Abstract: An intrauterine contraceptive system may include a contraceptive intrauterine device, a retrieval thread permanently attached to the intrauterine device and an insertion device for inserting the intrauterine device into a uterus. The system may also include a release thread releasably coupled with the intrauterine device. The intrauterine device may be deployable out of a distal end of the insertion device and may be configured to change from a delivery configuration when housed in the insertion device to a deployed configuration when deployed in a uterus. The retrieval thread and the optional release thread may be at least partially housed within the insertion device during insertion of the intrauterine device into the uterus. The release thread may extend from the intrauterine device through the insertion device to an attachment point at or near a proximal end of the insertion device.

Abstract: A bone screw may be insertable into a bone. The bone screw may have a distal member with bone-engaging threads, a proximal member configured to slidably engage the distal member, and a tension member with a proximal end coupled to the proximal member, and a distal end coupled to the distal member such that, in response to motion of the distal member away from the proximal member, the tension member elongates and urges the distal member to move toward the proximal member. The tension member may be configured such that, at a minimum length of the bone screw, the tension member is pre-stretched so that the tension member is under tension to urge the bone screw to shorten. The bone screw may be inserted in the pre-stretched state. A pre-stretch driver may be used to tension the bone screw prior to or during insertion.

Abstract: Intravesical drug delivery devices are provided which may include an elongated body formed of a matrix system of a drug dispersed in a silicone, wherein the elongated body has a first end, an opposed second end, and an intermediate portion between the first and second ends, and wherein the silicone of the matrix system is cured to bias the elongated body in a coiled retention shape, such that the device is elastically deformable between a relatively straightened shape suited for insertion of the device through a urethra and into the urinary bladder of a patient and the coiled retention shape which is suited to retain the device within the urinary bladder.

Abstract: An intrauterine device having at least one first pharmaceutically active ingredient and at least one first layer made of at least a first polymeric material, wherein between about 10 and about 60 v/v % of at least one particulate material is dispersed and/or incorporated in the first polymeric material. The presence of the particulate material will reduce the porosity of the polymer or otherwise obstruct the diffusion of the pharmaceutically active ingredient being released, thereby slowing its rate of release. In this way, it is possible to regulate the release rate and/or initial burst of the device, simply by adjusting the amount of particles/particulate material in the first layer, instead of having to adapt the size of the device to the desired release pattern, which requires expensive changes in production equipment and manufacturing processes.

Abstract: A tray for securing an implantable device to a carrier member includes a slot configured to retain the carrier member and a receptacle adjacent the slot. The carrier member surrounds a shaft of the implantable device. The receptacle has a first width at a proximal end of the receptacle to receive first and second arms of the implantable device in an initial state in which the first and second arms extend substantially perpendicularly from the shaft. The receptacle has a second width at a distal end of the receptacle for receiving the first and second arms of the implantable device in a collapsed state in which the first and second arms are folded against the shaft such that the carrier member can be slid over the first and second arms to retain the first and second arms. The second width is less than the first width.

Abstract: An intrauterine contraceptive system may include a contraceptive intrauterine device, a retrieval thread permanently attached to the intrauterine device and an insertion device for inserting the intrauterine device into a uterus. The system may also include a release thread releasably coupled with the intrauterine device. The intrauterine device may be deployable out of a distal end of the insertion device and may be configured to change from a delivery configuration when housed in the insertion device to a deployed configuration when deployed in a uterus. The retrieval thread and the optional release thread may be at least partially housed within the insertion device during insertion of the intrauterine device into the uterus. The release thread may extend from the intrauterine device through the insertion device to an attachment point at or near a proximal end of the insertion device.

Abstract: The present invention relates to ultrasonically detectable intrauterine systems and to a method for enhancing ultrasound detection of these systems. An intrauterine system having an inert metal coating on at least part of the body of the intrauterine system or at least one inert metal clip, pin, ring or sleeve fixedly positioned on the body of the intrauterine system is described.

Abstract: The present disclosure relates to methods, compositions and products for treating pain, and/or pain related symptoms, associated with dysmenorrhea in a subject. In certain embodiments, the present disclosure provides a method of treating pain, and/or pain related symptoms, associated with dysmenorrhea in a subject, the method comprising intrauterine and/or vaginal administration to the subject of an effective amount of an agent that reduces activation of the innate immune system and thereby treating the pain and/or the pain related symptoms in the subject. Other embodiments are also disclosed.

Abstract: The present invention relates generally to compositions and methods of using the same.

Abstract: Disclosed herein is a solid lyophilized vaginal dosage form that can have an effective amount of at least one active ingredient, a crystalline structure forming agent in an amount of about 5 wt. % to about 40 wt. %, based on the total weight of the lyophilized dosage form, and at least one polymeric mucoadhesive matrix forming agent. The dosage form can have a pH of about 4.0 to 5.0, and can disintegrate within 120 seconds after being contacted with a vaginal mucosa. A method of delivering an active ingredient to the vaginal mucosa using the disclosed solid dosage form is also described.

Abstract: The invention relates to a method for producing a drug delivery device, which has a body comprising a siloxane-based elastomer and at least one active agent. The method comprises applying adhesive material, which comprises non-cured siloxane based elastomer, into a contact with the body and curing the said adhesive material by subjecting it to radiation energy from a laser source. The invention relates also to a drug delivery device manufactured according to the method.

Abstract: An inserter is provided which includes a handle having an upper cover and a bottom cover, the upper cover having a longitudinal opening, a proximal end and a distal end; a mounting member extending from an inner surface of the bottom cover of the handle, the mounting member having a through-hole; an inner tube having a proximal end and a distal end, the proximal end of the inner tube attached to the mounting member; an insertion tube movably coupled to the inner tube with a longitudinal axis essentially parallel to a longitudinal axis of the inner tube; a switch coupled to a proximal end of the insertion tube and arranged in the opening; and a string having a proximal end removably coupled near the proximal end of the opening, a distal end of the string coupled to a device to be inserted inside a human anatomy.

Abstract: Implantable drug delivery devices include a housing defining a reservoir, a first unit within the reservoir, and a second unit within the reservoir. The first unit contains a drug and the second unit contains a functional agent that facilitates release of the drug. Intravesical drug delivery devices include a housing portion containing a drug formulation and a housing portion containing an excipient, and are configured to release the drug according to a first release profile and the excipient according to a second release profile. Methods include inserting any of these devices into a patient and releasing drug from the device.

Abstract: The present invention relates to an inserter for an intrauterine system comprising a handle (3), and an insertion tube (6) having a first end and a second end, and being arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube (6) comprises at least one frame slot for receiving a frame of the intrauterine system. The invention also relates to a kit comprising an inserter according to the present invention and an intrauterine system, wherein the intrauterine system (1) comprises a therapeutic component (1b) and a continuous, closed frame (1a), the therapeutic component (1b) being connected to the frame (1a) at least one point, and therapeutic component (1b) of the intrauterine system (1) is at least mainly arranged inside the first end of the insertion tube (6) and the frame (1a) of the intrauterine system (1) is at least mainly arranged outside the first end of the insertion tube (6).

Abstract: A method for promoting contraception by placing a contraceptive device within a uterus without blocking fallopian tubes may involve advancing a distal end of a delivery device through a cervix, advancing the contraceptive device comprising an elongate shape memory member out of the distal end of the delivery device and into the uterus, and limiting inferior migration of the contraceptive device within the uterus. Inferior migration may be limited by allowing the contraceptive device to assume a shape, when subjected to pressure that tends to cause a downward migration of the device within the uterus, in which an expandable middle portion of the device is expanded to contact the inner wall of the uterus and thus limit the downward migration of the device.

Abstract: An intrauterine contraceptive system may include a contraceptive intrauterine device, a retrieval thread permanently attached to the intrauterine device and an insertion device for inserting the intrauterine device into a uterus. The system may also include a release thread releasably coupled with the intrauterine device. The intrauterine device may be deployable out of a distal end of the insertion device and may be configured to change from a delivery configuration when housed in the insertion device to a deployed configuration when deployed in a uterus. The retrieval thread and the optional release thread may be at least partially housed within the insertion device during insertion of the intrauterine device into the uterus. The release thread may extend from the intrauterine device through the insertion device to an attachment point at or near a proximal end of the insertion device.

Abstract: A multilayered composite sheet for delivering one or more therapeutic agents to the skin is disclosed. The composite sheet comprises a flexible porous polymer with open cells of a sufficient size for holding a therapeutic agent, an encapsulating agent for encapsulating the flexible porous polymer and therapeutic agent, and an enrobing agent for enrobing the encapsulated flexible porous polymer and therapeutic agent. Additional layers of the flexible porous polymer, therapeutic agent and other materials are added to the first layer which is in contact with the skin. The first layer has particular particle sizes for the flexible porous polymer, open cell size, and therapeutic agent allowing for relatively quick delivery of the therapeutic agent to the skin. Each successive layer placed on top of the first layer has incrementally larger particle sizes of the flexible porous polymer and therapeutic agent providing successively longer delivery times than the first layer.

Abstract: A contraceptive intrauterine device having a support structure configured for transcervical implantation in a uterus, an active element coupled to the support structure, the active element having a core including copper that is at least partially coated with an outer layer including gold or gold alloy. A contraceptive intrauterine device having a support structure configured for transcervical implantation in a uterus, an active element coupled to the support structure, the active element including a copper core that is at least partially plated or coated with an outer layer including gold or gold alloy, wherein the copper core is configured to release copper ions after the device is implanted in a uterus, and wherein the gold or gold alloy outer layer is configured to control the release rate of copper ions release by the core. Methods for preventing conception by implanting said contraceptive intrauterine devices.

Abstract: A system for delivering a therapeutic agent to nasopharyngeal mucosa tissue has a shaft, a porous pad of compliant material coupled to the shaft near the distal end, and a drug reservoir. The porous pad is configured to expand from a contracted configuration to an expanded configuration. The expanded configuration is adapted to engage and conform to the mucosa tissue in a nasal cavity, and the contracted configuration has a size suitable for introduction into the nasal cavity. The drug reservoir holds a therapeutic agent and is at least partially covered by the porous pad. The drug reservoir is configured to release a fixed volume of the therapeutic agent into the porous pad within a period of less than about 120 minutes, and has a wall with a plurality of channels fluidly coupled with the porous pad.

Abstract: An intrauterine device having at least one first pharmaceutically active ingredient and at least one first layer made of at least a first polymeric material, wherein between about 10 and about 60 v/v % of at least one particulate material is dispersed and/or incorporated in the first polymeric material. The presence of the particulate material will reduce the porosity of the polymer or otherwise obstruct the diffusion of the pharmaceutically active ingredient being released, thereby slowing its rate of release. In this way, it is possible to regulate the release rate and/or initial burst of the device, simply by adjusting the amount of particles/particulate material in the first layer, instead of having to adapt the size of the device to the desired release pattern, which requires expensive changes in production equipment and manufacturing processes.

Abstract: Medical devices with surfaces on which viable biologic cells are magnetically attracted and retained are disclosed along with methods of magnetic coating. The medical devices can be located in a carrier liquid containing high concentrations of magnetic cells before or after implantation. The carrier liquid with magnetic cells may be contact with the medical device in vitro or in vivo. In either case, the carrier liquid may have a concentration of magnetic cells that is high enough to facilitate coating of the medical device within an acceptable period of time, e.g., several hours or less. Magnetization of medical devices before, during, and/or after implantation and apparatus for performing the same are disclosed. Degaussing of magnetic medical devices is also disclosed.

Abstract: A method for promoting contraception by placing a contraceptive device within a uterus without blocking fallopian tubes may involve advancing a distal end of a delivery device through a cervix, advancing the contraceptive device comprising an elongate shape memory member out of the distal end of the delivery device and into the uterus, and limiting inferior migration of the contraceptive device within the uterus. Inferior migration may be limited by allowing the contraceptive device to assume a shape, when subjected to pressure that tends to cause a downward migration of the device within the uterus, in which an expandable middle portion of the device is expanded to contact the inner wall of the uterus and thus limit the downward migration of the device.

Abstract: The present disclosure suggests an apparatus for determining at least one parameter in the vaginal channel of a user. The apparatus comprises a flexible pessary and a measurement unit comprising at least one sensor for measuring the at least one vaginal parameter. The measurement unit is reversibly mountable to the flexible pessary.

Abstract: An intrauterine contraceptive system may include a contraceptive intrauterine device, a retrieval thread permanently attached to the intrauterine device and an insertion device for inserting the intrauterine device into a uterus. The system may also include a release thread releasably coupled with the intrauterine device. The intrauterine device may be deployable out of a distal end of the insertion device and may be configured to change from a delivery configuration when housed in the insertion device to a deployed configuration when deployed in a uterus. The retrieval thread and the optional release thread may be at least partially housed within the insertion device during insertion of the intrauterine device into the uterus. The release thread may extend from the intrauterine device through the insertion device to an attachment point at or near a proximal end of the insertion device.

Abstract: The present disclosure is directed to a system, device and methods for treating or preventing genital tract infection. The system includes a point-of-use recharge kit having a first reusable intravaginal delivery device (RIDD1) and a second reusable intravaginal delivery device (RIDD2), and a therapeutic agent. Each RIDD includes a permeable wall defining an enclosed interior reservoir. The reservoir is adapted to receive the therapeutic agent. The system enables the point-of-use loading and reloading at least one of the RIDDs with the therapeutic agent by the end user.

Abstract: A method of forming a drug delivery device includes laser forming a top ceramic plate to include an inner portion including top laser micromachined through-holes while not lasering a planar outer portion. Top nanochannels are formed into the top ceramic plate to provide fluid connections between neighboring to micromachined through-holes. A bottom ceramic plate is laser formed to include an inner portion including bottom laser micromachined through-holes while not lasering a planar outer portion. Bottom nanochannels are formed into the bottom ceramic plate to provide fluid connections between neighboring to micromachined through-holes. A bonding material is applied to the planar outer portion of the top and/or bottom ceramic plate. The top and bottom ceramic plate are aligned so that the top and bottom laser micromachined through-holes are laterally offset from one another. The top ceramic plate is bonded to the bottom ceramic plate with a bonding material.

Abstract: An intrauterine contraceptive system may include a contraceptive intrauterine device, a retrieval thread permanently attached to the intrauterine device and an insertion device for inserting the intrauterine device into a uterus. The system may also include a release thread releasably coupled with the intrauterine device. The intrauterine device may be deployable out of a distal end of the insertion device and may be configured to change from a delivery configuration when housed in the insertion device to a deployed configuration when deployed in a uterus. The retrieval thread and the optional release thread may be at least partially housed within the insertion device during insertion of the intrauterine device into the uterus. The release thread may extend from the intrauterine device through the insertion device to an attachment point at or near a proximal end of the insertion device.

Abstract: An intrauterine contraceptive device may include a frame made completely or partially of a first metal having a first galvanic potential and at least one metallic member coupled with the frame that is made of a second metal having a second galvanic potential different from the first galvanic potential. In some embodiments, the first galvanic potential may be more anodic than the second galvanic potential. In alternative embodiments, the first galvanic potential may be more cathodic than the second galvanic potential. In one embodiment, the first metal is Nitinol, and the second metal is copper. In some embodiments, the first and second galvanic potentials may be configured to achieve, at least approximately, a desired copper ion elution rate for the intrauterine device.

Abstract: An intrauterine device for applying force to a wall of a uterus to promote contraception without blocking the fallopian tubes may include an elongate member formed of a resilient material and having a default expanded configuration and a spring portion disposed approximately at a midpoint between two ends of the elongate member. The IUD may also include two tissue contact members, one tissue contact member disposed at one of the two ends of the elongate member and the other tissue contact member disposed at the other end. The tissue contact members may generate a laterally directed force against the wall of the uterus when the intrauterine device assumes its default expanded configuration.

Abstract: The present invention relates to novel intrauterine systems and to methods for manufacturing these systems. An intrauterine system according to the invention comprises a reservoir and a continuous, closed and flexible frame.

Abstract: According to one claim of the invention, a method for occluding a fallopian tube in a vertebrate subject is described, which comprises comprising transcervically delivering a solid blocking material into the fallopian tube. In various embodiments, a fluid sealing material is delivered along with the solid blocking material. Other claims of the invention pertain to articles of manufacture, delivery devices and kits for use in occluding the fallopian tubes of a vertebrate subject.

Abstract: The various embodiments of the present inventions provide stabilization devices and methods for use of the stabilization devices with minimally invasive gynecological procedures such as methods of preventing pregnancy by inserting intrafallopian contraceptive devices into the fallopian tubes.

Abstract: The invention describes methods and apparatus for creating permanent occlusion of body lumens such as the fallopian tubes. The methods and apparatus use non-surgical approaches to deliver permanent implants which create acute occlusion of desired body lumens which resolve to permanent occlusions of the lumens.

Abstract: The present invention relates to an improved intra-uterine contraceptive device (IUCD) characterized by comprising polymer based material 1, and flexible structure 2, wherein the flexible structure 2 comprises one or more of tubelets 3, wherein the tubelets 3 are interconnected by connecting means 4, wherein the tubelets 3 are provided with a pulling means 5 on one end, wherein the tubelets 3 have perforations in the form of holes 6, and wherein the tubelets 3 have both sides 7, 8 open, and said sides are in sloping shape, wherein the tubelets 3 are arranged in the form of a chain, and wherein the combination of said polymer based material 1 and said flexible structure 2 is injectable or implantable in the uterine cavity. In one embodiment it relates to flexible structure referred to as intra-uterine device (IUD).

Abstract: A contraceptive intrauterine device having a support structure configured for transcervical implantation in a uterus, an active element coupled to the support structure, the active element having a core including copper that is at least partially coated with an outer layer including gold or gold alloy. A contraceptive intrauterine device having a support structure configured for transcervical implantation in a uterus, an active element coupled to the support structure, the active element including a copper core that is at least partially plated or coated with an outer layer including gold or gold alloy, wherein the copper core is configured to release copper ions after the device is implanted in a uterus, and wherein the gold or gold alloy outer layer is configured to control the release rate of copper ions release by the core. Methods for preventing conception by implanting said contraceptive intrauterine devices.

Abstract: The various embodiments of the present inventions provide stabilization devices and methods for use of the stabilization devices with minimally invasive gynecological procedures such as methods of preventing pregnancy by inserting intrafallopian contraceptive devices into the fallopian tubes.

Abstract: The invention described is directed to an intracorporeal occluding device having elements with non-traumatic ends and devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Abstract: The invention concerns a method for making a reservoir (5) containing an active substance and adapted to be introduced into a natural cavity of a living being, the reservoir (5) comprising a membrane (9) permeable to the active substance.

Abstract: The present invention relates to an inserter for an intrauterine system comprising a handle (3), and an insertion tube (6) having a first end and a second end, and being arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube (6) comprises at least one frame slot for receiving a frame of the intrauterine system. The invention also relates to a kit comprising an inserter according to the present invention and an intrauterine system, wherein the intrauterine system (1) comprises a therapeutic component (1b) and a continuous, closed frame (1a), the therapeutic component (1b) being connected to the frame (1a) at least one point, and therapeutic component (1b) of the intrauterine system (1) is at least mainly arranged inside the first end of the insertion tube (6) and the frame (1a) of the intrauterine system (1) is at least mainly arranged outside the first end of the insertion tube (6).

Abstract: An intrauterine device for applying pressure to the walls of the uterine cavity includes a resilient body having an elongated member which includes a first end and a second end which are resiliently biased away from each other. The first end of the elongated member includes a first leg having a first end and a second end. The second end of the elongated member includes a second leg having a first end and a second end. A connection member is positioned between the first end of the first leg and the first end of the second leg. A first plug member is secured at the second end of the first leg and a second plug member is secured at the first end of the second leg. The first and second plug members are shaped and dimensioned for bearing against the walls of the uterine cavity as the elongated member spreads outwardly with the first end and the second end moving apart. A method for preventing conception within the uterine cavity is also disclosed.

Abstract: A convenient and highly accurate intravaginal device with wireless sensors for monitoring fertility and sexual health of humans and animals is proposed. Sensors in the intravaginal device measure fertility and sexual health and via wireless transmitter send this information to a terminal on which the information is processed and displayed in convenient form.

Abstract: A method for promoting contraception by placing a contraceptive device within a uterus without blocking fallopian tubes may involve advancing a distal end of a delivery device through a cervix, advancing the contraceptive device comprising an elongate shape memory member out of the distal end of the delivery device and into the uterus, and limiting inferior migration of the contraceptive device within the uterus. Inferior migration may be limited by allowing the contraceptive device to assume a shape, when subjected to pressure that tends to cause a downward migration of the device within the uterus, in which an expandable middle portion of the device is expanded to contact the inner wall of the uterus and thus limit the downward migration of the device.

Abstract: A method for promoting contraception by placing a contraceptive device within a uterus without blocking fallopian tubes may involve advancing a distal end of a delivery device through a cervix, advancing the contraceptive device comprising an elongate shape memory member out of the distal end of the delivery device and into the uterus, and limiting inferior migration of the contraceptive device within the uterus. Inferior migration may be limited by allowing the contraceptive device to assume a shape, when subjected to pressure that tends to cause a downward migration of the device within the uterus, in which an expandable middle portion of the device is expanded to contact the inner wall of the uterus and thus limit the downward migration of the device.

Abstract: A system for delivering an IUD into an animal, including: (i) an IUD for a an animal, comprising: (a) a main body; and (b) a pair of bendable arms extending away from the main body, wherein the ends of the bendable arms fold together in a direction away from the main body; (ii) a delivery gun for inserting the IUD into an animal, wherein the delivery gun comprises a tubular barrel and a plunger moveable within the tubular barrel; and (iii) a loading gun for inserting the IUD into the tubular barrel of the delivery gun, wherein the loading gun is configured to insert the IUD into the delivery gun with the pair of bendable arms being folded together forward of the main body of the IUD.

Abstract: An intrauterine device includes an elongate member; and a flexible arm having a first end and a second end, wherein the first end is operatively coupled to the elongate member at a first location, and wherein the second end is operatively coupled to the elongate member at a second location, and wherein the flexible arm is adjustable between a closed configuration, in which the flexible arm is closely apposed to the elongate member, and an open configuration, in which the flexible arm extends away from the elongate member, and wherein the flexible arm is biased to be in the closed configuration.

Abstract: An inserter for placing a T-shaped intrauterine device inside a patient's uterus and a T-shaped intrauterine device are disclosed. The inserter includes a sleeve part and a plunger part, the sleeve part includes a tube and a first engaging member and the plunger part includes a rod, a handle attached to the rod and a second engaging member. The first and the second engaging members are configured for reversibly engaging the sleeve part and the plunger part to temporarily lock the relative position between the tube and the rod. The T-shaped intrauterine device includes a pair of wings having a relaxed extended configuration and a contracted folded configuration and an elongated contraceptive body suspended from a junction between the wings.

Abstract: An inserter for placing a T-shaped intrauterine device inside a patient's uterus and a T-shaped intrauterine device are disclosed. The inserter includes a sleeve part and a plunger part, the sleeve part includes a tube and a first engaging member and the plunger part includes a rod, a handle attached to the rod and a second engaging member. The first and the second engaging members are configured for reversibly engaging the sleeve part and the plunger part to temporarily lock the relative position between the tube and the rod. The T-shaped intrauterine device includes a pair of wings having a relaxed extended configuration and a contracted folded configuration and an elongated contraceptive body suspended from a junction between the wings.

Abstract: An intrauterine system is disclosed for use in the treatment of dysfunctional uterine bleeding; menorraghia; dysmenorrhoea; endometriosis; uterine fibroids; climacteric complaints; osteoporosis; and urogenital atrophy. The system is formed by a frame defining an interior space for receipt of a deposit of a therapeutically effective dose of a biologically active compound. The frame has an open structure allowing access to a substantial part of an outer surface of the deposit, and the deposit has a rate controlling structure that controls a rate of release of the compound within the uterus. One or more retention elements are provided on the frame for retaining the frame within the uterus of a female mammal.

Abstract: An intrauterine device includes a central support member, first and second internal flexures and first and second external flexures. The first and second internal flexures each include a first section having a first stiffness, a second section having a second stiffness, and third section having a third stiffness, wherein the second stiffness is more flexible than the first and third stiffness and wherein the first section of each internal flexure is coupled to the central support member. The first and second external flexures are coupled to the central support member and coupled to the third sections of the first and second internal flexures, the first and second external flexures in combination with the first and second internal flexures being configured to extend from a collapsed position parallel to the central support member to a deployed position flexing away from the central support member.

Abstract: The present invention relates to annular intravaginal devices comprising an aperture, methods of making, and uses thereof. The annular devices comprise an aperture extending into the device, the aperture having: (a) an interior diameter, and (b) an exterior entry diameter, wherein the exterior entry diameter of the aperture is less than the interior diameter of the aperture.