U.S. patent application number 11/367871 was filed with the patent office on 2006-07-06 for contraceptive transcervical fallopian tube occlusion devices and methods.
Invention is credited to Steven Bacich, Donnell W. Gurskis, Ashish Khera, Julian N. Nikolchev, Dai T. Ton.
Application Number | 20060144406 11/367871 |
Document ID | / |
Family ID | 26739284 |
Filed Date | 2006-07-06 |
United States Patent
Application |
20060144406 |
Kind Code |
A1 |
Nikolchev; Julian N. ; et
al. |
July 6, 2006 |
Contraceptive transcervical fallopian tube occlusion devices and
methods
Abstract
The invention provides intrafallopian devices and non-surgical
methods for their placement to prevent conception. The efficacy of
the device is enhanced by forming the structure at least in part
from copper or a copper alloy. The device is anchored within the
fallopian tube by a lumen-traversing region of the resilient
structure which has a helical outer surface, together with a
portion of the resilient structure which is biased to form a bent
secondary shape, the secondary shape having a larger cross-section
than the fallopian tube. The resilient structure is restrained in a
straight configuration and transcervically inserted within the
fallopian tube, where it is released. Optionally, permanent
sterilization is effected by passing a current through the
resilient structure to the tubal walls.
Inventors: |
Nikolchev; Julian N.;
(Portola Valley, CA) ; Ton; Dai T.; (San Jose,
CA) ; Khera; Ashish; (San Francisco, CA) ;
Gurskis; Donnell W.; (Pleasanton, CA) ; Bacich;
Steven; (Half Moon Bay, CA) |
Correspondence
Address: |
BLAKELY SOKOLOFF TAYLOR & ZAFMAN
12400 WILSHIRE BOULEVARD
SEVENTH FLOOR
LOS ANGELES
CA
90025-1030
US
|
Family ID: |
26739284 |
Appl. No.: |
11/367871 |
Filed: |
March 2, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10600298 |
Jun 20, 2003 |
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11367871 |
Mar 2, 2006 |
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09592123 |
Jun 12, 2000 |
6526979 |
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10600298 |
Jun 20, 2003 |
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09324078 |
Jun 1, 1999 |
6634361 |
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09592123 |
Jun 12, 2000 |
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PCT/US98/20031 |
Sep 23, 1998 |
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09324078 |
Jun 1, 1999 |
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09093835 |
Jun 8, 1998 |
6705323 |
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PCT/US98/20031 |
Sep 23, 1998 |
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08475252 |
Jun 7, 1995 |
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PCT/US98/20031 |
Sep 23, 1998 |
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08474779 |
Jun 7, 1995 |
6176240 |
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PCT/US98/20031 |
Sep 23, 1998 |
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60059861 |
Sep 24, 1997 |
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Current U.S.
Class: |
128/830 ;
128/831 |
Current CPC
Class: |
A61B 17/1215 20130101;
A61B 2017/12059 20130101; A61B 2090/378 20160201; A61B 18/082
20130101; A61F 6/225 20130101; A61F 6/18 20130101; A61F 2/0077
20130101; A61B 2017/00867 20130101; A61B 2017/12063 20130101; A61B
34/20 20160201; A61B 2017/12077 20130101; A61B 17/12099 20130101;
A61B 2090/376 20160201; A61B 17/12145 20130101; A61F 6/22 20130101;
Y10T 29/49826 20150115; A61B 17/12022 20130101; A61B 2017/12095
20130101; A61B 2018/046 20130101 |
Class at
Publication: |
128/830 ;
128/831 |
International
Class: |
A61F 6/06 20060101
A61F006/06 |
Claims
1. A device for implantation within a body lumen of a human or
veterinary subject, said device comprising: an intraluminal member
that is implantable in a body lumen to cause occlusion of the body
lumen; and a quantity of a therapeutic substance disposed on, in or
near the intraluminal member such that the substance will be
delivered to some target tissue for at least some period of time
following implantation of the intraluminal member within the body
lumen.
2. A device according to claim 1 wherein the device is implanted in
a fallopian tube or other lumen of the female reproductive tract
and is effective to occlude that lumen following implantation.
3. A device according to claim 2 wherein the therapeutic substance
delivered by the device comprises a contraceptive.
4. A device according to claim 2 wherein the therapeutic substance
delivered by the device comprises a spermicidal agent.
5. A device according to claim 1 where the substance is gradually
released over time.
6. A contraceptive delivery system for delivery of an occluding
apparatus into the lumen of a fallopian tube of a human or animal
subject, said system comprising: an occluding apparatus sized for
placement in a fallopian tube of the subject; delivery cannula that
is insertable through the uterus and into the fallopian tube into
which the occluding apparatus is to be placed, said delivery
cannula being useable to deliver said occluding apparatus into the
fallopian tube, said delivery cannula having at least one length
marking which may be utilized to discern the length of the delivery
cannula that has been advanced into the fallopian tube; and, an
imaging apparatus useable to view the delivery cannula and said at
least one length marking to determine the length of the delivery
cannula that has been advanced into the fallopian tube.
7. A contraceptive delivery system as in claim 6 wherein the at
least one marking comprises a colored area on said delivery
cannula.
8. A contraceptive delivery system as in claim 6 wherein the
imaging apparatus comprises a scope.
9. A contraceptive delivery system as in claim 8 wherein the scope
comprises a hysteroscope.
10. A contraceptive delivery system as in claim 6 wherein the
imaging apparatus comprises an ultrasound imaging apparatus.
11. A contraceptive delivery system as in claim 6 wherein the
imaging apparatus comprises a fluoroscope.
12. A system for causing contraception in a human or animal
subject, said system comprising: an expandable occluding member
which is implantable in a reproductive passageway of the subject,
said occluding member being a) disposable in a first configuration
wherein it is sufficiently compact to allow the occluding member to
be advanced into the reproductive passageway and b) subsequently
expandable to a second configuration wherein the occluding member
engages a wall of the reproductive passageway; and, a quantity of a
contraceptive substance which is delivered from the occluding
member in sufficient amount to cause a pharmacologic contraceptive
effect in the patient for a period of time following implantation
of the occluding member within the reproductive passageway.
13. A system according to claim 12 wherein the occluding member is
sized and configured to be implanted within the lumen of a
fallopian tube.
14. A system according to claim 12 wherein the occluding member
comprises an expandable frame and a matrix disposed substantially
within or on the frame.
15. A system according to claim 12 where the substance is gradually
released over time.
16. A system according to claim 14 wherein said matrix comprises
pores and wherein said substance is initially contained within said
pores.
17. A system according to claim 12 wherein the occluding member
causes a reversible occlusion of the reproductive passageway.
18. A system according to claim 12 wherein the occluding member
provokes an inflammatory response which augments occlusion of the
lumen of the reproductive passageway.
19. A system according to claim 12 wherein the occluding member
further comprises means for securing the occluding member to the
wall of the reproductive passageway.
20. A system according to claim 19 wherein the means for securing
the occluding member to the wall of the reproductive passageway
comprises a mechanical securing apparatus.
21. A system according to claim 12 wherein the expandable occluding
member facilitates tissue or cellular ingrowth into the occluding
member.
22. A method for preventing pregnancy in a human or animal subject
having a fallopian tube, said method comprising the steps of:
providing a device that i) is implantable in the fallopian tube to
cause occlusion of the fallopian tube and ii) delivers a
contraceptive or spermicidal substance in an amount that is
effective to cause contraception or spermicide for at least a
period of time following implantation of the device; and implanting
the device within a fallopian tube.
23. A method according to claim 22 wherein the device comprises an
expandable frame and a matrix disposed substantially within or on
the frame.
24. A method according to claim 23 wherein the matrix facilitates
tissue ingrowth.
25. A method according to claim 23 wherein the substance is
initially disposed on or in the matrix.
26. A device for implantation within a body lumen of a human or
veterinary subject, said device comprising: an intraluminal member
that is implantable in a body lumen to cause occlusion of the body
lumen, wherein the intraluminal member is configured to facilitate
tissue or cellular ingrowth into the intraluminal member; and a
quantity of a therapeutic substance disposed on, in or near the
intraluminal member such that the substance will be delivered to
some target tissue for at least some period of time following
implantation of the intraluminal member within the body lumen.
27. A device according to claim 26 wherein the device is
implantable in a body lumen comprising a fallopian tube or other
lumen of the female reproductive tract and is effective to occlude
that lumen following implantation.
28. A device according to claim 27 wherein the therapeutic
substance delivered by the device comprises a contraceptive.
29. A device according to claim 27 wherein the therapeutic
substance delivered by the device comprises a spermicidal
agent.
30. A device according to claim 26 where the substance is gradually
released over time.
31. A contraceptive delivery system for delivery of an occluding
apparatus into the lumen of a fallopian tube of a human or animal
subject, said system comprising: an occluding apparatus sized for
placement in a fallopian tube of the subject and configured to
facilitate tissue or cellular ingrowth into the occluding
apparatus; delivery cannula that is insertable through the uterus
and into the fallopian tube into which the occluding apparatus is
to be placed, said delivery cannula being useable to deliver said
occluding apparatus into the fallopian tube, said delivery cannula
having at least one length marking which may be utilized to discern
the length of the delivery cannula that has been advanced into the
fallopian tube; and, an imaging apparatus useable to view the
delivery cannula and said at least one length marking to determine
the length of the delivery cannula that has been advanced into the
fallopian tube.
32. A contraceptive delivery system as in claim 31 wherein the at
least one marking comprises a colored area on said delivery
cannula.
33. A contraceptive delivery system as in claim 31 wherein the
imaging apparatus comprises a scope.
34. A contraceptive delivery system as in claim 33 wherein the
scope comprises a hysteroscope.
35. A contraceptive delivery system as in claim 31 wherein the
imaging apparatus comprises an ultrasound imaging apparatus.
36. A contraceptive delivery system as in claim 31 wherein the
imaging apparatus comprises a fluoroscope.
37. A system for causing contraception in a human or animal
subject, said system comprising: an expandable occluding member
which is configured to facilitate tissue or cellular ingrowth into
the expandable occluding member and which is implantable in a
reproductive passageway of the subject, said occluding member being
a) disposable in a first configuration wherein it is sufficiently
compact to allow the occluding member to be advanced into the
reproductive passageway and b) subsequently expandable to a second
configuration wherein the occluding member engages a wall of the
reproductive passageway; and, a quantity of a contraceptive
substance which is delivered from the occluding member in
sufficient amount to cause a pharmacologic contraceptive effect in
the patient for a period of time following implantation of the
occluding member within the reproductive passageway.
38. A system according to claim 37 wherein the occluding member is
sized and configured to be implanted within the lumen of a
fallopian tube.
39. A system according to claim 37 wherein the occluding member
comprises an expandable frame and a matrix disposed substantially
within or on the frame.
40. A system according to claim 37 where the substance is gradually
released over time.
41. A system according to claim 39 wherein said matrix comprises
pores and wherein said substance is initially contained within said
pores.
42. A system according to claim 37 wherein the occluding member
causes a reversible occlusion of the reproductive passageway.
43. A system according to claim 37 wherein the occluding member is
configured to provoke an inflammatory response to augment occlusion
of the lumen of the reproductive passageway.
44. A system according to claim 37 wherein the occluding member
further comprises means for securing the occluding member to the
wall of the reproductive passageway.
45. A system according to claim 44 wherein the means for securing
the occluding member to the wall of the reproductive passageway
comprises a mechanical securing apparatus.
46. A system according to claim 37 wherein the expandable occluding
member facilitates tissue or cellular ingrowth into the occluding
member.
47. A method for preventing pregnancy in a human or animal subject
having a fallopian tube, said method comprising the steps of:
providing a device that i) is implantable in the fallopian tube to
cause occlusion of the fallopian tube, ii) facilitates tissue or
cellular ingrowth into the device and iii) delivers a contraceptive
or spermicidal substance in an amount that is effective to cause
contraception or spermicide for at least a period of time following
implantation of the device; and implanting the device within a
fallopian tube.
48. A method according to claim 47 wherein the device comprises an
expandable frame and a matrix disposed substantially within or on
the frame.
49. A method according to claim 48 wherein the matrix facilitates
tissue ingrowth.
50. A method according to claim 48 wherein the substance is
initially disposed on or in the matrix.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/600,298 filed on Jun. 20, 2003, which is a
continuation of U.S. patent application Ser. No. 09/592,123 filed
on Jun. 12, 2000, which is a continuation of U.S. patent
application Ser. No. 09/324,078 filed on Jun. 1, 1999, which is a
continuation-in-part of International Application No.
PCT/US98/20031, filed Sep. 23, 1998, which is a
continuation-in-part of U.S. patent application Ser. No.
09/093,835, filed Jun. 8, 1998, which claims the benefit of
priority from U.S. Provisional Application No. 60/059,861, filed
Sep. 24, 1997, and is also a continuation-in-part of U.S. patent
application Ser. No. 08/475,252 filed Jun. 7, 1995, and a
continuation-in-part of U.S. patent application Ser. No. 08/474,779
filed Jun. 7, 1995, now U.S. Pat. No. 6,176,240, the full
disclosures of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to contraception,
and more particularly to intrafallopian contraceptive devices and
nonsurgical methods for their delivery.
[0004] Worldwide demand exists for safe, effective methods of both
contraception and permanent sterilization. Although a variety of
contraception and sterilization methods are available, all of the
existing methods have limitations and disadvantages. Thus, the need
for additional safe, low cost, reliable methods of contraception
and permanent sterilization, both in developed and less developed
countries, is widely recognized.
[0005] Many presently available contraception methods require
significant user involvement, and user non-compliance results in
quite high rates of failure. While the theoretical effectiveness of
existing contraceptives, including barrier methods and hormonal
therapies, is well established, overcoming user noncompliance to
improve overall efficacy has proven difficult.
[0006] One form of contraception which is less susceptible to user
noncompliance is the intrauterine device (IUD). IUDs have been
found to have higher rates of reliability, and are effective for a
longer period of time, than most other commercially available
contraceptives. Unfortunately, IUDs are also associated with
serious infectious complications. For this reason, the use of IUDs
within the United States has decreased dramatically. Additionally,
IUDs are subject to unplanned expulsion, and must be removed due to
excessive pain or bleeding in a percentage of cases, further
reducing the acceptance of the IUD as a contraceptive method.
Interestingly, the efficacy of copper IUDs appears to be higher
than that of non-metallic IUDs. The reason for this has not been
fully explained.
[0007] Commercially available options for permanent sterilization
include fallopian tube ligation and vasectomy. These methods are
surgical, are difficult to reverse, and are not available to many
people in the world. It is common knowledge that fertilization
occurs in the fallopian tubes where the sperm and ovum meet. Tubal
ligation avoids this by complete occlusion of the fallopian
tubes.
[0008] It has previously been proposed to reversibly occlude the
fallopian tubes, for example, by in vitro formation of an
elastomeric plug, or otherwise anchoring a device on either side of
the narrowest region of fallopian tube, called the "isthmnus." Such
fallopian tube occlusion methods appear promising; however, an
unacceptably high percentage of the non-surgical devices proposed
to date have become dislodged during previous studies. Even where
non-surgical intrafallopian devices have remained in place, they
have been found to be only moderately effective at preventing
conception.
[0009] For these reasons, it would be desirable to provide
effective, reliable intrafallopian devices for contraception and
sterilization. It would be particularly desirable to provide highly
effective intrafallopian devices which did not require surgery for
placement. It would be especially desirable if such devices and
methods allowed easy placement of the device, but were less
susceptible to being dislodged than previously proposed
non-surgical intrafallopian devices.
[0010] 2. Description of the Related Art
[0011] The experimental use of a stainless steel intrafallopian
device is described in Transcatheter Tubal Sterilization in
Rabbits, Penny L. Ross, RT 29 "Investigative Radiology", pp.
570-573 (1994). The experimental use of an electrolytically pure
copper wire as a surgical contraceptive intrafallopian device in
rats was described in "Antifertility Effect of an Intrafallopian
Tubal Copper Device", D. N. Gupta, 14 Indian Journal of
Experimental Biology, pp. 316-319 (May 1976).
[0012] U.K. Patent Application Pub. No. 2,211,095 describes a
uterine screw plug for blocking the fallopian tube. European Patent
Application Pub. No. 0,010,812 describes a device for placement in
the oviducts having enlargements at either end for anchoring the
device. The same device appears to be described in Netherlands
Patent No. 7,810,696.
[0013] The use of tubal occlusion devices is described in
"Hysteroscopic Oviduct Blocking With Formed-in-Place Silicone
Rubber Plugs", Robert A. Erb, Ph.D., et al., The Journal of
Reproductive Medicine, pp. 65-68 (August 1979). A formed-in-place
elastomeric tubal occlusion device is described in U.S. Pat. No.
3,805,767, issued to Erb. U.S. Pat. No. 5,065,751, issued to Wolf,
describes a method and apparatus for reversibly occluding a
biological tube. U.S. Pat. No. 4,612,924, issued to Cimber,
describes an intrauterine contraceptive device which seals the
mouths of the fallopian tubes.
[0014] German Patent No. 28 03 685, issued to Brundin, describes a
device for plugging a body duct with a device which swells when in
contact with a body fluid.
[0015] Alternative contraceptive devices are disclosed in
co-pending U.S. patent application Ser. No. 08/474,779, the full
disclosure of which is herein incorporated by reference.
SUMMARY OF THE INVENTION
[0016] The present invention provides intrafallopian devices and
methods for their placement to prevent conception. The
intrafallopian devices of the present invention are transcervically
delivered and mechanically anchored within the fallopian tube to
provide long term contraception, or alternatively permanent
sterilization, without the need for surgical procedures or the
risks of increased bleeding, pain, and infection associated with
intrauterine devices (IUDs).
[0017] The intrafallopian devices of the present invention will
often comprise a structure having a lumen-traversing region with a
helical outer surface. The helical surface is mechanically anchored
by a resilient portion of the structure which is biased to form an
enlarged secondary shape, preferably forming distal and proximal
anchoring loops. The anchoring loops help prevent the helical outer
surface from rotating out of position, and also directly deter
axial motion within the fallopian tube. In alternative embodiments,
anchoring may be provided by a straight coil which is resiliently
deflected by the axial curvature of the tortuous fallopian tube,
and a radially expandable braid, malecott, or some other tubular
structure may help affix the device within the fallopian tube.
[0018] The use of copper in the intrafallopian device of the
present invention improves its efficacy as a contraceptive method.
Devices formed from plastically deformable materials, however, are
less readily restrained in the fallopian tube. Apparently, the
large variation in the actual shape and dimensions of fallopian
tubes does not provide reliable anchoring for a pre-formed
deformable intrafallopian device. The intrafallopian device of the
present invention therefore often comprises a resilient structure,
usually a metallic coil, which includes a copper alloy or plating,
ideally comprising an alloy including at least 75% copper. The coil
material typically includes beryllium, zinc, stainless steel,
platinum, a shape memory alloy, such as Nitinol.RTM., or the like.
Preferably, the coil is composed of an alloy of beryllium and
copper.
[0019] Although the present device will generally result in
occlusion, it need not completely occlude the fallopian tube to
prevent the meeting of the sperm and ovum. Instead, in some
embodiments, the presence of the copper on the resilient structure
is sufficient to provide effective contraception. Hence,
contraception can be provided by disrupting the normal architecture
and/or function of the fallopian tube, despite the presence of an
open lumen. This concept is referred to herein as "functional
occlusion". As used herein, functional occlusion means that the
device, when implanted in the fallopian tube, disrupts the normal
architecture and/or functioning of the fallopian tube so as to
inhibit fertilization and/or conception.
[0020] Conveniently, the present invention further comprises
non-surgical placement of such intrafallopian devices by
transcervical introduction. The resilient structure is restrainable
in a straight configuration, e.g., by use of a corewire, greatly
facilitating and reducing the risks of introduction. Thus, the cost
and dangers associated with existing surgical contraceptive and
sterilization procedures are avoided. The resilient structure will
often comprise a coil. In some embodiments, an element is disposed
along the coil, and is adapted to incite a tissue reaction in the
tubal tissues which inhibits conception. A distal anchor of the
coil may be inserted into the ampulla, distal of the isthmus, while
a proximal anchor is located in the ostium. These anchors prevent
rotation of the device, and also help avoid axial movement.
Alternatively, at least one of the anchors may be positioned
anywhere past the ostium and within the fallopian tube, while the
other extends into the uterus, depending on their length and
configuration. Preferably, at least some anchoring is provided
along the intramural to isthmic region of the fallopian tube. In
some embodiments, electrosurgical attachment of an intraluminal
device to a surrounding lumenal wall may provide effective
anchoring even without loops and other anchoring structures.
Electrical current may also be used to decouple the intrafallopian
device from the delivery system, typically by electrolytically
dissolving a solder bond. Current may also actuate an anchor, such
as by releasing a resilient radially expandable tubular structure
within the fallopian tube.
[0021] The present invention also provides improved contraceptive
devices which incite a tissue reaction within the fallopian tube to
prevent conception. This group of intrafallopian devices will often
make use of a highly flexible coil structure to avoid damaging or
penetrating through the delicate tubal tissues. The desired tissue
reaction may be the result of the material of intrafallopian
device, or may be incited by a coating, a surface treatment, a
mechanical interaction between the device and the surrounding tubal
wall, or the like. The tissue will often help impede conception by
occluding the fallopian tube, by interrupting the transport
mechanisms of the tubal tissues, and/or by restraining the
intrafallopian tubal device within the tube. Specific tissue
reactions which may provide these intended results include tissue
ingrowth into the contraceptive device and/or the tubal lumen, scar
tissue formation, sclerosing of the tubal tissues, and the
like.
[0022] In one aspect, the invention provides a tissue reaction
contraceptive device for use in a fallopian tube. The contraceptive
device comprises a coil having a proximal end and a distal end and
defining an axis therebetween. The coil is axially flexible and has
a cross-section suitable for insertion into the fallopian tube. An
element disposed along the coil is adapted to incite a tissue
reaction in the tubal tissues adjacent the coil so as to inhibit
conception.
[0023] In some embodiments, the element may promote ingrowth of the
tubal tissues into the contraceptive device. For example, the
element may include a braided or woven polyester, a micro-porous
material or surface treatment, or the like. Alternatively, a sharp
edged helical ribbon or other mechanical interaction element may
incite the formation of scar tissue, or a surface coating of the
coil may sclerose the tubal tissues, exciting formation of tough
fibrous connective tissues which interfere with conceptive
transport. In many embodiments, the presence of the contraceptive
device in combination with the tissue reaction can provide
effective contraception without having to rely on total occlusion
of the fallopian tube.
[0024] In another aspect, the present invention provides a tissue
ingrowth contraceptive device for use in a fallopian tube. The
contraceptive device comprises a tubular retention structure having
a proximal end, a distal end and an axis therebetween. The
retention structure is axially flexible, and is insertable within
the fallopian tube. A material which can incite ingrowth of the
tubal tissue is attached to, and exposed radially from, the
retention structure.
[0025] In the exemplary embodiment, the retention structure
comprises a helical coil in which the ingrowth material is
disposed. Such helical coils may optionally be radially expansible
within the fallopian tube, thereby allowing the device to
accommodate a wide variety of tubal physiologies. The ingrowth
material may be in the form of braided or woven fibers of
polyester, P.T.F.E., or the like.
[0026] In another aspect, the present invention provides a tissue
ingrowth contraceptive device for use in a fallopian tube. The
contraceptive device comprises a resilient elongate body having a
proximal end and a distal end and defining an axis therebetween. A
retention structure is disposed along the resilient body. The
retention structure is adapted to restrain the resilient body
within the fallopian tube. A bond affixes the retention structure
to the resilient body. At least one of the resilient body, the
retention structure, and the bond comprises a micro-porous material
which promotes tissue ingrowth therein.
[0027] In another aspect, the present invention provides a
contraceptive method comprising transcervically inserting a
contraceptive device within a fallopian tube. The device is
inserting by resiliently deflecting a distal body of the
contraceptive device against a tubal wall, so that the distal body
guides the contraceptive device axially along the fallopian tube. A
tissue reaction is incited with an element of the contraceptive
device in the tubal tissues. This tissue reaction affixes the
contraceptive device within the fallopian tube.
[0028] The present invention also provides improved contraceptive
devices, systems, and methods adapted for use in the widely varying
geometry of the fallopian tube. In recognition of the wide
variations in tubal physiology, the contraceptive structures of the
present invention are radially expandable within the fallopian tube
to engage the tubal wall. Surprisingly, the contraceptive devices
of the present invention will often make use of tubular structures
such as resilient helical coils. Such tubular devices will often
effect contraception by disrupting the architecture and/or
transport mechanisms of the tubal tissues, rather than relying
entirely on total blockage of the tube. The passages through the
tubular contraceptive devices of the present invention may
optionally be occluded by promoting tissue ingrowth within the
device, for example, by including woven or braided polyester fibers
within a helical coil. Regardless, such tubular retention
structures are capable of radially expanding against tubal walls
throughout a wide range of tubal sizes to safely anchor the
contraceptive device, without having to resort to protruding barbs
or the like.
[0029] In one aspect, the present invention provides a
contraceptive device for use in fallopian tube having a tubal wall.
The contraceptive device comprises a tubular retention structure
having a proximal end, a distal end, and an axis therebetween. The
retention structure is radially expandable in situ from a narrow
configuration (in which the retention structure has a first
diameter which is suitable for axial insertion into the fallopian
tube) so as to define a second, enlarged diameter. The expanded
retention structure is adapted to engage the surrounding tubal wall
and retain the contraceptive device within the fallopian tube.
[0030] In another aspect, the present invention provides a
contraceptive device for use in a fallopian tube having a tubal
wall. The contraceptive device comprises a conception inhibiting
body which defines an axis. A helical coil is disposed about the
body. A portion of the helical coil is movable relative to the body
so that the helical coil can expand resiliently throughout a range
of tubal cross-sectional sizes. Hence, the coil can radially engage
the surrounding tubal wall and safely affix the contraceptive
device within the fallopian tube.
[0031] The present invention also provides intrafallopian
contraceptive devices having elongate coils which are substantially
straight. Surprisingly, when such straight coils are positioned
axially within the tortuous fallopian tubes, the bends imposed on
the coil by the fallopian tube can result in resilient anchoring of
the coil. Such straight coils are also highly advantageous when
advancing the contraceptive device into (and within) the fallopian
tube. Straight resilient coils can act as an integral guidewire
during transcervical deployment of the device within the fallopian
tube, thereby avoiding the delay associated with the sequential use
of guidewires, tubal axis catheters, and the like.
[0032] The present invention provides an intrafallopian
contraceptive device for use in a fallopian tube. The contraceptive
device comprises an elongate coil having a proximal end, a distal
end, and an axis therebetween. The axis is substantially straight
when the coil is at rest, and the coil is axially resilient to
facilitate insertion of the body axially into the tube. The device
is adapted to be retained within the fallopian tube so as to
inhibit conception.
[0033] In another aspect, the present invention provides an
intrafallopian contraceptive device for use in a fallopian tube.
The tube has a tubal wall with a tubal cross-section and an axial
curvature. The contraceptive device comprises an elongate body
having a proximal end and a distal end and defining an axis
therebetween. The body has a cross-section suitable for axial
insertion within the tubal cross-section. At least a portion of the
body is straighter than the axial curvature of the fallopian tube.
The body is sufficiently flexible to deflect against the tubal wall
without injuring the tubal wall. The body is also sufficiently
resilient to impose an anchoring force against the tubal wall when
the straight portion flexes along the axial curvature of the
fallopian tube.
[0034] In another aspect, the present invention provides a
contraceptive device for use in a fallopian tube having an axis.
The contraceptive device comprises a structure having a proximal
end, a distal end, and an axis therebetween. The structure is
adapted to provide effective tubal occlusion when disposed
substantially coaxially within the fallopian tube. An elongate
member is affixed to the occlusion structure. The member extends
distally of the occlusion structure and is sufficiently flexible
and axially resilient to help guide distal advancement of the
occlusion structure within the fallopian tube.
[0035] In a contraceptive method provided by the present invention,
an elongate resilient body is transcervically inserted into an
axially curving fallopian tube so that the fallopian tube imposes
an axial bend on the body. The bent body imposes an anchoring force
which helps anchor the bent body within the fallopian tube. The
body is anchored within the fallopian tube so that the affixed
resilient body inhibits conception.
[0036] In another aspect, the present invention provides a
contraceptive method comprising transcervically inserting an
intrafallopian contraceptive device along the fallopian tube by
guiding the contraceptive device with a distal guidewire-like
structure of the contraceptive device. The device, including at
least a portion of the guidewire-like structure, is retained within
the fallopian tube so that the device inhibits conception.
[0037] In another aspect, the present invention provides a
contraceptive kit. The kit comprises an intrafallopian
contraceptive device and instructions for its use. The instructions
describe and/or set forth the method steps of transcervically
introducing the contraceptive device into a fallopian tube and
affixing the contraceptive device within the tube. Optionally, a
variety of delivery structures may also be provided in the kit,
including guidewires, corewires, delivery catheters, and the
like.
[0038] In yet another aspect, the invention provides an
intrafallopian contraceptive system comprising an elongate delivery
body having a proximal end and a distal end. A first energy conduit
extends therebetween, and an intrafallopian structure near the
distal end has a first cross-section. An energy source is coupled
to the structure by the first conduit. Energy from the energy
source reconfigures the structure to a second cross-section to
restrain the structure within a fallopian tube and inhibit
conception.
[0039] In a final aspect, the invention provides an elongate
delivery body having proximal and distal ends with first and second
conductors extending therebetween. An intrafallopian contraceptive
structure is near the distal end of the delivery body. An
electrical power supply can be coupled to the structure by the
first and second conductors. This advantageous bipolar arrangement
can, for example, allow actuation of a shape-memory alloy structure
by transmitting current through at least a portion of the structure
from a hand-held battery.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 illustrates a first embodiment of a contraceptive
intrafallopian device according to the present invention.
[0041] FIG. 2 illustrates a primary coil used in the contraceptive
intrafallopian device of FIG. 1.
[0042] FIG. 3 illustrates a secondary coil which has been imposed
on a primary coil as used in the contraceptive intrafallopian
device of FIG. 1.
[0043] FIG. 4 illustrates a corewire for use with the contraceptive
intrafallopian device of FIG. 1.
[0044] FIG. 5 is a cross-sectional view of a contraceptive delivery
system having the contraceptive intrafallopian device of FIG.
1.
[0045] FIG. 6 illustrates an alternative embodiment of the present
contraceptive intrafallopian device.
[0046] FIG. 7 illustrates a primary coil used in the contraceptive
intrafallopian device of FIG. 6.
[0047] FIG. 8 schematically illustrates a contraceptive delivery
system including the contraceptive intrafallopian device of FIG.
6.
[0048] FIGS. 9 and 10 illustrates a method of delivery of a
contraceptive intrafallopian device according to the present
invention.
[0049] FIGS. 11A-D illustrate intrafallopian contraceptive devices
having straight primary coils, together with associated delivery
devices and systems.
[0050] FIGS. 12A-E illustrate a variety of intrafallopian
contraceptive devices which are adapted to promote a tissue
reaction that enhances the contraceptive efficacy of the
device.
[0051] FIG. 13 illustrates a method for introducing a dense braid
of fiber material into a helical coil of a contraceptive
device.
[0052] FIGS. 14-14E illustrate helical coils which adapt to varying
tubal sizes to enhance retention of the contraceptive device within
the fallopian tube.
[0053] FIG. 15A-D illustrate cross-sectional views through the
fallopian tube before, during, and after delivery of a
contraceptive device having a radially expandable helical coil, and
also illustrates the enhanced efficacy provided by tissue reactions
such as tissue ingrowth into and around the helical coil.
[0054] FIG. 15E illustrates the self-guiding capabilities of a
contraceptive device having a straight primary coil.
[0055] FIG. 16 illustrates a contraceptive delivery system having a
detachable distal corewire.
[0056] FIG. 17 schematically illustrates a kit including a
contraceptive delivery system and instructions for its use.
[0057] FIGS. 18A-C schematically illustrate alternative tubular
radially expandable retention structures which can mechanically
anchor a contraceptive device in the fallopian tube.
[0058] FIGS. 19A and B illustrate an intrafallopian contraceptive
system in which a hand-held battery electrically actuates the
retention structure by transmitting a current which heats a
shape-memory alloy of the retention structure.
[0059] FIGS. 20A and B illustrate an intrafallopian contraceptive
device and method for its use to support a coil comprising copper
within the utero-tubal junction.
[0060] FIGS. 21A-C illustrate alternative structures comprising
copper and methods for their use to inhibit conception, according
to the principles of the present invention.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0061] The present invention encompasses a contraceptive
intrafallopian device which can alternatively be used as both a
permanent and a reversible means of contraception. The present
contraceptive methods and devices minimize the danger of non-use
which has limited the efficacy of prior art contraceptive
techniques. Moreover, the location of the present devices within
the fallopian tubes provides a reduced risk of the infectious
complications, increased bleeding, and pelvic pain associated with
intrauterine devices (IUDs). The location and the novel shape of
the present intrafallopian device provides significant advantages
over IUDs, which have been found to be susceptible to unplanned
expulsion and removal due to excessive pain and bleeding. The
present invention takes advantage of the increase in effectiveness
associated with copper IUDs, providing a resilient structure
including copper which may be transcervically positioned without
the need for surgery.
[0062] Although the present contraceptive method is included within
a group of contraceptive techniques generally referred to as
fallopian tube occlusion methods, the present invention does not
necessarily rely solely on blocking the fallopian tube to prevent
fertilization. Instead, contraception is apparently provided by
disrupting of ovum transport, the process of fertilization, and/or
cleavage of the ovum. While the effect that copper has on these
processes is not fully understood, it does appear that copper
intrafallopian devices offer potentially significant increases in
effectiveness over intrafallopian devices formed of other
materials. Contraception may alternatively be provided or enhanced
by a spermicidal agent attached to the device. Optionally, the
present invention further encompasses devices which promote the
growth of tissue within the tube to induce tubal occlusion, further
inhibiting conception. In some embodiments, polyester fibers such
as Dacron.RTM., Rayon.RTM., or the like, are bonded to the surface
of the coil using a polymeric adhesive. The polyester fibers
promote increased tissue growth around the coil, thus further
reducing the possibility of expulsion of the device from the
fallopian tube.
[0063] Conveniently, the present resilient structures are adapted
to be releasably affixed over a corewire, the corewire restraining
the resilient structure in a straight configuration. As the
resilient structure has an outer diameter when in the straight
configuration which is less than the inner diameter of the
fallopian tube, the catheter containing the present intrafallopian
device is easily transcervically introduced.
[0064] The present invention may be anchored within the isthmus of
the fallopian tube, overcoming the unintended expulsion of the
device and the resulting failure of the contraceptive method. Such
intrafallopian device expulsion has been the single greatest factor
limiting the efficacy of easily positioned intrafallopian
contraceptive techniques. The present intrafallopian devices are
generally elongate resilient structures pre-formed into secondary
shapes. These secondary shapes will preferably form anchors
proximally and distally of the narrowest portion of the fallopian
tube, called the isthmus. The secondary shape preferably has a
larger outer diameter than the inner diameter of the isthmus.
Anchoring may also be possible with a structure spanning other
portions of the tubal lumen, often between the ostial opening and
the isthmus.
[0065] The present device is generally readily removed by snaring
the resilient structure near the proximal end and pulling
proximally on the resilient structure, thereby straightening the
resilient structure and allowing it to be withdrawn without
injuring the fallopian tube. Alternatively, an electrical current
is applied to the device after it is positioned within the
fallopian tube, providing permanent sterilization. Electrical
current might also effect detachment of the device from the
delivery system using a system similar to that described in U.S.
Pat. No. 5,624,449, the full disclosure of which is incorporated
herein by reference. In situ actuation of an anchor might be
effected by releasing a resilient structure to expand in situ with
a similar mechanism, or by a current induced phase change of a
shape memory alloy (for example, causing a straight Nitinol.RTM.
ribbon to curl within the fallopian tube with a current).
[0066] Referring now to FIG. 1, a first embodiment of the present
contraceptive intrafallopian device 10 is formed from a resilient
primary coil 12. Primary coil 12 has a proximal end 14 and a distal
end 16, the latter having an atraumatic endcap 18. Primary coil 12
further includes three portions: a proximal anchor portion 20, a
distal anchor portion 22, and a lumen-traversing region 24.
Proximal and distal anchors 20,22 are biased to form anchoring
loops 26, as described hereinbelow.
[0067] Lumen-traversing region 24 comprises a substantially
straight portion of primary coil 12. A ribbon 28 is wound over the
outer surface of primary coil 12 to provide a helical shape. Ribbon
28 includes sharp outer edges 29, which firmly anchor
lumen-traversing region 24 in the fallopian tube wall when torque
is applied to intrafallopian device 10. The ribbon is preferably
formed of a high strength biocompatible metal, ideally being
stainless steel. The ribbon is attached to primary coil 12 at a
proximal joint 30 and a distal joint 32, which may be formed of
solder, heat-shrink tubing, or the like.
[0068] Referring now to FIG. 2, primary coil 12 is most easily
formed in a straight configuration as a cylindrical coil or spring,
preferably having an outer diameter in the range from 0.005 inch to
0.05 inch, and having a length in the range from 20 mm to 150 mm.
Ideally, primary coil 12 has an outer diameter in the range from
0.01 inch to 0.05 inch and a length in the range from 30 mm to 125
mm.
[0069] Preferably, primary coil 12 is formed from a beryllium
copper alloy wire. Beryllium copper provides the resilience
necessary to avoid expulsion of the device, and also provides the
increased effectiveness of a copper contraceptive intrafallopian
device. Such a beryllium copper wire will typically have a diameter
from 0.002 inch to 0.01 inch. To provide the increased efficacy of
a copper intrafallopian device, primary coil 12 preferably
comprises an alloy including 75% copper. Alternatively, primary
coil 12 is formed from a resilient metal, such as stainless steel,
platinum, a shape memory alloy, or the like. If such materials are
used, primary coil 12 is preferably plated with copper or a copper
alloy or otherwise has copper attached.
[0070] Primary coil 12 includes a body winding 42 and a thread
winding 44. Body winding 42 is formed with the minimum possible
pitch to increase the stiffness of primary coil 12. Thread winding
44 will typically comprise from 0.1 cm to 2.0 cm adjacent to
proximal end 14, and will have a pitch roughly twice that of body
winding 42.
[0071] Referring now to FIG. 3, the proximal and distal anchors are
formed by imposing a bent secondary shape on selected portions of
primary coil 12. The secondary shape preferably comprises loops 26
formed by bending primary coil 12, and heat treating the primary
coil while it is bent. A wide variety of secondary shapes may be
used, including sinusoidal curves, alternating loops, or loops
separated by straight sections so as to form a "flower coil," as
more fully described in co-pending U.S. patent application Ser. No.
08/474,779, the full disclosure of which is herein incorporated by
reference. In most cases, the bent secondary shape will have an
outer cross-section 46 which is larger than the fallopian tube to
provide effective anchoring.
[0072] Referring now to FIG. 4, a corewire 50 for use with
intrafallopian device 10 (FIG. 1) comprises a resilient wire 52
which tapers towards a distal end 54. Wire 52 is sufficiently stiff
to restrain intrafallopian device 10 in a straight configuration,
typically comprising stainless steel, platinum, or the like. A
short section of coil forms corewire threads 56 attached at
threadjoint 58. Threads 56 match the windings and pitch of
threadwindings 44 of primary coil 12.
[0073] Referring now to FIG. 5, an intrafallopian contraceptive
system 60 comprises corewire 50 inserted within a lumen 62 through
intrafallopian device 10. Intrafallopian device 10 is releasably
attached by engaging thread windings 44 with threads 56. Thus,
intrafallopian device 10 is disengaged by torquing a proximal end
of corewire 50 once intrafallopian device 10 is in position.
[0074] Referring now to FIG. 6, an alternative embodiment of the
present intrafallopian device is again formed from a resilient
primary coil 112 having a proximal end 114 and a distal end 116.
The former includes a friction fitting 15. Primary coil 112 again
includes three portions: a proximal anchor portion 120, a distal
anchor portion 122, and a lumen-traversing region 124. Proximal and
distal anchors 120, 122 are here biased to form opposed anchoring
loops 26, thereby increasing the relaxed overall cross-section of
the proximal and distal anchors. A ribbon 128 is wound over the
outer surface of primary coil 112 to provide a helical shape, as
described above.
[0075] Referring now to FIG. 7, primary coil 112 comprises a
uniform body winding 142. The secondary shape is imposed on
[0076] the straight cylindrical coil as opposed loops 126, or
alternatively as multiple loops of a flower coil.
[0077] Referring now to FIG. 8, an intrafallopian contraceptive
system using alternative intrafallopian device 100 includes a
corewire 152 which tapers towards a distal end 154. Friction
fitting 115 fittingly engages corewire 152, which restrains primary
coil 112 in a straight configuration. A release catheter 164 is
slidably disposed over corewire 152 proximally of alternative
intrafallopian device 100, allowing the device to be released by
withdrawing corewire 152 relative to the release catheter.
[0078] Use of the present contraceptive intrafallopian device will
be described with reference to FIGS. 9 and 10. A uterine introducer
canula 70 is inserted transcervically through a uterus 72 to the
region of an ostium 74. Alternatively, a hysteroscope may be used
in place of canula 70, or an echogenic and/or radiopaque device
might be placed under sonographic or radiopaque guidance.
[0079] Intrafallopian contraceptive system 60 is advanced distally
of introducer cannula 70 and maneuvered through the fallopian tube,
preferably until intrafallopian device 10 extends distally of the
isthmus. Optionally, intrafallopian contraceptive system 60 is
self-guided, with corewire 52 bent near distal end 54 to assist
intraluminal maneuvering. Alternatively, a guide wire and catheter
are advanced into the fallopian tube first, and the guide wire is
replaced with intrafallopian contraceptive system 60. In either
case, the intrafallopian device will generally be axially
positioned with lumen-traversing region 24 within a target region
84 adjacent to isthmus 80. Preferably, at least one loop of distal
anchor 22 is distal of target region 84, and at least one loop of
proximal anchor 20 is proximal of target region 84 to form the
distal and proximal anchor bends.
[0080] Once intrafallopian device 10 is properly positioned,
corewire 50 is torqued to set ribbon 28 in the tubal wall. The
corewire may then be unthreaded from intrafallopian device 10 by
rotating the corewire in the opposite direction, disengaging
threads 56 from thread windings 44. The corewire is then free to
slide proximally, releasing the primary coil. As the distal end of
the primary coil is released, a distal anchor bend 90 is formed.
Similarly, a proximal loop forms a proximal anchor bend 92. The
anchor bends help to axially restrain the device within the
fallopian tube, and also prevent rotation around the helical shape
of lumen-traversing region 24. As seen in FIG. 10, the loops need
not assume their relaxed form to provide effective distal or
proximal anchors.
[0081] The present invention further encompasses permanent
sterilization by passing a current through the corewire to the
intrafallopian device prior to withdrawing the corewire. Fallopian
tube tissue in contact with the intrafallopian device is
desiccated, and thus attached to the present intrafallopian device.
This action also causes permanent tubal damage, leading to the
formation of scar tissue which encapsulates the intrafallopian
device and causes permanent occlusion of the tubal lumen. Clearly,
the corewire/primary coil interface must be conductive to allow the
present non-surgical method of permanent sterilization.
[0082] The intrafallopian contraceptive methods and devices of the
present invention can provide highly effective contraception even
when the contraceptive device does not totally occlude the lumen of
the fallopian tube. To minimize distention of the delicate tubal
tissue, the present invention will often leave some open lumen
within the fallopian tube, at least when initially deployed. In
fact, these contraceptive devices will often comprise perforate
tubular structures having lumens. Nonetheless, contraception can be
provided by disrupting the normal architecture and/or function of
the fallopian tube, despite the presence of an open lumen. This
concept is referred to herein as "functional occlusion". As used
herein, a device which provides functional occlusion means that the
device, when implanted in the fallopian tube, disrupts the normal
architecture and/or functioning of the fallopian tube so as to
inhibit fertilization and/or conception.
[0083] The size of an occlusive device required to provide
functional occlusion may depend on the material of the device, the
position the device is to be deployed within the fallopian tube,
the interaction between the device and the surrounding tubal wall,
and the like. For example, intrafallopian contraceptive structures
which include fibers of polyester may incite ingrowth of the tubal
tissues into the device. As a result of this tissue/device
interaction, a relatively small device which promotes ingrowth may
be capable of providing effective occlusion. In fact, such a device
may be capable of providing total occlusion by inciting sufficient
ingrowth so that the hyperplastic tubal walls, in combination with
the device, block all passage through the tubal lumen. Hence,
relatively small, easily inserted structures may effectively
inhibit conception without the danger of distending the tubal
wall.
[0084] One easily inserted intrafallopian contraceptive structure
which may be capable of providing effective tubal occlusion is
illustrated in FIG. 11A. A straight contraceptive device 200
includes a straight primary coil 202 around which is disposed a
secondary helical coil 204 as described above. Secondary coil 204
is affixed to primary coil 202 at a pair of bonds 206. As
illustrated above in FIG. 6, the secondary helical coil may have an
inner surface which is larger than the outer surface of primary
coil 202, which may facilitate embedding the comers of the
secondary coil in the surrounding tubular wall. However, unlike the
intrafallopian devices described hereinabove, straight device 200
remains substantially straight between a proximal end 208 and a
distal end 210 when the primary coil is at rest.
[0085] Primary coil 202 will typically be formed from wire having a
diameter of between about 0.002 and 0.009 inches, by winding the
wire to form a coil having a diameter between about 0.010 and 0.040
inches. Primary coil 202 will often have a length of between 2.9
and 3.5 cm. The ribbon used to form secondary helical coil 204 will
generally have a width between about 0.005 and 0.020 inches, and a
thickness of between about 0.0005 and 0.005 inches.
[0086] In the exemplary embodiment, straight device 200 includes a
primary coil 202 having a total length of between about 3.0 and
3.35 cm. The exemplary primary coil 202 is wound from platinum
wire, the platinum wire having a thickness of 0.005 inches, which
is wound to provide a primary coil having an outer diameter of
about 0.018 inches and a length of about 3.0 cm. Secondary coil 204
is formed from a platinum ribbon having a width of 0.012 inches and
a thickness of 0.002 inches. Bonds 206 comprise gold solder and
secondary coil 204 has a length of about 0.5 to 1.0 cm and an outer
diameter of between about 0.035 to 0.040 inches when affixed to the
primary coil 202. Solder is also used to form an atraumatic tip at
distal end 210.
[0087] Referring now to FIGS. 11B and 11C, a self-guiding
contraceptive delivery system 212 includes straight contraceptive
device 200 and a flexible tip corewire 214. As described above,
threads 216 on flexible tip corewire 214 mate with the proximal end
208 of straight contraceptive device 200, the threads ideally
comprising a stainless steel coil having approximately the same
dimensions as primary coil 202 and affixed to the corewire with yet
another gold solder joint 206.
[0088] Advantageously, distal end 218 of corewire 214 need not have
sufficient stiffness and strength to restrain a coil biased to form
a bent secondary shape. As a result, the thickness of corewire 214
may be optimized to enhance the trackability and pushability of
self-guided contraceptive system 212, thereby enhancing the ability
of the contraceptive system to act as its own guidewire.
[0089] Delivery of the contraceptive device is facilitated by using
a corewire having a relatively long, stiff proximal section and a
relatively short, flexible section, the flexible section typically
being tapered as illustrated. The thickness and material properties
of these sections are selected to provide enough column strength to
allow corewire 214 to advance straight device 200 within the
fallopian tube, but enough flexibility at the distal end of the
delivery system for distal end 210 to navigate the tortuous
fallopian tube. A relatively thick proximal section also improves
the torque transmission capabilities of the wire, particularly for
torquing and embedding the outer coil against the tubal wall.
[0090] Proximal section 220 of corewire 214 will preferably be
flexible enough for delivery through a flexible catheter and/or
through the working channel of an endoscope. The corewire will
generally comprise a material which resists kinking and resiliently
returns to its original shape, ideally comprising a shape memory
alloy such as Nitinol.RTM. or a treated stainless steel. Such
resilience may be tailored to enhance the ability of the delivery
system to access the tubal ostium and advance the contraceptive
device into the fallopian tube. In some embodiments, corewire 214
will be capable of transmitting heat, electrical current, and/or
some other energy which induces scarring, electrocautery, or the
like, so as to attach the contraceptive device within the fallopian
tube. Alternatively, the transmitted energy may decouple the device
from the corewire, for example, by melting a coupler.
[0091] In a particularly advantageous aspect, threads 216 of
delivery system 200 may be adapted to enhance visualization of the
detachment process. For example, a first portion of the threads 222
may be a first color (such as green) while a second portion of the
threads 224 may be a second color which contrasts sharply with the
first color (such as red). As they are near the proximal end of the
device, threads 216 will often be more visible than the remainder
of the contraceptive device. The threads may even protrude through
the tubal os into the uterus for viewing through the hysteroscope.
By visually monitoring highly contrasting colors of the thread
portions through the hysteroscope, the attending physician will be
provided with direct feedback on the decoupling process. The thread
portions may be colored by coating, anodizing, oxidation,
polishing, the use of differing materials, or the like. A stripe or
other mark may also be provided on the delivery wire to help
monitor rotation. Alternative embodiments may use threads having
high contrast under imaging.
[0092] Still further capabilities may be incorporated into the
delivery system. For example, a "smart" delivery device may be able
to sense its position within the fallopian tube magnetically,
electrically, optically, ultrasonically, or the like. Similarly,
the deployed device may incorporate structures which allow the
physician to remotely verify the position and presence of the
device without having to access the fallopian tube (e.g., using a
magnetic sensor, impedance, and/or radio activity).
[0093] In the exemplary embodiment, corewire 214 comprises a shape
memory alloy such as Nitinol.RTM.. Proximal portion 220 of corewire
214 has a thickness of between about 0.018 and 0.040 inches,
ideally being about 0.035 cm, and the corewire tapers over a length
of about 5.0 cm to a minimum thickness of between about 0.002 and
0.008 inches, typically about 0.003 inches at distal end 218.
[0094] One method for attaching polyester fibers 226 to straight
contraceptive device 200 is illustrated in FIG. 11D. As described
above, such polyester fibers promote tissue ingrowth, which can
help affix the device within the fallopian tube. Additionally, such
tissue ingrowth may also help to further occlude the lumen of the
fallopian tube. Fibers 226 are shown tied in loops around the
secondary coil, ideally using between about 5 and 7 loops and
fiber.
[0095] A wide variety of alternative mechanisms may be employed to
incite a tissue reaction which enhances the functional occlusion of
the intrafallopian contraceptive device. For example, materials
such as collagen, hydroxyapatite, solid or fibrous PTFE, or the
like may be used. Biodegradable coatings may cause tissue ingrowth
or scarring, and then degrade to leave a fully or partially
occluded lumen. In some embodiments, the engagement between outer
coil 204 and the tubal wall injures the epithelial tissues, and the
healing process results in the formation of scar tissues which
interfere with the functioning of the fallopian tube.
[0096] A variety of alternative ingrowth promoting intrafallopian
contraceptive devices are illustrated in FIGS. 12A-E. Generally,
each of these devices includes some element which promotes ingrowth
of tubal tissues therein. A porous secondary coil 230 may be formed
of a porous metal, ideally comprising a micro-porous shape memory
alloy such as Nitinol.RTM.. In some embodiments, ingrowth bonds 232
may be formed of, or coated with, a material such as bioglass,
ceramics, or the like so as to promote tissue ingrowth, so that the
entire device may promote ingrowth. Surface treatments may also
encourage ingrowth. For example, blasting a surface with small
particulates can create a somewhat divoted and porous texture. Such
porous textures at the surface, with micron-sized pores, may
produce the desired tissue reaction. Alternative embodiments may
include an open cell ingrowth promoting structure, such as the open
cell foams used to attach some breast implants.
[0097] In some embodiments, discrete bodies 234 may be formed as
rings or annular beads using any of the above listed tissue
ingrowth materials, coatings, or treatments. Wound, wrapped, or
braided fiber material 236 may also be disposed between the primary
and secondary coils, the fiber material typically comprising a
polyester such as Dacron.RTM., Vicril.RTM., or the like. Dense
fiber materials within the device may enhance the reaction and/or
ingrowth of the surrounding tubal tissues, and also decreases the
amount of open space within the device, thereby minimizing any
prosthetic lumen. Fiber material 236 may also be in the form of a
thick felt, or may simply be spun with several layers of
windings.
[0098] Still further alternative ingrowth promoting elements are
possible, such as tubular fabric 238 of felt, braided or woven
material, or the like. Tubular fabric 238 provides an open conduit
at the proximal end of the device to avoid impeding with the
removal of the corewire, and the outer diameter of the tubular
fabric will preferably be less than the outer diameter of the
secondary coil. In some embodiments, simply providing an internal
fabric 240 in the form of a textile mesh or felt inside the primary
coil may be sufficient to incite ingrowth of the tubal tissues into
the coil, affixing the coil in place and providing functional
occlusion of the fallopian tube.
[0099] Referring now to FIG. 13, a particularly advantageous method
for producing a contraceptive device having a dense fiber braid 250
is illustrated. Dense fiber braid 250 is initially formed by
wrapping several layers of fiber around a mandrel. After about
fifteen layers of fiber have been wrapped over the mandrel, the
wound fiber is slid off the mandrel, and the windings are processed
to form the braid. The braid is affixed to contraceptive device 200
adjacent one of the bonds, and the fiber braid is then wound
between the windings of secondary coil 204. As a result, at least a
portion of fiber tube 250 is disposed in the annular space between
the primary coil and secondary coil 204. Often times, some portion
of the fiber will also extend radially beyond secondary coil 204,
as illustrated.
[0100] The use of dense fiber braid 250 provides a much greater
amount of fiber and a more radially compact, easily deployable
assembly than a structure which includes loops tied radially around
the secondary coil. Such densely packed fiber thereby makes use of
an otherwise open space, and the enhanced amount of fiber should
provoke a more robust tissue reaction. Specifically, dense fiber
braid 250 will have a smaller pore size, which is generally
advantageous for tissue ingrowth. This combination of an enhanced
tissue reaction, with a less axially open design, would appear to
provide significant advantages for functional occlusion of the
fallopian tube.
[0101] A still further alternative intrafallopian contraceptive
device 200' is illustrated in FIG. 14. Alternative device 200'
includes several of the same primary structures described
hereinabove regarding straight contraceptive device 200, but makes
use of a fiber tube 252 to provide the advantages of high fiber
density and a small radial package. In this embodiment, the fiber
is again wrapped around a mandrel several times (ideally about 15
times) and then removed as a fiber tube. Tube 252 is slid off the
mandrel and onto the primary coil. The tube may be positioned
before or after secondary coil 204 is attached at bond 206, and
will generally occupy the annular space between the primary and
secondary coils. The ends of tube 252 can be tied to keep the tube
in position during delivery.
[0102] Alternative contraceptive device 200' also differs from the
previous structures in that secondary coil 204 has a free end 254
which is not affixed to primary coil 202. As free end 254 can move
relative to primary coil 200, secondary coil 204 can expand
radially well beyond bond 206, and can also be radially compressed
to provide a very small outer diameter during delivery of the
device. Hence, the diameter of secondary coil 204 in alternative
device 200' provides a highly radially variable tubular structure
which can easily adapt to a wide variety of tubal lumen
cross-sectional sizes to retain the contraceptive device within the
fallopian tube.
[0103] A highly radially expandable tubular retention structure has
several significant advantages. First, the structure can be
inserted in a narrow profile configuration and radially expanded
within the fallopian tube to provide a secure anchor with minimal
danger of protruding through the delicate tubal wall. Additionally,
the stiffness of the helical secondary coil can be tailored to
provide the appropriate engagement force and/or damage to the wall
tissue so as to provoke the desired tissue reaction, whether it be
scar tissue formation, ingrowth, or the like. Torquing of a free
ended helical coil may also be used to adjust the outer diameter
during delivery.
[0104] The enhanced variability in outer diameter provided by an
outer coil 204 having a free end 254 can be understood with
reference to FIGS. 14A-C. Generally, outer coil 204 will here have
an outer diameter of over about 0.080 mm in its relaxed state, the
outer diameter of the secondary coil preferably being biased to
form a helix with an outer diameter of about 1.0 mm when at rest,
and will ideally be compressible to an outer diameter of 0.1 mm for
insertion. Outer coil 204 of alternative device 200' may be easily
radially compressed by drawing free end 254 proximally away from
bond 206, by wrapping the free end around primary coil 202, or by
some combination of both.
[0105] As illustrated in FIGS. 14B and C, the device may be
restrained in a small diameter configuration by a delivery catheter
256, by articulatable jaws 258, or the like. Regardless, secondary
coil 204 will generally be restrained until the device is
positioned within the fallopian tube, and will then be released in
situ by axially withdrawing catheter 256, articulating jaws 258, or
the like. Still further alternative in situ release mechanisms are
possible, such as dissolving or dissipating a crystal or
electrolytic coating which radially restrains the secondary coil, a
phase change in a shape memory alloy, or the like, as described
above. It should be noted that the free ended secondary coil is
illustrated in FIGS. 14A-C without the optional dense fiber tube of
FIG. 14A for clarity. Nonetheless, the enhanced radial variability
provided by a free ended helical coil (or by other perforate
tubular structures) may be either used alone or combined with other
tissue reaction structures described hereinabove to provide
functional occlusion and contraception.
[0106] Alternative helical retention structures are illustrated in
FIGS. 14D and 14E. A tapered coil 203 may be advanced distally,
either axially or by rotationally threading the device, to embed
the structure into a tapering portion of the tubal wall. The device
can accommodate a variety of tubal sizes, as it need only be
advanced until proper engagement has been achieved. Variable
stiffness along the outer coil may be provided by a coil formed
with a tapering ribbon 207, or the like.
[0107] Alternative structures for releasably restraining secondary
coil 204 are illustrated in FIGS. 14F-H. In the embodiments of
FIGS. 14F and G, corewire 152 is rotationally coupled to primary
coil 202, and hence to the distal portion of secondary coil 204 by
bond 206 (see FIG. 14C). A tab 259 is affixed to a proximal end of
secondary coil 204, the tab preferably protruding radially inwardly
from the coil, the tab ideally comprising a small diameter annulus
or collar having an axis parallel to the secondary coil axis. Tab
259 is releasably received by a keyhole slot 257 in delivery
catheter 256. The tab is axially restrained in the slot when the
tab engages one side of the slot, but is free to slide axially from
the slot when rotationally disengaged or pressed against the other
side.
[0108] Prior to delivery, secondary coil 204 is restrained in a
small diameter configuration by engagement between tab 259 and slot
257. Secondary coil 204 is tightly wound down, so that the
secondary coil biases the tab toward the restrained position. The
proximal portions of the corewire and delivery catheter can be
rotationally affixed to each other (ideally by a Tohey-Borst valve)
to restrain the device in the small configuration. This may also
prevent distal movement of the contraceptive device from the
catheter and corewire.
[0109] Once the device is positioned, allowing the proximal
portions of the corewire and catheter to rotate relative to each
other (by releasing the Tohey-Borst valve or the like), and/or
actively rotating one of these structures, can unwind the secondary
coil and allow tab 259 to slide axially free of the catheter.
Optionally, as shown in FIG. 14G, an alternative keyhole slot 263
having an angled or radiused proximal surface may be used to urge
tab 259 toward a release portion 261 of the slot by pushing the
surface distally against the tab.
[0110] Still further release mechanisms are possible, including the
system illustrated in FIG. 14H. A proximally inwardly tapering body
or brake 265 is affixed to primary coil 202, and is fittingly
received by a tapering receptacle at the distal end of delivery
catheter 267 when a proximal portion of secondary coil 204 is
disposed therebetween. Secondary coil 204 may optionally be held in
its wound-down configuration at the proximal end of the delivery
system by a Tohey-Borst valve, and can be released to unwind by
moving the catheter proximally relative to corewire 152 (and hence
primary coil 202 and body 265), and/or by releasing the Tohey-Borst
valve.
[0111] The use of a tubular, radially expandable intrafallopian
device, and also the significance of tissue reaction in providing
functional occlusion, can be further understood with reference to
FIGS. 15A-D. A lumen L of a fallopian tube F is largely a potential
space, much like a deflated balloon. Tubal wall W can expand around
structures which are inserted into lumen L, such as around catheter
256 which radially restrains a free ended secondary coil 204.
Hence, the size of the irregular lumenal cross-section may be
measured by the diameter of a device it can accommodate.
[0112] Work in connection with the present invention has found that
fallopian tubes can vary significantly in inner lumen
cross-sectional sizes. The maximum diameter of a device which a
fallopian tube can accommodate at its smallest point can range
anywhere from 0.2 to 1.5 mm. For devices having a fixed
cross-section, relatively large diameters will make the device more
difficult to deliver. However, if the device is made too small, it
can be more easily ejected from the fallopian tube. While fixed
cross-sectional devices may still be effective (for example, by
providing a range of different device sizes), the use of a radially
expandable tubular structure such as free ended helical coil 204
allows the device to compensate for the substantially anatomical
differences between users.
[0113] As generally described above, catheter 256 may optionally be
positioned by first accessing the fallopian tube with a guidewire,
and then advancing the catheter over the positioned guidewire.
Alternatively, the catheter and contraceptive device may be
advanced distally using the distal end of the primary coil as a
guidewire. Regardless, once the contraceptive device is positioned
at the desired axial location (generally from adjacent the isthmus
to the intraluminal region, but optionally anywhere from the
cornual area to adjacent the distal fimbria), catheter 256 is
withdrawn proximally while restraining the contraceptive device
axially with the proximal end of corewire 214. As catheter 256 is
withdrawn, secondary coil 204 expands radially and engages the
surrounding tubal wall W, as illustrated in FIG. 15C. Secondary
coil 204 may optionally be torqued against the surrounding tubal
wall from the proximal end of corewire 214, after which the
corewire is unthreaded from the contraceptive device and
removed.
[0114] Although the tissues of the tubal wall protrude between the
windings of secondary coil 204, a significant portion of lumen L
remains open. Nonetheless, functional occlusion is provided so long
as the deployed device adequately interferes with fertilization so
as to inhibit conception. Functional occlusion may be enhanced by
the formation of scar tissues and the growth of tissues from the
tubal wall so as to occlude lumen L (ideally both inside and
outside of the tubular retention structure), as illustrated in FIG.
15D. Such scar tissue formation will also aid in anchoring the
device.
[0115] As can be understood with reference to FIG. 15D and FIG. 16,
open areas within the contraceptive device along the axis of
fallopian tube F can present some risk of providing a passageway
for fertilization. To avoid providing a prosthetic lumen defined by
the inner surface of primary coil 202 after corewire 214 is
removed, a detachable delivery wire 260 is formed in two pieces.
Distal delivery wire 264 is coupled to proximal delivery wire 262
by a threaded fastener 266. Fastener 266 provides column strength
to the detachable delivery wire. This allows the distal portion of
the delivery wire to remain within the primary coil when the
contraceptive device is detached. Clearly, a wide variety of
coupling mechanisms might be used. Advantageously, a threaded
coupler allows the device to be torqued in one direction and
detached by rotating the proximal delivery wire 262 in the other
direction, generally as described above.
[0116] The use of primary coil 202 (in combination with corewire
214) as a guidewire can be understood with reference to FIG. 15E.
The good proximal column strength of the corewire and the distally
increasing flexibility of the combined corewire and primary coil at
the distal end of the delivery device greatly facilitates axially
advancing the device within fallopian tube F. The ability of the
corewire 214 to transmit torque can also help advance the delivery
system distally, as well as allowing the user to embed secondary
coil 204 into the surrounding tubal wall. As can also be understood
with reference to FIG. 15E, the use of a straight primary coil in a
portion of the fallopian tube having significant axial curvature
results in resilient engagement of the coil against the tubal wall,
and can thereby provide anchoring similar to that described above
for pre-bent coils in straight lumens.
[0117] Referring now to FIG. 17, a kit 300 includes contraceptive
system 212 (in which straight contraceptive device 200 is mounted
on corewire 214) within a sterile package 302. Also included in kit
300 are instructions 304, the sterile package and instructions
being disposed in packaging 306. The instructions may set forth any
of the method steps for using a contraceptive system as described
hereinabove. Delivery system 212 may be protected by a protective
sheath 308, and other system components described hereinabove may
also be included. Also visible in FIG. 17 is the proximal torquable
handle 310 of the delivery system.
[0118] Instructions 304 will often comprise printed material, and
may be found in whole or in-part on packaging 306 or sterile
packaging 302. Alternatively, instructions 304 may be in the form
of a recording disk or other computer readable data, a video tape,
a sound recording, or the like.
[0119] Alternative radially expandable retention structures are
illustrated in FIGS. 18A through C. A slotted tube retention
structure 320 can shorten and expand within the fallopian tube. In
general, such expansion may be the result of external forces (such
as actuation of a two part delivery system 322), or the retention
structure may self-expand when released in situ. Forcibly expanded
retention structures may have a latching mechanism which prevents
collapse when the device is detached from the delivery system in
the fallopian tube, and such detachment may be effected by any of
the mechanisms described hereinabove.
[0120] Still further alternative retention structures may be used
in place of helical secondary coil 204 and slotted tube 320. For
example, a Malecott retention structure 324 or a braided filament
retention structure 326 might be expanded to engage a surrounding
tubal wall. In some cases, tubal anchoring may be enhanced by
including two or more retention structures, or by providing small
barbs which extend axially and/or radially from the expanded
retention structure to prevent axial migration. Preferably, such
barbs would be too short to perforate through the tubal wall. A
wide variety of alternative radially expansible structures which
might be adapted for use as a retaining structure in the present
intrafallopian contraceptive device are described with reference to
vascular stents.
[0121] An intrafallopian device having a retaining structure
comprising a shape memory alloy is illustrated in FIGS. 19A and B.
In general, the system applies energy to the contraceptive device
so that the device expands from a low profile (for delivery) to a
deployed profile so as to hold the device in place. The device may
be heated by transmitting current along two electrically isolated
conductors to primary coil 202. Corewire 152 here has an insulating
layer 271 and is coupled to a first portion of the coil, while a
conductor 269 in delivery catheter 256 is coupled to another
portion of the coil. The resistance of the coil to a small current
is sufficient to heat and reconfigure the retaining structure.
Electrical energy from a common 9-volt hand-held battery within
energy source will be sufficient to reconfigure secondary coil 204,
which will generally remain in the deployed configuration at body
temperature. Alternative energizing systems may use heated saline
or the like.
[0122] As described above, copper may enhance the efficacy of an
intrafallopian contraceptive device 400. Al illustrated in FIGS.
20A and B, a copper body (for example, in the form of copper coil
402) may extend proximally into and/or through the utero-tubal
junction from the fallopian tube. As can be seen in FIGS. 21A and
C, the copper may alternatively be in the form of copper beads 404,
which may be used to form bonds, ingrowth structures, or the like.
The copper may be in the form of a plating 406 over a core material
408 for use in the primary coil, secondary coil, or the like.
[0123] The release rate of copper is often closely related to the
surface area of copper on the device. A total copper surface area
over 100 mm2, and most often in a range from about 300 mm2 to about
400 mm2 will be preferred to provide contraception.
[0124] The total volume of copper will affect the duration of the
enhanced efficacy the copper provides. To provide lifelong
contraception, we should provide sufficient copper for about 25
years (based on the fertility life of a woman). For an exposed
copper surface area of 400 mm2, average copper release rates may be
about 25 micrograms per day, based on intrauterine device studies.
To allow our intrafallopian contraceptive devices to release copper
at this rate for 25 years, we will preferably include at least 0.23
grams or 25.6 mm3 of total copper. To provide a reasonable safety
factor, a 25-year device may include at least about 0.34 grams or
38.4 mm2 of copper volume. These quantities may be provided by each
device, or by two devices (in the left and right fallopian tubes)
in combination. Similar calculations may be performed for 5-year
devices (using the same exposed area and at least 1/5 of the above
volume), or to adjust for differing release/areal efficacy
resulting from the copper structures being carried in different
regions of the fallopian tubes.
[0125] In conclusion, the present invention provides a
contraceptive intrafallopian device which may be positioned without
surgery. While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. For example, a wide variety of
secondary shapes, including open loops, continuous bends,
sinusoidal curves, or the like, may be imposed on the primary coil.
Additionally, aspects of these intrafallopian contraceptive devices
which are described separately may often be combined (for example,
a self-guiding device may also promote ingrowth to affix the device
in the fallopian tube). Therefore, the above description should not
be taken as limiting the scope of the invention, which is defined
instead solely by the appended claims.
* * * * *