US20110259341A1 - Fallopian Tube Occlusion Device - Google Patents
Fallopian Tube Occlusion Device Download PDFInfo
- Publication number
- US20110259341A1 US20110259341A1 US13/173,418 US201113173418A US2011259341A1 US 20110259341 A1 US20110259341 A1 US 20110259341A1 US 201113173418 A US201113173418 A US 201113173418A US 2011259341 A1 US2011259341 A1 US 2011259341A1
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- United States
- Prior art keywords
- retention member
- struts
- mesh
- tube
- fallopian tube
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- 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
Abstract
A device for occluding the fallopian tube including a retention member and a mesh material supported by the retention member. The retention member has a first lower profile configuration for delivery and a second expanded configuration for placement within the fallopian tube. The mesh material is configured to block passage of an egg through the tube. The member has a plurality of tube engagement members to secure the retention member to the fallopian tube.
Description
- This application claims priority from provisional application Ser. No. 60/932,405, filed May 31, 2007, the entire contents of which is incorporated herein by reference.
- 1. Field of the Invention
- This application relates to a minimally invasive device for occluding the fallopian tubes.
- 2. Background of Related Art
- Tubal ligation is one method of female sterilization. It can be performed laparascopically by access through the patient's abdomen where the surgeon severs and closes the ends of the fallopian tubes by tying, applying clamps or cauterization. These devices achieve occlusion by external application to the tube.
- Other methods involve transcervical access. In some techniques, various agents are injected within each of the fallopian tubes to close or block the tubes. In other transcervical procedures, mechanical devices are inserted and anchored within the tube to promote tissue ingrowth and scar tissue formation to occlude the tubes. In other techniques, radiofrequency energy electrodes are inserted and energized to thermally damage the tube, causing scarring to occlude it.
- The need exists for an improved device for occluding the fallopian tubes which can be inserted in a minimally invasive fashion.
- The present invention overcomes the problems and deficiencies of the prior art. The present invention provides a device for occluding the fallopian tube comprising a retention member and a mesh material supported by the retention member. The retention member has a first lower profile configuration for delivery and a second expanded configuration for placement within the fallopian tube. The mesh material is configured to block passage of an egg through the fallopian tube. The retention member has a plurality of fallopian tube engagement members to secure the retention member to the fallopian tube.
- In one embodiment, the mesh is attached to an outer surface of the retention member. In another embodiment, the retention member has a plurality of struts defining a space therebetween and the mesh fills a substantial region of the space. In another alternate embodiment, the mesh is a strip of material connected to the retention member and spanning an opening of the retention member. In this embodiment, the mesh is preferably positioned at a region adjacent the tube engagement members. In a preferred embodiment, the retention member is composed of shape memory material.
- The tube engagement members may include a plurality of teeth. In a preferred embodiment, the retention member has a plurality of struts and the struts terminate in the tube engagement members. In a preferred embodiment, the retention member is composed of shape memory material.
- The present invention also provides a device for occluding the fallopian tube comprising a tube laser cut to form a series of struts, wherein the tube has a first lower profile configuration for delivery and a second expanded configuration for placement. The struts extend outwardly so that a distal region of the struts has a greater dimension and the struts define a space therebetween. A mesh material is supported by the struts and provides a blocking member to block the egg from passage through the fallopian tube.
- In one embodiment, the mesh material fills a substantial area of the space between the struts. In another embodiment, the mesh material is in the form of a narrow strip attached to one or more of the struts. In another embodiment, the mesh material is attached to an outer surface of the struts, and extends across a proximal region of the device.
- A method for fallopian tube occlusion is also provided comprising the steps of inserting into the fallopian tube a sheath containing a retention member having a plurality of struts in a reduced profile position, exposing the retention member from the sheath to enable it to expand to engage a wall of the fallopian tube, subsequently inserting mesh material within a space between the plurality of struts, and withdrawing the sheath to leave the retention member in the fallopian tube so the mesh material fills the space within the tube to occlude the tube.
- In one embodiment, the retention member has a plurality of shape memory struts and the step of exposing the retention member enables the struts to move toward a shape memorized position.
- Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
-
FIG. 1 is a perspective view of a the mesh retention member of the fallopian tube occlusion device of the present invention shown in the collapsed position for delivery; -
FIG. 2 is a transverse cross-sectional view taken along line 2-2 ofFIG. 1 ; -
FIG. 3 is a cross-sectional view taking along lines 3-3 ofFIG. 1 showing a portion of the retention member within a delivery sheath; -
FIG. 4 is a perspective view showing the occlusion device in the expanded condition without the mesh therein; -
FIG. 5 is a view similar toFIG. 4 showing the mesh positioned in the device; -
FIGS. 6 and 7 are side and front views of the device ofFIG. 5 : -
FIG. 8 is an anatomical view showing insertion of the delivery device through the uterus of a patient to access the fallopian tubes; -
FIG. 9 shows the delivery device being inserted into one of the fallopian tubes; -
FIG. 10 is a close up view showing the delivery device within the fallopian tube; -
FIG. 11 is a close up view showing the occlusion device deployed in the fallopian tube; -
FIGS. 12 and 13 are views similar toFIGS. 10 and 11 except showing placement of the occlusion device in the other fallopian tube; -
FIG. 14 is an anatomical view illustrating placement of the occlusion device in both fallopian tubes; -
FIGS. 15 and 16 are perspective and side views, respectively, of an alternate embodiment of the present invention showing the occlusion device having a strip of mesh supported therein; -
FIG. 17 is a side view of another alternate embodiment of the occlusion device having a mesh filling substantially the entire space between the struts; -
FIG. 18 is a side view of another alternate embodiment of the occlusion device having a mesh positioned on the outside of the retention member; and -
FIG. 19 is a perspective view of another alternate embodiment of the occlusion device having a mesh supported by a wound wire. - Referring now in detail to the drawings where like reference numerals identify similar or like components throughout, the several views, an occlusion device for placement in the fallopian tubes for contraception is disclosed. The device can be inserted minimally invasively and preferably in an office procedure. A hysteroscope can be used for direct visualization. The occlusion device includes a securement member and mesh material. The securement member provides for attachment to the fallopian tube as well as a support or retention for the various embodiments of the mesh described below.
- With initial reference to
FIGS. 1-3 which shows theocclusion device 10 in the low profile collapsed delivery configuration, andFIG. 4 , which shows theocclusion device 10 in the expanded placement configuration, theocclusion device 10 includes a securement or retention component (member) 12.Securement member 12 hasengagement hooks 14 for engaging the fallopian tube wall to retain thesecurement member 12 in the tube to prevent migration as described below. The mesh can be advanced into themember 12 in situ or alternatively can be positioned in the securementmember 12 in the delivery position and then advanced together with thesecurement member 12 for placement in the fallopian tube. Theocclusion device 10 is preferably formed from a laser cut tube, although other ways of forming the device are also contemplated. The mesh is not shown inFIG. 1-4 for clarity. - Turning to
FIGS. 4-7 illustrating thedevice 10 in the expanded (deployed) position, theretention component 12 is in the form of a bell shaped device with struts as described in detail with respect to the vessel filter disclosed in patent application Ser. No. 10/899,429, filed Jul. 13, 2004, (the '429 application), the entire contents of which is incorporated herein by reference. Thedevice 10 has a proximal end 11 a and distal end 11 b.Securement member 12 is preferably composed of shape memory material, such as Nitinol, with an austenitic shape memorized position illustrated inFIG. 4 and has a plurality ofstruts 13 emerging from apex 18 at proximal end 11 a and terminating in engaging or retention hooks 14 at distal end 11 b. In this embodiment, six struts are provided although a different number of struts is also contemplated. Aretrieval hook 16 is positioned on the proximal end 11 a to enable thedevice 10 to be grasped by a snare or other retrieval device and removed if desired. Thestruts 13 can be interconnected by interconnectingstruts 17 which join adjacent struts. More specifically, the struts preferably divide atregion 19 into two connectingstruts 17, angling away from each other, and then join atregion 21 to form extendingstrut portions 23 terminating inhooks 14. The interconnecting struts 17 stiffen the device to enhance retention and increase the radial force. They also provide a more symmetric and uniform deployment. The hooks are configured to engage the wall of the fallopian tube for maintaining the position of theocclusion device 10. Thus struts are preferably flared and create a distal opening and a space between the struts. For clarity, not all the identical parts are labeled throughout the drawings. It should be appreciated that materials other than Nitinol or shape memory are also contemplated. - The
hooks 14 preferably extend substantially perpendicular from the strut, and are preferably formed by torquing the struts so the hooks bend out of the plane. Preferably, a first set of hooks is larger than a second set of hooks. Preferably, when formed from a laser cut tube, the larger hooks are formed so that they occupy a region equivalent to the transverse dimension of two adjacent struts. Preferably, three smaller hooks and three larger hooks are provided in alternating arrangement in the embodiment utilizing six struts. The smaller hooks are preferably spaced axially with respect to each other and axially inwardly with respect to the larger hooks as in the filter hooks of the '429 application to minimize the collapsed profile (transverse dimension) of the filter when collapsed for insertion. The penetrating tips 14 a (FIG. 3 ) preferably point toward the proximal end 11 a of thedevice 10 and penetrate the tissue to retain the occlusion device. - Each of the
hooks 14 can have a series of teeth 14 c to engage the fallopian tube wall to provide additional retention to prevent movement of thedevice 10. A heel 14 d is provided which extends past the hook to function as a stop to prevent the occlusion device from going through the fallopian tube wall. The angle of the heel 14 d in the smaller hooks is less than the angle in the larger hooks to provide room for nesting of the hooks as shown inFIG. 3 . For clarity, not all of the hooks are fully labeled. - The securement (retention)
member 12 is maintained in a substantially straightened softer martensitic configuration within the delivery catheter orsheath 50 for delivery as shown inFIG. 3 . The smaller hooks preferably nest within the larger hooks. Cold saline can be injected during delivery to maintain thedevice 10 in this martensitic condition to facilitate exit from the distal opening 52 at the distal end portion 54 (FIG. 3 ) ofcatheter 50. When thestruts 13 exit the delivery sheath (tube 50), they are warmed by body temperature and move toward their illustrated memorized expanded position as shown inFIGS. 4-7 . - As shown in
FIGS. 8-11 and 14, thedevice 10 is preferably inserted through the uterus withindelivery catheter 50 and into the fallopian tube. It is positioned in this embodiment with the struts opening in a distal direction. When positioned in the fallopian tube, thehooks 14 engage the tube wall to retain the device. - The
device 10 in the embodiment ofFIGS. 1-7 has mesh material positioned within theretention member 12, filling substantially the entire region of themember 12. Asmall gap 24 can be left at the proximal region (see e.g.FIG. 6 ). However, in an alternate embodiment, the gap is filled in with mesh so the mesh fills more of the area between the struts as shown for example inFIG. 17 wherein mesh 61 fills substantially the entire space between thestruts 63.Retention member 60 is otherwise identical toretention member 12 ofFIG. 1 . The mesh is preferably in the form a tightly woven material to provide sufficiently small spaces to effectively block the eggs from the ovaries traveling through the fallopian tube. - The mesh can be delivered within the
retention member 12 such that in the collapsed position the mesh is contained and compressed therein. After delivery, it would expand within the space of theretention member 12, i.e. within the space between the struts. - In an alternate embodiment, the
retention member 12 would be placed within the fallopian tube first, and then once in place, the mesh would be delivered through the opening in the distal end 11 b of the device and within the space between thestruts 13 and/or 17. This in situ delivery could occur in embodiments wherein thedevice 10 is implanted in an orientation opposite to that ofFIG. 11 , i.e. the opening between the struts would face in the other direction such that the distal 11 b would be closer to the uterus than proximal end 11 a. - In an alternate embodiment, instead of the mesh filing the space between the struts, the mesh is in the form of a narrow strip. The mesh in this embodiment functions as a screen type blocking member, as shown in
FIGS. 15 and 16 and is substantially circular. The retention (securement)member 72 is otherwise identical tosecurement member 12 ofFIG. 1 , e.g. struts 73 divide atregion 79 into interconnecting struts 77, join atregion 81, and terminate in engaging hooks 74. Thestrip 85 of mesh would preferably be positioned slightly proximal of thehooks 74, e.g. at the region where the strut twists out of the plane so as not to interfere with the hooks. However, the mesh could be placed at other locations along the struts as long as it functions as a cover or blocking member to occlude the fallopian tube. Although a thin strip of mesh is shown, other size blocking strips could also be provided. The mesh is shown attached to an inner surface of the struts but could alternatively be attached to the outer surface. It could be attached to one or more of the struts. - As noted above, although the retention member is shown inserted with the engaging
hooks 14 facing in the distal direction, it is also contemplated that the retention member could be oriented in the opposite direction. In this version (not shown), the mesh can be inserted along with the retention member or alternatively if desired could be delivered in situ within the distal opening between the struts. - In the alternate embodiment of
FIG. 18 , the mesh 92 is positioned on the outside of the retention member 90. In all other respects, retention member 90 is similar tomember 12. In this embodiment, the mesh 92 is placed on an outer region, covering the outer surfaces of the struts and apex region and interposed between the struts and the fallopian tube when placed. Thus, the mesh functions as a sleeve which prevents passage of the eggs as they would be captured within the sleeve or net-like device. - The mesh in the foregoing embodiments can be attached to the retention member by various methods such as bonding, clamping and suturing.
- The method of placement of the occlusion device of the present invention will now be described for occluding a fallopian tube and with reference to
FIGS. 8-14 which illustrate by way of example the device ofFIG. 5 with the mesh delivered in conjunction with the securement member (the other embodiments are inserted in a similar fashion). Adelivery catheter 50 is inserted through anintroducer sheath 100 through the vagina and cervix into the uterus U. Thecatheter 50 is then advanced into fallopian tube F1. For insertion, the retention member 12 (and mesh) is in the collapsed position. - A pusher (not shown) is advanced distally to advance the
occlusion device 10 from thecatheter 50. As the struts ofdevice 10 are exposed, they are warmed by body temperature and return toward their shape memorized deployed position as shown inFIG. 11 to engage the wall W I of the fallopian tube. The extent they return to their fully memorized position will depend on the size of the fallopian tube. Thecatheter 50 is then withdrawn into the uterus and inserted into fallopian tube F2 (FIG. 12 ) (or another catheter is used) wherein anotherocclusion device 10 is exposed from thecatheter 50 so the struts move to the expanded position to engage the wall W2 of tube F2 as illustrated inFIG. 13 . The expanded mesh functions to block the travel of eggs through the tube. - As can be appreciated, although described for closing the fallopian tube, the occlusion device can be used in other areas of the body.
- Note, the material inside or outside the retention member could be non-porous or porous. It could alternatively be made of pericardium, SIS, PET, PTFE, or other materials.
- In the alternate embodiment of
FIG. 19 , awound wire 100 provides a support member formesh 110. The wire as shown has a substantially conical mesh so the diameter (transverse dimension) at region 112 exceeds the diameter (transverse dimension) at region 114. Themesh 110 is provided on an outer surface as shown. Alternatively, the mesh could be positioned inside or a strip of mesh spanning the opening could be provided. The wire could have hooks, barbs or other surfaces to enhance retention in addition to the outward radial force against the fallopian tube wall. - While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. For example other materials can be contained or mounted to the retention member to function to block eggs from passage through the fallopian tubes. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.
Claims (17)
1. A device for occluding the a fallopian tube comprising a retention member and a mesh material supported by the retention member, the retention member having a first lower profile configuration for delivery and a second expanded configuration for placement within the fallopian tube, the mesh material configured to block passage of an egg through the fallopian tube, the retention member having at least one fallopian tube engagement member to secure the retention member to the fallopian tube, the mesh material is a strip of material to form a screen type blocking member to span an opening of the retention member, the retention member having a center point and the mesh material positioned proximal of the at least one engagement member and only distal of the center point of the retention member.
2. The device of claim 1 , wherein the mesh is attached to an outer surface of the retention member.
3. The device of claim 1 , wherein the mesh is positioned within the retention member.
4. The device of claim 1 , wherein the retention member has a plurality of struts defining a space therebetween and the mesh fills a substantial region of the space.
5. The device of claim 1 , wherein the strip of material is connected to an inner surface of the retention member.
6. The device of claim 5 , wherein the mesh is positioned at a region adjacent the at least one tube engagement member.
7. The device of claim 1 , wherein the retention member has a plurality of struts forming a space therebetween and the mesh is positioned to span the space.
8. The device of claim 1 , wherein the at least one tube engagement member includes a plurality of teeth.
9. The device of claim 1 , wherein the retention member has a plurality of struts and the struts terminate in the at least one tube engagement member.
10. The device for claim 1 , wherein the retention member comprises a wound wire.
11. The device of claim 1 , wherein the retention member is composed of shape memory material.
12. A device for occluding a fallopian tube comprising a tube laser cut to form a series of struts, the tube having a first lower profile configuration for delivery and a second configuration for placement, in the second configuration the tube having an expanded configuration, the struts extending outwardly so that a distal region of the struts has a greater dimension and the struts defining a space therebetween, a mesh material supported by the struts and providing a blocking member to block the egg from passage through the fallopian tube, the mesh material is a strip of material to form a screen type blocking member to span an opening of the retention member, the device having a center point, and the mesh material positioned proximal of the at least one engagement member and only distal of the center point.
13-14. (canceled)
15. The device of claim 12 , wherein the mesh material is attached to an outer surface of the struts.
16. (canceled)
17. The device of claim 12 , wherein the retention member is composed of shape memory material.
18-19. (canceled)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/173,418 US20110259341A1 (en) | 2007-05-31 | 2011-06-30 | Fallopian Tube Occlusion Device |
Applications Claiming Priority (3)
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US93240507P | 2007-05-31 | 2007-05-31 | |
US12/151,953 US7992565B2 (en) | 2007-05-31 | 2008-05-09 | Fallopian tube occlusion device |
US13/173,418 US20110259341A1 (en) | 2007-05-31 | 2011-06-30 | Fallopian Tube Occlusion Device |
Related Parent Applications (1)
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US12/151,953 Continuation US7992565B2 (en) | 2007-05-31 | 2008-05-09 | Fallopian tube occlusion device |
Publications (1)
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US20110259341A1 true US20110259341A1 (en) | 2011-10-27 |
Family
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US13/173,418 Abandoned US20110259341A1 (en) | 2007-05-31 | 2011-06-30 | Fallopian Tube Occlusion Device |
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US12/151,953 Active 2028-11-22 US7992565B2 (en) | 2007-05-31 | 2008-05-09 | Fallopian tube occlusion device |
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EP (1) | EP2152212A1 (en) |
JP (1) | JP2010532180A (en) |
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CA (1) | CA2687777A1 (en) |
WO (1) | WO2008153653A1 (en) |
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2008
- 2008-05-09 WO PCT/US2008/006000 patent/WO2008153653A1/en active Application Filing
- 2008-05-09 AU AU2008262587A patent/AU2008262587B2/en not_active Ceased
- 2008-05-09 US US12/151,953 patent/US7992565B2/en active Active
- 2008-05-09 CA CA002687777A patent/CA2687777A1/en not_active Abandoned
- 2008-05-09 JP JP2010510283A patent/JP2010532180A/en active Pending
- 2008-05-09 EP EP08754329A patent/EP2152212A1/en not_active Withdrawn
-
2011
- 2011-06-30 US US13/173,418 patent/US20110259341A1/en not_active Abandoned
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Publication number | Priority date | Publication date | Assignee | Title |
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US20070100372A1 (en) * | 2005-11-02 | 2007-05-03 | Cook Incorporated | Embolic protection device having a filter |
Also Published As
Publication number | Publication date |
---|---|
US7992565B2 (en) | 2011-08-09 |
JP2010532180A (en) | 2010-10-07 |
CA2687777A1 (en) | 2008-12-18 |
WO2008153653A1 (en) | 2008-12-18 |
US20080302368A1 (en) | 2008-12-11 |
AU2008262587B2 (en) | 2013-05-23 |
EP2152212A1 (en) | 2010-02-17 |
AU2008262587A1 (en) | 2008-12-18 |
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