, the ureter may 25 a ureteral stent 10 incorporating features of the invention .
stretch up to 5 cm in either direction during a patient's Although the invention will be described with reference to
normal bodily movements, such as movement during breath- the exemplary embodiments shown in the drawings, it
ing . If the stent is not sufficiently anchored, this may result should be understood that the invention can be embodied in
in stent migration and displacement. many alternate forms of embodiments . In addition , any
Ureteral stents are placed in a ureter to support opening of 30 suitable size , shape or type of elements or materials could be
the passageway of the ureter between the kidney and the used .
bladder to promote the flow path of urine. Traditional The ureteral stent 10 comprises a wire 12 and a delivery
ureteral stents may be formed of an outer plastic material catheter 14. The wire 12 comprises a distal end 16 and an
surrounding an inner lumen . Urine may be encouraged to opposite proximal end 18. The delivery catheter comprises
flow down from the kidney to the bladder partially via the 35 ration
a first end 20 and an opposite second end 22. The configu
shown in FIG . 1 illustrates the ureteral stent in a
inner lumen and partially around the outside of the stent in
the space between the stent and the ureter. It has been shown delivery configuration wherein the distal end 16 of the wire
that a majority of flow created by the stent may be between 12 is substantially aligned with the first end 20 of the
the outer lumen of the ureteral stent and the inner wall of the catheter 14 and the proximal end 18 of the wire 12 is
ureter. 40 substantially aligned with the second end of the catheter 14 .
The Cook Resonance ureteral stent, for example, uses a The wire 12 comprises a solid wire formed from a
coiled nitinol tube as a ureteral stent and which is provided shape-memory alloy such as nitinol, for example . However,
with pigtail coils on both the distal kidney end and proximal in alternate embodiments any suitable shape-memory alloy
bladder end for maintaining positioning in a patient. may be provided . The wire 12 comprises any suitable
It would be desirable to have a ureteral stent that was a 45 diameter configured to fit within the delivery catheter 14 .
thin wire so that in the event a benign or metastatic obstruc- The delivery catheter 14 comprises a general hollow tube
tion was present in the ureter, there would be relatively low shape. The catheter may comprise a size and shape of a 5 Fr.
difficulty in getting the stent to push past the obstruction due catheter (i.e. a catheter having a size five on the French scale
to the relatively small diameter and high column strength . It or French gauge system) . However, in alternate embodi
would also be desirable to have a ureteral stent that was 50 ments, any suitably sized catheter may be provided . Accord
capable of being delivered via small delivery member con- ing to various exemplary embodiments, the delivery catheter
figured for increased patient comfort. 14 comprises a metal support structure 24 configured to
rigidly support the delivery catheter in maintaining a straight
SUMMARY configuration of the solid nitinol wire 12 during delivery of
55 the stent. The metal support structure may include a coil
In accordance with one aspect of the invention , an appa- braid which is woven within a polymer layer. However, in
ratus is disclosed . The apparatus includes a solid wire and a alternate embodiments, any suitable support structure may
delivery catheter. The solid wire being provided with one or be provided
more retention mechanisms at a proximal end , a distal end, As mentioned above , in the delivery configuration shown
or both . The delivery catheter being capable of maintaining 60 in FIG . 1 the ends 16 , 20 are substantially aligned and the
the one or more retention mechanisms in a delivery con- ends 18 , 22 are substantially aligned such that the catheter
figuration. The one or more retention mechanisms are con- 14 surrounds the wire 12 .
figured to expand to a deployed configuration upon removal Referring now to FIG . 2 , there is shown the wire 12 and
of the delivery catheter. catheter 14 in a transition from the delivery configuration to
In accordance with another aspect of the invention , a 65 a deployed configuration. For example, FIG . 2 shows the
method is disclosed . A delivery catheter is provided. A solid catheter 14 slidably repositioned such that the first end 20 of
wire is inserted into the delivery catheter. The solid wire the catheter 14 is moved in a direction towards the proximal
US 11,033,412 B2
3 4
end 18 of the wire . This provides for the distal end 16 of wire shown that metallic stents can be maintained in situ for
12 to be exposed. With the distal end exposed ( and no longer twelve months without significant encrustation .
surrounded by the catheter which supports and maintains the Additional technical effects of any one or more of the
wire in a straight configuration ) the wire is configured to exemplary embodiments provide for a nitinol wire provided
deform to a defined shape of the shape - memory alloy. In the 5 with curls at a distal and proximal end to act as a ureteral
embodiment shown in FIG . 2 , the defined shape of the stent, wherein a catheter is also provided for flattening the
shape-memory alloy is a general curl or coil shape which is nitinol wire curls during placement of the stent. Many of the
heat set at the distal end 16 of the wire 12. The general curl conventional configurations provide a lack of patient com
or coil shape provides a retention mechanism for the wire at fort, as even the smallest stents of 4.5 Fr represent a big
the distal end 16 . 10 structure in the ureter, stopping the natural peristaltic move
It should be noted that although various exemplary ment and allow for the reflux from the bladder through the
ureteral orifice .
embodiments have been described in connection with a
general curl or coil shape as a retention mechanism , one Below are provided further descriptions of various non
limiting , exemplary embodiments. The below - described
skilled in the art will appreciate that the various exemplary 15 with
embodiments are not necessarily so limited and that in
exemplary embodiments may be practiced in conjunction
one or more other aspects or exemplary embodiments.
alternate embodiments any suitable shape for a retention That is , the exemplary embodiments of the invention , such
feature may be provided. For example, as shown in FIG . 3 , as those described immediately below, may be implemented,
a flared end or flared shape and a flattened tip may be practiced or utilized in any combination ( e.g. , any combi
provided as the retention mechanism . Additionally, in other 20 nation that is suitable, practicable and /or feasible) and are
embodiments, a long , thin , floppy tip shape may be pro- not limited only to those combinations described herein
vided . and / or included in the appended claims .
When the catheter 14 is fully removed from the wire 12 , In one exemplary embodiment, a ureteral stent compris
the other end of the wire is exposed to provide another ing : a solid wire , the solid wire being provided with one or
retention mechanism at the proximal end 18 of the wire 12. 25 more retention mechanisms at a proximal end, a distal end ,
This deployed configuration is shown in FIG . 4 , wherein or both ; a delivery catheter, the delivery catheter being
both the distal end and the proximal end of the wire capable of maintaining the one or more retention mecha
comprise a general curl or coil shape as a retention mecha- nisms in a delivery configuration ; wherein the one or more
nism . However, it should be noted that in alternate embodi- retention mechanisms are configured to expand to a
ments , different shapes could be provided at the distal and 30 deployed configuration upon removal of the delivery cath
proximal ends. eter.
As shown in FIG . 4 , the stent 10 is provided as a catheter A ureteral stent as above , wherein the solid wire com
inserted wire . According to various exemplary embodi- prises a shape -memory alloy.
ments , there would be no flow through the wire , however the A ureteral stent as above , wherein the solid wire com
flow around the wire would likely be considered sufficient. 35 prises a solid nitinol wire .
For example, urine may be encouraged to flow down from A ureteral stent as above , wherein the solid wire is heat set
the kidney 26 to the bladder 28 around the outside of the to form the one or more retention mechanisms.
wire 12 in the space between the wire and the ureter 30 . A ureteral stent as above , wherein the one or more
Additionally, the wire would be locked in the kidney with a retention mechanisms are curls at both the proximal end and
curl or spiral type structure ( or retention mechanism ) at the 40 the distal end .
distal end 16 , similar to a conventional stent. In the bladder, A ureteral stent as above , wherein the one or more
the wire could also be provided with a curl shaped structure retention mechanisms include a curl at one end and a flared
or any other suitable shape at the proximal end 18 which end at the other end .
would strive to reduce bladder irritation . A ureteral stent as above , wherein the delivery catheter is
While various exemplary embodiments of the invention 45 configured to surround the solid wire during insertion into an
have been described in connection with the retention mecha- anatomical region of interest.
nisms mentioned above, one skilled in the art will appreciate A ureteral stent as above , wherein the delivery catheter
that the various exemplary embodiments are not necessarily comprises a metal support structure configured to rigidly
so limited and that other exemplary embodiments may support the delivery catheter in maintaining a straight con
include an expandable nitinol cage section . Additionally, it 50 figuration of the solid nitinol wire during delivery.
is contemplated that different output accessories can be used A ureteral stent as above , wherein the metal support
with the device of the present invention . In one embodiment, structure is a coil braid which is woven within a polymer
a lithotripsy shaft may be used in combination with a stone layer.
retrieval device (i.e. stone basket or stone grasper ). Another In another exemplary embodiment, a method, comprising:
embodiment might include a laser fiber used in combination 55 providing a delivery catheter; and inserting a solid wire into
with a stone retrieval device. Various other alternatives and the delivery catheter, wherein the solid wire comprises one
configurations are possible to remove a calculus of interest or more retention mechanisms at a proximal end , a distal
and are herein incorporated by reference . end , or both , and wherein the delivery catheter is configured
Technical effects of any one or more of the exemplary to maintain the one or more retention mechanisms in a
embodiments provide a stent made out of nitinol wire which 60 delivery configuration .
would replace the traditional polymer stent. Instead of A method as above, wherein the one or more retention
placing a tube structure over a guidewire, the present inven- mechanisms are configured to deform to a deployed con
tion places a guidewire via a catheter ( such as a 5 Fr catheter, figuration upon removal of the delivery catheter.
for example ). Various exemplary embodiments of the inven- A method as above, wherein the solid wire comprises a
tion provide drainage for patients with both benign and 65 shape -memory alloy.
malignant obstructions with good patient tolerance and A method as above, wherein the solid wire comprises a
without significant encrustation . Additionally , it has been solid nitinol wire .
US 11,033,412 B2
5 6
A method as above , wherein the solid wire is heat set to nism at the distal end, where the solid wire comprises
form the one or more retention mechanisms. a general cylindrical shape along a majority of a length
A method as above , wherein the one or more retention of the solid wire ; and
mechanisms are curls at both the proximal end and the distal a delivery catheter on the solid wire , where the delivery
end . 5 catheter is configured to maintain the first retention
It should be understood that components of the invention mechanism at the distal end in a delivery configuration,
can be operationally coupled or connected and that any where the first retention mechanism is configured to
number or combination of intervening elements can exist transition from the delivery configuration to a deployed
( including no intervening elements ). The connections can be configuration when the delivery catheter is at least
direct or indirect and additionally there can merely be a 10 partially removed from the solid wire, where the solid
functional relationship between components. wire is configured to provide a flow path between an
It should be understood that the foregoing description is outer side of the general cylindrical shape and an
anatomical region of interest without another member
only illustrative of the invention . Various alternatives and therebetween, where the first retention mechanism at
modifications can be devised by those skilled in the art the distal end comprises the solid wire having a non
without departing from the invention. Accordingly, the 15 curled shape and a flattened tip at the distal end, and
invention is intended to embrace all such alternatives , modi- where the first retention mechanism is configured to be
fications and variances which fall within the scope of the inserted through a ureter into a kidney .
appended claims . 11. The ureteral stent as in claim 10 where the non - curled
shape comprises a flared shape which is straight along a
What is claimed is : 20 centerline of the solid wire at the distal end .
1. A ureteral stent, comprising : 12. The ureteral stent as in claim 10 where the solid wire
is heat set to form at least one of the one or more retention
a solid wire having a first retention mechanism at a distal mechanisms.
end, the solid wire comprising a general straight cylin 13. The ureteral stent as in claim 10 where the delivery
drical shape along a majority of a length of the solid
wire ; 25 catheter comprises a metal support structure configured to
a delivery catheter configured to maintain the first reten rigidly support the delivery catheter in maintaining a gen
tion mechanism in a delivery configuration ; erally straight configuration of the solid wire in the delivery
wherein the first retention mechanism is configured to configuration.
14. The ureteral stent as in claim 13 where the metal
transition to a deployed configuration when the deliv
ery catheter is removed from the solid wire, and 30 within
supporta structure
polymer comprises
layer. a coil braid which is woven
wherein the solid wire is configured to provide a flow
path between an outside diameter of the general cylin 15. The ureteral stent as in claim 10 where a proximal end
drical shape and an anatomical region of interest with of the solid wire comprises a curled shape.
out another member therebetween , where the first 16. A ureteral stent comprising:
retention mechanism comprises the solid wire having a 35 a solid wire comprising a proximal end and a distal end,
flared shape and a flattened tip at the distal end, and where the solid wire comprises a first retention mecha
where the first retention mechanism is configured to be nism at the distal end and a second retention mecha
inserted through a ureter into a kidney. nism at the proximal end ; and
2. The ureteral stent of claim 1 wherein the solid wire a delivery catheter configured to be located on the solid
comprises a shape -memory alloy . 40 wire , where the delivery catheter is configured to
3. The ureteral stent of claim 1 wherein the solid wire maintain the first retention mechanism at the distal end
comprises a solid nitinol wire . and the second retention mechanism at the proximal
4. The ureteral stent of claim 1 , wherein the solid wire is end in a delivery configuration ,
heat set to form the one or more retention mechanisms. where the first retention mechanism at the distal end and
5. The ureteral stent of claim 1 , wherein the delivery 45 the second retention mechanism at the proximal end are
catheter is configured to surround the solid wire during configured to transition from the delivery configuration
insertion into the anatomical region of interest. to a deployed configuration when the delivery catheter
6. The ureteral stent of claim 1 , wherein the delivery is at least partially removed from the solid wire , where
catheter comprises a metal support structure configured to the solid wire is configured to provide a flow path
between an outer lateral side of the solid wire and an
rigidly support the delivery catheter in maintaining a straight 50
configuration of the solid wire during delivery. anatomical region of interest without another member
7. The ureteral stent of claim 6 , wherein the metal support therebetween , where the first retention mechanism at
structure is a coil braid which is woven within a polymer the distal end comprises the solid wire ing a flared
layer. straight solid wire shape at the distal end , and where the
8. The ureteral stent of claim 1 where the solid wire 55 first retention mechanism is configured to be inserted
comprises a second retention mechanism at a proximal end, through a ureter into a kidney.
where at least one of the retention mechanisms comprises a 17. The ureteral stent as in claim 16 where the flared shape
non -curled shape. comprises a non- curled shape .
9. The ureteral stent of claim 1 where the flared shape has 18. The ureteral stent as in claim 16 where the proximal
a solid straight wire shape. 60 end of the solid wire has a curled shape .
19. The ureteral stent as in claim 16 where the flared
10. A ureteral stent comprising: straight solid wire shape comprises a flattened tip .
a solid wire comprising a proximal end and a distal end,
where the solid wire comprises a first retention mecha

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