U.S. patent application number 14/839153 was filed with the patent office on 2015-12-24 for tip protector sleeve.
This patent application is currently assigned to BAYER HEALTHCARE LLC. The applicant listed for this patent is Bayer HealthCare LLC. Invention is credited to JULIAN CRUZADA, CHRIS SEPE, CHRISTOPHER A. STOUT, BETSY SWANN.
Application Number | 20150366584 14/839153 |
Document ID | / |
Family ID | 46321456 |
Filed Date | 2015-12-24 |
United States Patent
Application |
20150366584 |
Kind Code |
A1 |
STOUT; CHRISTOPHER A. ; et
al. |
December 24, 2015 |
TIP PROTECTOR SLEEVE
Abstract
Assemblies and methods of inserting a delivery catheter assembly
into a working channel are disclosed. In accordance with some
embodiments, a delivery catheter assembly is disclosed in which a
tip protector sleeve is locked onto an elongated catheter sheath
and slideable over a length of the elongated catheter sheath
between a proximal-stop position and a distal-stop position along
the elongated catheter sheath.
Inventors: |
STOUT; CHRISTOPHER A.; (San
Bruno, CA) ; SWANN; BETSY; (Grass Valley, CA)
; CRUZADA; JULIAN; (San Jose, CA) ; SEPE;
CHRIS; (Campbell, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bayer HealthCare LLC |
Whippany |
NJ |
US |
|
|
Assignee: |
BAYER HEALTHCARE LLC
Whippany
NJ
|
Family ID: |
46321456 |
Appl. No.: |
14/839153 |
Filed: |
August 28, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13149631 |
May 31, 2011 |
9138343 |
|
|
14839153 |
|
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Current U.S.
Class: |
606/119 ; 29/428;
29/509 |
Current CPC
Class: |
A61B 2017/4233 20130101;
A61B 2090/034 20160201; Y10T 29/49828 20150115; A61B 17/42
20130101; A61F 6/18 20130101; A61F 6/225 20130101; Y10T 29/49826
20150115; A61B 2017/1205 20130101; F04C 2270/041 20130101; Y10T
29/49917 20150115 |
International
Class: |
A61B 17/42 20060101
A61B017/42 |
Claims
1. A method of forming a delivery catheter assembly comprising:
sliding a tip protector sleeve over a distal end of an elongated
catheter sheath and toward a control device; fixing a bump onto a
distal region of the elongated catheter sheath, wherein the bump
prevents the tip protector sleeve from sliding off of a distal end
of the elongated catheter sheath.
2. The method of claim 1, wherein fixing a bump onto a distal
region of the elongated catheter sheath comprises crimping.
3. The method of claim 2, wherein crimping comprises crimping a
distal end of a band onto the elongated catheter sheath.
4. The method of claim 3, further comprising not crimping a
proximal end of the band onto the elongated catheter shaft.
5. A method of delivering an insert comprising: providing a
delivery catheter assembly comprising: a control device; an
elongated catheter sheath having a distal end and a proximal end
connected to the control device; an insert releasably disposed
within the elongated catheter sheath; and a tip protector sleeve
locked onto the elongated catheter sheath and slideable over a
length of the elongated catheter sheath between a proximal-stop
position and a distal-stop position along the elongated catheter
sheath; positioning the tip protector sleeve at the distal-stop
position; inserting the tip protector sleeve through an access port
of a hysteroscope system and into a working channel of the
hysteroscope system; advancing the distal end of the elongated
catheter sheath to a target location within a body lumen; and
deploying the insert inside the body lumen.
6. The method of claim 5, wherein inserting the tip protector
sleeve further comprises advancing a distal end of the tip
protector sleeve past a valve clamp of the hysteroscope system.
7. The method of claim 6, wherein inserting the tip protector
sleeve comprises advancing the tip protector sleeve into the
working channel until a flanged mechanical stop on the tip
protector sleeve abuts the access port or a sealing cap coupled to
the access port.
8. The method of claim 6, wherein the distal end of the elongated
catheter sheath is advanced to the target location within the body
lumen while the flanged mechanical stop on the tip protector sleeve
abuts the access port or the sealing cap.
9. The method of claim 5, further comprising removing the delivery
catheter assembly from the working channel after deploying the
insert inside the body lumen.
10. The method of claim 5, wherein removing the delivery catheter
assembly from the working channel comprises withdrawing a bump on
the elongated catheter sheath proximally against a backstop of the
tip protector sleeve to cause the tip protector sleeve to be
withdrawn from the working channel.
11. The method of claim 5, further comprising tightening a sealing
valve of the tip protector sleeve onto the elongated catheter
sheath after positioning the tip protector sleeve at the
distal-stop position, and prior to inserting the tip protector
sleeve through the access port of the hysteroscope system.
Description
BACKGROUND
[0001] Embodiments of the present invention relate to the field
minimally invasive surgical medical devices and medical procedures.
More specifically, embodiments of the present invention relate to
devices and methods used for transcervical gynecological
procedures.
[0002] Female contraception and sterilization may be affected by
transervically introducing an object into a fallopian tube to
inhibit conception. Devices, systems and methods for such a
contraceptive approach have been described in various patents and
patent applications assigned to the present assignee. For example,
U.S. Pat. No. 6,526,979, U.S. Pat. No. 6,634,361, U.S. patent
application Ser. No. 11/165,733 published as U.S. Publication No.
2006/0293560 and U.S. patent application Ser. No. 12/605,304
describe transcervically inserting an insert (also referred to as
implant and device) into an ostium of a fallopian tube and
mechanically anchoring the insert within the fallopian tube. One
example of such an assembly is known as "Essure" .RTM. from
Conceptus, Inc. of Mountain View, Calif. Tissue in-growth into the
"Essure" .RTM. insert provides long-term contraception and/or
permanent sterilization without the need for surgical
procedures.
[0003] The insert may be delivered to the fallopian tube with a
delivery catheter assembly such as the one illustrated in FIG. 1.
The delivery catheter assembly 100 is formed of a control device
102 such as a handle, an elongated sheath 104, and an insert 106.
The delivery catheter assembly 100 may be transcervically
positioned into the uterus and the fallopian tubes via a
hysteroscope system.
[0004] Referring to FIG. 2 the hysteroscope system 200 may include
a working channel 202 into which the delivery catheter assembly is
inserted. Advancement of the delivery catheter system within the
uterus and the fallopian tubes is usually facilitated by distending
the uterus with a distention fluid, such as saline, and viewing the
placement with the hysteroscope system. A valve clamp 208, such as
a ball valve clamp, and an access port 206 are positioned at the
tip of the working channel 202. Closing the valve clamp 208 may
seal the entrance of the working channel 202 to prevent a
distention fluid from leaking out of the access port 206. A sealing
cap 230 including a pierceable end 232 can be placed over the
access port 206 to prevent distention fluid from leaking out of the
hysteroscope system when a delivery catheter assembly occupies the
working channel of the hysteroscope system.
[0005] An introducer 220 may be used in order to prevent damaging
the tip the elongated sheath 104 or insert 106 of the delivery
catheter assembly 100 during insertion through the pierceable end
232 of the sealing cap 230 and access port 206, and into the
working channel 202 of the hysteroscope system 200. Introducer 220
includes a sheath portion 222 and slit opening 224 to aid in
grasping and in the removal of the introducer 220. The introducer
220 is inserted through the pierceable end 232 of the sealing cap
230 and into the working channel 202 prior to inserting the
delivery catheter assembly 100. When the introducer 220 is inserted
through the sealing cap 230, fluid can spray out of the introducer
220 and onto the physician or physician's assistant. The amount of
fluid spray-back can be significant depending on the distention
fluid pressure during the procedure.
[0006] Referring to FIG. 3, after placing the introducer 220 into
the working channel 202, the tip of delivery catheter assembly 100
is inserted into the slit opening 224 and through the sheath 222 of
the introducer 220 in order to advance the delivery catheter
assembly 100 into the working channel 202 of the hysteroscope
system. This is typically performed as soon as possible after
placement of the introducer 220 into the working channel 202 in
order to minimize the amount of fluid spray-back from the
introducer. The introducer 220 may then be removed or may be kept
in place throughout the procedure. After insertion of the delivery
catheter assembly 100 into the introducer 200, an amount of
distention fluid may still leak from between the introducer and
elongated sheath 104 of the delivery catheter assembly 100.
SUMMARY
[0007] Embodiments of the present invention generally provide
assemblies and methods of inserting a delivery catheter into a
working channel of an endoscope, such as a hysteroscope system for
accessing a female reproductive system. While embodiments of the
invention are described with reference to a hysteroscope system, it
is understood that the embodiments are not limited to such and may
also be compatible with other optical surgical devices. In one
aspect, embodiments of the invention describe a tip protector
sleeve which functions as an introducer and protects the tip of a
delivery catheter assembly when piercing a sealing cap, as well as
during insertion through an access port, into the working channel
and past a valve clamp of a hysteroscope system. In another aspect,
embodiments of the invention describe a method and system which may
reduce the amount of fluid spray-back and leakage associated with
inserting a delivery catheter assembly into the working channel of
a hysteroscope system.
[0008] One embodiment of the present invention relates to a
delivery catheter assembly which may be used to deliver an insert
to an ovarian pathway (e.g. a fallopian tube) of a female body. The
delivery catheter assembly may include a control device, an
elongated catheter sheath having a distal end and a proximal end
connected to the control device, and a tip protector sleeve. The
tip protector sleeve may be locked onto the elongated catheter
sheath and slideable over a length of the elongated catheter sheath
between a proximal-stop position and a distal-stop position along
the elongated catheter sheath. The delivery catheter assembly may
further include an interference stop which determines the
distal-stop position and prevents the tip protector sleeve from
sliding off of the distal end of the elongated catheter sheath. For
example, the interference stop may include a male interference part
which interferes with sliding of a female interference part over
the elongated catheter sheath. The male interference part may be
fixed to the elongated catheter sheath, and the tip protector
sleeve may comprise the female interference part. The tip protector
sleeve may additionally incorporate a sealing valve to reduce the
amount of fluid spray-back and leakage associated with inserting
the delivery catheter assembly into the working channel of a
hysteroscope system
[0009] Another embodiment of the present invention relates to a
method of forming a delivery catheter assembly which includes
sliding a tip protector sleeve over a distal end of an elongated
catheter sheath and toward a control device, and then fixing a bump
onto a distal region of the elongated catheter sheath.
Alternatively, the bump may be fixed onto the distal region of the
elongated catheter sheath, and then the tip protector sleeve is
slid over a proximal end of the elongated catheter sheath toward
the bump prior to attaching the control device to the elongated
catheter sheath. The control device may prevent the tip protector
sleeve from sliding off a proximal end of the elongated sheath and
define, in part, a proximal-stop position. The bump may prevent the
tip protector sleeve from sliding off of a distal end of the
elongated catheter sheath and define, in part, a distal-stop
position. In an embodiment, the bump may be fixed onto a distal
region of the elongated catheter sheath by crimping a band onto the
elongated catheter sheath. It is not necessary to crimp the entire
length of the band, and only a proximal end of the band is crimped
onto the elongated catheter shaft in an embodiment.
[0010] Another embodiment of the present invention relates to a
method of delivering an insert into a body lumen such as an ovarian
pathway (e.g. a fallopian tube) of a female body. Utilizing a
delivery catheter assembly in accordance with embodiments of the
invention the tip protector sleeve is positioned at the distal-stop
position, and the tip protector sleeve is inserted through a
pierceable end of a sealing cap, through an access port of a
hysteroscope system and into a working channel of the hysteroscope
system. In accordance with embodiments of the invention, the distal
end of the elongated catheter sheath and insert are inserted
through the pierceable end of the sealing cap, through the access
port and into the working channel of the hysteroscope system
simultaneously with the tip protector sleeve in the distal-stop
position. The distal end of the elongated catheter sheath and
insert may then be advanced through the tip protector sleeve and
beyond the hysteroscope system to a target location within the body
lumen where the insert is deployed within the body lumen. In an
embodiment, the tip protector sleeve is advanced through the
sealing cap into the working channel until a flanged mechanical
stop, such as a bead or flared portion, abuts the sealing cap (or
access port if a sealing cap is not utilized) prior to advancing
the elongated sheath and insert to the target location.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a cross-sectional side view illustration of a
delivery catheter assembly.
[0012] FIG. 2 is an isometric view illustration of a hysteroscope
system and an introducer.
[0013] FIG. 3 is an isometric view illustration of a delivery
catheter assembly inserted into an introducer and working channel
of a hysteroscope system.
[0014] FIG. 4 is a side view illustration of a tip protector sleeve
in accordance with an embodiment of the invention.
[0015] FIG. 5A is a side view illustration of a delivery catheter
assembly with a tip protector sleeve at a proximal-stop position in
accordance with an embodiment of the invention.
[0016] FIG. 5B is a side view illustration of a delivery catheter
assembly with a flanged mechanical stop of a tip protector sleeve
in a cavity of a control device in accordance with an embodiment of
the invention.
[0017] FIG. 5C is a side view illustration of a delivery catheter
assembly with a tip protector sleeve fastened into the
proximal-stop position by a friction fitting in accordance with an
embodiment of the invention.
[0018] FIG. 5D is a side view illustration of a delivery catheter
assembly with a tip protector sleeve screwed into the proximal-stop
position in accordance with an embodiment of the invention.
[0019] FIG. 6 is a side view illustration of a delivery catheter
assembly with a tip protector sleeve at a distal-stop position in
accordance with an embodiment of the invention.
[0020] FIG. 7 is a close-up side view illustration of the proximal
end of a tip protector sleeve over an elongated catheter sheath in
accordance with an embodiment of the invention
[0021] FIG. 8 is a close-up cross-sectional side view illustration
of the proximal end of a tip protector sleeve over an elongated
catheter sheath in accordance with an embodiment of the
invention
[0022] FIG. 9 is a cross-sectional side view illustration of a tip
protector sleeve in accordance with an embodiment of the
invention.
[0023] FIG. 10 is a cross-sectional side view illustration of a tip
protector sleeve in accordance with an embodiment of the
invention.
[0024] FIGS. 11A-11C are cross-sectional side view illustrations of
tip protector sleeves incorporating various sealing valves in
accordance with embodiments of the invention.
[0025] FIGS. 12A-12C are isometric view illustrations of inserting
a delivery catheter assembly into a working channel of a
hysteroscope system in accordance with an embodiment of the
invention.
DETAILED DESCRIPTION
[0026] Embodiments of the present invention generally provide
assemblies and methods of inserting a delivery catheter into a
working channel of an endoscope, such as a hysteroscope system or
other optical surgical device for accessing a female reproductive
system. Various embodiments and aspects will be described with
reference to details discussed below and the accompanying drawings
will illustrate the various embodiments. The following description
and drawings are illustrative of the invention and are not to be
construed as limiting the invention. Numerous specific details are
described to provide a thorough understanding of various
embodiments of the present invention. However, in certain
instances, well-known or conventional details are not described in
order to provide a concise discussion of embodiments of the present
invention.
[0027] In an embodiment, a delivery catheter assembly includes a
control device, an elongated catheter sheath having a distal end
and a proximal end connected to the control device, and a tip
protector sleeve. Referring to the FIG. 4 the tip protector sleeve
300 may include an elongated shaft 302, a flanged mechanical stop
304 at a proximal end, and a distal end 306. The distal end 306 can
be flat or angled to assist with piercing of a sealing cap. In an
embodiment, the distal end 306 has an approximately 45 degree
angled tip. Elongated shaft 302 may be formed of a material and to
a thickness which can be molded and does not buckle when piercing a
sealing cap. For example, elongated shaft 302 may be formed of a
material such as polyether ether ketone (PEEK).
[0028] Flanged mechanical stop 304 may provide variety of
functions, be formed of a variety of materials and have a variety
of shapes and sizes as will be explained in further detail with
regard to FIGS. 5A-12C. For example, flanged mechanical stop 304
may be formed of a moldable material such as polycarbonate, or from
the same material as the elongated shaft 302. Flanged mechanical
stop 304 may be sized and shaped larger than the inside diameter
(ID) of a corresponding access port opening to a working channel or
pierceable end of a sealing cap if present in order to act as a
stop mechanism that controls the insertion depth of the tip
protector sleeve 300 into the working channel. Flanged mechanical
stop 304 may also be sized and shaped to be gripped by an
operator's hand to assist with sliding of the tip protector sleeve
300 over a length of the elongated catheter sheath 404 of a
catheter assembly. In this respect, one function may be as a handle
at the proximal end of the tip protector sleeve 300. Flanged
mechanical stop 304 may also incorporate a sealing valve to reduce
the amount of fluid spray-back and leakage associated with
inserting the delivery catheter assembly into a working
channel.
[0029] Referring to FIGS. 5A-6, a delivery catheter assembly 400 in
accordance with embodiments of the invention is illustrated in
which the tip protector sleeve 300 is locked onto and slideable
over a length of the elongated catheter sheath 404. The delivery
catheter assembly 400 may be formed by sliding a tip protector
sleeve 300 over a distal end of an elongated catheter sheath 404
and toward a control device 402, and then fixing a bump 408 onto a
distal region of the elongated catheter sheath 402. Alternatively,
the bump 408 may be fixed onto the distal region of the elongated
catheter sheath 402, and then the tip protector sleeve 300 is slid
over a proximal end of the elongated catheter sheath 402 toward the
bump 408 prior to attaching the control device 402 to the elongated
catheter sheath 402. The control device 402 may prevent the tip
protector sleeve 300 from sliding off a proximal end of the
elongated sheath 402 and define, in part, a proximal-stop position.
The bump 408 may prevent the tip protector sleeve 300 from sliding
off of a distal end of the elongated catheter sheath 402 and
define, in part, a distal-stop position. An operator may grip the
flanged mechanical stop 304 by hand, for example between a thumb
and index finger, and slide the tip protector sleeve over the
elongated catheter sheath 404 between the proximal-stop and
distal-stop positions.
[0030] FIG. 5A is an illustration of the tip protector sleeve 300
positioned at a proximal-stop position. In the embodiment
illustrated in FIG. 5A, the flanged mechanical stop 304 abuts a
distal end of the control device 402, though other proximal-stop
positions along the elongated catheter sheath 404 are contemplated
in accordance with embodiments of the invention. For example, FIGS.
5B-5D are illustrations of embodiments in which the control device
402 is configured to allow flanged mechanical stop 304 to slide
within a cavity 420 located at a distal portion of the control
device 402. Such embodiments may be useful during operation in
order to utilize the full working length of the elongated catheter
sheath 404. In this manner, the distal end of the control device
402 can be advanced to abut the access port 206 of the hysteroscope
system or the pierceable end 232 of a sealing cap 230 if desired
during operation. Alternatively, the distal end of the control
device 402 can be advanced over the access port 206 of the
hysteroscope system or over sealing cap 230 and the flanged
mechanical stop 304 is allowed to abut the access port 206 or the
pierceable end 232 of the sealing cap 230. As illustrated in FIG.
5B, flanged mechanical stop 304 may be slid into cavity 420 to abut
a back wall 422 of the cavity at the proximal-stop position.
Flanged mechanical stop 304 may be also configured to fasten onto
the handle 402 at the proximal-stop position. For example, FIG. 5C
is an illustration of an embodiment in which flanged mechanical
stop 304 may be slid into cavity 420 and fastened into the
proximal-stop position by a friction fitting with sloped walls 424
of the cavity. FIG. 5D is an illustration of an embodiment in which
flanged mechanical stop 304 may be screwed into cavity 420 in which
threads 330 on flanged mechanical stop 304 mate with threads 430
inside cavity 420 to fasten tip protection sleeve 300 in the
proximal-stop position. In an embodiment, a suitable fastening
mechanism for fastening tip protector sleeve 300 onto control
device 402 is able to hold the tip protector sleeve 300 in the
proximal-stop position during withdrawal of the delivery catheter
assembly 400 from the working channel of the hysteroscope
system.
[0031] Referring now to FIG. 6 an operator may slide the tip
protector sleeve over the elongated catheter sheath 404 between the
proximal-stop position and the distal-stop position illustrated in
FIG. 6. As illustrated, the distal end 306 of tip protector sleeve
300 may extend distally beyond a distal end of the elongated
catheter sheath 404 and insert 406 when at the distal-stop
position. In this manner, the tip protector sleeve 300 may protect
the distal ends of the elongated catheter sheath 404 and insert 406
during piercing of a sealing cap and during insertion into the
working channel and past a valve clamp of the hysteroscope
system.
[0032] An interference stop may determine the distal-stop position
and prevent the tip protector sleeve 300 from sliding off of the
distal end of the elongated catheter sheath 404. In an embodiment,
the interference stop includes a male interference part which
interferes with sliding of a female interference part over the
elongated catheter sheath. Referring again to FIG. 5A, the male
interference part may comprise a bump 408 fixed to the elongated
catheter sheath 404. Bump 408 may be formed along only a portion of
the circumference of the elongated sheath, or may encircle the
circumference of the elongated sheath. In an embodiment, bump 408
is a band fixed to and encircling the circumference of the
elongated catheter sheath. In an embodiment, bump 408 is fixed to
the elongated catheter sheath 404 with a sufficient shear strength
to ensure that the tip protector sleeve may be removed from a
working channel of a hysteroscope system along with removal of the
elongated catheter sheath 404.
[0033] FIG. 7 is a close-up side view illustration of the proximal
end of a tip protector sleeve over an elongated catheter sheath in
accordance with an embodiment of the invention. FIG. 8 is a
close-up cross-sectional side view illustration of the proximal end
of a tip protector sleeve over an elongated catheter sheath in
accordance with an embodiment of the invention. As illustrated in
FIGS. 7-8, flanged mechanical stop may be a bead 304A having a
barrel-like shape, though embodiments of the invention are not
limited to such a shape. In an embodiment, bead 304A is fixed to
shaft 302 with an adhesive.
[0034] Referring to FIG. 8, in an embodiment bead 304A may be fixed
to a proximal end of the elongated shaft 302. Bead 304A may include
a distal portion 308 surrounding the proximal end of the elongated
shaft 302, a shoulder portion 310 extending proximally of the
elongated shaft 302, and a backstop 312. The distal portion 308 may
be fixed to the elongated shaft 302 with an adhesive. In an
embodiment, the backstop 312 abuts the proximal end of the
elongated shaft 302. Backstop 312 may also have a height which is
greater than a thickness of the elongated shaft 302. For example,
the height may be defined as the distance between and inside
diameter (ID) of the backstop and an ID of the distal portion 308
of the bead 304A. In accordance with various embodiments of the
invention, the dimensions and location of the backstop 312 as they
relate to the dimensions and location of bump 410 create an
interference stop which determines the distal-stop position and
prevents the tip protector sleeve from sliding off of the distal
end of the elongated catheter sheath 404.
[0035] In an embodiment, the tip protector sleeve 300 is locked
onto an "Essure" .RTM. delivery catheter assembly. In such an
embodiment, the ID of elongated catheter sheath 404 may be between
0.0405 and 0.0420 inches and the outside diameter (OD) of elongated
catheter sheath 404 may be between 0.0538 and 0.0560 inches.
Elongated catheter sheath 404 may be formed of a polyether block
amide also known under the trade name PEBAX. The OD of elongated
catheter sheath 404 may be used to determine the ID of bump 408. In
an embodiment, bump 408 may have an ID between 0.0545 and 0.0555
inches and an OD between 0.0575 and 0.0580 inches. In one
embodiment, the ID of bump 408 may be smaller than the OD of the
elongated catheter sheath 404. In another embodiment, the OD of the
elongated catheter sheath 404 is smaller than the ID of bump 408.
For example, the OD of the elongated catheter sheath 404 may be
between 0.0538 and 0.0542 inches.
[0036] Bump 408 may be a band that is fixed to and encircles the
elongated catheter sheath. Bump may be fixed to the elongated
catheter sheath 404 by a variety of mechanisms including adhesive
and crimping. In an embodiment, bump 408 is formed of a material
which is strong enough to resist deformation during operation of
the delivery catheter assembly, yet malleable enough to be suitable
for crimping. For example, stainless steel possesses suitable
strength and malleability. In an embodiment, only a distal end 410
of the band is crimped onto the elongated catheter sheath, as
illustrated in FIG. 8. This leaves the proximal end, with the
original OD between 0.0575 and 0.0580 inches to act as the male
interference part which interferes with the ID of backstop 312
functioning as a part of the female interference part. While an
embodiment of bump 408 is described in detail in FIG. 8 in operable
relationship with bead 304A, it is understood that bump 408 can be
in operable relationship with other flanged mechanical stops, such
as those illustrated in FIGS. 9-11C.
[0037] Still referring to FIG. 8, bead 304A may be formed of a
variety of materials and have a variety of shapes and sizes to
perform a variety of functions. In one aspect, bead 304A may be
sized and shaped larger than the inside diameter (ID) of a
corresponding access port opening to a working channel or
pierceable end of a sealing cap if present in order to act as a
stop mechanism that controls the insertion depth of the tip
protector sleeve 300 into the working channel. In one aspect, bead
304A may perform the function as a handle for gripping by the
operator. In another aspect, bead 304A may include a backstop 312
which functions as part of the female interference part. In an
embodiment, bead 304A has an OD of approximately 0.112 inches. The
distal portion 308 of bead 304A may have an ID of approximately
0.070 and may be bonded to the OD of elongated shaft 302. Backstop
312 may have an ID which is smaller than an OD of the proximal end
of bump 408. For example, backstop 312 may have an ID between
0.0565 and 0.0575 inches. In such an embodiment, backstop 312 has a
height that extends from the ID of back stop 312 to the ID of the
distal portion 308 of the bead 304, or approximately 0.013
inches.
[0038] In accordance with embodiments of the invention tip
protector sleeve 300 may be locked onto the delivery catheter
assembly 400. Shaft 302 may be used to pierce a sealing cap and
protect the tip of the insert 406, elongated catheter sheath 404 or
guidewire during insertion into the working channel and past a
valve clamp of a hysteroscope system. In an embodiment, the shaft
302 and elongated catheter sheath 404 may be advanced into a
working channel of a hysteroscope system without allowing a
significant amount of fluid (e.g. saline) spray-back or leakage
from the delivery catheter assembly. The elongated catheter sheath
404 may additionally be slid through the shaft 302 to deliver the
insert 406 to a body lumen, while the delivery catheter assembly
400 does not allow a significant amount of fluid leakage. Referring
now to FIG. 12A, the shaft 302 may pierce the pierceable end 232 of
a sealing cap 230 with the tip of the shaft 306. The outside
diameter of the shaft 302 may fit tightly in the pierceable end 232
effectively creating a water tight seal between the sealing cap 230
and tip protector sleeve 300.
[0039] The reduction of fluid spray-back and leakage may also be
achieved by controlling the shape and dimensions of the tip
protector sleeve 300 as it interacts with the elongated catheter
sheath 404 and bump 408. In an embodiment, shaft 302 may be
approximately 2.82 inches long from the proximal end to the distal
end of the tip 306, which may be angled. Shaft 302 may have an ID
between 0.0585 and 0.0605 inches and an OD between 0.0690 and
0.0710 inches. The shaft 302 ID may be selected to not allow for
fluid to flow proximally between the shaft 302 and elongated
catheter sheath 404 (and bump 408), while still allowing for the
elongated catheter sheath 404 to slide and be advanced through the
shaft 302. In such and embodiment, a minimum clearance between the
ID of the elongated shaft 302 (e.g. 0.059 inches) and the OD of the
elongated catheter sheath 404 (e.g. 0.055 inches) provides
sufficient resistance to spray-back and leakage. Such a minimum
clearance may be effective for overlapping constant diameters of
the elongated shaft 302 and elongated catheter sheath 404.
[0040] Referring now to FIG. 9, an embodiment for tip protector
sleeve 300B is illustrated. As illustrated in FIG. 9, tip protector
sleeve 300B includes an elongated shaft 302, a bead 304B and inner
shaft 320. Tip protector sleeve 300B operates similarly as tip
protector sleeve 300 with one difference being that backstop 322 is
the distal end of inner shaft 320. In such an embodiment, the shape
and dimensions of tip protector sleeve 300B are controlled so that
bump 408 interferes with movement of the distal end, backstop 322
of inner shaft 320. In such an embodiment, bead 304B may be sized
and shaped to act as a stop mechanism that controls the insertion
depth of the tip protector sleeve 300B into the working channel and
may perform the function as a handle for gripping by the
operator
[0041] Referring now to FIG. 10, another embodiment for tip
protector sleeve 300C is illustrated. As illustrated in FIG. 10,
tip protector sleeve 300C includes an elongated shaft 302, a neck
portion 332, and a flared portion 304C. Tip protector sleeve 300C
operates similarly as tip protector sleeves 300 and 300B. One
difference is that the neck portion 332 operates as the backstop
for bump 408. The neck portion 332 may be integrally formed with
the elongated shaft 302 or be a separate member bonded to the
inside diameter of elongated shaft 302 Likewise flared portion 304C
may be integrally formed with the elongated shaft 302 or be a
separate member bonded to the outside diameter of elongated shaft
302. In such an embodiment, flared portion 304C may be sized and
shaped to act as a flanged mechanical stop that controls the
insertion depth of the tip protector sleeve 300C into the working
channel and may perform the function as a handle for gripping by
the operator.
[0042] Embodiments of the invention are also envisioned in which
the elongated catheter sheath 404 does not have a constant OD along
its length. In accordance with some embodiments, the tip protector
sleeve 300 may include a change in ID or a valve to accommodate
variations in the OD of the elongated catheter sheath 404, or to
more effectively seal an elongated catheter sheath 404 with a
constant OD. Referring again to FIG. 9, inner shaft 320 is
illustrated as having a smaller ID than the ID of elongated shaft
302. In addition to functioning as an interference part, the ID of
inner shaft 320 may more effectively accommodate a reduction in OD
of the elongated catheter sheath 404. Referring again to FIG. 10,
the ID of neck portion 332 may also more effectively accommodate a
reduction in OD of the elongated catheter sheath 404 in addition to
functioning as an interference part. Thus, a minimum clearance
between the ID of inner shaft 320 or ID of neck portion 332 and the
OD of the elongated catheter shaft 404 may provide enhanced
resistance to fluid-spray back.
[0043] FIGS. 11A-11C are illustrations embodiments of a tip
protector sleeve incorporating various sealing valves to reduce the
amount of fluid spray-back and leakage between the tip protector
sleeve and elongated sheath of the delivery catheter assembly.
While illustrated separately, it is understood that the embodiments
illustrated in FIGS. 11A-11C may be combined with other embodiments
of the invention. More specifically, any of the sealing valves
described in reference to the illustrations in FIGS. 11A-11C may be
combined with any of the embodiments further describing the
proximal-stop and distal-stop positions.
[0044] FIG. 11A is an illustration of a tip protector sleeve 300D
including an elongated shaft 302, a housing 304D, and valve 340.
Housing 304D may function as a stop mechanism that controls the
insertion depth of the tip protector sleeve 300D into the working
channel and may perform the function as a handle for gripping by
the operator. The elongated shaft 302 may be coupled to a distal
tip 342 of the housing 304D which may function as a backstop for
interference with a bump 408 fixed to the elongated catheter sheath
404 at the distal-stop position. Housing 304D additionally houses
valve 340 which is capable of accommodating multiple variations in
OD of the elongated catheter sheath 404. For example, valve 340 may
be a silicone valve containing a slit at the distal end that allows
for a catheter shaft to pass through it. The silicone material may
allow for the slit to conform to different shapes or diameters
while providing a seal. Due to the geometry on the distal end of
the silicone valve, as fluid tries to pass from distal to proximal,
the end of the valve may be pushed closed due to a chamfer on the
end of the valve.
[0045] FIG. 11B is an illustration of a tip protector sleeve 300E
including an elongated shaft 302, a housing 304E, and a compression
valve 350 including an screw cap 354 which may be threaded down
onto an O-ring 352 to compress it against the elongated catheter
sheath 404. Housing 304E may function as a stop mechanism that
controls the insertion depth of the tip protector sleeve 300E into
the working channel and may perform the function as a handle for
gripping by the operator. The elongated shaft 302 may be coupled to
a distal tip 342 of the housing 304E which may function as a
backstop for interference with a bump fixed to the elongated
catheter sheath at the distal-stop position.
[0046] FIG. 11C is an illustration of a tip protector sleeve 300F
including an elongated shaft 302, a housing 304F, and a compression
valve 360 including a cap 362, a compression spring 364 and a thin
walled tube (not illustrated) inside the housing. For example, the
thin walled tube may be made of a material such as silicone.
Threads between the cap 362 and the housing 304F apply a twist
motion to the tube. When the tube is twisted, an inner diameter of
the tube tightens like an iris. The compression spring 364 keeps
the cap 362 extended and the threads hold the twist or keep the
iris closed. When the cap 362 is pushed towards the housing 304F
(spring compressed) the cap 362 untwists and the iris opens. In
this manner the opening of the iris can be adjusted based upon the
OD of the elongated catheter sheath 404. Similar to tip protector
sleeves 300D and 300E, housing 304F may function as a stop
mechanism that controls the insertion depth of the tip protector
sleeve 300F into the working channel and may perform the function
as a handle for gripping by the operator. The elongated shaft 302
may be coupled to a distal tip 342 of the housing 304F which may
function as a backstop for interference with a bump fixed to the
elongated catheter sheath at the distal-stop position.
[0047] A delivery catheter assembly in accordance with embodiments
of the invention may be utilized to deliver an insert to an ovarian
pathway (e.g. a fallopian tube) of a female body. The delivery
catheter assembly may protect the tip of an elongated catheter
sheath, guidewire, or insert during piercing of a sealing cap and
insertion into the working channel and past a valve clamp of a
hysteroscope system and reduce the amount of fluid spray-back and
leakage associated with inserting a delivery catheter assembly into
the working channel of a hysteroscope system. In an embodiment, the
delivery catheter assembly includes a control device, an elongated
catheter sheath having a distal end and a proximal end connected to
the control device, and a tip protector sleeve locked onto the
elongated catheter sheath and slideable over a length of the
elongated catheter sheath between a proximal-stop position and a
distal-stop position along the elongated catheter sheath. The
delivery catheter assembly may further include an insert releasably
disposed within the elongated catheter sheath. In an embodiment,
the insert extends distally beyond the elongated catheter sheath.
In an embodiment, the insert includes a preformed bend, as
illustrated in FIG. 5, which may be utilized to assist with
navigation through a curved portion of a fallopian tube. Upon
providing the delivery catheter assembly the operator may grasp a
flanged mechanical stop 304 or other suitable portion of the tip
protector sleeve 300 to position the tip protector sleeve at the
distal-stop position illustrated in FIG. 6. If a sealing valve is
present on the tip protection sleeve 300, the sealing valve may
then be tightened onto the elongated catheter sheath 404 if
necessary to provide an optimal seal to protect against fluid
spray-back and leakage.
[0048] Referring now to FIGS. 12A-12C, the operator may then pierce
a pierceable end 232 of a sealing cap 230 with the tip protector
sleeve 300 and insert the tip protector sleeve 300 through an
access port 206 of a hysteroscope system 200 and into the working
channel 202 of the hysteroscope system. During insertion the tip
protector sleeve 300 may be advanced past a valve clamp 208 of the
hystero scope system. The tip protector sleeve protects against the
possibility of the exposed portion of the insert 406 from catching
on the valve clamp 208 and compromising the insert integrity. In
accordance with embodiments of the invention, the distal end 410 of
the elongated catheter sheath 404 and insert 406 are inserted
through the sealing cap 230 and access port 206, and into the
working channel 202 of the hysteroscope system simultaneously with
the tip protector sleeve 300 in the distal-stop position. The
simultaneous insertion of the tip protector sleeve 300 and
elongated catheter sheath 404 may avoid a problem of fluid
spray-back associated with sequentially inserting an introducer
followed by an elongated catheter sheath. In an embodiment, the tip
protector sleeve 300 may be advanced into the working channel
simultaneously with the elongated catheter sheath and insert 406
until the flanged mechanical stop 304 abuts against the access port
206 or sealing cap 230, if present, as illustrated in FIG. 12B.
[0049] The distal end 410 of the elongated catheter sheath 404 may
then be advanced past the hysteroscope system 200 as illustrated in
FIG. 12C, and onto a target location with the body lumen. The
insert 406 may then be deployed into the body lumen. Depending upon
operator preference, the tip protector sleeve 300 may remain
inserted in the working channel 202 during the elongated catheter
sheath 404 advancement and insert 406 deployment procedures or
removed from the working channel 202. In accordance with many
embodiments of the invention it is understood that the tip
protector sleeve 300 is permanently locked onto the elongated
catheter sheath. It is also contemplated that the tip protector
sleeve 300 could be removed from the catheter assembly after
initially advancing the catheter assembly into the working channel,
for example, by including a tear joint in the tip protector sleeve
in which the tip protector sleeve can be manually torn off of the
elongated catheter sheath by the operator.
[0050] In an embodiment, the insert 406 and distal end 410 of the
elongated catheter sheath 404 are advanced to the target location
within the body lumen while the flanged mechanical stop 304 on the
tip protector sleeve 300 abuts the access port 206 or sealing cap
320, if present. The amount of elongated catheter sheath 404
spanning between the flanged mechanical stop 304 and control device
402 may depend upon the procedure and patient's anatomy. It is
envisioned that circumstances arise where the operator may wish to
insert the entire available working length of the elongated
catheter sheath 404 into the patient and advance the control device
402 all the way to the access port or sealing cap, if present. In
accordance with embodiments of the invention illustrated in FIGS.
5B-5D, this can be possible by including a cavity 420 in the
control device 402 to accommodate the flanged mechanical stop
304.
[0051] Once the insert 406 is deployed into the body lumen the
delivery catheter assembly may be withdrawn from the working
channel of the hysteroscope system. In one embodiment, during
withdrawal of the delivery catheter assembly 400 from the working
channel, the bump 408 on the elongated catheter sheath 404 may be
withdrawn proximally against the backstop of the tip protector
sleeve 300 and cause the tip protector sleeve 300 to be withdrawn
from the working channel 202 of the hysteroscope system 200. In
another embodiment, the flanged mechanical stop 304 on the tip
protector sleeve 300 can be fastened to the control device 402. In
this manner, during withdrawal of the delivery catheter assembly
400 from the working channel, the tip protector sleeve 300 remains
fastened to the control device 402.
[0052] In the foregoing specification, various embodiments of the
invention have been described. It will, however, be evident that
various modifications and changes may be made thereto without
departing from the broader spirit and scope of the invention as set
forth in the appended claims. The specification and drawings are,
accordingly, to be regarded in an illustrative sense rather than a
restrictive sense. Hence, the scope of the present invention is
limited solely by the following claims.
* * * * *