Patent Description:
Another more recent intervention is based on providing an artificial fluid communication path between the lacrimal apparatus and a paranasal sinus through a paranasal sinus access implant device implanted through an artificially formed surgical path between the lacrimal apparatus in the paranasal sinus to provide direct fluid communication access from the lacrimal apparatus to the paranasal sinus through an internal passage of the implanted implant device. One surgical approach is through the palpebral fissure to form a surgical path between the lacrimal apparatus in the orbit and a paranasal sinus, often the ethmoid sinus. Examples of some paranasal sinus access implant devices and implantation tools and procedures for implanting such implant devices to provide a fluid communication between the lacrimal apparatus and a paranasal sinus are disclosed for example in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT> published by the World Intellectual Property Organization. <CIT> discloses an implantation tool to implant a paranasal sinus fluid access implant device, the implantation tool comprising: a carrier member; a handle portion; and an internal working space housed within the handle portion and the carrier member. <CIT> discloses a biliary stent delivery device comprising a securement mechanism and a release mechanism.

When implanted, such paranasal sinus access implant devices provide convenient access to the paranasal sinus for administration of drugs or irrigation fluid directly to the paranasal sinus or performance of medical procedures in the paranasal sinus. However, for enhanced compatibility and interaction with surgically-penetrated tissue, such paranasal sinus access implant devices may be made of relatively soft and flexible material, for example polymeric materials, such as medical grade silicone, having a Shore A hardness often in a range of about <NUM>-<NUM>. Advancing such flexible implant devices through a properly sized surgical route, and without additional inflammation of tissue in and adjacent to the surgical path, can be difficult. Such implant devices may include anchor protrusions configured to interact with issue exposed in the surgical path to help anchor the implanted implant device. For enhanced fit through and retention in the surgical path, the outside diameter of the implant device may be larger than the diameter of the surgical cut made to form the surgical path, especially at locations of the anchor protrusions. Resistance to insertion through the surgical path when an implant device is advanced into and through the surgical path during an implantation procedure may result in accordion-like deformation of the flexible implant device that further increases resistance to advancement of the implant device and complicating performance of the implantation procedure and increasing potential for additional inflammation of tissue that can lead to patient discomfort and longer heal times. Additionally, the wall of the sinus bone that is penetrated by the surgical cut to access the paranasal sinus may be very thin and susceptible to fracture and breakage during the implantation procedure. Such fracturing and breakage of the wall of the sinus bone may be detrimental to good securement of the implanted device in the implantation position through the surgical cut, and is also not desired for good surgical practice.

Although surgical implantation techniques for implantation of such paranasal sinus access implant devices to fluidly connect the lacrimal apparatus in the orbit and a paranasal sinus have achieved a significant level of success in accessing and treating conditions of the paranasal sinuses, implantation tools and procedures still may suffer from one or more of these problems, and there is a significant need for improved implantation tools and procedures to further address such problems.

The inventors have inventively recognized that these problems may be addressed at least in part for implantation of paranasal sinus access implant devices of the type summarized above implanted with a surgical approach through the palpebral fissure to provide an artificial fluid communication connection between the lacrimal apparatus in the orbit and a paranasal sinus by providing implantation tools and implantation procedures that maintain the paranasal access implant device mostly in tension as the implant device is advanced from the palpebral fissure approach through the surgical path during implantation procedure. Stated another way, when most of the length of the implant device that is advanced through the surgical path is pulled through the surgical path (in tension) rather than being pushed through the surgical path (in compression), the implant device is allowed to stretch out rather than bunch up in an accordion-like fashion during advancement into and through the surgical path, which eases advancement of the implant device through the surgical path and tends to reduce potential for causing fracture or breakage of the sinus wall bone, other tissue inflammation and the difficulty for the medical professional to perform the implantation procedure. A result may be both that the implantation procedure is faster and easier for a medical professional to perform and with reduced potential for surgical complications.

A first aspect of this disclosure provides an implantation tool to implant a paranasal sinus fluid access implant device with an internal fluid communication passage through an artificial, surgical path between a lacrimal apparatus in the orbit and a paranasal sinus in an implantation procedure to provide direct fluid communication access through the internal passage from the lacrimal apparatus in the orbit to the paranasal sinus. This implantation tool, which is the implantation tool according to the invention, comprises:.

A second aspect of this disclosure provides an implantation assembly for implanting a paranasal sinus fluid access implant device through a surgical path between a lacrimal apparatus in the orbit and a paranasal sinus in an implantation procedure to provide direct fluid communication access from the lacrimal apparatus in the orbit to the paranasal sinus through an internal passage of the implant device. The implantation assembly of this second aspect may include:.

The implantation tool in the implantation assembly of this second aspect may be according to the first aspect of this disclosure.

A third aspect of this disclosure provides an implantation kit for implanting a paranasal sinus fluid access implant device through a surgical path between a lacrimal apparatus in the orbit and a paranasal sinus in an implantation procedure to provide direct fluid communication access from the lacrimal apparatus in the orbit to the paranasal sinus through an internal passage of the implant device. The implantation kit of this third aspect may include:.

The implantation tool of the kit of this third aspect may be according to the first aspect of this disclosure. The implantation assembly of the kit of this third aspect may be according to the second aspect of this disclosure.

A fourth aspect of this disclosure provides a method for implanting a paranasal sinus access implant device to fluidly connect a lacrimal apparatus in the orbit with a paranasal sinus. The method of this fourth aspect may include:.

The implantation tool used in the method of this fourth aspect may be according to the first aspect of this disclosure. The implantation assembly used in the method of this fourth aspect may be according to the second aspect of this disclosure. The implant device and the implantation tool used in the implantation assembly used in the method of this fourth aspect may be provided in an implantation kit according to the third aspect of this disclosure.

A fifth aspect of this disclosure provides a method for implanting a paranasal sinus fluid access implant device through an artificial, surgical path between a lacrimal apparatus in the orbit and a paranasal sinus to provide direct fluid communication access from the lacrimal apparatus in the orbit to the paranasal sinus through an internal passage of the implant device. The method of this fifth aspect may include:.

The method of this fifth aspect may include performance of the method of the fourth aspect of this disclosure. The implantation tool used in the method of this fifth aspect may be according to the first aspect. The implant device secured to an exterior of a carrier member of an implantation tool in the method of this fifth aspect may be provided in an implantation assembly according to the second aspect of this disclosure. The implant device and the implantation tool used in the method of this fifth aspect may be provided in an implantation kit according to the third aspect of this disclosure.

These and other aspects of this disclosure and features for use therewith are further described below. A number of feature refinements and additional features disclosed below are applicable to each of the aspects of this disclosure, including to an implantation tool, implantation assembly, implantation kit and an implantation method of any such aspect. These feature refinements and additional features may be used individually or in any combination in any or all of these aspects. As such, each of the features that will be discussed below may be, but are not required to be, used with any other feature or combination of features of the same or any other aspect of this disclosure.

Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided below.

The term "lacrimal apparatus" or "lacrimal system" refers to the collection of physiological components that accomplish the production and secretion of lacrimal fluid to lubricate the eyeball, containment of lacrimal fluid in a reservoir of lacrimal fluid in the orbit and drainage of lacrimal fluid from the orbit to the nasal cavity. The lacrimal apparatus includes the lacrimal glands, the tear drainage system and the reservoir of lacrimal fluid located between the lacrimal glands and the tear drainage system. The reservoir of lacrimal fluid includes the eyelid margins and the conjunctival sac (and including the pool of tears in the lower conjunctival cul-de-sac that is sometimes referred to as the lacrimal lake). The tear drainage system includes the puncta, canaliculi and nasolacrimal duct (including the so-called lacrimal sac located at the top of the nasolacrimal duct) through which excess tears drain to Hasner's valve and into the nasal cavity. <FIG> shows generally the lacrimal apparatus. Lacrimal fluid is produced and secreted from lacrimal glands <NUM> to lubricate the surface of the eyeball <NUM> disposed within the orbit. Lacrimal fluid forms a coating over the eyeball <NUM> and is generally contained within the conjunctival sac (the space between the lower eyelid <NUM>, upper eyelid <NUM> and eyeball <NUM> that is lined by the conjunctiva). Excess lacrimal fluid is conducted to the vicinity of the medial canthus (medial corner of the eye) and drains through the lacrimal puncta <NUM> into the lacrimal canaliculi <NUM> and into the lacrimal sac <NUM> of the nasolacrimal duct <NUM>. The lacrimal fluid then drains from the nasolacrimal duct <NUM> through Hasner's valve and into the nasal cavity.

As used herein, a surgical path refers to an artificially-created passage prepared by surgical means from an approach through the palpebral fissure between the lacrimal apparatus in the orbit and a paranasal sinus for implantation therethrough of an implant device with an internal passage to provide direct fluid communication access from the lacrimal apparatus in the orbit to the paranasal sinus. As may be appreciated, the palpebral fissure is an anatomical opening between eyelids, also referred to as the rima palpebrarum. Such an implant device may, for example, be of a design as described in any of <CIT>; <CIT>; <CIT> or <CIT>, each of which is incorporated by reference herein.

The paranasal sinuses include the frontal sinuses, maxillary sinuses, ethmoid sinuses and sphenoid sinuses, which are cavities contained within frontal, maxilla, ethmoid and sphenoid bones, respectively. The paranasal sinuses drain into the nasal cavity. <FIG> also shows the general proximity of the frontal sinus <NUM>, maxillary sinus <NUM> and ethmoid sinus <NUM> relative to features of the lacrimal apparatus and some example routes for a surgical path are shown by dashed lines. A first example route <NUM> for a surgical path is from the lacrimal apparatus in the orbit to the frontal sinus. A second example surgical path route <NUM> is from the lacrimal apparatus in the orbit to the ethmoid sinus <NUM>. A third example surgical path route <NUM> is from the lacrimal apparatus in the orbit to the maxillary sinus <NUM>. The example surgical path routes shown in <FIG> are for purposes of general illustration only and not to show precise locations where a surgical path might be formed to connect a part of the lacrimal apparatus with the corresponding paranasal sinus. Although not shown in <FIG>, another example route for a surgical path is from the lacrimal apparatus in the orbit to the sphenoid sinus. One more specific example of a preferred route for a surgical path to a paranasal sinus is for the surgical path to pass directly through the lacrimal caruncle and through tissue to the targeted paranasal sinus. Such a route for a surgical path benefits from relatively easy location of the surgical entry point by a medical professional performing an implantation procedure.

<FIG> and <FIG> show an example implant device <NUM> of a design as described in <CIT>. The implant device <NUM> includes a head <NUM> and a conduit <NUM>. The conduit <NUM> includes a first longitudinal portion <NUM> and a second longitudinal portion <NUM> disposed distal of the first longitudinal portion <NUM>. The first longitudinal portion <NUM> includes a smooth exterior surface and second longitudinal portion <NUM> includes an anchoring surface feature including anchoring protrusions in the form of spaced circumferential ridges <NUM> and recess areas <NUM> between the ridges <NUM>. When the implant device <NUM> is implanted through a surgical path to fluidly connect the lacrimal apparatus in the orbit with a paranasal sinus, one or more of the ridges <NUM> may be located in the vicinity of the paranasal sinus bone wall that is penetrated by the implant device <NUM> when implanted, preferably with one or more of the anchor protrusions disposed on each side of the bone, and more preferably with the wall of the sinus cavity bone penetrated by the implant device <NUM> disposed between two adjacent ones of the ridges <NUM>. The implant device <NUM> includes an internal passage <NUM> extending between the proximal end <NUM> and the distal end <NUM>, passing through the head <NUM> and the full length of the conduit <NUM>. The internal passage <NUM> is open at the proximal end <NUM> for fluid communication with the lacrimal apparatus in the orbit when implanted and is open at the distal end <NUM> for fluid communication with a paranasal sinus when implanted, whereby the implant device <NUM> when implanted provides a fluid communication path between the lacrimal apparatus in the orbit and the paranasal sinus. Disposed between the most distal pair of adjacent ridges <NUM>, the implant device <NUM> includes two side ports <NUM> disposed on opposite sides of a longitudinal axis <NUM> of the implant device <NUM>, and which side ports are designed to be disposed in the paranasal sinus when the implant device <NUM> is implanted.

Various dimensions are shown in <FIG> for the implant device <NUM>. The implant device <NUM> includes a length <NUM> measured longitudinally between the proximal end <NUM> and the distal end. The circumferential ridges <NUM> have a width <NUM> at the base of the ridges <NUM> and a height <NUM> above adjacent recess areas <NUM>. The ridges <NUM> are spaced on a center-to-center spacing <NUM>, with inter-ridge spacing <NUM> between adjacent bases of adjacent ridges <NUM>. The conduit <NUM> has a maximum exterior width <NUM> corresponding with the tops of the ridges <NUM>, equal to the diameter of the circle of the cross-section through the conduit <NUM> at the top of the ridges <NUM>. The conduit <NUM> has a minimum exterior width <NUM> at locations corresponding with the recess areas <NUM> on the second longitudinal portion <NUM> of the conduit <NUM>. The head <NUM> has a circular perimeter having a diameter <NUM> and a depth <NUM>. The beginning, or proximal end, of the second longitudinal portion <NUM> is located at a distance <NUM> from the proximal end <NUM>, at the base of the ridge <NUM> nearest to the proximal end <NUM> and the second longitudinal portion <NUM> has a length <NUM>. The internal passage <NUM> has a circular cross-section along the length of the implant device <NUM>, which is of constant diameter except that the diameter of the internal passage flares to a larger diameter in transition portions adjacent the proximal end <NUM> and the distal end <NUM>, which are further described below.

Some example values for a number of the dimensions shown in <FIG> for one example embodiment of the implant device <NUM> are summarized in Table <NUM>.

Further features of the example implant device <NUM> are described in <CIT>.

<FIG> shows an example of implant placement of the implant device <NUM> in an implantation position to fluid connect the lacrimal apparatus in the orbit with the ethmoid sinus. In the implantation position shown in <FIG>, the head <NUM> and proximal end <NUM> are disposed in the lacrimal apparatus in the orbit in the conjunctival sac and the distal end <NUM> is disposed in the ethmoid sinus <NUM>, with the conduit <NUM> passing through the surgical path across tissue including conjunctiva and a wall of the ethmoid bone in which the ethmoid sinus <NUM> is located, with some anchor ridges <NUM> disposed within the surgical path to engage tissue and help anchor the implant device <NUM>, and with other ones of the anchor ridges <NUM> and the side ports <NUM> disposed in the ethmoid sinus. In an alternative example, the surgical path from the lacrimal apparatus in the orbit may pass directly through the lacrimal caruncle <NUM>, and in the implantation position the head <NUM> may be disposed over and engage tissue of the lacrimal caruncle <NUM>.

Whether the implanted implant design has a design of a type as illustrated in <FIG> and <FIG> or a different design, after implantation, the implant device may be used to provide access to the paranasal sinus to perform medical procedures or treatments directed to the paranasal sinus, for example to administer a treatment composition (also referred to as a treatment formulation) the paranasal sinus or to aspirate fluid from the paranasal sinus. Such a treatment formulation may include one or more drugs for treatment of sinusitis or may be an irrigation fluid to irrigate the paranasal sinus.

With reference also to <FIG>, an embodiment of a paranasal sinus fluid access implantation tool <NUM> and various components of and example implantation procedures involving the implantation tool <NUM> will be described. For illustration purposes, the implantation tool <NUM> is shown in an implantation assembly with or being operated in connection with implantation of the example paranasal sinus fluid access implant device <NUM> shown in <FIG>.

The implantation tool <NUM> includes an insertion portion <NUM> configured to carry the implant device <NUM> for insertion through a surgical path between the lacrimal apparatus in the orbit and a paranasal sinus during an implantation procedure. The implantation tool <NUM> also includes a handle portion <NUM> configured to remain outside of the surgical path during the implantation procedure and which is manipulable by a medical practitioner to direct implantation of the implant device <NUM> during the implantation procedure. The insertion portion <NUM> includes a carrier member <NUM> on which the implant device <NUM> may be mounted to be carried to an implantation position through the surgical path from an approach through the palpebral fissure during an implantation procedure. The carrier member <NUM> includes a mounting portion <NUM>. The mounting portion <NUM> is a longitudinal portion of the carrier member <NUM> on which the implant device <NUM> is secured to be carried by the carrier member <NUM> during an implantation procedure. As illustrated in <FIG> and <FIG>, the mounting portion <NUM> of the carrier member <NUM> corresponds with the length of the carrier member <NUM> along which the implant device <NUM> is secured to be carried by the implantation tool <NUM> during an implantation procedure. In this regard, a distal end of the mounting portion <NUM> may correspond with the distal end <NUM> of the implant device <NUM> and the proximal end of the mounting portion <NUM> may correspond with the proximal end <NUM> of the implant device <NUM> as the implant device <NUM> is secured to the carrier member <NUM> for an implantation procedure. It is noted that although the implant device <NUM> is mounted on and secured to such a mounting portion <NUM> of the carrier member <NUM> in preparation for an implantation procedure, when the implant device <NUM> is inserted on the carrier member <NUM> into the surgical passage during an implantation procedure, the implant device <NUM> may deform or shift somewhat relative to the carrier member <NUM>, which may include a movement of some portion or portions of the implant device <NUM> along the carrier member <NUM> outside of the mounting portion <NUM>, on which the implant device <NUM> was initially confined as initially mounted. For instance, with the implantation tool <NUM>, only a distal portion the implant device <NUM> is secured to the carrier member <NUM>, so that portions of the implant device <NUM> located proximal to the locations of securement will be in tension as the implant device <NUM> is inserted into and advanced through the surgical path for implant placement. This advantageously permits the implant device <NUM> to stretch out and elongate along the carrier member <NUM> proximal of the securement locations, and proximal portions of the stretched implant device <NUM> may extend proximal of the mounting portion <NUM> of the carrier member <NUM>. Likewise, the secured distal portion of the implant device <NUM> may deform and shift position slightly around the locations of securement, which may slightly shift the positioning of the distal end <NUM> of the implant device <NUM> relative to the distal end of the mounting portion <NUM> of the carrier member <NUM>.

As shown in <FIG>, a slidable member <NUM> is disposed mostly in internal working space housed within the handle portion <NUM> and the carrier member <NUM>. The slidable member <NUM> is slidable along a translation path within the internal working space, and a spring <NUM> may provide a force to propel the slidable member <NUM> to release the implant device <NUM> from securement to the carrier member <NUM> to deploy the implant device <NUM> for implantation after the implant device <NUM> has been advanced in a surgical path to an implantation position. As shown in the figures, the slidable member <NUM> includes a first portion <NUM> in the form of an elongated conduit (e.g., hypodermic tube, also referred to as a hypo tube). The slidable member also includes a second portion <NUM> to interact with the spring <NUM> and has a depressable member <NUM> that may be depressed by a medical professional during an implantation procedure to release the spring <NUM> from a charged state (pre-compressed state) to propel the slidable member <NUM> toward a proximal end <NUM> of the implantation tool <NUM> to retract the slidable member <NUM> within the internal working space to release the implant device <NUM> from securement to the carrier member <NUM> for implantation deployment. The depressable member <NUM> interfaces with an actuation member in the form of an actuation button <NUM>, which may be pushed by a medical professional to depress the depressable member <NUM> to actuate release of the implant device <NUM> from securement to the carrier member <NUM> during an implantation procedure. By way of example, the first portion <NUM> of the slidable member <NUM> may be in the form of a small diameter hypo tube (e.g., of stainless steel) and the second portion <NUM> of the slidable member <NUM> may be a plastic structure (e.g., of polypropylene) molded over the hypo tube.

<FIG> illustrates the first portion <NUM> of the slidable member <NUM> in the form of a hypo tube with a flared proximal end <NUM> for more secure engagement with the over-molded second portion <NUM> of the slidable member <NUM>, as illustrated in <FIG>. The second portion <NUM> of the slidable member <NUM> includes retaining projections <NUM> to engage and retain the spring <NUM> relative to the slidable member <NUM>. In the example of the implantation tool <NUM>, the actuation button <NUM> is part of a molded handle body piece (e.g., of polypropylene). In a compressed state, a distal end of the spring <NUM> is disposed against a shoulder feature <NUM> in the handle body. The implantation tool <NUM> includes a lumen provided through the first portion <NUM> of the slidable member <NUM> for passage of a guide wire therethrough to guide a distal end of the implantation tool <NUM> to the surgical path during an implantation procedure. The lumen is accessible from the proximal end <NUM> of the implantation tool <NUM> through an opening <NUM> though an end-cap insert <NUM> with tab portions <NUM> that lock into a proximal portion of an opening feature <NUM> in the handle body. The end-cap insert <NUM> encloses the internal working space adjacent the proximal end <NUM> and acts as a stop for movement of the slidable member <NUM> when propelled toward the proximal end <NUM> when the spring <NUM> in a compressed state is released by depression of the depressable member <NUM> through manipulation of the actuation button <NUM>.

A key feature of the implantation tool <NUM> is a securement mechanism provided to secure the implant device <NUM> in an implantation orientation on the carrier member <NUM> to carry the implant device <NUM> to an implantation position through the surgical path during an implantation procedure. The securement mechanism is reconfigurable from a securement configuration to secure the implant device <NUM> to the carrier member <NUM> to a released configuration to release the implant device <NUM> from securement to the carrier member <NUM> after being advanced through a surgical path to an implantation position, permitting withdrawal of the implantation tool <NUM>, and the carrier member <NUM>, to disengage the carrier member <NUM> from the positioned implant device <NUM> to leave the implant device <NUM> in place for implantation. In the embodiment illustrated for the implant tool <NUM>, the securement mechanism includes two securement members in the form of sheath members <NUM> that are integral with and provided as extensions at a distal end of the carrier member <NUM>. In one example contemplated implementation, the carrier member <NUM> may be made of a polymeric composition with material properties permitting the integral sheath members <NUM> to be sufficiently ductile to be routed through the distally-located side ports <NUM> of the implant device <NUM> from inside of to outside of the side ports <NUM> and then distally over distal portions of the exterior of the implant device <NUM> to engage and be retained in a secured configuration by retainment structure features provided on distal end portions of the slidable members <NUM>. As seen in <FIG> and <FIG>, a distal end portion of the slidable member <NUM> includes securement tabs <NUM> cut into the wall of opposing sides of the distal end portion of the first portion <NUM> of the slidable member <NUM>. Each of the securement tabs <NUM> is defined by a slot <NUM> cut through the wall of the first portion <NUM> of the slidable member <NUM> so that each securement tab <NUM> is configured be received through a corresponding opening <NUM> through a corresponding distal end portion of a sheath member <NUM> for securement of a sheath members <NUM> to the distal end portion of the slidable member <NUM>. This permits the distal end portion of each sheath member <NUM> to be hooked over a corresponding securement tab <NUM> with the securement tab <NUM> projecting through the opening <NUM> of the sheath member <NUM> to hold the sheath member <NUM> secured in place in a securement configuration for advancement of the implant device <NUM> mounted on the carrier member <NUM> into and through a surgical route during an implantation procedure. An example of the engagement between the sheath members <NUM> and corresponding ones of the securement tabs <NUM> projecting through the openings <NUM> in an implantation assembly reading for an implantation procedure is illustrated for example, in <FIG>. The secured sheath members <NUM> in the securement configuration engaged with the securement tabs <NUM> both secure the implant device <NUM> in an implantation orientation mounted on the carrier member <NUM> and provide a sheath-like protection of distal end portions of the implant device <NUM> that are covered by the sheath members <NUM>, facilitating insertion of the implant device <NUM> into a surgical path and advancing the implant device <NUM> through the surgical path to an implantation position with reduced resistance to advancement from the distal end edge of the implant device <NUM>. Securement of the implant device <NUM> to the carrier member <NUM> only at locations at and distal to the side ports <NUM> results in a majority of the length of the implant device <NUM> located proximal to the side ports <NUM> that is advanced into and through the surgical path to be advanced in a state of tension as a result of resistance to advancement from tissue in the surgical path pulling on the exterior of the conduit <NUM> of the implant device <NUM> when the implant device <NUM> is advanced through the surgical path, until the head <NUM> of the implant device <NUM> engages conjunctival tissue adjacent to the proximal opening of the surgical path when the implant device <NUM> has been fully advanced to an implantation position. As shown in <FIG>, the mounting portion <NUM> of the carrier member <NUM> extends to the distal end of the implant device <NUM>, with a distal end portion of the carrier member <NUM> extending along an exterior of the implant device <NUM> to the distal end of the implant device <NUM>. In the embodiment of the implantation tool <NUM>, the securement members in the form of the sheath members <NUM> are integral portions of the carrier member <NUM>, which together with the distal end portion of the slidable member <NUM> including the tab portions <NUM> are part of a securement mechanism to secure the implant device in the implantation orientation on the carrier member <NUM>. Is should be appreciated that the term "carrier member" as used herein refers to a carrying structure, which may be a combination of pieces or parts that during an implantation procedure provide the carrying function with the implant device mounted in a supported manner for advancing the implant device to an implantation position relative to a surgical path during an implantation procedure. In some alternative configurations to the implantation tool <NUM> as illustrated in <FIG>, one or more sheath members may extend out of the end of the internal passage of an implant device and fold back over the distal end of the implant device to extend over an exterior of a distal end portion of the implant device. For example, such a folded-over sheath member may be retained along a distal end portion of the implant device <NUM> by a snare-type structure, for example similar to as described below with respect to <FIG>, or by retainment features on a slidable member disposed in the vicinity of the side ports <NUM> of the implant device <NUM>. In other alternative configurations, sheath members may be separate from a carrier member, and not an integral part of a carrier member.

The implantation tool <NUM> includes a safety cover <NUM> attached to the handle body to cover the actuation button <NUM> to prevent hand access to the actuation button <NUM> to prevent premature release of the implant device <NUM> from securement to the carrier member <NUM> during an implantation procedure. When the implant device <NUM> has been positioned through a surgical path in an implantation position and ready to be released from securement to the carrier member <NUM> for implantation, the safety cover <NUM> may be selectively removed from the handle body by pulling up on the safety cover <NUM>, thereby permitting hand access to the actuation button <NUM> to permit a medical practitioner to press the actuation button <NUM> to depress the depressable member <NUM> and to disengage a proximal projection <NUM> on the depressable member <NUM> from a corresponding recess feature in the handle body, as seen best in <FIG>. As shown in <FIG>, when the projection <NUM> is received in the corresponding recess feature in the handle body, the depressable member <NUM> is in a locked configuration maintaining the spring <NUM> in a compressed state. When the actuation button <NUM> is pushed down after removal from of the safety cover <NUM>, the projection <NUM> is moved out of the locked configuration to permit expansion of the spring <NUM> from the compressed state to propel the slidable member <NUM> toward the proximal end <NUM> of the implantation tool <NUM>, resulting in disengagement of the securement tabs <NUM> from the sheath members <NUM> to release the sheath members <NUM> from securing the implant device <NUM> to the carrier member <NUM>. As the slidable member <NUM> moves toward the proximal end <NUM>, a distal portion of the slidable member <NUM> is retracted into the interior working space within the carrier member <NUM>, for example as illustrated in <FIG>.

With continued reference primarily to <FIG>, performance of an example implantation procedure will be described using the implantation tool <NUM>. <FIG> illustrates an implantation assembly ready for performing an implantation procedure with the implant device <NUM> mounted in an implantation orientation and secured to the carrier member <NUM>. <FIG> illustrates a distal portion of the implantation tool <NUM> with the implant device <NUM> secured to the carrier member <NUM> by the sheath members <NUM> engaged with the securement tabs <NUM> on the first portion <NUM> of the slidable member <NUM>, with the securement tabs <NUM> received through the openings <NUM> and the corresponding sheath members <NUM>. As illustrated in <FIG>, the securement tabs <NUM> may be slightly flared outward to enhance performance of the securement tabs <NUM> both for securing the sheath members <NUM> insertion into the surgical path and for release of the sheath members <NUM> when the tool member slidable member <NUM> is retracted to disengage from the sheath members <NUM> and to release the implant device <NUM> from securement to the carrier member <NUM>. <FIG> illustrates actuation of the implantation tool <NUM> to reconfigure the securement mechanism from the securement configuration to the released configuration during an implantation procedure after the implant device <NUM> has been advanced into a surgical path to an implantation position with the distal end <NUM> disposed in a paranasal sinus (e.g., ethmoid sinus, maxillary sinus or frontal sinus) and with the proximal end <NUM> disposed in the lacrimal apparatus in the orbit, and preferably with a distal side of the head <NUM> in contact with conjunctival tissue in the orbit. Such an implantation position for the implant device <NUM> may be as illustrated for example in <FIG>, but with the implant device <NUM> still secured to the carrier member <NUM> of the implantation tool <NUM>. As shown in <FIG>, with the implant device <NUM> in the implantation position through the surgical path, the safety cover <NUM> may be removed to permit access to the actuation button <NUM>, which may be pushed to reconfigure the securement mechanism of the implantation tool <NUM> to the released configuration in which the implant device <NUM> is released from securement to the carrier member <NUM>, as illustrated in <FIG>. After the actuation button <NUM> has been pressed to release the implant device <NUM> from securement to the carrier member <NUM>, a medical professional performing an implantation procedure may pull back on the handle portion <NUM> to withdraw the carrier member <NUM> from the surgical path to leave the implant device <NUM> in place implanted in the implantation position to fluidly connect a paranasal sinus with the lacrimal apparatus in the orbit, as shown in <FIG>. As the carrier member <NUM> is being withdrawn relative to the implant device <NUM>, the distal portions of the sheath members <NUM> are retracted through the side ports <NUM> of the implant device <NUM> leaving the implant device <NUM> implanted in the implantation position completely disengaged from the implantation tool <NUM>, as shown in <FIG> and <FIG>, which may be in the implantation position as illustrated in <FIG>.

The carrier member <NUM> of the implantation tool <NUM> may be made of a uniform material of construction throughout, or may be made of a first material of construction (e.g., metallic or hard engineering plastic material) with higher rigidity to carry the implant device <NUM> and a second material of construction for the sheath members <NUM> with a lower rigidity that is sufficiently malleable to be readily deformed to be passed through the side ports <NUM> and to engage with the securement tabs <NUM>. Because of the support provided to the carrier member <NUM> by the slidable member <NUM> (e.g., made of stainless steel or another hard, rigid material) disposed through the carrier member <NUM>, the entire carrier member <NUM>, including the integral sheath members <NUM>, may be made of a uniform material with properties advantageously selected for performance of both the sheath members <NUM> and other portions of the carrier member <NUM> to carry the implant device during an implantation procedure. Some example materials that may be used as a single material of construction for the carrier member <NUM>, including the integral sheath members <NUM>, or that may be used for only the sheath members <NUM>, include polyimide, polyamide (e.g., nylon), Mylar, PET (polyethylene terephthalate), FEP (fluorinated ethylene propylene), PTFE (polytetrafluoroethylene), nitinol suture, PVF (polyvinyl fluoride), composite polymer and silicone composite compositions. Some preferred compositions are polymeric compositions, such as polyimide, polyamide (e.g., nylon), Mylar, PET (polyethylene terephthalate), FEP (fluorinated ethylene propylene) and PTFE (polytetrafluoroethylene) compositions, with polyamide (e.g., nylon) compositions more preferred for some implementations. One example for particularly preferred materials of construction for the carrier member <NUM>, including the integral sheath members <NUM>, are thermoplastic elastomers, and preferably polyether block amide elastomers (PEBAs). Polymeric compositions, or polymeric matrix for composites with a polymeric matrix, for the carrier member, and preferably for PEBA materials, with or without integral sheath members, may in some implementations have a Shore D hardness in a range of <NUM> to <NUM>, preferably <NUM>-<NUM> and more preferably <NUM>-<NUM>. One useful group of such PEBA materials are the Pebax® compositions from Arkema, and preferably some of the harder Pebax® materials (e.g., with a Shore D hardness of <NUM> or larger). For example some Pebax® compositions have a Shore D hardness of around <NUM> and are especially useful. Another useful group of such thermoplastic elastomers are the Vestamid® E compositions from Evonik, and preferably some of the harder such materials (e.g., having a Shore D hardness of <NUM> or larger).

With reference also to <FIG>, another embodiment of a paranasal sinus fluid access implantation tool <NUM> and various components of an example implantation procedures involving the implantation tool <NUM> will be described. For illustration purposes, the implantation tool <NUM> is described for mounting and implanting the example paranasal sinus fluid access implant device <NUM> shown in <FIG>.

The implantation tool <NUM> includes an insertion portion <NUM> configured to carry the implant device <NUM> for insertion through a surgical path between the lacrimal apparatus in the orbit and a paranasal sinus during an implantation procedure. The implantation tool <NUM> also includes a handle portion <NUM> configured to remain outside of the surgical path during the implantation procedure in which is manipulable by a medical practitioner to direct implantation of the implant device <NUM> during the implantation procedure. The insertion portion <NUM> includes a carrier member <NUM> on which the implant device <NUM> may be mounted to be carried to an implantation position through the surgical path with an approach through the palpebral fissure during an implantation procedure. The carrier member <NUM> includes a mounting portion <NUM>, which is a longitudinal portion of the carrier member <NUM> on which the implant device <NUM> is secured to be carried by the carrier member <NUM> during an implantation procedure. The mounting portion <NUM> generally corresponds with the length of the carrier member <NUM> along which the implant device <NUM> is secured to be carried by the implantation tool <NUM> during an implantation procedure. A distal end of the mounting portion <NUM> may correspond with the distal end <NUM> of the mounted implant device <NUM> and the proximal end of the mounting portion <NUM> may correspond with the proximal end <NUM> of the mounted implant device <NUM>. Similar to the discussion above concerning the implantation tool <NUM>, although the implant device <NUM> is mounted on and secured to such a mounting portion <NUM> of the carrier member <NUM> in preparation for an implantation procedure, when the implant device <NUM> is inserted on the carrier member <NUM> into a surgical passage during an implantation procedure, the implant device <NUM> may deform or shift somewhat relative to the carrier member <NUM>, including possibly moving somewhat outside of the mounting portion <NUM> on which the implant device <NUM> was initially confined as initially mounted.

A handle body of the handle portion <NUM> and the carrier member <NUM> provide a housing for internal components disposed in internal space within the implantation tool <NUM>. A slidable release member <NUM> is disposed in the internal working space within the handle portion <NUM> and the carrier member <NUM>. The release member <NUM> is slidable along a translation path within the internal working space. The release member <NUM> is connected with a release pin <NUM> that is engaged with and retains a release spring <NUM>. A proximal end of the release pin <NUM> is threaded into an end piece <NUM> located adjacent a proximal end <NUM> of the implantation tool. The end piece <NUM> is selectively manipulable by a medical professional during an implantation procedure to reconfigure a securement mechanism of the implantation tool <NUM> from a securement configuration to a released configuration to release the implant device <NUM> from securement to the carrier member <NUM> to permit the implantation tool <NUM> and the carrier member <NUM> to be withdrawn and disengaged from the implant device <NUM> to leave the implant device <NUM> implanted in an implantation position.

The implantation tool <NUM> includes a securement member in the form of a snare member <NUM> and an alignment member <NUM> to assist in properly positioning and aligning the implant device <NUM> adjacent to the mounting portion <NUM> of the mounting member <NUM> with a distal end portion of the implant device <NUM> disposed through a snare loop formed by the snare member <NUM> for securing the implant device <NUM> to the carrier member <NUM> in the secured configuration. The snare member <NUM> is configured to be retractable to retract the snare loop about a distal portion of the implant device <NUM> disposed along the mounting portion <NUM> of the carrier member <NUM> to secure the implant device <NUM> to the carrier member <NUM>. The implantation tool <NUM> also includes a guide loop member <NUM> that provides a small diameter loop near a distal end <NUM> of the implantation tool <NUM> for receiving a guide wire therethrough to guide the distal and <NUM> of the implantation tool <NUM> to a surgical path during an implantation procedure. The interior working space of the carrier member <NUM> is enclosed at a distal end of the carrier member <NUM> by a spherical end piece <NUM>. The carrier member <NUM> may, for example, be in the form of a metallic hypo tube (e.g., stainless steel hypo tube) with a small diameter metallic ball (e.g., stainless steel bearing ball) for the spherical end piece <NUM> attached to and enclosing a distal end of the hypo tube.

The carrier member <NUM> includes five side apertures disposed toward the distal end <NUM>. Two apertures <NUM> on opposing sides of the carrier member <NUM> provide passages for the guide loop member to exit from the interior working space of the carrier member <NUM>. From the apertures <NUM> the guide loop member <NUM> may extend in a proximal direction through the interior working space of the carrier member <NUM> and may be connected to the handle transition piece <NUM> at a distal end of the handle portion <NUM> to retain the guide member loop <NUM> in a fixed orientation with a desired small diameter loop open to receive a guide wire for guiding the carrier member <NUM> to a proximal end of the surgical path during an implantation procedure. An aperture <NUM> provides a passage for the alignment member to exit the interior working space of the carrier member <NUM>. From the aperture <NUM>, the alignment member <NUM> may extend in a proximal direction through the interior working space of the carrier member <NUM> and may be connected to a slidable loading member <NUM> disposed in the interior working space within the handle portion <NUM>. Apertures <NUM> and <NUM> provide passages for the snare member to exit the interior working space of the carrier member <NUM>. From the aperture <NUM>, a first portion of the snare member <NUM> may extend in a proximal direction through the interior working space of the carrier member <NUM> and may be connected with the loading member <NUM>. A second portion of the snare member <NUM> may be disposed in the interior working space of the carrier member <NUM> with an engagement portion of the snare member <NUM> in the form of an end loop <NUM> retained in the interior working space by a distal end portion of the release member <NUM> disposed through the end loop <NUM> when the snare member <NUM> is in the securement configuration to secure the implant device <NUM> to an exterior of the carrier member <NUM>. The release member <NUM> disposed through the loop end <NUM> maintains the loop member <NUM> with a snare loop adjacent an exterior of the carrier member <NUM> extending between the aperture <NUM> and the aperture <NUM>. However, in the released configuration, the release member <NUM> is retracted to disengage from the loop end <NUM> of the loop member <NUM> to release the snare loop and accordingly to release the implant device <NUM> from securement to the carrier member <NUM>.

The snare member <NUM> may be disposed in three different configurations, referred to as a loading configuration, a securement configuration and a released configuration, respectively. In the loading configuration and the released configuration, the release pin <NUM> is disposed through the loop end <NUM> of the snare member <NUM> to maintain the snare member <NUM> with a snare loop extending between the aperture <NUM> and the aperture <NUM>. In the loading configuration, the loading member <NUM> is in a forward position, as illustrated in <FIG>, and accordingly the end of the snare loop <NUM> connected to the loading member <NUM> is also in a forward position and the snare loop is in an expanded position to receive the implant device <NUM> to be secured to the mounting portion <NUM> of the carrier member <NUM>. With the snare member <NUM> in the loading configuration, the implant device <NUM> may be guided to the proper position for securement to the carrier member <NUM> by inserting the alignment member <NUM> into the internal passage from the distal end <NUM> of the implant device <NUM> and sliding the implant device <NUM> over the alignment member <NUM> until the distal end <NUM> of the implant device <NUM> is stopped adjacent the aperture <NUM> by a bend portion of the alignment member <NUM> where the alignment member <NUM> exits the aperture <NUM>. As fully advanced along the alignment member <NUM>, a distal end portion of the implant device <NUM> will be disposed through and distal of the snare loop of the snare member <NUM>. With the implant device <NUM> in such a position fully advanced along the alignment member <NUM>, the snare member <NUM> may be repositioned to the securement configuration by a medical professional by retracting the loading member <NUM> along a translation path in the interior working space of the handle portion, resulting in retraction of the end of the snare member <NUM> connected to the loading member <NUM> to retract the snare loop of the snare member <NUM> to a retracted position around the distal end portion of the implant device <NUM> disposed through the snare loop <NUM>. In the retracted position, the snare loop closes around the exterior of the implant device <NUM> and collapses the internal passage through the implant device <NUM> at the retracted snare loop location to firmly secure the implant device <NUM> to the mounting portion <NUM> of the carrier member <NUM>. In contrast to the example implantation tool <NUM> in which the implant device <NUM> has the carrier member <NUM> disposed through the internal passage of the implant device <NUM> when the implant device <NUM> is secured to the carrier member <NUM>, in the example implementation tool <NUM>, the mounted implant device <NUM> is in the absence of the carrier member <NUM> disposed through the internal passage of the implant device <NUM> secured to the carrier member <NUM>.

To reconfigure the snare member <NUM> from the loading configuration to the securement configuration, a medical professional may pull back on an actuation projection in the form of a knob member <NUM> connected with the loading member <NUM> with a portion of the knob member <NUM> disposed through and guided by a longitudinal portion of a slot track formed in a wall of a handle body providing a housing for components in the interior working space of the handle portion <NUM>. As the knob member <NUM> is pulled back to retract the loading member <NUM>, the loading member <NUM> compresses a loading spring <NUM> within the interior working space in the handle portion <NUM>. When the knob member <NUM> has been pulled fully back to a retracted position at the end of the longitudinal portion of the slot track <NUM>, the knob member may be translated in a transverse direction into a side portion <NUM> of the slot track <NUM> to lock the knob member <NUM> and the loading member <NUM> in a retracted position held securely in place by the force exerted by the compressed loading spring <NUM>, thereby also maintaining the snare loop of the snare member <NUM> in the retracted position of the securement configuration. As the alignment member <NUM> is also connected to the loading member <NUM>, as the loading member <NUM> is retracted, the alignment member <NUM> is also retracted with at least a portion of the alignment member being pulled into the interior working space of the carrier member <NUM>, and including retracting into the interior working space a bend portion of the alignment member <NUM> that will make it easier for the alignment member <NUM> disengage from the implant device <NUM> during an implantation procedure after the implant device <NUM> has been released from securement to the carrier member <NUM>. The alignment member may be made for example of a shape memory material, such as a nitinol material (nickel-titanium alloy), with shape memory for the bend portion. The snare member <NUM> may also be made of such a shape memory material with shape memory for the snare loop.

<FIG> more particularly illustrate the process of mounting the implant device <NUM> on the mounting portion <NUM> of the carrier member <NUM>. <FIG> shows the implantation tool <NUM> in the loading configuration ready to receive the implant device <NUM> for mounting. <FIG> shows sliding the implant device <NUM> over the alignment member <NUM> toward the snare loop of the snare member <NUM>. <FIG> shows the implant device <NUM> fully advanced over the alignment member <NUM> into an implantation orientation for mounting on the mounting portion <NUM> of the carrier member <NUM>. With the implant device <NUM> in the position as shown in <FIG>, the knob member may be retracted along the longitudinal portion of the slot track <NUM> to retract the snare loop of the snare member <NUM> around a location on the distal end portion of the implant device <NUM> in the securement configuration. Preferably, the snare loop secures the implant device <NUM> to the carrier member at a securement location along the distal end portion of the implant device <NUM> that corresponds with a recess area <NUM> between anchor ridges <NUM>, and preferably corresponds with the recess area <NUM> between the most distal pair of adjacent anchor ridges <NUM> (between which the side ports <NUM> are positioned in the example implant device <NUM>). After the snare loop <NUM> is fully retracted around the implant device <NUM> to securely hold the implant device <NUM> to the carrier member <NUM>, the knob member may be translated to the side into the side portion <NUM> of the slot track <NUM> to lock the snare member <NUM> in the securement configuration. With the implant device <NUM> secured to the carrier member in an implantation orientation, the carrier member <NUM> and the implant device <NUM> secured thereto may be advanced into a surgical path during an implantation procedure until the implant device <NUM> is advanced to an implantation position, preferably with the head <NUM> of the implant device <NUM> engaging tissue in the lacrimal apparatus in the orbit adjacent a proximal end of the surgical path. Once the implant device <NUM> is fully advanced to the implantation position, then the snare loop of the snare member <NUM> may be released to the released configuration for implantation of the implant device <NUM>.

To reconfigure the snare member <NUM> from the securement configuration to the released configuration to release the implant device <NUM> from securement to the carrier member <NUM>, the release member <NUM> may be retracted along a translation path within the interior working space of the implantation tool <NUM> by a medical professional pulling back on the end piece <NUM> to retract the release pin <NUM> and the release member <NUM> connected to the release pin <NUM>, and to disengage the distal end portion of the release member <NUM> from the loop end <NUM> of the snare member <NUM>. As the loop end <NUM> of the snare member <NUM> is released, the loop end <NUM> is no longer secured in the interior working space within the carrier member <NUM> and the snare loop is released, releasing the implant device <NUM> from securement to the carrier member <NUM>, and permitting the implantation tool <NUM>, and accordingly the carrier member <NUM> to be withdrawn from a surgical path relative to the implant device <NUM> to leave the implant device <NUM> implanted in an implantation position through the surgical path to fluidly connect the lacrimal apparatus in the orbit with a paranasal sinus.

The implantation tool <NUM> includes a lock member <NUM> that is normally maintained in a raised position as shown in <FIG>, <FIG> by a lock spring <NUM>. In the raised position, the lock member <NUM> engages the release pin <NUM> to maintain the release pin <NUM> in a locked position to prevent premature retraction of the release pin <NUM> and the release member <NUM>. Prior to pulling back on the end piece <NUM> to retract the release pin <NUM>, the medical professional would depress the lock member <NUM> to unlock the release pin <NUM>, and while holding the lock member <NUM> in the depressed position would pull back on the end piece <NUM> to retract the release pin <NUM> and the release member <NUM>. The release spring <NUM> may initially be in an uncharged state or, preferably, in a charged extension state with the release spring <NUM> biasing the release pin <NUM> and the release member <NUM> toward the proximal end <NUM> of the implantation tool <NUM> and urging the end piece <NUM> toward the release pin <NUM>, such that when a medical professional pulls back on the end piece <NUM>, the medical professional must pull with sufficient force to overcome the biasing force of the release spring <NUM>. As may be appreciated, in the configuration shown for the implantation tool <NUM> the release spring <NUM> and the loading spring <NUM> will be isolated from each other.

In alternative configurations to the configuration of the implantation tool <NUM> illustrated in <FIG>, an implantation tool with a snare-type securement structure of the type illustrated in <FIG> may be adapted for mounting an implant device with the carrier member extending through the internal passage of the implant device and with a snare loop extending around at least circumferential portion of the exterior of the implant device, for example including alignment of snare exit apertures such as apertures <NUM> and <NUM> with features such as side ports <NUM> of the implant device <NUM>.

The foregoing description of the present invention and various aspects thereof has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain known modes of practicing the invention and to enable others skilled in the art to utilize the invention in such or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.

The description of a feature or features in a particular combination do not exclude the inclusion of an additional feature or features in a variation of the particular combination. Processing steps and sequencing are for illustration only, and such illustrations do not exclude inclusion of other steps or other sequencing of steps to an extent not necessarily incompatible. Additional steps may be included between any illustrated processing steps or before or after any illustrated processing step to an extent not necessarily incompatible.

Claim 1:
An implantation tool (<NUM>, <NUM>) to implant a paranasal sinus fluid access implant device (<NUM>) with an internal fluid communication passage (<NUM>) through an artificial, surgical path between a lacrimal apparatus in the orbit and a paranasal sinus in an implantation procedure to provide direct fluid communication access through the internal passage from the lacrimal apparatus in the orbit to the paranasal sinus, the implantation tool comprising:
a carrier member (<NUM>, <NUM>) configured to carry the implant device on a mounting portion (<NUM>, <NUM>) of the carrier member in a mounted orientation to position the implant device in an implantation position through the surgical path from an approach through the palpebral fissure during the implantation procedure;
a securement mechanism (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to secure the implant device in the implantation orientation on the carrier member to carry the implant device to the implantation position during the implantation procedure, the securement mechanism being reconfigurable from a securement configuration to secure the implant device to the mounting portion of the carrier member in the implantation orientation to a released configuration to release the implant device from securement to the carrier member to permit withdrawal of the carrier member relative to the implant device to leave the implant device implanted in the implantation position during the implantation procedure, wherein the securement mechanism comprises at least one securement member (<NUM>, <NUM>) positioned to extend over and press against an exterior portion of the implant device in the implantation orientation when the securement mechanism is in the securement configuration;
a handle portion (<NUM>, <NUM>) connected with the carrier member and configured to remain outside of the surgical path during the implantation procedure and being manipulable by a medical practitioner to direct implantation of the implant device during the implantation procedure;
internal working space housed within at least a portion of the handle portion and at least a portion of the carrier member;
a release mechanism (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) disposed at least in part in the internal working space and manipulable to reconfigure the securement mechanism from the securement configuration to the released configuration.