US6176240B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Contraceptive transcervical fallopian tube occlusion devices and their delivery
Assignee: Bayer Essure Inc
•
Filing: 1995-06-07
•
Granted: 2001-01-23
•
Expires: 2015-06-07
Abstract
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 imposing a secondary shape on a resilient structure, 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. The resilient structure is then restrained by the walls of the fallopian tube, imposing anchoring forces as it tries to resume the secondary shape.
Inventors
- 👤 Julian Nikolchev
- 👤 Dai Ton
- 👤 Amy Thurmond
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:44
CPC Classifications
A; A61; A61F; A61F6/00; A61F6/20; A61F6/22; A61F6/225; A61B; A61B17/00; A61B17/12; A61B17/12022; A61B17/12099; A61B17/12131; A61B17/1214; A61B17/12145; A61B17/1215; A61F6/06; A61F6/14; A61F6/18; A61B2017/1205
Claims Analysis
Total Claims: 51
Claim 1
Independent Claim
94 words
An intrafallopian contraceptive device comprising: a pre-formed resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one distal anchor adapted for insertion through an isthmus of a fallopian tube and capable of anchoring against a tubal wall of the fallopian tube when released therein, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween.
Claim 2
Dependent Claim
94 words
An intrafallopian contraceptive device comprising: a pre-formed resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one distal anchor adapted for insertion through an isthmus of a fallopian tube and capable of anchoring against a tubal wall of the fallopian tube when released therein, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween.
Claim 3
Dependent Claim
19 words
An intrafallopian contraceptive device as claimed in claim 1 , wherein the resilient structure comprises a resilient primary coil.
Claim 4
Dependent Claim
32 words
An intrafallopian contraceptive device as claimed in claim 2 , wherein the primary coil comprises a material selected from the group consisting of beryllium, zinc, stainless steel, platinum, and shape memory alloy.
Claim 5
Dependent Claim
22 words
An intrafallopian contraceptive device as claimed in claim 2 , wherein the primary coil comprises an alloy including at least 75% copper.
Claim 6
Dependent Claim
30 words
An intrafallopian contraceptive device as claimed in claim 2 , wherein the primary coil comprises a plated layer of a material selected from the group containing copper and copper alloy.
Claim 7
Dependent Claim
33 words
An intrafallopian contraceptive device as claimed in claim 1 , wherein the distal anchor of the resilient structure is restrainable in a straight configuration for insertion through the isthmus of the fallopian tube.
Claim 8
Dependent Claim
44 words
An intrafallopian contraceptive device as claimed in claim 6 , wherein the resilient structure has an outer diameter in the range between 0.2 mm and 5 mm and a length in the range between 20 mm and 150 mm when in the straight configuration.
Claim 9
Dependent Claim
27 words
An intrafallopian contraceptive device as claimed in claim 6 , wherein the resilient structure has a width of at least 3 mm when in a relaxed state.
Claim 10
Dependent Claim
30 words
An intrafallopian contraceptive device as claimed in claim 1 , wherein the device comprises at least three bends which form loops in the resilient structure when in a relaxed state.
Claim 11
Dependent Claim
82 words
An intrafallopian contraceptive device comprising: a resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween, wherein the resilient structure comprises a primary coil, and wherein the primary coil comprises an alloy including beryllium and copper.
Claim 12
Dependent Claim
82 words
An intrafallopian contraceptive device comprising: a resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween, wherein the resilient structure comprises a primary coil, and wherein the primary coil comprises an alloy including beryllium and copper.
Claim 13
Dependent Claim
82 words
An intrafallopian contraceptive device comprising: a resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween; and fibers carried on the resilient structure, the fibers comprising a material selected from the group containing copper and polyester.
Claim 14
Dependent Claim
82 words
An intrafallopian contraceptive device comprising: a resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween; and fibers carried on the resilient structure, the fibers comprising a material selected from the group containing copper and polyester.
Claim 15
Dependent Claim
96 words
An intrafallopian contraceptive device comprising: a resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween, wherein the device comprises at least three bends which form loops in the resilient structure when in a relaxed state, and wherein the loops are separated by straight sections when in a relaxed state.
Claim 16
Dependent Claim
96 words
An intrafallopian contraceptive device comprising: a resilient structure having a proximal end and a distal end, the resilient structure comprising copper and being biased to form at least one proximal anchor adjacent the proximal end and at least one distal anchor adjacent the distal end, the at least one proximal anchor and at least one distal anchor defining an isthmus-traversing region therebetween, wherein the device comprises at least three bends which form loops in the resilient structure when in a relaxed state, and wherein the loops are separated by straight sections when in a relaxed state.
Claim 17
Dependent Claim
19 words
An intrafallopian contraceptive device as claimed in claim 12 , wherein the isthmus-traversing region includes one of the bends.
Claim 18
Dependent Claim
122 words
An intrafallopian contraceptive device comprising: a resilient primary coil having a proximal end, a distal end, and a primary coil diameter, wherein: 1) the primary coil comprises copper; 2) the primary coil forms a secondary shape when in a relaxed state, the secondary shape defining a plurality of bends which are separated along the primary coil to define an overall width which is larger than the primary coil diameter; and 3) the primary coil is restrainable in a straight configuration for insertion into a fallopian tube, and the bends of the secondary shape are capable of imposing resilient anchoring forces against an inner surface of a tubal wall so as to avoid inadvertent expulsion of the primary coil from the fallopian tube.
Claim 19
Dependent Claim
122 words
An intrafallopian contraceptive device comprising: a resilient primary coil having a proximal end, a distal end, and a primary coil diameter, wherein: 1) the primary coil comprises copper; 2) the primary coil forms a secondary shape when in a relaxed state, the secondary shape defining a plurality of bends which are separated along the primary coil to define an overall width which is larger than the primary coil diameter; and 3) the primary coil is restrainable in a straight configuration for insertion into a fallopian tube, and the bends of the secondary shape are capable of imposing resilient anchoring forces against an inner surface of a tubal wall so as to avoid inadvertent expulsion of the primary coil from the fallopian tube.
Claim 20
Dependent Claim
32 words
An intrafallopian contraceptive device as claimed in claim 14 , wherein the primary coil comprises a material selected from the group consisting of beryllium, zinc, stainless steel, platinum, and shape memory alloy.
Claim 21
Dependent Claim
24 words
An intrafallopian contraceptive device as claimed in claim 14 , wherein the coil diameter is in the range between 0.2 mm and 5 mm.
Claim 22
Dependent Claim
31 words
An intrafallopian contraceptive device as claimed in claim 14 , wherein the primary coil has a length in the range between 20 mm and 150 mm when in a straight configuration.
Claim 23
Dependent Claim
19 words
An intrafallopian contraceptive device as claimed in claim 14 , wherein the overall width is at least 6 mm.
Claim 24
Dependent Claim
22 words
An intrafallopian contraceptive device as claimed in claim 14 , wherein each of the bends forms a loop in the primary coil.
Claim 25
Dependent Claim
18 words
An intrafallopian contraceptive device as claimed in claim 19 , wherein the loops are separated by straight sections.
Claim 26
Dependent Claim
71 words
An intrafallopian contraceptive device comprising: a resilient primary coil having a proximal end, a distal end, and a primary coil diameter, wherein: 1) the primary coil comprises copper; and 2) the primary coil forms a secondary shape when in a relaxed state, the secondary shape defining a plurality of bends and an overall width which is larger than the primary coil diameter; wherein the coil comprises an alloy including beryllium copper.
Claim 27
Dependent Claim
71 words
An intrafallopian contraceptive device comprising: a resilient primary coil having a proximal end, a distal end, and a primary coil diameter, wherein: 1) the primary coil comprises copper; and 2) the primary coil forms a secondary shape when in a relaxed state, the secondary shape defining a plurality of bends and an overall width which is larger than the primary coil diameter; wherein the coil comprises an alloy including beryllium copper.
Claim 28
Dependent Claim
82 words
An intrafallopian contraceptive device comprising: a resilient primary coil having a proximal end, a distal end, and a primary coil diameter, wherein: 1) the primary coil comprises copper; and 2) the primary coil forms a secondary shape when in a relaxed state, the secondary shape defining a plurality of bends and an overall width which is larger than the primary coil diameter; and fibers disposed on the resilient structure, the fibers comprising a material selected from the group containing copper and polyester.
Claim 29
Dependent Claim
82 words
An intrafallopian contraceptive device comprising: a resilient primary coil having a proximal end, a distal end, and a primary coil diameter, wherein: 1) the primary coil comprises copper; and 2) the primary coil forms a secondary shape when in a relaxed state, the secondary shape defining a plurality of bends and an overall width which is larger than the primary coil diameter; and fibers disposed on the resilient structure, the fibers comprising a material selected from the group containing copper and polyester.
Claim 30
Dependent Claim
194 words
An intrafallopian contraceptive delivery system comprising: an elongate body having a proximal end, a distal end, and a delivery lumen; a resilient primary coil slidably disposed within the elongate body, the primary coil having a proximal end and a distal end, the primary coil comprising copper and being biased to form at least one proximal anchor bend at the proximal end and at least one distal anchor bend at the distal end, the proximal and distal anchor bends defining an isthmus-traversing region therebetween, the proximal and distal anchor bends capable of imposing resilient anchoring forces against an inner surface of a tubal wall proximally and distally of an isthmus of a fallopian tube, respectively, so as to avoid inadvertent expulsion of the primary coil proximally and distally beyond the isthmus; and a shaft slidably disposed within the delivery lumen of the elongate body proximally of the primary coil, the shaft having a coil interface surface near the distal end; wherein the elongate body radially restrains the primary coil in a straight configuration, and the coil may be released by axially restraining the coil against the coil interface surface while proximally withdrawing the elongate body.
Claim 31
Dependent Claim
194 words
An intrafallopian contraceptive delivery system comprising: an elongate body having a proximal end, a distal end, and a delivery lumen; a resilient primary coil slidably disposed within the elongate body, the primary coil having a proximal end and a distal end, the primary coil comprising copper and being biased to form at least one proximal anchor bend at the proximal end and at least one distal anchor bend at the distal end, the proximal and distal anchor bends defining an isthmus-traversing region therebetween, the proximal and distal anchor bends capable of imposing resilient anchoring forces against an inner surface of a tubal wall proximally and distally of an isthmus of a fallopian tube, respectively, so as to avoid inadvertent expulsion of the primary coil proximally and distally beyond the isthmus; and a shaft slidably disposed within the delivery lumen of the elongate body proximally of the primary coil, the shaft having a coil interface surface near the distal end; wherein the elongate body radially restrains the primary coil in a straight configuration, and the coil may be released by axially restraining the coil against the coil interface surface while proximally withdrawing the elongate body.
Claim 32
Dependent Claim
51 words
An intrafallopian contraceptive delivery system as claimed in claim 23 , wherein the shaft, the coil interface surface, and the coil are electrically conductive so that the electrical current can be transmitted from a proximal end of the shaft to affix the coil to a tubal wall of the fallopian tube.
Claim 33
Dependent Claim
66 words
An intrafallopian contraceptive method comprising: restraining a pre-formed resilient structure in a straight configuration, the resilient structure comprising copper and having an isthmus-traversing region which includes at least one bend; transcervically inserting the restrained resilient structure into an isthmus of a fallopian tube; releasing the resilient structure within the isthmus, so that the isthmus-traversing region exerts an anchoring force against a wall of the fallopian tube.
Claim 34
Dependent Claim
66 words
An intrafallopian contraceptive method comprising: restraining a pre-formed resilient structure in a straight configuration, the resilient structure comprising copper and having an isthmus-traversing region which includes at least one bend; transcervically inserting the restrained resilient structure into an isthmus of a fallopian tube; releasing the resilient structure within the isthmus, so that the isthmus-traversing region exerts an anchoring force against a wall of the fallopian tube.
Claim 35
Dependent Claim
71 words
A method as claimed in claim 25 , further comprising: releasing a distal portion of the resilient structure distally of the isthmus, the distal portion including at least one bend which resiliently engages the surface of the surrounding tubal wall; and releasing a proximal portion of the resilient structure proximally of the isthmus, the proximal portion including at least one bend which resiliently engages the surface of the surrounding tubal wall.
Claim 36
Dependent Claim
43 words
A method as claimed in claim 25 , wherein the restraining step comprises inserting the resilient structure within a lumen of a catheter, the resilient structure being released within the fallopian tube by axially restraining the resilient structure and proximally withdrawing the catheter.
Claim 37
Dependent Claim
31 words
A method as claimed in claim 25 , further comprising inhibiting fertilization by exposing a multiplicity of copper fibers within the fallopian tube, the fibers being disposed on the resilient structure.
Claim 38
Dependent Claim
52 words
A method as claimed in claim 25 , wherein the introducing step comprises: positioning a distal end of a tubular body adjacent to an ostium; inserting a delivery catheter containing the resilient structure through the tubular body to the target region, the delivery catheter restraining the resilient body in the straight configuration.
Claim 39
Dependent Claim
44 words
A method as claimed in claim 25 , further comprising applying an electrical current through the resilient body to the fallopian tube to dessechate the wall and affix the resilient body to the wall of the fallopian tube so as to effect permanent sterilization.
Claim 40
Dependent Claim
136 words
An intrafallopian contraceptive device comprising a pre-formed resilient structure having a proximal end and a distal end, the resilient structure comprising a resilient coil and including: a proximal anchor adjacent the proximal end to anchor the resilient structure within a fallopian tube; an isthmus-traversing region extending distally from the proximal anchor, the isthmus-traversing region insertable through an isthmus of the fallopian tube; a distal anchor separated from the proximal anchor by the isthmus-traversing region with a straight section of the coil disposed between the proximal anchor and the distal anchor, the distal anchor restrainable in a straight configuration for insertion through the isthmus of the fallopian tube, the distal anchor capable of imposing a resilient anchoring force against an inner surface of the fallopian tube where the inner surface is larger in cross-section than the isthmus.
Claim 41
Dependent Claim
136 words
An intrafallopian contraceptive device comprising a pre-formed resilient structure having a proximal end and a distal end, the resilient structure comprising a resilient coil and including: a proximal anchor adjacent the proximal end to anchor the resilient structure within a fallopian tube; an isthmus-traversing region extending distally from the proximal anchor, the isthmus-traversing region insertable through an isthmus of the fallopian tube; a distal anchor separated from the proximal anchor by the isthmus-traversing region with a straight section of the coil disposed between the proximal anchor and the distal anchor, the distal anchor restrainable in a straight configuration for insertion through the isthmus of the fallopian tube, the distal anchor capable of imposing a resilient anchoring force against an inner surface of the fallopian tube where the inner surface is larger in cross-section than the isthmus.
Claim 42
Dependent Claim
26 words
An intrafallopian contraceptive device as claimed in claim 31 , wherein the coil comprises a plated material selected from the group containing copper or copper alloy.
Claim 43
Dependent Claim
65 words
An intrafallopian contraceptive device as claimed in claim 31 , wherein the coil comprises copper, wherein each anchor includes at least one bend imposed on the coil so that an axis of the coil defines a loop, wherein the isthmus-traversing region comprises a bend imposed on the coil so that an axis of the coil defines a loop, and wherein straight sections separate the loops.
Claim 44
Dependent Claim
30 words
An intrafallopian contraceptive device as claimed in claim 31 , wherein the isthmus-traversing region maintains separation between the proximal anchor and the distal anchor when the coil is at rest.
Claim 45
Dependent Claim
131 words
An intrafallopian contraceptive device comprising a pre-formed resilient structure having a proximal end and a distal end, the resilient structure including: a proximal anchor adjacent the proximal end to anchor the resilient structure within a fallopian tube; an isthmus-traversing region extending distally from the proximal anchor, the isthmus-traversing region insertable through an isthmus of the fallopian tube; a distal anchor separated from the proximal anchor by the isthmus-traversing region, the distal anchor restrainable in a straight configuration for insertion through the isthmus of the fallopian tube, the distal anchor capable of imposing a resilient anchoring force against an inner surface of the fallopian tube where the inner surface is larger in cross-section than the isthmus; and polyester fibers disposed between the proximal end and the distal end of the resilient structure.
Claim 46
Dependent Claim
131 words
An intrafallopian contraceptive device comprising a pre-formed resilient structure having a proximal end and a distal end, the resilient structure including: a proximal anchor adjacent the proximal end to anchor the resilient structure within a fallopian tube; an isthmus-traversing region extending distally from the proximal anchor, the isthmus-traversing region insertable through an isthmus of the fallopian tube; a distal anchor separated from the proximal anchor by the isthmus-traversing region, the distal anchor restrainable in a straight configuration for insertion through the isthmus of the fallopian tube, the distal anchor capable of imposing a resilient anchoring force against an inner surface of the fallopian tube where the inner surface is larger in cross-section than the isthmus; and polyester fibers disposed between the proximal end and the distal end of the resilient structure.
Claim 47
Dependent Claim
121 words
An intrafallopian sterilization system comprising: an elongate body having a proximal end, a distal end, and a delivery lumen therebetween; a resilient structure slidably disposed within the elongate body, the resilient structure being insertable into a fallopian tube within the elongate body and adapted to resiliently engage the surrounding tubal wall when released therein, the resilient structure having an electrically conductive surface; a shaft removably disposed within the delivery lumen of the elongate body proximally of the resilient structure to effect release of the resilient structure from the elongate body; wherein the resilient structure is electrically coupled to the shaft for the application of electrical current which attaches the resilient structure to the tubal wall so as to effect permanent sterilization.
Claim 48
Dependent Claim
121 words
An intrafallopian sterilization system comprising: an elongate body having a proximal end, a distal end, and a delivery lumen therebetween; a resilient structure slidably disposed within the elongate body, the resilient structure being insertable into a fallopian tube within the elongate body and adapted to resiliently engage the surrounding tubal wall when released therein, the resilient structure having an electrically conductive surface; a shaft removably disposed within the delivery lumen of the elongate body proximally of the resilient structure to effect release of the resilient structure from the elongate body; wherein the resilient structure is electrically coupled to the shaft for the application of electrical current which attaches the resilient structure to the tubal wall so as to effect permanent sterilization.
Claim 49
Dependent Claim
103 words
An intrafallopian contraceptive method comprising: transcervically introducing a resilient coil into a fallopian tube; releasing a distal anchor of the coil distally of an isthmus of the fallopian tube so that the distal anchor resiliently engages the inner surface of the tubal wall; releasing a proximal anchor of the coil proximally of the isthmus so that the proximal anchor resiliently engages the inner surface of the tubal wall, the proximal and distal anchors being coupled to each other and separated by an isthmus-traversing region of the coil so as to avoid inadvertent expulsion of the coil proximally and distally from the fallopian tube.
Claim 50
Dependent Claim
103 words
An intrafallopian contraceptive method comprising: transcervically introducing a resilient coil into a fallopian tube; releasing a distal anchor of the coil distally of an isthmus of the fallopian tube so that the distal anchor resiliently engages the inner surface of the tubal wall; releasing a proximal anchor of the coil proximally of the isthmus so that the proximal anchor resiliently engages the inner surface of the tubal wall, the proximal and distal anchors being coupled to each other and separated by an isthmus-traversing region of the coil so as to avoid inadvertent expulsion of the coil proximally and distally from the fallopian tube.
Claim 51
Dependent Claim
29 words
A intrafallopian contraceptive method as claimed in claim 37 , further comprising exposing a plating material on the resilient coil within the fallopian tube, the plating material comprising copper.
References Cited (Backward Citations)
US3561438A
Cited
US3687129A
Cited
US3774600A
Cited
US3858586A
Cited
USRE29345E
Cited
US3805767A
Cited
US3858571A
Cited
US3973560A
Cited
US4111196A
Cited
US4057063A
Cited
US4416660A
Cited
US4185618A
Cited
US4509504A
Cited
DE2803685A1
Cited
EP0010812A1
Cited
NL7810696A
Cited
US4353363A
Cited
GB2038186A
Cited
US4365621A
Cited
US4612924A
Cited
US4579110A
Cited
US4595000A
Cited
US4638803A
Cited
US4628924A
Cited
US4727866A
Cited
US4606336A
Cited
US4700701A
Cited
US4788966A
Cited
GB2211095A
Cited
US4994069A
Cited
US4932421A
Cited
CN1047447A
Cited
US5065751A
Cited
US5095917A
Cited
US5474089A
Cited
WO1993006884A1
Cited
US5354309A
Cited
US5207684A
Cited
WO1994006503A1
Cited
US5522822A
Cited
WO1994010936A1
Cited
US5562641A
Cited
US5556396A
Cited
US5458636A
Cited
US5514176A
Cited
US5582619A
Cited
WO1998026737A1
Cited
WO1998055046A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-01-23 | 2004-07-24 | 2005-01-23 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-01-23 | 2008-07-24 | 2009-01-23 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-01-23 | 2012-07-24 | 2013-01-23 | $7700.00 | Window Closed / Lapsed |