US20210212727A1 - Medical device and method for preventing adhesions - Google Patents
Medical device and method for preventing adhesions Download PDFInfo
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- US20210212727A1 US20210212727A1 US17/145,755 US202117145755A US2021212727A1 US 20210212727 A1 US20210212727 A1 US 20210212727A1 US 202117145755 A US202117145755 A US 202117145755A US 2021212727 A1 US2021212727 A1 US 2021212727A1
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- uterine cavity
- agent
- tether
- interval
- thin film
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- 238000000034 method Methods 0.000 title claims abstract description 43
- 210000004291 uterus Anatomy 0.000 claims description 23
- 239000010409 thin film Substances 0.000 claims description 21
- 239000002831 pharmacologic agent Substances 0.000 claims description 18
- 239000003795 chemical substances by application Substances 0.000 claims description 10
- 238000002271 resection Methods 0.000 claims description 9
- 229940030225 antihemorrhagics Drugs 0.000 claims description 7
- 239000002874 hemostatic agent Substances 0.000 claims description 7
- 230000000740 bleeding effect Effects 0.000 claims description 5
- 239000012530 fluid Substances 0.000 claims description 5
- 230000007246 mechanism Effects 0.000 claims description 5
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims description 5
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims description 5
- 238000002679 ablation Methods 0.000 claims description 4
- 239000000730 antalgic agent Substances 0.000 claims description 4
- 210000003679 cervix uteri Anatomy 0.000 claims description 3
- 230000008878 coupling Effects 0.000 claims description 3
- 238000010168 coupling process Methods 0.000 claims description 3
- 238000005859 coupling reaction Methods 0.000 claims description 3
- 238000007789 sealing Methods 0.000 claims description 3
- 230000004888 barrier function Effects 0.000 claims description 2
- 238000002513 implantation Methods 0.000 claims description 2
- 238000002560 therapeutic procedure Methods 0.000 claims description 2
- 230000000202 analgesic effect Effects 0.000 claims 1
- 239000002260 anti-inflammatory agent Substances 0.000 claims 1
- 229940121363 anti-inflammatory agent Drugs 0.000 claims 1
- 238000011477 surgical intervention Methods 0.000 abstract description 2
- 201000010260 leiomyoma Diseases 0.000 description 6
- 238000000576 coating method Methods 0.000 description 5
- 238000001356 surgical procedure Methods 0.000 description 5
- 230000001419 dependent effect Effects 0.000 description 3
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- 238000012986 modification Methods 0.000 description 3
- 239000008177 pharmaceutical agent Substances 0.000 description 3
- 208000037062 Polyps Diseases 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 208000031737 Tissue Adhesions Diseases 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 239000000701 coagulant Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00893—Material properties pharmaceutically effective
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00951—Material properties adhesive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B2017/4216—Operations on uterus, e.g. endometrium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0815—Implantable devices for insertion in between organs or other soft tissues
- A61B2090/0816—Implantable devices for insertion in between organs or other soft tissues for preventing adhesion
Definitions
- the present invention relates to an intra-uterine device adapted for temporary placement in a uterine cavity to prevent adhesions following a surgical intervention.
- a method for treating a uterine cavity includes deploying a device within the uterine cavity in a delivery profile, the device having a contact surface carrying a first pharmacological agent; expanding the device to cause the contact surface to move into an expanded profile where the contact surface engages a surface of the uterine cavity to tamponade a bleeding at the surface of the uterine cavity and such that the first pharmacological agent releases from the contact surface into the surface of the uterine cavity over a first interval; collapsing the device to a collapsed profile to provide a barrier between uterine cavity surfaces wherein a second pharmacological agent releases from the contact surfaces over a second interval; and removing the device after the second interval.
- Variations of the method can include a second interval that begins after a first interval ends.
- the intervals can overlap or can be spaced in time.
- the first pharmacological agents can be selected from a group constanting of a hemostatic agent, an analgesic agent, an anti-cramping agent, and a non-steroidal anti-inflammatory agent.
- the second pharmacological agent can be selected from a group consisting of an anti-adhesion agent, an analgesic agent, an anti-cramping agent, and a non-steroidal anti-inflammatory agent.
- the disclosure includes the use of any pharmacologic, biologic, or medicinal agent as needed.
- the uterine cavity can include one or more regions of tissue that are damaged, including but not limited to tissue that is damaged after a therapeutic procedure. Such procedures can include resection, curettage and/or ablation of tissue.
- deploying the device includes trans-cervically introducing an elongate introducer into the uterine cavity and deploying the device from a passageway in the elongate introducer.
- Variations of the methods and device can include deploying the device using a spring-like element in the device to expand the device to a triangular shape in the uterine cavity.
- deploying the device includes removing introducer from a uterus and a cervix and leaving a tether extending through a cervical canal, where the tether is connected to the device.
- Expanding the device can include inflating the device with a fluid injected through a lumen of a tether coupled to an interior chamber of the device.
- any inflation or expansion means is within the scope of this disclosure.
- the device can be maintained in the expanded position by sealing the lumen of the tether.
- Additional variations of the tether can include an actuatable a stop mechanism in a portion of the tether outside the uterine cavity, inside the uterine cavity, or at any location relative to the device. In such cases, releasing the device to reduce the expanded profile can comprise actuating the stop mechanism to unseal the lumen.
- Additional pharmacological agents can be dispensed through a second tether channel into the uterine cavity.
- the device can be removed from the uterine cavity after the second interval.
- removal can occur by pulling a tether or other structure coupled to the device outwardly from a cervical canal and uterine cavity.
- the present disclosure further includes devices configured for temporary implantation in a uterine cavity following a medical procedure therein.
- a device can include a tissue contacting structure being moveable between a deployment configuration, a collapsed, configuration, and an expanded configuration in which the tissue contacting structure engages a surface of the uterine cavity; where the tissue contacting structure comprises a thin film member disposed around a spring element; and at least one pharmacological agent located on or in the thin film member and configured to be releasable from a surface of the thin film member over a time release interval.
- the device can include a thin film member that has a fluid tight interior chamber to allow inflation of the thin film member.
- the devices can include one or more tethers for inflation, delivery of substances, and/or retrieval of the device from the uterine cavity.
- one or more of the tethers can include an inflation balloon therein adapted for coupling to an inflation source.
- FIG. 1 illustrates a variation of the present invention which consists of an expandable-collapsible anti-adhesion device adapted for temporary deployment in a patient's uterus together with an introducer that is configured for trans-cervical introduction of the anti-adhesion device into a patient's uterus.
- FIG. 2A is a schematic view of the patient's uterus with the fibroid in the uterine wall, and an endoscope and resection device in phantom view introduced through the cervical canal into the uterine cavity to resect the fibroid in a myomectomy procedure.
- FIG. 2B is a subsequent view of the patient's uterus after the fibroid has been resected with the resecting device, again shown in phantom view.
- FIG. 3A is a subsequent view of the patient's uterus as in FIGS. 2A-2B after removal of the endoscope and resection device further showing initial step in the method of the invention which consists of the trans-cervical introduction of an elongated introducer sleeve of the present invention that carries a deployable anti-adhesion device.
- FIG. 3B illustrates another step of the invention comprising an initial stage of the deployment of the anti-adhesion adhesion device of the invention, wherein the introducer sleeve is withdrawn to deploy the anti-adhesion device.
- FIG. 3C illustrates a subsequent step of the invention comprising the full deployment of the anti-adhesion adhesion device following further retraction of the introducer sleeve into the cervical canal.
- FIG. 3D illustrates a subsequent step of the invention comprising the deployment of the anti-adhesion adhesion device following removal of the introducer sleeve altogether which leaves a tether in place, and the further step of inflating the anti-adhesion device.
- FIG. 3E illustrates a final step in a method of using the invention which comprising pulling on tether to remove the anti-adhesion device from the patient's uterus.
- anti-adhesion system 100 which consists of an expandable-collapsible device 105 and an elongate introducer 110 .
- the anti-adhesion device 105 when expanded and deployed in a patient's uterus has drug-delivery surfaces 111 that engage and contact the walls 112 of the patient's uterus 114 (see FIG. 3C ).
- the anti-adhesion device 105 consists of a thin film member 115 that can be elastomeric or non-elastomeric and is laterally expandable from a collapsed state to an expanded state by an interior spring element 120 .
- the spring element 120 is a wire or flat ribbon member that has resilient spring characteristics capable of expanding the thin film member 115 to its expanded state or shape.
- the thin film member 115 surrounds the spring element 120 and comprises an inflatable structure, which can be inflated and expanded by a liquid or gas from an inflation source 125 following deployment in a patient's uterus.
- a tether 140 is coupled to a proximal end 142 of the thin wall member and device 105 .
- the tether 140 is tubular and has an interior lumen 144 for coupling to the inflation source 125 for inflating the anti-adhesion device.
- the spring element 120 can assist in the lateral expansion of the anti-adhesion device 105 and the inflation source 125 can further assist in expanding the thickness of the device 105 to ensure contact of the outer surface 111 of the thin film member 115 with the uterine cavity walls for tamponading the uterine cavity wall following a resection procedure.
- the anti-adhesion device 105 can be collapsed and carried in the interior passageway 148 of a thin wall introducer member 110 .
- the introducer 110 has a handle 150 and carries an internal pusher member or rod 158 for pushing the anti-adhesion device 105 outwardly from the interior passageway 148 .
- the manual withdrawal of the introducer 110 while maintaining the pusher member 158 in place can be used to deploy the anti-adhesion device 105 in the patient's uterus.
- the elongated introducer 110 consists of a sleeve fabricated of a plastic or metal having a length suited for extending through the patient's cervical canal 164 and the length of the uterine cavity 114 ( FIG. 3A ).
- the outer diameter of the introducer 110 can be 5 mm or less and is often 3 mm in diameter or less.
- the anti-adhesion device 105 is adapted to perform multiple functions which may be necessary to prevent or eliminate the potential for adhesions in a patient's uterus following a surgical procedure such as a myomectomy, polyp removal, ablation or other surgical treatment.
- the inflation of the thin film member 115 can be used as a tamponade in the uterus following a resection procedure as will be described further below.
- the outer surface of the thin film layer and edges of the device carry at least one pharmaceutical agent adapted to provide a hemostatic effect. More in particular, the outer surface of the thin film member 115 is adapted for time-release of the hemostatic agent(s) within a 24-hour period following deployment in the patient's uterus.
- hemostatic agents or coagulants may act on blood coagulation pathways in different manners to prevent or promote blood clot formation, many of which are known in the art.
- the controlled, timed-release aspect of the invention can be provided by any bioerodible, dissolvable, or bioresorbable coating on the device that carries the hemostatic agents.
- the outer surface of the thin film member carries one or more additional pharmaceutical agents there are adapted to provide at least one of an anti-inflammatory effect, pain relief, or an anti-cramping effect.
- Anti-inflammatory drugs such as NSAIDs well known in the art. These agents are adapted for release from the surface of the device within an interval ending after 72 hours following deployment in the patient's uterus.
- the time release aspect again can be provided by leaders of the bioerodible, bioabsorbable or resorbable coatings on the thin film member.
- the outer surface of the anti-adhesion device 105 can carry one or more other pharmaceutical agents adapted to provide anti-cramping that extend to 28 days following deployment in a patient's uterus.
- the coatings on the surface of the thin film member can include 2 or 3 different layers that offer time release of different pharmacological agents over time.
- FIG. 2A is a schematic sectional view of a patient's uterus 115 with a fibroid 170 in the uterine wall 112 .
- an endoscope 172 and resection device 175 are shown in phantom view introduced through the cervical canal 164 into the uterine cavity to resect the fibroid 170 in a myomectomy procedure.
- the resection device 175 can be a tubular cutter is known in the art.
- 2B is a subsequent view of the patient's uterus 114 after the fibroid 170 has been resected with the resecting device, indicating a resected wall surface 177 that may be bleeding.
- the endoscope 172 and resection device 175 are again shown in phantom view.
- FIGS. 3A-3E the steps of a method of the invention are illustrated.
- the elongate introducer 110 carrying the collapsed anti-adhesion device 105 is introduced through the patient's cervical canal 164 into the patient's uterine cavity.
- FIG. 3B it can be seen that the elongate introducer 110 is withdrawn in the proximal direction while the pusher member or rod 158 is held stationary which deploys the anti-adhesion device 105 outwardly from the distal tip 182 of the introducer 110 .
- introducer 100 is fully retracted and the pusher rod 158 remains stationary to thereby fully deploy the device 105 outwardly from the distal tip 182 of the introducer 110 .
- FIG. 3C that shows the anti-adhesion device 105 fully deployed with the spring member 120 expanding the device into its triangular shape in the uterine cavity.
- FIG. 3D next shows the anti-adhesion device 105 deployed with the introducer 110 completely removed from the patient's body which thereby leaves a tubular tether 140 extending from the device through the cervical canal 164 and cervix to the exterior of the patient's body. Thereafter, an inflation source 125 is connected to the tubular tether 140 .
- the tether is highly elongated and extends through the passageway 148 in the introducer 110 and handle 150 together with the pusher rod 158 .
- the tether 140 can be carried on the outside of the introducer 110 .
- tubular tether 140 which is adapted for fluid expansion or inflation of the device 105 can be independent and detachable from the device 105 after inflation of the device.
- another thread-like tether can be provided for later withdrawal of the device 105 from the uterine cavity.
- FIG. 3D then further illustrates the inflation source 125 that is coupled to the tubular tether 140 to inflate the anti-adhesion device 105 .
- the expansion of the device 105 and uterine cavity can serve as a tamponade to stop any bleeding at the treatment site.
- the coatings on the device can erode or dissolve stepwise, or layer by layer, with the first pharmacological component of the invention (hemostatic agents) being bioavailable immediately and then terminating after 12 to 24 hours following deployment.
- the inflated anti-adhesion device 105 can be deflated through a valve 185 or pressure release mechanism at the proximal end of the tubular tether 140 . Thereafter, the flattened but still laterally expanded anti-adhesion device 105 can remain in the patient's uterus 114 for a subsequent time interval that can extend to 15 days or to 30 days after deployment. Most often, the device would remain deployed for a period of time ranging from 7 days to 30 days. During such a third time interval, the coatings would provide for timed release of additional anti-cramping drugs as described above.
- the anti-adhesion device 105 can be removed from the uterus 114 by pulling on the tether 140 which collapses the spring member 120 and the thin film member 115 to allow its withdrawal through the cervical canal 164 .
- method of the invention prevents adhesions by positioning a mechanical member between walls of the uterus so they cannot adhere to one another, by providing a tamponading effect immediately following the surgery, and by pharmacological agents in a timed-release manner to ensure that adhesions do not occur.
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Abstract
Methods and devices for treatment of a uterine cavity to prevent adhesions following a surgical intervention.
Description
- This application claims benefit of U.S. provisional application 62/959,686 filed on Jan. 10, 2020, the entirety of which is incorporated by reference.
- The present invention relates to an intra-uterine device adapted for temporary placement in a uterine cavity to prevent adhesions following a surgical intervention.
- Following a gynecological procedure or surgery, such as a myomectomy, polyp removal, ablation, curettage or another uterine surgery, a frequent complication are post-surgical adhesions between anterior and posterior walls of the uterus.
- The present disclosure includes methods and devices for treating a uterine cavity. For example, the treatment can include a uterine cavity that is injured following a medical procedure or other trauma that causes bleeding therein. In one example, a method for treating a uterine cavity includes deploying a device within the uterine cavity in a delivery profile, the device having a contact surface carrying a first pharmacological agent; expanding the device to cause the contact surface to move into an expanded profile where the contact surface engages a surface of the uterine cavity to tamponade a bleeding at the surface of the uterine cavity and such that the first pharmacological agent releases from the contact surface into the surface of the uterine cavity over a first interval; collapsing the device to a collapsed profile to provide a barrier between uterine cavity surfaces wherein a second pharmacological agent releases from the contact surfaces over a second interval; and removing the device after the second interval.
- Variations of the method can include a second interval that begins after a first interval ends. Alternatively, the intervals can overlap or can be spaced in time.
- The first pharmacological agents can be selected from a group constating of a hemostatic agent, an analgesic agent, an anti-cramping agent, and a non-steroidal anti-inflammatory agent. The second pharmacological agent can be selected from a group consisting of an anti-adhesion agent, an analgesic agent, an anti-cramping agent, and a non-steroidal anti-inflammatory agent. However, the disclosure includes the use of any pharmacologic, biologic, or medicinal agent as needed.
- As noted above, the uterine cavity can include one or more regions of tissue that are damaged, including but not limited to tissue that is damaged after a therapeutic procedure. Such procedures can include resection, curettage and/or ablation of tissue.
- In an additional variation of the method deploying the device includes trans-cervically introducing an elongate introducer into the uterine cavity and deploying the device from a passageway in the elongate introducer.
- Variations of the methods and device can include deploying the device using a spring-like element in the device to expand the device to a triangular shape in the uterine cavity.
- In an additional variation of methods described herein include deploying the device includes removing introducer from a uterus and a cervix and leaving a tether extending through a cervical canal, where the tether is connected to the device.
- Expanding the device can include inflating the device with a fluid injected through a lumen of a tether coupled to an interior chamber of the device. However, any inflation or expansion means is within the scope of this disclosure. Once expanded, the device can be maintained in the expanded position by sealing the lumen of the tether. Additional variations of the tether can include an actuatable a stop mechanism in a portion of the tether outside the uterine cavity, inside the uterine cavity, or at any location relative to the device. In such cases, releasing the device to reduce the expanded profile can comprise actuating the stop mechanism to unseal the lumen.
- Additional pharmacological agents can be dispensed through a second tether channel into the uterine cavity.
- In an additional variation, the device can be removed from the uterine cavity after the second interval. For example, removal can occur by pulling a tether or other structure coupled to the device outwardly from a cervical canal and uterine cavity.
- The present disclosure further includes devices configured for temporary implantation in a uterine cavity following a medical procedure therein. For example, such a device can include a tissue contacting structure being moveable between a deployment configuration, a collapsed, configuration, and an expanded configuration in which the tissue contacting structure engages a surface of the uterine cavity; where the tissue contacting structure comprises a thin film member disposed around a spring element; and at least one pharmacological agent located on or in the thin film member and configured to be releasable from a surface of the thin film member over a time release interval.
- Variations of the device can include a thin film member that has a fluid tight interior chamber to allow inflation of the thin film member. As noted above, the devices can include one or more tethers for inflation, delivery of substances, and/or retrieval of the device from the uterine cavity. Moreover, one or more of the tethers can include an inflation balloon therein adapted for coupling to an inflation source.
-
FIG. 1 illustrates a variation of the present invention which consists of an expandable-collapsible anti-adhesion device adapted for temporary deployment in a patient's uterus together with an introducer that is configured for trans-cervical introduction of the anti-adhesion device into a patient's uterus. -
FIG. 2A is a schematic view of the patient's uterus with the fibroid in the uterine wall, and an endoscope and resection device in phantom view introduced through the cervical canal into the uterine cavity to resect the fibroid in a myomectomy procedure. -
FIG. 2B is a subsequent view of the patient's uterus after the fibroid has been resected with the resecting device, again shown in phantom view. -
FIG. 3A is a subsequent view of the patient's uterus as inFIGS. 2A-2B after removal of the endoscope and resection device further showing initial step in the method of the invention which consists of the trans-cervical introduction of an elongated introducer sleeve of the present invention that carries a deployable anti-adhesion device. -
FIG. 3B illustrates another step of the invention comprising an initial stage of the deployment of the anti-adhesion adhesion device of the invention, wherein the introducer sleeve is withdrawn to deploy the anti-adhesion device. -
FIG. 3C illustrates a subsequent step of the invention comprising the full deployment of the anti-adhesion adhesion device following further retraction of the introducer sleeve into the cervical canal. -
FIG. 3D illustrates a subsequent step of the invention comprising the deployment of the anti-adhesion adhesion device following removal of the introducer sleeve altogether which leaves a tether in place, and the further step of inflating the anti-adhesion device. -
FIG. 3E illustrates a final step in a method of using the invention which comprising pulling on tether to remove the anti-adhesion device from the patient's uterus. - Referring to
FIG. 1 , inanti-adhesion system 100 corresponding to the present invention is shown which consists of an expandable-collapsible device 105 and anelongate introducer 110. Theanti-adhesion device 105 when expanded and deployed in a patient's uterus has drug-delivery surfaces 111 that engage and contact thewalls 112 of the patient's uterus 114 (seeFIG. 3C ). In one variation, theanti-adhesion device 105 consists of athin film member 115 that can be elastomeric or non-elastomeric and is laterally expandable from a collapsed state to an expanded state by aninterior spring element 120. In one variation, thespring element 120 is a wire or flat ribbon member that has resilient spring characteristics capable of expanding thethin film member 115 to its expanded state or shape. - In the variation shown in
FIG. 1 , thethin film member 115 surrounds thespring element 120 and comprises an inflatable structure, which can be inflated and expanded by a liquid or gas from aninflation source 125 following deployment in a patient's uterus. As can be seen inFIG. 1 , atether 140 is coupled to aproximal end 142 of the thin wall member anddevice 105. In one variation, thetether 140 is tubular and has aninterior lumen 144 for coupling to theinflation source 125 for inflating the anti-adhesion device. Thus, thespring element 120 can assist in the lateral expansion of theanti-adhesion device 105 and theinflation source 125 can further assist in expanding the thickness of thedevice 105 to ensure contact of theouter surface 111 of thethin film member 115 with the uterine cavity walls for tamponading the uterine cavity wall following a resection procedure. - Still referring to
FIG. 1 , it can be understood that theanti-adhesion device 105 can be collapsed and carried in theinterior passageway 148 of a thin wall introducermember 110. Further, theintroducer 110 has ahandle 150 and carries an internal pusher member orrod 158 for pushing theanti-adhesion device 105 outwardly from theinterior passageway 148. As will be described below, the manual withdrawal of theintroducer 110 while maintaining thepusher member 158 in place can be used to deploy theanti-adhesion device 105 in the patient's uterus. In one variation, theelongated introducer 110 consists of a sleeve fabricated of a plastic or metal having a length suited for extending through the patient'scervical canal 164 and the length of the uterine cavity 114 (FIG. 3A ). The outer diameter of theintroducer 110 can be 5 mm or less and is often 3 mm in diameter or less. - The
anti-adhesion device 105 is adapted to perform multiple functions which may be necessary to prevent or eliminate the potential for adhesions in a patient's uterus following a surgical procedure such as a myomectomy, polyp removal, ablation or other surgical treatment. In a first aspect of the invention, the inflation of thethin film member 115 can be used as a tamponade in the uterus following a resection procedure as will be described further below. - In a second aspect of the invention, the outer surface of the thin film layer and edges of the device carry at least one pharmaceutical agent adapted to provide a hemostatic effect. More in particular, the outer surface of the
thin film member 115 is adapted for time-release of the hemostatic agent(s) within a 24-hour period following deployment in the patient's uterus. Such hemostatic agents or coagulants may act on blood coagulation pathways in different manners to prevent or promote blood clot formation, many of which are known in the art. The controlled, timed-release aspect of the invention can be provided by any bioerodible, dissolvable, or bioresorbable coating on the device that carries the hemostatic agents. - In a third aspect of the invention, the outer surface of the thin film member carries one or more additional pharmaceutical agents there are adapted to provide at least one of an anti-inflammatory effect, pain relief, or an anti-cramping effect. Anti-inflammatory drugs such as NSAIDs well known in the art. These agents are adapted for release from the surface of the device within an interval ending after 72 hours following deployment in the patient's uterus. The time release aspect again can be provided by leaders of the bioerodible, bioabsorbable or resorbable coatings on the thin film member.
- In another aspect of the invention, the outer surface of the
anti-adhesion device 105 can carry one or more other pharmaceutical agents adapted to provide anti-cramping that extend to 28 days following deployment in a patient's uterus. In other words, the coatings on the surface of the thin film member can include 2 or 3 different layers that offer time release of different pharmacological agents over time. - Now turning to
FIGS. 2A-2B andFIGS. 3A-3E , a number of steps relating to a method of the invention are illustrated.FIG. 2A is a schematic sectional view of a patient'suterus 115 with afibroid 170 in theuterine wall 112. InFIG. 2A , anendoscope 172 andresection device 175 are shown in phantom view introduced through thecervical canal 164 into the uterine cavity to resect thefibroid 170 in a myomectomy procedure. Theresection device 175 can be a tubular cutter is known in the art.FIG. 2B is a subsequent view of the patient'suterus 114 after thefibroid 170 has been resected with the resecting device, indicating a resectedwall surface 177 that may be bleeding. Theendoscope 172 andresection device 175 are again shown in phantom view. - Now referring to
FIGS. 3A-3E , the steps of a method of the invention are illustrated. InFIG. 3A , theelongate introducer 110 carrying the collapsedanti-adhesion device 105 is introduced through the patient'scervical canal 164 into the patient's uterine cavity. InFIG. 3B , it can be seen that theelongate introducer 110 is withdrawn in the proximal direction while the pusher member orrod 158 is held stationary which deploys theanti-adhesion device 105 outwardly from the distal tip 182 of theintroducer 110. - Now turning to
FIG. 3C ,introducer 100 is fully retracted and thepusher rod 158 remains stationary to thereby fully deploy thedevice 105 outwardly from the distal tip 182 of theintroducer 110.FIG. 3C that shows theanti-adhesion device 105 fully deployed with thespring member 120 expanding the device into its triangular shape in the uterine cavity. -
FIG. 3D next shows theanti-adhesion device 105 deployed with theintroducer 110 completely removed from the patient's body which thereby leaves atubular tether 140 extending from the device through thecervical canal 164 and cervix to the exterior of the patient's body. Thereafter, aninflation source 125 is connected to thetubular tether 140. In one variation the tether is highly elongated and extends through thepassageway 148 in theintroducer 110 and handle 150 together with thepusher rod 158. In other variations, thetether 140 can be carried on the outside of theintroducer 110. Further, it should be appreciated that thetubular tether 140 which is adapted for fluid expansion or inflation of thedevice 105 can be independent and detachable from thedevice 105 after inflation of the device. In such a case, where thetubular tether 140 is removable, another thread-like tether can be provided for later withdrawal of thedevice 105 from the uterine cavity. -
FIG. 3D then further illustrates theinflation source 125 that is coupled to thetubular tether 140 to inflate theanti-adhesion device 105. The expansion of thedevice 105 and uterine cavity can serve as a tamponade to stop any bleeding at the treatment site. In the deployed position ofFIG. 3D , the coatings on the device can erode or dissolve stepwise, or layer by layer, with the first pharmacological component of the invention (hemostatic agents) being bioavailable immediately and then terminating after 12 to 24 hours following deployment. - After a first-time interval, which may be from 3 hours to 24 hours, the inflated
anti-adhesion device 105 can be deflated through avalve 185 or pressure release mechanism at the proximal end of thetubular tether 140. Thereafter, the flattened but still laterally expandedanti-adhesion device 105 can remain in the patient'suterus 114 for a subsequent time interval that can extend to 15 days or to 30 days after deployment. Most often, the device would remain deployed for a period of time ranging from 7 days to 30 days. During such a third time interval, the coatings would provide for timed release of additional anti-cramping drugs as described above. - Thereafter, referring to
FIG. 3E , theanti-adhesion device 105 can be removed from theuterus 114 by pulling on thetether 140 which collapses thespring member 120 and thethin film member 115 to allow its withdrawal through thecervical canal 164. Generally, method of the invention prevents adhesions by positioning a mechanical member between walls of the uterus so they cannot adhere to one another, by providing a tamponading effect immediately following the surgery, and by pharmacological agents in a timed-release manner to ensure that adhesions do not occur. - Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.
- Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
- Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
- All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
Claims (24)
1. A method of treating a uterine cavity following a medical procedure therein, the method comprising:
deploying a device within the uterine cavity in a delivery profile, the device having a contact surface carrying a first pharmacological agent;
expanding the device to cause the contact surface to move into an expanded profile where the contact surface engages a surface of the uterine cavity to tamponade a bleeding at the surface of the uterine cavity and such that the first pharmacological agent releases from the contact surface into the surface of the uterine cavity over a first interval;
collapsing the device to a collapsed profile to provide a barrier between uterine cavity surfaces wherein a second pharmacological agent releases from the contact surfaces over a second interval; and
removing the device after the second interval.
2. The method of claim 1 , where the second interval begin after the first interval ends.
3. The method of claim 1 , wherein the first pharmacological agent is selected from a group constating of a hemostatic agent, an analgesic agent, an anti-cramping agent, and a non-steroidal anti-inflammatory agent.
4. The method of claim 1 , wherein the second pharmacological agent is selected from a group consisting of an anti-adhesion agent, an analgesic agent, an anti-cramping agent, and a non-steroidal anti-inflammatory agent.
5. The method of claim 1 , wherein the uterine cavity comprises an area of damaged produced by a therapeutic procedure.
6. The method of claim 5 , wherein the area of damaged tissue is produced by a procedure selected form a group consisting of resection, curettage and ablation.
7. The method of claim 1 , wherein deploying the device includes trans-cervically introducing an elongate introducer into the uterine cavity and deploying the device from a passageway in the elongate introducer.
8. The method of claim 1 , wherein deploying the device includes allowing a spring-like element in the device to expand the device to a triangular shape in the uterine cavity.
9. The method of claim 1 , wherein deploying the device includes removing introducer from a uterus and a cervix and leaving a tether extending through a cervical canal, where the tether is connected to the device.
10. The method of claim 1 , wherein expanding the device includes inflating the device with a fluid injected through a lumen of a tether coupled to an interior chamber of the device.
11. The method of claim 10 , further comprising maintaining the device in the expanded profile for the first interval by sealing the lumen of the tether.
12. The method of claim 11 , wherein sealing the lumen of the tether comprises actuating a stop mechanism in a portion of the tether outside the uterine cavity.
13. The method of claim 12 , wherein releasing the device comprises actuating the stop mechanism to unseal the lumen.
14. The method of claim 1 , wherein the first interval comprises 24 hours or less.
15. The method of claim 1 , wherein the second interval comprises 28 days from an end of the first interval.
16. The method of claim 1 , further comprising injecting at least one additional pharmacological agent through a second tether channel into the uterine cavity.
17. The method of claim 1 , further comprising removing the device from the uterine cavity after the second interval.
18. The method of claim 17 , wherein removing the device comprises pulling a tether coupled to the device outwardly from a cervical canal and uterine cavity.
19. A device configured for temporary implantation in a uterine cavity following a medical procedure therein, the device comprising:
a tissue contacting structure being moveable between a deployment configuration, a collapsed, configuration, and an expanded configuration in which the tissue contacting structure engages a surface of the uterine cavity;
where the tissue contacting structure comprises a thin film member disposed around a spring element; and
at least one pharmacological agent located on or in the thin film member and configured to be releasable from a surface of the thin film member over a time release interval.
20. The device of claim 19 , wherein a pharmacological agent is a hemostatic agent.
21. The device of claim 19 , wherein a pharmacological agent is selected from a group of an anti-inflammatory agent, an analgesic, an anti-cramping agent or an anti-adhesion agent.
22. The device of claim 19 , wherein the thin film member has a fluid tight interior chamber to allow inflation of the thin film member.
23. The device of claim 19 , further comprising an elongated tether couple to the device.
24. The device of claim 23 , where the elongated tether has an inflation balloon therein adapted for coupling to an inflation source.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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US17/145,755 US20210212727A1 (en) | 2020-01-10 | 2021-01-11 | Medical device and method for preventing adhesions |
US18/351,375 US20230355274A1 (en) | 2020-01-10 | 2023-07-12 | Medical device and method for preventing adhesions |
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US202062959686P | 2020-01-10 | 2020-01-10 | |
US17/145,755 US20210212727A1 (en) | 2020-01-10 | 2021-01-11 | Medical device and method for preventing adhesions |
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US18/351,375 Division US20230355274A1 (en) | 2020-01-10 | 2023-07-12 | Medical device and method for preventing adhesions |
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US17/145,755 Abandoned US20210212727A1 (en) | 2020-01-10 | 2021-01-11 | Medical device and method for preventing adhesions |
US18/351,375 Pending US20230355274A1 (en) | 2020-01-10 | 2023-07-12 | Medical device and method for preventing adhesions |
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US20060089658A1 (en) * | 2004-10-21 | 2006-04-27 | Harrington Douglas C | Method and apparatus for treating abnormal uterine bleeding |
CN200984216Y (en) * | 2006-12-04 | 2007-12-05 | 李秀梅 | Hemostatic arrangement of the uterus concealed hemorrhage |
WO2013033791A1 (en) * | 2011-09-09 | 2013-03-14 | Endoluminal Sciences Pty Ltd | Means for controlled sealing of endovascular devices |
US20150196300A1 (en) * | 2014-01-16 | 2015-07-16 | Boston Scientific Scimed Inc. | Retrieval wire centering device |
US20200187985A1 (en) * | 2017-12-03 | 2020-06-18 | Nasser Kamal Abd Elaal | Medicated Uterine Balloon with Cervical Barricade for Management of Postpartum Hemorrhage |
-
2021
- 2021-01-11 US US17/145,755 patent/US20210212727A1/en not_active Abandoned
-
2023
- 2023-07-12 US US18/351,375 patent/US20230355274A1/en active Pending
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US20060089658A1 (en) * | 2004-10-21 | 2006-04-27 | Harrington Douglas C | Method and apparatus for treating abnormal uterine bleeding |
CN200984216Y (en) * | 2006-12-04 | 2007-12-05 | 李秀梅 | Hemostatic arrangement of the uterus concealed hemorrhage |
WO2013033791A1 (en) * | 2011-09-09 | 2013-03-14 | Endoluminal Sciences Pty Ltd | Means for controlled sealing of endovascular devices |
US20150196300A1 (en) * | 2014-01-16 | 2015-07-16 | Boston Scientific Scimed Inc. | Retrieval wire centering device |
US20200187985A1 (en) * | 2017-12-03 | 2020-06-18 | Nasser Kamal Abd Elaal | Medicated Uterine Balloon with Cervical Barricade for Management of Postpartum Hemorrhage |
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