NZ618487B2 - Tip protector sleeve - Google Patents
Tip protector sleeve Download PDFInfo
- Publication number
- NZ618487B2 NZ618487B2 NZ618487A NZ61848712A NZ618487B2 NZ 618487 B2 NZ618487 B2 NZ 618487B2 NZ 618487 A NZ618487 A NZ 618487A NZ 61848712 A NZ61848712 A NZ 61848712A NZ 618487 B2 NZ618487 B2 NZ 618487B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- elongated
- sheath
- tip protector
- delivery catheter
- protector sleeve
- Prior art date
Links
- 230000001012 protector Effects 0.000 title claims abstract description 103
- 238000007789 sealing Methods 0.000 claims abstract description 33
- 239000011324 bead Substances 0.000 claims description 18
- 235000007575 Calluna vulgaris Nutrition 0.000 claims 1
- 241000353097 Molva molva Species 0.000 claims 1
- 239000012530 fluid Substances 0.000 abstract description 30
- 206010000060 Abdominal distension Diseases 0.000 abstract description 9
- 210000003101 Oviducts Anatomy 0.000 abstract description 9
- 238000000034 method Methods 0.000 abstract description 8
- 210000004291 Uterus Anatomy 0.000 abstract description 7
- 230000000712 assembly Effects 0.000 abstract description 4
- 230000001850 reproductive Effects 0.000 abstract description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract description 4
- 239000011780 sodium chloride Substances 0.000 abstract description 4
- 239000007921 spray Substances 0.000 abstract description 4
- 238000003780 insertion Methods 0.000 description 12
- 150000002500 ions Chemical class 0.000 description 9
- 239000000463 material Substances 0.000 description 9
- 210000000554 Iris Anatomy 0.000 description 4
- 238000007906 compression Methods 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- 230000037250 Clearance Effects 0.000 description 3
- 230000001070 adhesive Effects 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 3
- 230000035512 clearance Effects 0.000 description 3
- 230000002611 ovarian Effects 0.000 description 3
- 230000037361 pathway Effects 0.000 description 3
- 239000004696 Poly ether ether ketone Substances 0.000 description 2
- 229920002614 Polyether block amide Polymers 0.000 description 2
- 238000002788 crimping Methods 0.000 description 2
- 230000003287 optical Effects 0.000 description 2
- 229920002530 poly[4-(4-benzoylphenoxy)phenol] polymer Polymers 0.000 description 2
- 230000001954 sterilising Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 210000003811 Fingers Anatomy 0.000 description 1
- 210000001138 Tears Anatomy 0.000 description 1
- 210000003813 Thumb Anatomy 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 238000004873 anchoring Methods 0.000 description 1
- 230000002254 contraceptive Effects 0.000 description 1
- 239000003433 contraceptive agent Substances 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 230000000875 corresponding Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000006011 modification reaction Methods 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 210000001519 tissues Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B2017/4233—Operations on Fallopian tubes, e.g. sterilization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
- A61F6/18—Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/20—Vas deferens occluders; Fallopian occluders
- A61F6/22—Vas deferens occluders; Fallopian occluders implantable in tubes
- A61F6/225—Vas deferens occluders; Fallopian occluders implantable in tubes transcervical
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/041—Controlled or regulated
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49828—Progressively advancing of work assembly station or assembled portion of work
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49908—Joining by deforming
- Y10T29/49915—Overedge assembling of seated part
- Y10T29/49917—Overedge assembling of seated part by necking in cup or tube wall
Abstract
delivery catheter assembly (400) is disclosed in which a tip protector sleeve (300) is locked onto an elongated catheter sheath (404) and slideable over a length of the elongated catheter sheath between a proximal - stop position (402) and a distal -stop position (408) along the elongated catheter sheath. 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. 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. During the proceedure fluid can spray 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. The delivery catheter assembly may 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. 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. sheath. 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. 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. During the proceedure fluid can spray 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. The delivery catheter assembly may 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. 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.
Description
PCT/U82012/040013
TIP PROTECTOR SLEEVE
BACKGROUND
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.
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, US.
Patent No. 6,526,979, U.S. Patent No. 6,634,361, US. Patent Application No.
11/165,733 hed as US. Publication No. 2006/0293560 and US. Patent
Application No. 12/605,304 describe ervically inserting an insert (also
referred to as implant and device) into an ostium of a ian tube and
mechanically anchoring the insert within the ian tube. One example of such
an assembly is known as “Essure” ® from Conceptus, Inc. of Mountain View,
rnia. Tissue in-growth into the “Essure” ® inseit provides long—term
contraception and/or permanent sterilization without the need for al
procedures.
The insert may be delivered to the fallopian tube with a delivery catheter
assembly such as the one illustrated in The delivery catheter assembly 100
is formed of a control device 102 such as a , an elongated sheath 104, and an
insert 106. The ry catheter assembly 100 may be ervically positioned
into the uterus and the fallopian tubes via a hysteroscope system.
ing to the hysteroscope system 200 may include a working
channel 202 into which the delivery catheter assembly is inserted. Advancement of
the delivery er system within the uterus and the fallopian tubes is usually
facilitated by distending the uterus with a distention fluid, such as saline, and
g 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
PCT/U52012/040013
channel 202 to prevent a distention fluid from leaking out of the access port 206. A
sealing cap 230 ing 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 ly occupies the working channel of the hysteroscope
system.
An introducer 220 may be used in order to prevent damaging the tip the
elongated sheath 104 or insert 106 of the delivery er assembly 100 during
insertion through the able 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 202pri0r 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 220and onto the physician or
physician’s assistant. The amount of fluid spray—back can be significant depending
on the distention fluid pressure during the ure.
ing to 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 er assembly 100 into the working l 202 of the hysteroscope
system. This is typically performed as soon as possible after placement of the
introducer 220 into the g 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 ly 100 into the introducer 200, an amount of distention fluid may
still leak from n the introducer and ted sheath 104 of the delivery
catheter assembly 100.
SUMMARY
Embodiments of the t 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 nce to a oscope 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 ons 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 ated with
inserting a delivery catheter ly into the working channel of a hysteroscope system.
One embodiment of the present invention relates to a delivery er assembly which may
be used to deliver an insert to an ovarian pathway (e.g. a ian tube) of a female body. In one
aspect, the invention provides 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; a
tip tor sleeve locked onto the elongated catheter sheath and slideable over a length of the
elongated catheter sheath between a proximal-stop on and a distal-stop position along the
elongated catheter sheath while locked onto the elongated catheter sheath; and an interference stop
comprising a male erence part fixed to the elongated catheter sheath at a first distance from the
distal end of the elongated , and a female interference part; wherein the male interference part
eres with sliding of the female interference part over the elongated sheath such that the
interference stop determines the distal-stop position and prevents the tip protector sleeve from
sliding off of the distal end of the elongated catheter sheath, and the tip protector sleeve is longer
than the first distance such that the tip protector sleeve extends distally beyond the distal end of the
elongated catheter sheath when at the distal-stop position. 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 onally 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.
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 , 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 ted catheter sheath, and
PCT/U52012/040013
then the tip tor sleeve is slid over a proximal end of the elongated catheter
sheath toward the bump prior to attaching the l device to the elongated
catheter sheath. The control device may prevent the tip protector sleeve from
sliding off a al 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 pait, a distal-stop position.
In an embodiment, the bump may be fixed onto a distal region of the ted
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 al end of the
band is crimped onto the elongated catheter shaft in an embodiment.
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
on, and the tip protector sleeve is inserted through a pierceable end of a sealing
cap, h 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 er 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 inseit is deployed
within the body lumen. In an embodiment, the tip tor sleeve is advanced
h the sealing cap into the working l 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
is a cross—sectional side View illustration of a delivery catheter
assembly.
PCT/U82012/040013
is an isometric view illustration of a oscope system and an
introducer.
is an isometric view ration of a delivery catheter assembly
inserted into an introducer and working channel of a hysteroscope system.
is a side view illustration of a tip protector sleeve in accordance with
an embodiment of the invention.
is a side View illustration of a delivery catheter assembly with a tip
protector sleeve at a proximal—stop position in accordance with an ment of
the invention.
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 ment of the invention.
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.
is a side view illustration of a delivery catheter assembly with a tip
protector sleeve screwed into the al—stop position in ance with an
embodiment of the ion.
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.
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
is a close—up cross—sectional side view illustration of the proximal end
of a tip protector sleeve over an elongated er sheath in accordance with an
embodiment of the invention
is a cross—sectional side view illustration of a tip protector sleeve in
accordance with an embodiment of the invention.
is a sectional side view illustration of a tip protector sleeve in
accordance with an embodiment of the invention.
WO 66805 PCT/U52012/040013
FIGS. llA-l 1C are cross—sectional side view illustrations of tip protector
s incorporating various g valves in accordance with embodiments of the
invention.
FIGS. l2A—12C are ric 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
Embodiments of the present invention lly provide assemblies and
methods of inserting a delivery catheter into a g channel of an endoscope,
such as a hysteroscope system or other optical surgical device for accessing a
female reproductive system. Various embodiments and s will be described
with reference to details discussed below and the anying gs will
illustrate the various embodiments. The following description and drawings are
illustrative of the ion and are not to be construed as limiting the invention.
Numerous specific details are described to provide a thorough understanding of
various ments 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.
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 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 ess which can be molded and does not buckle when ng
a sealing cap. For example, elongated shaft 302 may be formed of a material such
as polyether ether ketone (PEEK).
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
PCT/U52012/040013
304 may be fonned 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 con'esponding 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 ls the ion depth of the tip tor 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 ical stop 304 may also incorporate a sealing valve to
reduce the amount of fluid spray—back and leakage associated with inseiting the
ry catheter assembly into a working channel.
Referring to FIGS. 5A—6, a ry catheter ly 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 er 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
piior to attaching the l device 402 to the elongated er 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 or 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.
is an illustration of the tip protector sleeve 300 positioned at a
proximal—stop position. In the embodiment illustrated in , the flanged
2012/040013
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 ical stop 304 to slide within a cavity 420 located at a distal portion
of the control device 402. Such embodiments may be useful during ion 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 ed 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 d to abut the access port 206 or
the pierceable end 232 of the sealing cap 230. As illustrated in , flanged
mechanical stop 304 may be slid into cavity 420 to abut a back wall 422 of the
cavity at the proximal—stop on. Flanged mechanical stop 304 may be also
configured to fasten onto the handle 402 at the proximal—stop position. For
example, 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 on fitting with sloped walls 424 of the cavity. is an illustration of an
embodiment in which flanged mechanical stop 304 may be d 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 ing 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 oscope system.
Referring now to an operator may slide the tip protector sleeve over
the elongated er sheath 404 between the proximal-stop position and the distal-
stop position illustrated in 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 ng of a sealing cap and during ion into the working
channel and past a valve clamp of the hysteroscope system.
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 erence part over the elongated
catheter sheath. ing again to , 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 ted sheath. In an ment, 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.
is a close—up side view illustration of the proximal end of a tip
protector sleeve over an elongated er sheath in accordance with an
embodiment of the invention. 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 ment of the ion. 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.
Referring to in an embodiment bead 304A may be fixed to a
proximal end of the elongated shaft 302. Bead 304A may include a distal n
308 sun‘ounding 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.
op 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
n and inside diameter (ID) of the backstop and an ID of the distal portion 308
PCT/U52012/040013
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 ines the distal—stop
position and prevents the tip protector sleeve from g off of the distal end of the
ted catheter sheath 404.
In an embodiment, the tip protector sleeve 300 is locked onto an “Essure” ®
delivery er 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 ted 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 n 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 er sheath 404 may be between 0.0538 and 0.0542 inches.
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 le for Climping.
For example, stainless steel ses suitable th and malleability. In an
embodiment, only a distal end 410 of the band is crimped onto the elongated
catheter sheath, as illustrated in 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 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. 91 1C.
PCT/U52012/040013
Still referring to 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
, 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
g 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 on 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.
In accordance with ments 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 oscope system. In an embodiment, the shaft 302 and elongated catheter
sheath 404 may be advanced into a working channel of a hysteroscope system
without ng a icant 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 A, the shaft 302 may pierce the pierceable
end 232 of a sealing cap 230 with the tip of the shaft 306. The outside er of
the shaft 302 may fit tightly in the pierceable end 232effectively creating a water
tight seal between the g cap 230 and tip protector sleeve 300.
The reduction of fluid spray—back and leakage may also be ed by
controlling the shape and dimensions of the tip tor sleeve 300 as it interacts
W0, 2012/166805 2012/040013
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)
es sufficient resistance to spray—back and leakage. Such a minimum
clearance may be effective for pping constant diameters of the elongated shaft
302 and elongated catheter sheath 404.
Referring now to an embodiment for tip protector sleeve 300B is
illustrated. As illustrated in 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
nt of the distal end, backstop 322 of inner shaft 320. In such an
ment, 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 m the function as a handle for gripping by the operator
Referring now to , r embodiment for tip protector sleeve 300C
is illustrated. As illustrated in , tip protector sleeve 300C includes an
elongated shaft 302, a neck p01tion 332, and a flared portion 304C. Tip protector
sleeve 300C operates similarly as tip protector sleeves 300 and 300B. One
ence 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 e diameter of ted shaft 302. In such an
embodiment, flared portion 304C may be sized and shaped to act as a flanged
W0 6805 PCT/U52012/040013
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.
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 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 er sheath 404. Referring again to , the ID of neck portion
332 may also more effectively accommodate a reduction in OD of the ted
catheter sheath 404 in addition to functioning as an interference part. Thus, a
minimum clearance n 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.
FIGS. llA—l 1C are illustrations embodiments of a tip protector sleeve
incorporating various g valves to reduce the amount of fluid spray—back and
leakage between the tip tor sleeve and elongated sheath of the delivery
er assembly. While illustrated separately, it is tood that the
embodiments illustrated in FIGS. llA-l lC may be combined with other
embodiments of the ion. More specifically, any of the sealing valves
described in reference to the illustrations in FIGS. llA—l 1C may be combined with
any of the embodiments further describing the proximal-stop and distal—stop
positions.
A 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 ted shaft 302 may be coupled to a distal tip 342
of the g 304D which may function as a op for interference with a bump
W0 . 112/166805 PCT/U82012/040013
408 fixed to the elongated catheter sheath 404 at the —stop position. Housing
304D additionally houses valve 340 which is capable of accommodating multiple
ions 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 er shaft
to pass h 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 al, the end
of the valve may be pushed closed due to a chamfer on the end of the valve.
B 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 ed down onto an O—ring 352 to ss it
t 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.
C 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 tor
sleeve 300F into the g channel and may perform the function as a handle for
ng by the operator. The elongated shaft 302 may be coupled to a distal tip 342
PCT/U52012/040013
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.
A delivery catheter assembly in accordance with embodiments of the
invention may be ed to deliver an insert to an ovarian pathway (6.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 g channel and past a valve clamp of a hysteroscope system
and reduce the amount of fluid spray—back and leakage ated with inserting a
delivery catheter assembly into the working channel of a hysteroscope . 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 . The delivery
catheter assembly may r include an insert releasably disposed within the
elongated catheter sheath. In an embodiment, the insert extends ly beyond the
elongated catheter sheath. In an embodiment, the insert includes a preformed bend,
as illustrated in which may be utilized to assist with navigation through a
curved portion of a fallopian tube. Upon providing the delivery er ly
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 If a sealing valve is t 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 t against fluid spray—back
and leakage.
Referring now to FIGS. l2A—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 oscope system. During insertion the tip
protector sleeve 300 may be advanced past a valve clamp 208 of the hysteroscope
system. The tip protector sleeve protects against the possibility of the exposed
portion of the insert 406 from ng on the valve clamp 208 and compromising
2012/040013
the insert integrity. In accordance with ments of the invention, the distal end
410 of the elongated catheter sheath 404 and insert 406 are inseited through the
sealing cap 230 and access port 206, and into the working l 202 of the
hysteroscope system simultaneously with the tip protector sleeve 300 in the distal-
stop position. The simultaneous ion 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 B.
The distal end 410 of the elongated catheter sheath 404 may then be
advanced past the hysteroscope system 200 as illustrated in C, 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 g channel 202 during the elongated catheter sheath 404
advancement and insert 406 ment 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 er 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 or.
In an embodiment, the insert 406 and distal end 410 of the elongated catheter
sheath 404 are ed to the target on 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 or 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 rated in FIGS. 5B—5D, this can
be possible by including a cavity 420 in the control device 402 to accommodate the
flanged ical stop 304.
Once the inseit 406 is deployed into the body lumen the delivery catheter
assembly may be awn from the working channel of the hysteroscope .
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 ry catheter assembly 400 from the working
channel, the tip protector sleeve 300 remains fastened to the control device 402.
In the foregoing ication, 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 gs 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.
Claims (12)
1. A delivery catheter assembly comprising: a control device; an elongated catheter sheath having a distal end and a al end connected to the control device; 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 ted catheter sheath while locked onto the elongated catheter sheath; and an interference stop comprising a male interference part fixed to the elongated er sheath at a first distance from the distal end of the elongated sheath, and a female interference part; n the male interference part eres with g of the female erence part over the elongated sheath such that the interference stop determines the distal-stop position and prevents the tip protector sleeve from sliding off of the distal end of the elongated catheter sheath, and the tip protector sleeve is longer than the first distance such that the tip protector sleeve extends distally beyond the distal end of the elongated catheter sheath when at the distal— stop position.
2. The delivery catheter assembly of claim 1, wherein the tip protector sleeve comprises an elongated shaft and a backstop together functioning as the female interference part, and the male interference part is fixed to the elongated catheter sheath.
3. The delivery catheter assembly of claim 2, wherein the male interference part comprises a bump fixed to the elongated catheter sheath.
4. The delivery catheter assembly of claim 3, wherein the bump comprises a band fixed to and ling the elongated er sheath.
5. The delivery catheter assembly of claim 4, wherein a distal end of the band is crimped onto the elongated catheter sheath, and a proximal end of the band is not crimped onto the elongated shaft.
6. The delivery catheter assembly of claim 2, wherein the backstop has an inner diameter which is smaller than an outer diameter of the male interference part.
7. The delivery catheter assembly of claim 6, further comprising a molded bead fixed to a proximal end of the elongated shaft.
8. The delivery catheter of claim 7, wherein the molded bead comprises: a distal portion surrounding the proximal end of the elongated shaft; a shoulder portion extending proximally of the elongated shaft; and the backstop, wherein the backstop abuts the al end of the elongated shaft.
9. The delivery catheter assembly of claim 6, n the tip protector sleeve further comprises an inner shaft fixed to a proximal end of the elongated shaft, and the backstop is a distal end of the inner shaft.
10. The delivery catheter assembly of claim 1, further comprising an insert disposed within and extending distally beyond the distal end of the elongated catheter sheath, n the tip protector sleeve s ly beyond the insert when at the distal-stop position.
11. The delivery catheter ly of claim 1, wherein the tip protector sleeve further ses a sealing valve.
12. A delivery catheter assembly substantially as herein described with reference to and as shown in any one of
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/149,631 US9138343B2 (en) | 2011-05-31 | 2011-05-31 | Tip protector sleeve |
US13/149,631 | 2011-05-31 | ||
PCT/US2012/040013 WO2012166805A1 (en) | 2011-05-31 | 2012-05-30 | Tip protector sleeve |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ618487A NZ618487A (en) | 2016-03-31 |
NZ618487B2 true NZ618487B2 (en) | 2016-07-01 |
Family
ID=
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