text:
A microcatheter for delivery of embolic fluids includes an outer member dimensioned for insertion within a blood vessel adjacent an embolization site. The outer member defines a first longitudinal lumen, and an inner member is selectively positionable within the first longitudinal lumen of the outer member. The inner member defines a second longitudinal lumen and has a delivery port in fluid communication with the second longitudinal lumen for passage and delivery of embolic fluids toward the embolization site. A valve is disposed within the outer member. The valve is dimensioned to establish a substantial seal about the inner member, to minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery thereof toward the embolization site.
The present disclosure generally relates to intravascular devices and methods for facilitating delivery of an embolic composition into a blood vessel of a patient. In particular, the disclosure relates to an apparatus, system and method for the containment and restraint of a fluid embolic composition to or within an embolization site.
The delivery of fluid embolic compositions that solidify in vivo is particularly useful for a variety of reasons including treatment of blood vessels, tumors, aneurysms, arteriovenous malformations (“AVMs”), and arteriovenous fistulas (“AVF”). Delivery of such compositions is preferably accomplished via catheter techniques that permit the selective placement of the catheter at the delivery site. In practice, the catheter tip is directed to the vascular delivery site by use of conventional visualization techniques such as fluoroscopy, which allow the clinician to visualize the catheter tip. After placement of the catheter, the composition is introduced into the catheter and delivered to this site. Upon delivery, a biocompatible solvent of the composition dissipates into the blood, fluid, or tissue, and a water insoluble polymer of the composition precipitates to form a coherent mass, which solidifies in vivo. In the treatment of an AVM, for example, depending on the rate at which the liquid embolic composition is delivered and the amount of blood flow present, the dissipation of the biocompatible solvent may be sufficiently slow to permit the polymer, in liquid form, to migrate away from the AVM or embolization site. This migration may cause the occlusion of undesired locations in the vasculature, or the undesired occlusion of an intravascular device provided for delivering the liquid embolic composition.
Accordingly, it would be desirable to provide an apparatus for delivery of a liquid embolic composition to an AVM or aneurysm to prevent the embolic composition from passing outside of the desired embolization site into the vasculature.
Similarly, it would be desirable to provide an apparatus for delivery of a liquid embolic composition to an aneurysm that prevents backflow or reflux of the embolic composition into the vasculature.
In accordance with one embodiment of the present disclosure, a microcatheter for delivery of embolic fluids includes an outer member dimensioned for insertion within a blood vessel adjacent an embolization site. The outer member defines a first longitudinal lumen, and an inner member is selectively positionable within the first longitudinal lumen of the outer member. The inner member defines a second longitudinal lumen and has a delivery port in fluid communication with the second longitudinal lumen for passage and delivery of embolic fluids toward the embolization site. A valve is disposed within the outer member. The valve is dimensioned to establish a substantial seal about the inner member, to thereby minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery of the fluids toward the embolization site.
The outer member may include an expandable member disposed on an exterior wall surface adjacent the delivery port. The expandable member may be dimensioned to expand and engage an interior wall portion of the blood vessel to at least partially isolate the embolization site. The expandable member may include an inflatable balloon. The inflatable balloon may be in fluid communication with the first longitudinal lumen of the outer member, and may be adapted to inflate upon passage of inflation fluids through the first longitudinal lumen.
The valve may be monolithically formed with the outer member, or the valve may be connected to an inner wall surface of the outer member. The valve may be dimensioned and adapted to substantially close in the absence of the inner member to substantially close the first longitudinal lumen of the outer member. The valve may comprise a passive valve, and the passive valve may comprise a plurality of resilient flaps formed by a plurality of radial slits. The plurality of resilient flaps may be biased to normally close the first longitudinal lumen when the inner member is removed from the passive valve. The passive valve may comprise an active hydrogel configured to harden in the presence of blood.
According to a further aspect of the disclosure, a system for embolizing a body lumen includes a microcatheter dimensioned for insertion within a blood vessel and being advanceable within the blood vessel to an embolization site. The microcatheter includes an outer member and an inner member selectively positionable within the outer member and defining a fluid lumen terminating at a fluid port. A valve is disposed within the outer member, and is adapted to establish a seal about the inner member when positioned within the outer member. The system further includes a fluid source having an embolic composition and being in fluid communication with the fluid lumen of the inner member. The embolic composition is deliverable to exit the fluid port for delivery within the embolization site.
The system may include a balloon member mounted about the outer member. The balloon member may be adapted for expansion to engage an interior wall of the blood vessel to at least partially isolate the embolization site to assist in containing the embolic composition within the embolization site. The system may further include a guidewire to facilitate accessing the embolization site. The guidewire may be dimensioned to be received within the outer member. The valve may be adapted to substantially close in the absence of the inner member.
According to a further aspect of the disclosure, a method of embolizing a body lumen includes the steps of: (i) advancing a guidewire through a vasculature to position a leading end of the guidewire at a target location; (ii) advancing an outer member over the guidewire until a leading end of the outer member is adjacent the leading end of the guidewire; (iii) withdrawing the guidewire from outer member; (iv) inserting an inner member through the outer member until a leading end of the inner member is disposed adjacent the leading end of the outer member; and (v) delivering an embolic composition to the target location through the inner member.
The step of advancing the guidewire may include positioning the leading end of the guidewire at a location within the vasculature that is distal of an aneurysm. The step of inserting an inner member through the outer member may include forming a seal between the outer and inner members. The method may further include the steps of: (vi) providing an inflatable balloon on an exterior wall surface of the outer member; and (vii) introducing an inflation fluid into the outer member to inflate the balloon.
FIGS. 9A-9C are partial, schematic views of the system of FIG. 1 in various stages of an alternate use at a second target location within the vasculature of the patient.
In the following description, the terms “proximal” and “distal” as used herein refer to the relative position of the instrument in a lumen. The “proximal” or “trailing” end of the instrument is generally the segment of the instrument that extends outside the body of a patient and is closest to the clinician. The “distal” or “leading” end of the instrument is the segment of the instrument placed farthest into a body lumen from the entrance site.
The microcatheter of the present disclosure includes has particular application in an intracranial or neurovascular procedure. However, the microcatheter may be used in any interventional, diagnostic, and/or therapeutic procedure including coronary vascular, peripheral vascular, and gastro-intestinal applications in addition to a neurovascular application. The microcatheter may be a component of an apparatus or system used in conjunction with any of the above applications. As discussed in greater detail hereinbelow, the apparatus or system may include additional components including, e.g., a guidewire, an embolic fluid source or any other component necessary to facilitate the performance of the contemplated medical procedure.
In the figures below, the full length of the microcatheter and/or guidewire is not shown. The length of the microcatheter and/or guidewire can vary depending on the type of interventional procedure, though typically it ranges in length from 30 to 400 centimeters (cm). Common lengths of microcatheters and/or guidewires for coronary, peripheral and neurovascular interventions may range from 170 to 300 cm.
The various embodiments of the disclosure will now be described in connection with the drawing figures. It should be understood that for purposes of better describing the disclosure, the drawings may not be to scale. Further, some of the figures include enlarged or distorted portions for the purpose of showing features that would not otherwise be apparent.
Referring to FIG. 1, a medical system 10 of the present disclosure may include an elongate microcatheter 100, a source of a fluid embolic composition “E” and a source of an inflation media or fluid “I.” The medical system 10 may further include a guidewire 200 upon which microcatheter 100 may be positioned or advanced toward a targeted treatment site. The microcatheter 100 defines a longitudinal axis K-K, and has a leading end 100A and a trailing end 100B. The microcatheter 100 includes an outer catheter member 102 and an inner catheter member 104 disposed therein. The inner catheter member 104 is movable within the outer catheter member 102, and as discussed below, may be removed from the outer catheter member 102 to permit at least partial passage of the guidewire 200 through the outer catheter member 102.
In general, the guidewire 200 includes an actuator 202 and an elongate guide member 204 extending from the actuator 202. The elongate guide member 204 is dimensioned for insertion within the vasculature or a blood vessel of a subject, and includes a leading end 208 and a trailing end 210. The guidewire 200 may include any commonly used guidewire.
The source of embolic composition “E” is provided in fluid communication with a proximal access port 106 of the inner catheter member 104. The embolic composition “E” may be any biocompatible composition that solidifies within the body such as a biocompatible polymer dissolved in a biocompatible solvent, e.g., dimethylsulfoxide (DMSO), acetone and the like. Examples of embolic compositions are described in U.S. Pat. Nos. 5,667,767, 5,580,568 and 5,695,480, the entire disclosure of each being incorporated by reference herein. The source of the embolic composition “E” may include a syringe, pump or other mechanism (not shown) to permit a clinician to selectively control the flow of the embolic composition “E” to and through the inner catheter member 104.
The source of inflation fluid “I” is provided in fluid communication with a first proximal access port 110 of the outer catheter member 102. The inflation fluid “I” may include fluids such as air or saline, and may be selectively transmitted to the outer catheter member 102 to inflate an inflatable balloon 154 thereof.
Referring now to FIG. 2, in conjunction with FIG. 1, further features of microcatheter 100 are illustrated and will be discussed in greater detail. The outer catheter member 102 of the microcatheter 100 generally includes an outer elongate member 112 which is dimensioned for insertion within a blood vessel adjacent an embolization site. The outer elongate member 112 has a leading end 114, a trailing end 116, and at least one longitudinal lumen 120 extending therethrough. The outer elongate member 112 may be constructed of a flexible material, e.g., a cylindrical stock of one or more polymers, such as Grilamid brand polyamide/nylon from EMS Chemie, Switzerland, Pebax brand polyether/polyamide, from Actinofina Chemicals, France and the like. A first leading-end segment 122 is defined at the leading end 114 of the outer elongate member 112.
The inner catheter member 104 generally includes an inner elongate member 124, which is selectively positionable within the longitudinal lumen 120 of the outer elongate member 112. The inner elongate member 124 may be constructed of materials similar to the outer elongate member 112 discussed above, and may have an outer diameter substantially similar to the elongate guide member 204 of the guidewire 200 (FIG. 1). The inner elongate member 124 has a leading end 128, a trailing end 130, and at least one longitudinal lumen 132 extending therethrough. The longitudinal lumen 132 defines a fluid lumen and may extend the entire length of the inner elongate member 124. A second leading-end segment 134 is defined at the leading end 128 of the inner elongate member 124.
The first leading-end segment 122 adjacent the leading end 114 of the outer elongate member 112 may be monolithically formed with the outer elongate member 112, or may be a separate component attached to the outer elongate member 112 through bonding, adhesive, thermofusion techniques or other known methods. The first leading-end segment 122 includes a distal access port 146 at the distal end of lumen 120.
A valve 140 is disposed within the first leading-end segment 122 or the outer elongate member 112. The valve 140 is dimensioned to establish a substantial seal about the inner elongate member 124, to thereby minimize entry of embolic fluids within the longitudinal lumen 120 of the outer elongate member 112 subsequent to delivery of the embolic fluids toward the embolization site. The valve 140 is configured to selectively close an annular gap between the outer and inner elongate members 112, 124.
The inflatable balloon 154 is an expandable member supported near the leading end 114 of the outer elongate member 112. The balloon 154 is connected to an exterior wall surface of the outer elongate member 112 at a proximal seal area 156 and a distal seal area 158, thereby defining an enclosed interior space 160. The enclosed interior space 160 is in fluid communication with the lumen 120 through inflation holes 162 extending laterally through the outer elongate member 112. As discussed in greater detail hereinbelow, the balloon 154 is dimensioned to expand and engage an interior wall portion of a blood vessel to at least partially isolate an embolization site.
The outer catheter member 102 may further include a manifold 166 at the trailing end 116 of the outer elongate member 112. The manifold 166 includes the first proximal access port 110 and a second proximal access port 168. The first proximal access port 110 is configured for connection to the source of inflation fluid “I.” The inflation fluid “I” may be selectively transmitted into the second proximal access port 110, and then through the lumen 120 of the outer elongate member 112 and the inflation holes 162 to the interior space 160 to inflate the balloon 154. The second proximal access port 168 receives the inner catheter member 104. A sealing member 172 is provided within the manifold 166 between the first and second proximal access ports 110, 168. The sealing member 172 may be constructed of a flexible, elastomeric material and permits fluid isolation of the first and second proximal access ports 110, 168.
The inner catheter member 104 includes a hub or access port 106 at the trailing end 130 of the inner elongate member 124. The access port 106 is in fluid communication with the longitudinal lumen 132. At the leading end 128 of the inner elongate member 124, the second leading-end segment 134 is defined, which includes a distal access port 176 at a distal end of the longitudinal lumen 132. The distal access port 176 defines a fluid port or delivery port in fluid communication with the longitudinal lumen 132 for passage and delivery of embolic fluids toward an embolization site. The embolic composition “E” (FIG. 1) may be selectively delivered to the microcatheter 100 through the proximal access port 106 of the inner catheter member 104. The embolic composition “E” may be selectively transmitted through the longitudinal lumen 132 of the inner catheter member 104 to the second leading-end segment 134, and may be expelled through the distal access port 176.
The inner elongate member 124 is selectively positionable within the lumen 120 of the outer elongate member 112, and is longitudinally movable therewithin. The inner elongate member 124 engages the valve 140 whereby the valve establishes a sealing relationship with the inner elongate member 124. A mechanism (not shown) may be provided to releasably secure or lock the inner elongate member 124 to the outer elongate member 112. Alternatively, the sealing member 172 and/or the valve 140 may establish a frictional relationship with the inner elongate member 124 to impede longitudinal movement of the inner elongate member 124.
Referring now to FIGS. 3A and 3B, the leading end 114 of the outer elongate member 112 is depicted with the balloon 154 in a deflated configuration. The valve 140 comprises a membrane 178, which may be formed monolithically with, or attached to, an outer wall of the first leading-end segment 122. A central aperture 180 extends through the membrane 178. The aperture 180 may have a diameter of about 0.005 inches, and, thus, the lumen 120 may be substantially, but not be completely closed by the valve 140. The membrane 178 may be constructed of a material having sufficient resilience to permit elastic expansion of the aperture 180 to facilitate passage of the inner elongate member 124 (FIG. 2) and/or the elongate guide member 204 of the guidewire 200 (FIG. 1) therethrough while also creating a substantial sealing relation about the outer surfaces of these components. Suitable materials for the valve 140 include thermoplastic elastomers, e.g., polyisoprene, or natural rubber. In an alternative, the valve 140 may be fabricated from a low durometer thermoplastic elastomer or a gel material. Other materials are also envisioned. The valve 140 may be characterized as a passive valve since the valve 140 responds to the introduction of the guidewire 200 (FIG. 1) or the inner elongate member 124 therethrough by automatically forming a seal therewith without any further positive action by a clinician.
Alternate embodiments of valves in accordance with the present disclosure are illustrated in FIGS. 4A through 7B. A duckbill valve 302 is depicted in FIGS. 4A and 4B at a leading end 304 of an outer elongate member 306. The valve 302 is configured generally as a conical or tapered duckbill including first and second leaflets 308, 310. The leaflets 308, 310 are resilient and biased to the closed configuration in which an inner lumen 312 of the elongate member 306 is completely closed. The leaflets 308, 310 are inclined to depend radially inwardly in the distal direction. The distal incline allows the leaflets 308, 310 to readily open to permit a sealed passage of the inner elongate member 124 (FIG. 2) from a proximal direction, and also to resist the influx of a fluid such as blood and/or an embolic composition “E” at a relatively higher pressure into the inner lumen 312 from the distal side of the valve 302. In other embodiments, a duckbill valve (not depicted) may be provided that exhibits a proximal incline to resist opening when a relatively higher pressure inflation fluid “I” (FIG. 1) is introduced into the inner lumen 312 to inflate balloon 154.
A tri-leaf valve 318 is depicted in FIGS. 5A and 5B. The tri-leaf valve 318 is constructed of a plurality of resilient flaps 320A, 320B, 320C formed by a plurality of radial slits 322A, 322B, 322C. Any number of flaps and slits may be provided that cooperate to permit the passage of the guidewire 200 (FIG. 1) or the inner elongate member 124 (FIG. 2) and resiliently return to a relatively closed configuration (as illustrated) upon removal of the guidewire 200 or the inner elongate member 124. The flaps 320A, 320B, 320C may be constructed of a resilient material to provide a bias to return the flaps 320A, 320B, 320C to the closed configuration in which a lumen 324 through an outer elongate member 326 is closed.
Referring now to FIGS. 6A and 6B, a valve 332 includes a self-sealing or closing plug or membrane 334 positioned proximally with respect to a flexible membrane 336. The flexible membrane 336 may be similar to the membrane 178 (FIG. 3B) described above, and the self-sealing membrane 336 may be constructed of an active hydrogel. The membrane 336 may provide a seal with a guidewire 200 (FIG. 1) as outer elongate member 340 is moved along the guidewire 200 to position the outer elongate member 336 within a vasculature. Thereafter, the guidewire 200 may be withdrawn through lumen 342 permitting blood to move through an aperture 344 in the membrane 336 to contact the membrane 334. In the presence of blood, the membrane 334 may swell to occupy an entire inner diameter of the lumen 342.
Each of the valves 140, 302, 318 and 332 described above may be characterized as passive since each is configured to automatically form a seal with an object inserted therethrough without any further positive action by a clinician. In other embodiments, an active valve, such as valve 348 as depicted in FIGS. 7A and 7B, may be employed to selectively close a lumen 350 extending through an outer elongate member 352. The valve 348 includes an inflatable balloon 356 disposed on an interior side of the outer elongate member 352. The balloon 356 is in fluid communication with an inflation lumen 362 that extends to a proximal end (not shown) of the outer elongate member 352. A clinician may selectively deliver the inflation fluid “I” through the lumen 362 to selectively expand the balloon 356, and thereby substantially close the lumen 362.
With reference to FIG. 7A, a valve 366 may also be provided on an inner elongate member 370 to permit selective closure of the annular gap between outer and inner elongate members 352, 370. The valve 366 may include an inflatable balloon 372 in fluid communication with an inflation lumen 374. The balloon 372 is disposed on an exterior of the inner elongate member 370 such that the balloon 372 may be inflated to selectively obstruct the lumen 350 when positioned within a leading-end segment 376 of outer elongate member 352 by a clinician.
Referring now to FIGS. 8A through 8F, a procedure for treating an aneurysm “a1” with the system 10 (FIG. 1) is discussed. Initially, the elongate guide member 204 of guidewire 200 may be positioned within the vasculature of a patient (FIG. 8A). The elongate guide member 204 may be advanced through a vessel “v1” to position the leading end 208 of the elongate guide member 204 at a target location with respect to the aneurysm “a1” as determined by the clinician. Next, the outer elongate member 112 may be advanced over the elongate guide member 204 until the distal access port 146 and the first leading-end segment 122 are positioned adjacent the leading end 208 of the elongate guide member 204 (FIG. 8B). The leading end 114 of the outer elongate member 112 is thus positioned at the target location, e.g., adjacent the aneurysm “a1.” The valve 140 may establish a sealing relation with the elongate guide member 204 preventing the influx of blood into the outer elongate member 112 through the distal access port 146.
The elongate guide member 204 may then be withdrawn from the longitudinal lumen 120 leaving the outer elongate member 112 in place (FIG. 8C). The valve 140 may substantially close the lumen 120 in the absence of the elongate guide member 204. Thus, the inflation holes 162 may be protected from an influx of blood or other fluids, which may otherwise clog the inflation holes 162.
With the outer elongate member 112 positioned within the vasculature, the inner elongate member 114 may be inserted through the longitudinal lumen 120 of the outer elongate member 112 until the distal access port 176 at the leading end 128 of the inner elongate member 114 is positioned distally of the valve 140 (FIG. 8D). The valve 140 establishes a sealing relationship with the inner elongate member 114. With a seal established between the valve 140 and the inner elongate member 114, the inflation fluid “I” may be introduced and transmitted through the longitudinal lumen 120 of the outer elongate member 112 to inflate the balloon 154 (FIG. 8E). The balloon 154 expands to engage interior wall portions of vessel “v1” and may form a seal therewith to at least partially isolate an embolization site. The valve 140 prevents the escape of the inflation fluid “I” through the distal access port 146 of the longitudinal lumen 120. With the balloon 154 expanded, the embolic composition “E” may be transmitted through the lumen 132 of the inner elongate member 124 and expelled through the distal access port 176 of second leading-end segment 134 (FIG. 8F).
The flow of embolic composition “E” may be continued until the aneurysm “a1” or the desired embolization site is filled and the embolic composition “E” solidifies. During the procedure, backflow of the embolic composition “E” through the vessel “v1” is prevented by the balloon 154, and backflow of the embolic composition “E” through the longitudinal lumen 120 of the outer elongate member 112 is prevented by the valve 140.
Referring now to FIGS. 9A through 9C, an alternate procedure is described for treating an aneurysm “a2” with the system 10 (FIG. 1). Initially, the elongate guide member 204 of guidewire 200 is positioned within the vasculature “v2” of a patient such that the leading end 208 of the elongate guide member 204 is advanced until positioned distal of the aneurysm “a2” (FIG. 9A). Thereafter, the outer elongate member 112 may be advanced over the elongate guide member 204 toward the aneurysm“a2”, the elongate guide member 204 may be withdrawn from the longitudinal lumen 120 of the outer elongate member 112 and the inner elongate member 114 may be inserted through the outer elongate member 112. The balloon 154 may be inflated, and the embolic composition “E” may be delivered through the inner elongate member 114 as described above (FIG. 9B).
Since the leading end 208 of the elongate guide member 204 is positioned distal of the aneurysm “a2,” the distal access port 176 from which the embolic composition “E” is expelled may also be positioned distal of the aneurysm “a2.” The embolic composition “E” may be induced to flow in a proximal or trailing direction relative to the inserted microcatheter 100 into the aneurysm “a2” by the flow of blood in the direction “d” within the vasculature “v2.” The proximal flow of the embolic composition “E” may cause the embolic composition “E” to solidify within the aneurysm “a2” and against exterior surfaces of the outer and inner elongate members 112, 114.
The above description and the drawings are provided for the purpose of describing embodiments of the present disclosure and are not intended to limit the scope of the disclosure in any way. It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.
wherein the outer member includes an expandable member disposed on an exterior wall surface thereof adjacent the delivery port, the expandable member dimensioned to expand and engage an interior wall portion of the blood vessel to at least partially isolate the embolization site.
2. The microcatheter according to claim 1, wherein the expandable member includes an inflatable balloon.
3. The microcatheter according to claim 2, wherein the inflatable balloon is in fluid communication with the first longitudinal lumen of the outer member, and is adapted to inflate upon passage of inflation fluids through the first longitudinal lumen.
4. The microcatheter according to claim 1, wherein the valve is monolithically formed with the outer member.
5. The microcatheter according to claim 1 wherein the valve is connected to an inner wall surface of the outer member.
6. The microcatheter according to claim 1, wherein the valve is dimensioned and adapted to substantially close in the absence of the inner member to substantially close the first longitudinal lumen of the outer member.
7. The microcatheter according to claim 1, wherein the valve comprises a passive valve.
8. The microcatheter according to claim 7, wherein the passive valve comprises a plurality of resilient flaps formed by a plurality of radial slits.
9. The microcatheter according to claim 8, wherein the plurality of resilient flaps are biased to normally close the first longitudinal lumen when the inner member is removed from the passive valve.
10. The microcatheter according to claim 7, wherein the passive valve comprises an active hydrogel configured to harden in the presence of blood.
wherein the outer member includes an expandable member disposed on an exterior wall surface thereof adjacent the fluid port, the expandable member dimensioned to expand and engage an interior wall portion of the blood vessel to at least partially isolate the embolization site.
12. The system according to claim 11, wherein the expandable member includes a balloon member mounted about the outer member.
13. The system according to claim 11 further including a guidewire to facilitate accessing the embolization site.
14. The system according to claim 13 wherein the guidewire is dimensioned to be received within the outer member.
15. The system according to claim 11 wherein the valve is adapted to substantially close in the absence of the inner member.
17. The method according to claim 16, wherein advancing the guidewire includes positioning the leading end of the guidewire at a location within the blood vessel that is distal of an aneurysm.
18. The method according to claim 16, wherein inserting an inner member within the first longitudinal lumen of the outer member includes forming a seal between the outer and inner members with the valve.
introducing an inflation fluid into the outer member to inflate the expandable member, wherein the expandable member includes an inflatable balloon.
WO2002096264A2 (en) 2001-05-25 2002-12-05 Concentric Medical, Inc. Single lumen balloon catheter having chemical-resistant or adherence-resistant balloon section.
European Search Report for European Application No. 13177079.4, dated Nov. 28, 2013, 3 pages.
Examination Report from counterpart European Application No. 13177079.4, dated Jun. 29, 2018, 5 pp.
Examination Report from counterpart European Application No. 13177079.4-1501, dated Dec. 16, 2016, 4 pp.
Notice of Final Rejection, and translation thereof, from counterpart Korean Application No. 10-2015-0164014, dated Nov. 24, 2016, 5 pp.
Notice of Final Rejection, and translation thereof, from counterpart Korean Patent Application No. 10-2013-0092439, dated Jun. 24, 2015, 5 pp.
Notice of Preliminary Rejection, and translation thereof, from counterpart Korean Application No. 10-2015-0164014, dated Jan. 5, 2016, 9 pp.
Notice of Preliminary Rejection, and translation thereof, from counterpart Korean Patent Application No. 10-2013-92439, dated Nov. 7, 2014, 10 pp.
Notice of Second Final Rejection, and translation thereof, counterpart Korean Application No. 10-2013-0092439, dated Oct. 21, 2015, 5 pp.
Notification of Preliminary Rejection, and English translation thereof, from counterpart Korean Application No. 10-2016-0178933, dated Nov. 2, 2018, 10 pp.
Notification of the First Office Action, and translation thereof, from counterpart Chinese Patent Application No. 201310337910.4, dated Dec. 10, 2014, 20 pp.
Office Action, and translation thereof, from counterpart Russian Patent Application No. 2013134195/14, dated Oct. 19, 2014, 11 pp.
Response to Examination Report dated Jun. 29, 2018, from counterpart European Application No. 13177079.4, filed Oct. 22, 2018, 14 pp.
Second Office Action, and translation thereof, from counterpart Chinese Application No. 201310337910.4, dated Jul. 21, 2015, 18 pp.

matches:
Application No. 13177079
Application No. 13177079
Application No. 13177079
Application No. 10
Application No. 10
Application No. 10
Application No. 10
Application No. 10
Application No. 10
Application No. 201310337910
Application No. 2013134195
Application No. 13177079
Application No. 201310337910


§ 28-5 Prohibition on use of Municipal position for personal or private gain.
§ 28-6 Disclosure of interest in legislation and other matters.
§ 28-7 Treatment of public.
§ 28-8 Recusal and abstention.
§ 28-10 Investments in conflict with official duties.
§ 28-11 Private employment in conflict with official duties.
§ 28-13 Personal representations and claims permitted.
§ 28-14 Use of Municipal resources.
§ 28-15 Interests in contracts.
§ 28-17 Political solicitations and campaign activities.
§ 28-20 Board of Ethics.
§ 28-21 Complaints and investigations.
§ 28-23 Confidential ethics advisory opinions.
§ 28-24 Posting and distribution of code.
§ 28-25 Penalties for offenses.
This chapter shall be known as the "Code of Ethics."
Officers and employees of the City of Watervliet hold their positions to serve and benefit the public and not for obtaining unwarranted personal or private gain in the exercise and performance of their official powers and duties. The City of Watervliet recognizes that, in furtherance of this fundamental principle, there is a need for clear and reasonable standards of ethical conduct. This Code of Ethics establishes those standards.
The City Council and any Municipal administrative board (e.g., Planning Board, Zoning Board of Appeals), commission or other agency or body comprised of two or more Municipal officers or employees.
A direct or indirect financial or material benefit, but does not include any benefit arising from the provision or receipt of any services generally available to the residents or taxpayers of the municipality or an area of the municipality, or a lawful class of such residents or taxpayers. A Municipal officer or employee is deemed to have an interest in any private organization when he or she, his or her spouse or a member of his or her household is an owner, partner, member, director, officer or employee or directly or indirectly owns or controls more than 5% of the organization's, outstanding stock.
The City of Watervliet. The word "municipal" refers to the municipality.
A paid or unpaid officer or employee of the City of Watervliet, including, but not limited to, the members of any Municipal board.
A spouse, domestic partner, parent, stepparent, sibling, stepsibling, stepsibling's spouse, child, stepchild, uncle, aunt, nephew, niece, first cousin or household member of a Municipal officer or employee and individuals having any of these relationships to the spouse of the officer or employee.
This Code of Ethics applies to the officers and employees of the City of Watervliet and shall supersede any prior Municipal Code of Ethics. The provisions of this Code of Ethics shall apply in addition to all applicable state and local laws relating to conflicts of interest and ethics, including, but not limited to, Article 18 of the General Municipal Law and all rules, regulations, policies and procedures of the City of Watervliet.
No Municipal officer or employee shall use his or her Municipal position or official powers to secure a financial or material benefit for himself or herself, a relative or any private organization in which he or she is deemed to have an interest.
Whenever a matter requiring the exercise of discretion comes before a Municipal officer or employee, either individually or as a member of a board, and disposition of the matter could result in a direct or indirect financial or material benefit to himself or herself, a relative or any private organization in which he or she is deemed to have an interest, the Municipal officer or employee shall disclose, in writing, the nature of the interest.
The disclosure shall be made when the matter requiring disclosure first comes before the Municipal officer or employee or when the Municipal officer or employee first acquires knowledge of the interest requiring disclosure, whichever is earlier.
In the case of a person serving in an elective office, the disclosure shall be filed with the City Council of the municipality. In all other cases, the disclosure shall be filed with the person's supervisor, or, if the person does not have a supervisor, the disclosure shall be filed with the Municipal officer, employee or board having the power to appoint to the person's position. In addition, in the case of a person serving on a Municipal board, a copy of the disclosure shall be filed with the board. Any disclosure made to a board shall be made publicly at a meeting of the board and must be included in the minutes of the meeting.
An officer or employee of the City of Watervliet shall treat all members of the public, whether a person, firm or corporation or other organization, with respect and in a professional manner, with equal consideration and without special advantage in carrying out his or her official duties.
No Municipal officer or employee may participate in any decision or take any official action with respect to any matter requiring the exercise of discretion including discussing the matter and voting on it, when he or she knows or has reason to know that the action could confer a direct or indirect financial or material benefit on himself or herself, a relative or any private organization in which he or she is deemed to have an interest.
If the power or duty is vested in a Municipal employee, he or she must refer the matter to his or her immediate supervisor, and the immediate supervisor shall designate another person to exercise or perform the power or duty.
Adoption of the municipality's annual budget.
Any matter that does not require the exercise of discretion.
Which comes before a board when a majority of the board's total membership would otherwise be prohibited from acting by § 28-8 of this code.
Which comes before a Municipal officer when the officer would be prohibited from acting by § 28-8 of this code and the matter cannot be lawfully delegated to another person.
Investments from any City of Watervliet auction if the employee or officer is in the position to negotiate, prepare, authorize or approve the contract for the sale upon which he or she is bidding.
Bonds or notes issued by the municipality and acquired more than one year after the date on which the bonds or notes were originally issued.
Requires representation of a person or organization other than the municipality in connection with litigation, negotiations or any other matters to which the municipality is a party.
No Municipal officer or employee may ask for, pursue or accept a private post-government employment opportunity with any person or organization that has a matter requiring the exercise of discretion pending before the Municipal officer or employee, either individually or as a member of a board, while the matter is pending or within the 90 days following final disposition of the matter.
No Municipal officer or employee, for the one-year period after serving as a Municipal officer or employee, may represent or render services to a private person or organization in connection with any matter involving the exercise of discretion before the Municipal office, board, department or comparable organizational unit for which he or she serves.
No Municipal officer or employee at any time after serving as a Municipal officer or employee, may represent or render services to a private person or organization in connection with any particular transaction in which he or she personally and substantially participated while serving as a Municipal officer or employee.
Asserting a claim against the municipality on his or her own behalf, or on behalf of his or her spouse or minor children.
Municipal resources shall be used for lawful Municipal purposes. Municipal resources include, but are not limited to, Municipal personnel and the municipality's money, vehicles, equipment, materials, supplies or other property.
The occasional and incidental use during the business day of Municipal telephones and computers for necessary personal matters such as family care and changes in work schedule.
No Municipal officer or employee shall cause the municipality to spend more than is reasonably necessary for transportation, meals or lodging in connection with official travel.
No Municipal officer or employee may have an interest in a contract that is prohibited by § 801 of the General Municipal Law.
Every Municipal officer and employee shall disclose interests in contracts with the municipality at the time and in the manner required by § 803 of the General Municipal Law.
No Municipal officer or employee, either individually or as a member of a board, may participate in any decision specifically to appoint, hire, promote, discipline or discharge a relative for any position at, for or within the municipality or a Municipal board.
No Municipal officer or employee may supervise a relative in the performance of the relative's official powers or duties.
No Municipal officer or employee shall directly or indirectly compel or induce a subordinate Municipal officer or employee to make, or promise to make, any political contribution, whether by gift of money, service or other thing of value.
No Municipal officer or employee may act or decline to act in relation to appointing, hiring, promoting, discharging or disciplining, or in any manner changing the official rank, status or compensation of, any Municipal officer or employee, or an applicant for a position as a Municipal officer or employee, on the basis of the giving or withholding or neglecting to make any contribution of money or service or any other valuable thing for any political purpose.
No employee shall engage in political campaign activities during his or her official City of Watervliet workday.
No Municipal officer or employee who acquires confidential information in the course of exercising or performing his or her official powers or duties may disclose or use such information unless the disclosure or use is required by law or in the course of exercising or performing his or her official powers and duties.
No Municipal officer or employee shall solicit, accept or receive a gift in violation of § 805-a (l)(a) of the General Municipal Law as interpreted in this section.
No Municipal officer or employee may directly or indirectly solicit any gift.
The gift is intended as a reward for any official action on the part of the officer or employee.
For purposes of this section, a gift includes anything of value, whether in the form of money, service, loan, travel, entertainment, hospitality, thing or promise, or in any other form. The value of a gift is the gift's fair market value, determined by the retail cost of the item or a comparable item. The fair market value of a ticket entitling the holder to food, refreshments, entertainment or any other benefit is the face value of the ticket, or the actual cost to the donor, whichever is greater. Determination of whether multiple gifts from a single donor exceed $75 must be made by adding together the value of all gifts received from the donor by an officer or employee during the twelve-month period preceding the receipt of the most recent gift.
Gifts intended to influence or reward.
A gift to a Municipal officer or employee is presumed to be intended to influence the exercise or performance of his or her official powers or duties when the gift is from a private person or organization that seeks Municipal action involving the exercise of discretion by or with the participation of the officer or employee.
A gift to a Municipal officer or employee is presumed to be intended as a reward for official action when the gift is from a private person or organization that has obtained Municipal action involving the exercise of discretion by or with the participation of the officer or employee during the preceding 12 months.
Meals and refreshments provided when a Municipal officer or employee is a speaker or participant at a job-related professional or educational conference or program and the meals and refreshments are made available to all participants.
A local Board of Ethics, to be known as the City of Watervliet Board of Ethics, is hereby established pursuant to Article 18 of the General Municipal Law.
The Board of Ethics shall consist of three members appointed by a majority of the City Council. One alternate may be appointed by a majority of the City Council to serve in the absence of another member.
There shall be three members of the Board of Ethics initially serving one three-year term, one two-year term and one one-year term. The alternate member shall serve for one three-year term. Subsequently, each member shall be appointed for a three-year term or until such time as a successor is appointed.
Vacancy in office. If a vacancy shall occur otherwise than by expiration of term, the City Council shall appoint the new member for the unexpired term.
Removal of members. The City Council shall have the power to remove, after public hearing, any member of the Board for cause.
The Board of Ethics in existence at the time of the enactment of this section shall be dissolved.
All members of the Board of Ethics must be residents of the municipality.
The members of the Board of Ethics should be qualified by temperament and experience to carry out the duties and responsibilities of the Board.
No member of the Board of Ethics may hold office in a partisan political party or hold elective office in the City of Watervliet. A Board member may make campaign contributions and vote, but not otherwise participate in any City of Watervliet election campaign.
Not more than two members of the Board of Ethics may be members of the same political party.
No current officer or employee of the City of Watervliet is eligible to serve on the Board of Ethics.
Compensation. Members of the Board of Ethics shall serve without compensation but may be reimbursed for reasonable and necessary expenses, as approved by the City Council.
Powers and duties of the Board of Ethics.
The Board of Ethics shall select its own Chairperson from within the Board for a one-year term and appoint such staff as necessary to carry out its duties under this chapter and to delegate authority to the Chairperson, if any, to act in the name of the Board between meetings of the Board, provided that the delegation is in writing and the specific powers to be delegated are enumerated, and further provided that the Board may not delegate the power to conduct hearings, determine violations, recommend disciplinary action, impose civil fines, refer any matter to a prosecutor or render advisory opinions, except as stated in § 28-20E(9).
To prescribe and promulgate rules and regulations governing its own internal organization and procedures in a manner not inconsistent with this chapter or state or federal law.
To conduct investigations pursuant to § 28-21.
To conduct hearings, recommend disciplinary action and initiate appropriate actions and proceedings pursuant to §§ 28-19 and 28-20.
To issue advisory opinions pursuant to § 28-23.
To provide ethics training and education to City officers and employees on the provisions of the City Code of Ethics and Article 18 of the General Municipal Law.
The Board of Ethics of the City of Watervliet may act only with respect to officers and employees of the municipality and persons having business dealing with the municipality. The termination of a City officer's or employee's term of office or employment with the City shall not affect the jurisdiction of the City Board of Ethics with respect to requirements imposed by this chapter on former City officers or employees to the extent permitted by law.
The City Board of Ethics may refer any matter within its jurisdiction to the County Ethics Board in its discretion.
A member of the Board of Ethics may be removed from office by a majority vote of the City Council for failure to fulfill the duties of the office or for violation of this chapter. The City Council must give the Board member written notice and an opportunity to reply.
The Board of Ethics must prepare an annual report to the City Council on its activities and recommend changes to the City Code of Ethics.
Upon receipt of a form duly sworn by the person requesting an investigation of an alleged violation of this chapter or upon the Board determining on its own initiative that a violation of this chapter may exist, the Board of Ethics shall have the power and duty to conduct any investigation necessary to carry out the provisions of this chapter. In conducting any such investigation, the Board may administer oaths or affirmations, subpoena witnesses and compel their attendance and require the production of any books or records which it may deem relevant or material. The form to be utilized in requesting an investigation of an alleged violation of this chapter shall be the form available in the office of the City Clerk and on the City website.
The City Board of Ethics investigation shall be confidential until such time that a final determination of the City Board of Ethics has been made. Thereafter, the City Board of Ethics shall state, in writing, its disposition of every sworn complaint it receives and of every investigation it conducts and shall set forth the reasons for the disposition to the City Council. Any findings of violations of this chapter or other applicable law shall be served upon the subject of the investigation within seven days of such service of any findings of violations of this chapter, and violations shall be made a public record and shall be indexed and maintained on file by the City Clerk.
In its discretion and after a hearing in accordance with Article 3 of the State Administrative Procedure Act (SAPA), and subject to § 75 of the Civil Service Law and any collective bargaining agreements, to the extent practicable, the City Board of Ethics may recommend for action appropriate disciplinary action which may include a written warning or reprimand, forfeiture of accrued leave with pay, required attendance at ethics training seminars, suspension or termination of employment to the authority or person or body authorized by law to impose such sanctions.
The City Board of Ethics shall conduct and complete the hearing with reasonable promptness and shall not act without notice and opportunity to be heard and shall observe appropriate due process.
The Board of Ethics shall render confidential advisory opinions only to officers and employees of the City of Watervliet with respect to Article 18 of the General Municipal Law and this Code of Ethics. Officers and employees of the municipality are encouraged to seek advisory opinions whenever they are uncertain whether their conduct may violate the Code of Ethics.
The Board of Ethics will prepare an advisory opinion based on a thorough review of the facts and applicable law. The Board's opinion is to be based solely on the facts presented in the request or subsequently submitted in a written, signed document. The opinion will be rendered, in writing, to the requester as expeditiously as is practicable, with special attention to the time requirements of a given case.
An officer or employee of the municipality whose conduct or action is the subject of an advisory opinion will not be subject to penalties or sanctions by virtue of acting, or failing to act, due to a reasonable reliance on the opinion, unless material facts were omitted or misstated in the material submitted by the requester.
The Board of Ethics will maintain a confidential, indexed file of all advisory opinions issued by the Board.
The Mayor must promptly cause a copy of this code, and a copy of any amendment to this code, to be posted publicly and conspicuously in each building under the municipality's control. The code must be posted within 10 days following the date on which the code takes effect. An amendment to the code must be posted within 10 days following the date on which the amendment takes effect.
The Mayor must promptly cause a copy of this code, including any amendments to the code, to be distributed to every person who is or becomes an officer or employee of the City of Watervliet.
Every Municipal officer or employee who receives a copy of this code, or an amendment to the code, must acknowledge such receipt in writing. Such acknowledgment must be filed with the City Clerk who must maintain such acknowledgment as a public record.
The failure to post this code, or an amendment to the code, does not affect either the applicability or enforceability of the code or the amendment. The failure of a Municipal officer or employee to receive a copy of this Code of Ethics, or an amendment to the code, or to acknowledge receipt thereof in writing, does not affect either the applicability or enforceability of the code or amendment to the code.
Any Municipal officer or employee who violates this code may be censured, fined, suspended or removed from office or employment in the manner provided by law.


Alam v. Brandywine School District, et al. Date: December 30, 2015 ... Wells Fargo Bank, NA v. Strong. ... Docket Number: 0606006590. State of Delaware v. Taylor. Date: December 17, 2015 ...... al. v. Astrazeneca Pharmaceuticals, L.P., et al.
Jun 19, 2013 ... Brangman alleges that AstraZeneca subjected her to disparate treatment on ... of Title VII of the Civil Rights Act of 1964 (“Title VII”), 42 U.S.C. § 2000e et seq. ... judgment, seeking judgment in its favor against Brangman on all of her claims. ..... Police Dep't, 380 F.3d 751, 761 (3d Cir.2004) (quoting Taylor v.
Animal Science Products, Inc., et al. v. Heibei Welcome Pharmaceutical Co. Ltd., et al. U.S. v. Anova Holding AG; Stephan Schmidheiny; and Unotec Holding AG.