Abstract
The various embodiments of the subject invention included herein provide devices and methods to deliver nasal packing material to a body lumen, cavity, or other anatomical structure along with methods of use of the same.
Claims
1. A device for use in positioning a material in a nasal cavity of a subject, comprising; a handle having a distal end, a proximal end and a channel wherein the handle is disposed at the proximal end of the device; an actuator slidably disposed on the handle; an elongate member having a distal end, a proximal end and at least one lumen, wherein the proximal end is joined to the distal end of the handle; a shuttle having a distal end and a proximal end slidably disposed on the elongate member; a link member having a distal end and a proximal end slidably disposed on the elongate member and the handle, wherein the distal end of the link member is joined to the shuttle and the proximal end is joined to the actuator.
2. The device of claim 1, wherein movement of the actuator along the handle is directly translated to the shuttle via the link member.
3. The device of claim 1, wherein the shuttle comprises at least two tines.
4. The device of claim 1, wherein the shuttle comprises a shape that is U-shaped in cross section.
5. The device of claim 1, wherein the shuttle extends beyond the distal end of the elongate member
6. The device of claim 1, wherein a portion of the actuator is disposed within the handle and a portion of the actuator is external to a surface of the handle.
7. The device of claim 1, wherein a longitudinal axis of the elongate member is offset from a longitudinal axis of the handle.
8. A device for use in positioning a material in a nasal cavity of a subject, comprising; a handle having a distal end, a proximal end and a channel wherein the handle is disposed at the proximal end of the device; an actuator disposed on the handle; a disk slidably disposed in the channel of the handle; an elongate member having a distal end, a proximal end and at least one lumen, wherein the proximal end of the elongate member is joined to the distal end of the handle; a shuttle having a distal end and a proximal end slidably disposed on the elongate member; a link member having a distal end and a proximal end slidably disposed on the lumen of the elongate member and the channel of the handle, wherein the distal end of the link member is joined to the proximal end of the shuttle and the proximal end is joined to the disc; and a spring disposed in the channel of the handle and on the link member, wherein the proximal end of the spring is positioned against the disk.
9. The device of claim 8, wherein a longitudinal axis of the handle is offset from a longitudinal axis of the elongate member.
10. The device of claim 8, wherein the distal end of the handle has a shape comprising of at least one bend.
11. The device of claim 8, wherein the actuator further comprises a latch extending in the channel of the handle for engaging with the disk.
12. The device of claim 11, wherein the actuator further comprises a spring that maintains the latch in a biased position that keeps the actuator latch engaged with the disk.
13. The device of claim 12, wherein pressing the actuator disengages the disk from the actuator latch.
14. The device of claim 8, wherein the disk further comprises an edge that keeps the latch of the actuator in an engaged position.
15. The device of claim 8, wherein the link member comprises a flexible material.
16. The device of claim 8, wherein the shuttle further comprises at least two tines.
17. The device of claim 16, wherein the shuttle comprises two tines for positioning a material there between.
18. The device of claim 8, wherein the shuttle comprises a shape that is U-shaped in cross section.
19. The device of claim 18, wherein the shuttle further comprises an opening sized for holding a material.
20. The device of claim 8, wherein the shuttle further comprises a post disposed at the proximal end of the shuttle.
21. The device of claim 8, wherein the elongate member comprises a cap disposed at the distal end of the elongate member.
22. The device of claim 21, wherein the cap further comprises an opening to slidably receive the shuttle and maintain orientation of the shuttle relative to the elongate member and the handle.
23. The device of claim 8, wherein the spring exerts a force against the disk when the disk is engaged on the latch of the actuator.
24. The device of claim 23, wherein the force exerted by the spring shifts the disk from a first position to a second position when the disk is disengaged from the latch of the actuator.
25. The device of claim 24, wherein the movement of the disk from the first position to the second position is directly translated to the shuttle.
26. The device of claim 24, wherein movement of the shuttle from the first position to the second position releases the material.
27. A device for use in positioning a material in a nasal cavity or a subject, comprising; an elongate member having a distal end, a proximal end, a lumen, and at least one sidewall port; a flange disposed at the proximal end of the elongate member; an extension line disposed at a proximal end of the device, wherein the extension line comprises a distal end, a proximal end, and a lumen, wherein the proximal end of the extension line is joined to the distal end of the elongate member, a connection port disposed at the proximal end of the extension line, an expandable member disposed at the distal end of the elongate member and joined to the elongate member between the distal end and proximal end of the elongate member such that a space bounded by the internal surface of the expandable member and external surface of the elongate member is in fluid communication with the injection ports of the elongate member; and a material disposed within the expandable member.
28. The device of claim 27, wherein the lumen of the extension line is in fluid communication with the lumen of the elongate member.
29. The device of claim 27, wherein the packing material is secured in place.
30. The device of claim 29, wherein a weld secures the packing material in place.
31. The device of claim 29, wherein a weave, braid, or suture secures the packing material in place.
32. The device of claim 27, wherein infusion of a fluid into the connection port expands the expandable member.
33. The device of claim 32, wherein expansion of the expandable member releases the packing material from the apparatus.
34. A delivery system comprising a nasal packing material and the device of claim 1.
35. The delivery system of claim 34, wherein the nasal packing material is positioned within the shuttle prior to use.
36. The delivery system of claim 27, wherein the nasal packing material is provided separately from the device of claim 1 and positioned in the shuttle prior to use by an operator.
37. A delivery system comprising a nasal packing material and the device of claim 8.
38. The delivery system of claim 37, wherein the nasal packing material is positioned within the shuttle prior to use.
39. The system of claim 37, wherein the nasal packing material is provided separately from the device of claim 11 and positioned in the shuttle prior to use by the operator.
40. A delivery system comprising a nasal packing material and the device of claim 27.
41. The delivery system of claim 40, wherein the nasal packing material is positioned within the expandable member prior to use.
42. The system of claim 40, wherein the nasal packing material is provided separately from the device of claim 27 and positioned in the expandable member prior to use by the operator.
43. A method of treating epistaxis comprising; advancing a distal end of the elongate member of the device of claim 26 into a nostril of a patient until the flange contacts the alar rim and/or the columella; expanding the expandable member from a first diameter to a second diameter; releasing the nasal packing from the apparatus; applying the nasal packing to the site of bleeding; maintaining the expandable member at the second diameter to compress and apply pressure to the nasal packing against the site of bleeding; collapsing the expandable member from the second diameter to the first diameter; and removing the apparatus from the nostril of the patient.
44. A method of delivering a nasal packing material to a target nasal anatomical space of a subject, comprising; advancing a distal end of the device of claim 1 into a nostril of a subject, placing the shuttle containing a nasal packing material into a target nasal anatomical space; retracting the actuator in the proximal direction to release the nasal packing material in the target nasal anatomical space, and removing the apparatus from the nostril of the subject.
45. The method of claim 44, wherein the target nasal anatomical space is the middle meatus.
46. The method of claim 44, wherein the target nasal anatomical space is the frontal sinus ostium.
47. The method of claim 44, wherein the target nasal anatomical space is the maxillary sinus ostium.
48. The method of claim 44, wherein the target nasal anatomical space is an ethmoid cell.
49. The method of claim 44, wherein the target nasal anatomical space is the sphenoid sinus ostium.
50. A method of delivering a nasal packing material to a target nasal anatomical space of a subject, comprising; advancing a distal end of the device of claim 8 into a target nasal anatomical space of a subject; placing the shuttle containing the nasal packing material into the target nasal anatomical space; activating the actuator to release the nasal packing in the target nasal anatomical space; and removing the apparatus from the nostril of the subject.
51. The method of claim 50, wherein the target nasal anatomical space is the middle meatus.
52. The method of claim 50, wherein the target nasal anatomical space is the frontal sinus or frontal sinus ostium.
53. The method of claim 50, wherein the target nasal anatomical space is the maxillary sinus or maxillary sinus ostium.
54. The method of claim 50, wherein the target a nasal anatomical space is an ethmoid cell.
55. The method of claim 50, wherein the target nasal anatomical space is the sphenoid sinus or sphenoid sinus ostium.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures.
[0041] FIGS. 1A through 1H show examples of an elongate member and the different numbers and geometries of lumens that may be incorporated in the invention.
[0042] FIGS. 2A through 2F show different embodiments of the flange of the elongate member.
[0043] FIGS. 3A and 3B illustrate exemplary embodiments of lumens and channels in the elongate member.
[0044] FIGS. 4A through 4D illustrate exemplary embodiments of the plunger and the relationship between the plunger and the elongate member.
[0045] FIGS. 5A and 5B illustrate two exemplary embodiments of the fluid delivery member.
[0046] FIGS. 6A and 6B illustrate an embodiment of the invention for treatment of epistaxis.
[0047] FIG. 7 depicts a method of using an embodiment of the invention to treat epistaxis.
[0048] FIGS. 8A through 8C depict an embodiment of the invention for delivering a payload into the nasal cavity or paranasal sinuses.
[0049] FIGS. 9A and 9B depict an alternative embodiment of the invention for delivering a packing material into the nasal cavity or paranasal sinuses.
[0050] FIG. 10 depicts another alternative embodiment of the invention for delivering a packing material into the nasal cavity or paranasal sinuses.
[0051] FIGS. 11A through 11C depict top, side, and cross-sectional views of an embodiment of the invention for delivery a packing material into the nasal cavity.
[0052] FIGS. 12A and 12B depict side and cross-sectional views of the embodiment of the invention of FIG. 11 with the shuttle retracted.
[0053] FIGS. 13A and 13B depict top and side views of an embodiment of the invention for delivery a packing material into the nasal cavity, along with cross-sectional views of proximal portions of the embodiment of the invention.
[0054] FIGS. 14A and 14B depict side cross-sectional views of the embodiment of the invention of FIG. 13 with the actuator in the neutral and depressed states.
[0055] FIGS. 15A through 15C depict an alternative embodiment of a means of releasing a packing material into the nasal cavity.
DETAILED DESCRIPTION OF THE INVENTION
[0056] Before the present invention is described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
[0057] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
[0058] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.
[0059] It must be noted that as used herein and in the appended claims, the singular forms a, an, and the include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a compound includes a plurality of such compounds and reference to the polymer includes reference to one or more polymer and equivalents thereof known to those skilled in the art, and so forth.
[0060] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
[0061] Examples of the elongate member 101 with varying numbers and geometries of the lumens disclosed in this invention are illustrated in cross-section views shown in FIGS. 1A through 1H. FIG. 1A is an illustration of a single lumen 102 in an elongate member 101. While lumen 102 is shown a concentrically aligned with elongate member 101, it should be clear to those of skill in the art that lumen 102 may possess any size and/or location within the boundary established by the outer diameter of elongate member 101. FIG. 1B shows an elongate member 101 with two lumens, 102 and 103. While lumens 102 and 103 are shown as being circular in cross-section, identical in diameter, and symmetric about the vertical and horizontal centerlines of the cross-section of elongate member 101, it should be obvious to one of skill in the art that other arrangements of lumens 102 and 103 are possible. For instance, FIG. 1C shows lumens 102 and 103 as having identical D shapes and maintaining symmetry about the vertical and horizontal centerlines of the cross-section of elongate member 101. Another example is shown in FIG. 1D, wherein lumen 102 is much larger than lumen 103, and the pair of lumens is symmetric about the vertical centerline of the cross-section of elongate member 101 and non-symmetric about the horizontal centerline of the cross-section of elongate member 101. FIGS. 1E through 1F show examples of an elongate member 101 with three (3) lumens 104, 105, 106 as shown in FIG. 1E, four lumens 107, 108, 109, and 110 as shown in FIGS. 1F and 1G, and nine (9) total lumens with eight (8) lumens 112 and one (1) lumen 111 as shown in FIG. 1H. Referring to FIG. 1E, while lumens 104, 105, and 106 are shown as having an identical wedge shape and an even radial orientation about the center point of the cross section of elongate member 101, it should be clear that other sizes, shapes, and relative spatial arrangements of lumens 104, 105, and 106 are contemplated. FIG. 1F is one example of an elongate member 101 where lumens 107, 108, 109, and 110 are shown as circular in cross-section, identical in size, and symmetric about the horizontal and vertical centerlines of the cross-section of elongate member 101. FIG. 1G is an alternative example of an elongate member 101 showing identical and symmetric lumens 107, 108, 109 and 110. FIG. 1H shows an elongate member 101 comprising one large lumen 111 and eight identical smaller lumens 112. The lumens 112 are located in the wall of elongate member 101 and are located at angles of 0, 45, 90, 135, 180, 225, 270, and 315 from the intersection of the horizontal and vertical centerlines of the cross-section of elongate member 101. The examples shown in these figures are not an exhaustive list of the configurations of an elongate member and one or more lumens, and it should be clear that many such configurations are possible and are contemplated by this invention.
[0062] Examples of the feature component of the elongate member are illustrated in FIGS. 2A through 2F. FIG. 2A shows a transverse cross section and a front view of an elongate member 201 comprising a lumen 202 and a feature 203 shaped as a circular flange. In this example, the feature 203 and lumen 202 are concentrically aligned with the elongate member 201. FIG. 2B is an example of a non-circular feature 204 that is not concentrically aligned with elongate member 201 and lumen 202, shown in a front view. This design may be preferred in applications where a centered feature (as shown in FIG. 2A) would not be able to access the desired anatomy, would have more difficulty accessing the desired anatomy, or would be uncomfortable or harmful to the patient. One such application would be inserting the delivery device into a nostril and using the alar rim and/or columella as an anchor or stabilization point; the flat segment of the asymmetric feature 204 could rest comfortably against the nasal sill while the rounded segments of feature 204 could contact and stabilize the device against the alar rim and/or columella. FIG. 2C is a front view of an elongate member 201 comprising a lumen 202 and a feature 205, wherein feature 205 comprises two wings or wedges. A feature of this shape may be beneficial in locating the delivery device at a particular anatomical feature, as the number, size, shape, and arrangement of the wings or wedges may be chosen to match the anatomical target of interest. FIG. 2D is a front view of an elongate member 201 comprising a lumen 202 and a feature 206, wherein feature 206 comprises four narrow extensions arranged along lines aligned at 45, 135, 225, and 315 with respect to the intersection of the horizontal and vertical centerlines of elongate member 201. It should be clear to one skilled in the art that the number, shape, length, and radial location of the extensions comprising feature 206 may take any one of a set of myriad permutations. For example, feature 206 may alternatively comprise four extensions that are joined to elongate member 201 in the same location as shown in FIG. 2D, have the same length and thickness as shown in FIG. 2D, but differ in that each of the four extensions assumes a clockwise spiral arc as the distance from elongate member 201 increases. Similarly, the same extensions could arc counterclockwise as the distance from elongate member 201 increases, or assume any other shape without changing either the length or thickness of the individual extensions. FIGS. 2E and 2F are transverse cross sections of an elongate member 201 comprising a lumen 202 and either a feature 207 that arcs distally or a feature 208 that arcs proximally as the distance from elongate member 201 increases. While the examples shown in FIGS. 2E and 2F illustrate relatively simple geometries for features 207 and 208, it should be clear to one of skill in the art that any shape may be possible.
[0063] FIG. 3A provides an illustration of the distal end of an elongate member 301 comprising a central lumen 302, peripheral lumens 303, and multiple holes or apertures 304. It should be noted that the number and position of holes or apertures 304 can vary, and that all such permutations are contemplated by this disclosure. Furthermore, additional holes or apertures (not shown) may be located at the distal end of elongate member 301 such that any material flowing through peripheral lumens 303 may exist peripheral lumens 303 in the distal direction. In this example, holes or apertures 304 may or may not present in elongate member 301. FIG. 3B shows a cross-sectional view of an elongate member 301 comprising a central lumen 302 and multiple channels 305. Again, the number, location, size and or depth of channels 305 may vary from the exemplary illustration shown in FIG. 3B, and permutations of such are contemplated in this disclosure. It should be clear to one of skill in the art that an elongate member of the invention may comprise any or all of the lumens, channels, features, holes, or apertures shown in FIGS. 1 through 3.
[0064] FIG. 4A is a transverse cross section showing plunger 401 slidably disposed within the lumen 402 of elongate member 403. FIG. 4B is a transverse cross section showing plunger 401 slidably disposed within the lumen 402 of elongate member 403. Plunger 401 further comprises a cylindrical tube or an extrusion 404 extending from the distal face of plunger 401. The length and outer dimension (e.g. the outer diameter in the case of a cylindrical extrusion) of extrusion 404 can cover a wide range of measurements, and can preferably be chosen to accommodate inclusion of a nasal packing material, a stent, or other material (not shown) in the space between elongate member 403 and extrusion 404. FIG. 4C is a transverse cross section of a plunger 401 comprising an extrusion 404 and a lumen 405 slidably disposed within elongate member 403. While lumen 405 is depicted as coaxially disposed within plunger 401, it should be clear to one skilled in the art that additional lumens located at any position within plunger 401 are contemplated. Furthermore, the inclusion of a lumen 405 within plunger 401 is not dependent on the presence of extrusion 404; that is, lumen 405 may be present in plungers 401 of the type shown in FIG. 4A. FIG. 4D is a transverse cross section of a plunger 401 comprising a central lumen 405, peripheral lumens 406, extrusion 404, and exit ports or apertures 407 slidably disposed within the lumen of elongate member 403. Alternatively (not shown), central lumen 405 may extend through the distal tip of extrusion 404.
[0065] FIG. 5A is a transverse cross section of a fluid delivery member 501 coaxially disposed within a lumen of plunger 502 and elongate member 503. Fluid delivery member 501 further comprises a lumen 504, and is positioned such that the distal end of fluid delivery member 501 is aligned with the distal end of elongate member 503. Alternatively (not shown), the distal end of fluid delivery member may be offset either proximally or distally from the distal end of elongate member 503. Furthermore, fluid delivery member 501 may be fixed in translation with respect to elongate member 503 and/or plunger 502. For example, an embodiment of the invention that comprises a movable elongate member 503 and a fixed plunger 502 may further comprise a fixed fluid delivery member. In another example, an embodiment of the invention may comprise a fixed plunger 502, with both elongate member 503 and fluid delivery member 501 free to move. In this example, a payload (not shown) may be loaded into the space bounded by the inner surface of elongate member 503, the outer surface of fluid delivery member 501, and the distal end of plunger 502. Once the device is positioned to deliver the payload to the desired target anatomy, the following general sequence of steps occurs: (1) elongate member 503 is retracted proximally with respect to the fixed plunger 502 to expose the payload, (2) fluid delivery member 501 is retracted proximally with respect to fixed plunger 502 to release the payload (not shown), and (3) the delivery device of the invention is removed from the target anatomy. Fluid may be delivered through fluid delivery member 501 at any point in this general sequence. Furthermore, if elongate member 503 or fixed plunger 502 comprise additional lumens as described in FIG. 3A, 3B, or 4D, fluid may be delivered through these additional lumens at any point in the general sequence previously described or as desired by a user. Delivery of fluid through multiple independent lumens may be performed in a synchronous or asynchronous manner Examples include, but are not limited to all lumens delivering the same type of fluid at the same time, each lumen delivering one of a selection of fluids at an independent time, each lumen delivering an identical fluid at a different time, each lumen delivering a unique fluid at the same time, combinations thereof, and the like. Different volumes of fluid may be delivered through the different lumens, and the duration of the delivery times may vary based on factors including, but not limited to the viscosity of the fluid, the size and shape of the lumen, the delivery of a desired dose of a medication or therapeutic agent (in the case of fluids that comprise a therapeutic agent), the volume of fluid needed to hydrate an absorbent payload, combinations thereof, and the like.
[0066] In yet another example, a delivery device of the invention may comprise a fixed elongate member 503, a fixed fluid delivery member 501, and a movable plunger 502. A payload may be loaded into the space bounded by the inner surface of elongate member 503, the outer surface of fluid delivery member 501, and the distal end of plunger 502. Once the device is positioned to deliver the payload to the desired target anatomy, the following general sequence of steps occurs: 1) the plunger 502 is advanced distally with respect to the elongate member 503 and the fluid delivery member 501 to push the payload out of the lumen of elongate member 503, and 2) the delivery device of the invention is removed from the target anatomy. As with the prior example, fluid may be delivered through lumen 504 of fluid delivery member 501 at any point in this general sequence and the use of elongate members and/or plungers comprising addition lumens for fluid delivery as previously described is contemplated by this invention.
[0067] FIG. 5B shows the elongate member 503, plunger 502, fluid delivery member 501 and fluid delivery member lumen 504 of FIG. 5A wherein the fluid delivery member 501 further comprises at least one hole or aperture 505. The at least one hole or aperture 505 extends from fluid delivery member lumen 504 to the surface of fluid delivery member 501. It should be clear that any number and/or arrangement of holes or apertures 505 in fluid delivery member 501 are contemplated in this invention, and that the size, shape, orientation, and location of the at least one hole or aperture 505 may be altered or modified to suit a particular application.
[0068] FIG. 6A depicts a transverse cross section of an embodiment of the invention 600 suited for the treatment of epistaxis comprising an elongate member 601, a plunger 604, an o-ring 608, elastic connector 609, and a nasal packing material, stent or other material 610. Elongate member further comprises a distal flange 602 and an optional proximal flange 603. While distal flange 602 and proximal flange 603 are depicted as laterally extending symmetric features in transverse cross section, it should be clear to one of skill in the art that these features may take any geometry. Plunger 604 further comprises a lumen 605, a stopper 606, an extrusion extended from the distal face of the plunger body, and a series of holes or apertures 607. Plunger 604 is slidably disposed within and concentrically aligned with elongate member 601. Proximal flange 603 and stopper 606 are sized such that stopper 606 can not translate distally past the proximal face of proximal flange 603 of elongate member 601, or conversely, such that proximal flange 603 can not translate proximally past the distal face of stopper 606. Nasal packing material 610 is positioned within the space defined by the inner surface of elongate member 601, the outer surface of the plunger extrusion, and the distal face of plunger 604. O-ring 608 is positioned about plunger lumen 605 at the proximal end of plunger lumen 605. Elastic connector 609 may be fabricated from an elastic material such as silicone rubber, and stretched over the proximal portion of plunger 604. Furthermore, the proximal portion of elastic connector 609 may be sufficiently elastic to fit over, secure and seal against the nozzle 611 of a fluid reservoir (e.g. a squeeze bottle) (not shown). Nasal packing material 610 may be any of those previously described herein, but may preferably be a xerogel formulated as disclosed in co-pending U.S. patent application 61/259,564.
[0069] FIG. 6B depicts the embodiment of the invention 600 joined to a fluid reservoir nozzle 611 wherein the plunger 604 is fully inserted into elongate member 601 such that the proximal flange 603 of elongate member 601 abuts stopper 606, exposing nasal packing material 610 to the environment in the immediate vicinity of the target anatomy. The advancement of plunger 604 with respect to elongate member 601 may be achieved by stabilizing the distal feature 602 against a desired anatomical feature, such as the alar rim and/or columella. The nozzle 611 of the fluid reservoir is joined to the embodiment of the invention 600 by the proximal portion of elastic connector 609. Furthermore, nozzle 611 abuts and seals against o-ring 608, creating a flow path from nozzle 611, through plunger lumen 605, and out of the series of holes or apertures 607. The fluid contained within the reservoir may be any of those previously described herein, but may preferably be a solution of 0.5% oxymetazoline in buffered saline, commercially available under the trade name of Afrin (Schering-Plough HealthCare Products, Inc.).
[0070] One method of using embodiment of the invention 600 (as detailed in FIGS. 6A and 6B) to treat epistaxis is shown in the flowchart depicted in FIG. 7. In a first step, the delivery device 600 is joined to a fluid reservoir. As an exemplary embodiment the connector 609 is shown previously as a component that can be stretched over and secured about the outside surface of the nozzle 611 of a typical squeeze bottle reservoir (e.g. a typically used Afrin bottle), it is clear that the delivery device could be connected to the desired fluid reservoir using any number of joining modalities (e.g. luer locks, slip luers or any modality that adequately joins and secures the delivery device with the reservoir). The nasal packing material 610 disposed in the distal portion of delivery device 600 may optionally be wetted prior to enacting the second step of the method. In a second step, the distal portion of elongate member 601 is inserted into the nostril of the patient. The delivery device 600 is then advanced into the nasal cavity until the distal flange 602 contacts the alar rim and/or columella (not shown) of the patient in a third step. In a fourth step, the body of elongate member 601 is grasped and plunger 604 is advanced distally until stopper 606 contacts proximal flange 603 of elongate member 601. Fluid is then infused into the nasal packing material 610 through plunger lumen 605 and holes or apertures 607 in a fifth step. In a sixth step, the patient or physician or caregiver then applies external pressure or digital compression to the nose (e.g. pinches the nose) to hold and secure the nasal packing material 610 against the source of the bleeding or epistaxis. As a final step, the delivery device 600 is withdrawn while external pressure or digital compression is maintained. It should be obvious that (if desired) the digital compression could be released prior to device removal in the final step of the method described herein as well. This method is shown exemplary embodiment only and it should be obvious to those skilled in the art that the individual steps of the method may be permuted as desired to gain the desired clinical effect.
[0071] FIG. 8A is a transverse cross-section of an embodiment of the delivery device 800 that may be useful in deploying a nasal pack, stent or other material to the nasal cavity and/or paranasal sinuses. Embodiment 800 comprises an elongate member 801, a handle 803, an infusion tube 804, an infusion port 805, plunger 806, a backstop 807, and a support member 808. Elongate member 801 further comprises a slide button 802 located in the proximal portion of elongate member 801. Handle 803 further comprises a channel 810. Infusion tube 804 further comprises at least one infusion lumen 811 and exit ports or apertures 809. Exit ports 809 are preferentially located in the distal portion of infusion tube 804, and are even more preferentially located distal to backstop 807 and all along the length of the space where the payload (not shown) would be positioned at the distal portion of delivery device 800. Elongate member 801 is slidably disposed within handle 803 and oriented such that slide button 802 can move in the proximal or distal direction within channel 810 of handle 803. Plunger 806 is disposed within and coaxially disposed within elongate member 801. The distal end of plunger 806 is joined to handle 803 using techniques known in the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like such that elongate member 801 can translate in the proximal and distal directions with respect to plunger 806. Plunger 806 is preferably stiffer than elongate member 801. Infusion tube 804 is coaxially disposed within plunger 806 and may optionally be joined to plunger 806 using techniques known to the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. The proximal end of infusion tube 804 is joined to infusion port 805 using techniques known to the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Infusion port 805 may be of any configuration or shape that enables a connection between infusion tube 804 and a source of fluid, but preferably is a luer fitting, such as a male or female luer lock or male or female slip luer commonly used in the art. Alternatively, the infusion port may comprise an elastic connector as described previously and serve as a means to secure the delivery device 800 to the desired fluid reservoir. The distal portion of infusion member 804 comprises exit ports 809. The distal end of infusion member 804 may be formed into an atraumatic shape such as a ball, hemisphere, tapered tip, and the like. Support member 808 is disposed within infusion lumen 811 of infusion member 804. The distal end of support member 808 is joined to the distal end of infusion member 804 using techniques known to the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Support member 808 may extend a distance proximally within infusion member 804, and may preferentially be sized such that fluid infused through infusion lumen 811 can pass around support member 808 and out of exit ports 809. Alternatively, the support member 808 may extend proximally and be secured within infusion lumen 811 of infusion member 804 using bonding methods well known in the art. Support member 808 may be adjusted to any angle desired by the surgeon, but in one preferred embodiment, is adjusted to approximately 70 (as measured from the long axis of the plunger 806) to improve the capability to access the frontal sinus or frontal sinus recess or the frontal sinus ostium. Other angles and orientations suited to accessing the maxillary sinus or maxillary sinus ostium, an ethmoid sinus or an ethmoid sinus ostium (either a natural ostium or a surgical antrostomy) or ethmoid infindibulum, or the sphenoid sinus or sphenoid sinus ostium are contemplated. It is obvious to those skilled in the art that support member 808 may be substituted with an infusion tube 804 that is constructed from a material is itself rigid and malleable eliminating the need for support member 808. It is contemplated that the rigid and malleable infusion tube 804 or support member 808 may be constructed from materials including, but not limited to stainless steel, titanium, nickel titanium, alloys thereof and numerous other metallic materials well known in the art. Backstop 807 is coaxially disposed about and joined to infusion tube 804 using techniques known to the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Backstop 807 may be preferentially sized to prevent the payload (not shown) from moving distally when elongate member 801 translates in the distal direction, and may be preferentially located such that the distal face of backstop 807 is offset from the distal end of the infusion tube 804 a distance equal to the length of the payload. For example, a payload that is 4.0 cm in length may require the backstop 807 to be positioned such that the distal face of backstop 807 is 4.0 cm from the distal end of infusion tube 804.
[0072] FIGS. 8B and 8C illustrate the action of the elongate member 801 when slide button 802 is moved from the distal to proximal positions within channel 810 of handle 803 (as shown in FIG. 8A). As seen in FIG. 8B, elongate member 801 further comprises a slit 812 located in the distal portion of elongate member 801. Slit 812 may preferably be a v-cut that extends over 50% of the diameter of elongate member 801. Slit 812 may also comprise other geometries known to the art, including but not limited to angular notches, arcs, channels, combinations thereof, and the like. Retraction of elongate member 801 in the proximal direction pulls the distal portion of elongate member 801 over plunger 806, slit 812 and straightening the distal portion of elongate member 801 to expose the payload (not shown) and the distal portion of infusion tube 804, as shown in FIG. 8C.
[0073] FIG. 9A is a side view of an embodiment of the invention 900 and a cross-sectional view of embodiment 900 along the section line A-A. Embodiment 900 comprises a handle 901, tines 902, common elongate member 903, footplate 904, additional elongate member 905, and actuator 906. Packing material 907 is shown for reference. FIG. 9B is a top view of embodiment 900 depicting slot 908 in handle 901 and a cross-sectional view of footplate 904 and tines 902 along section line B-B. In both figures, the distal portion of tines 902 grasp packing material 907 and the proximal portion of tines 902 merge into common elongate member 903. Common elongate member 903 is slidably disposed within handle 901 and connected to actuator 906. Handle 901 further comprises two thru holes 909 that are sized to accept tines 902 with sufficient clearance to allow tines 902 to translate freely through the distal face of handle 901. Actuator 906 is slidably disposed within slot 908 such that moving actuator 906 in the proximal direction moves the distal ends of tines 902 in the proximal direction and moving actuator 906 in the distal direction moves the distal ends of tines 902 in the distal direction. The footplate 904 is positioned proximal to nasal packing 907 and is fixed in position relative to tines 902 by additional elongate member 905. Additional elongate member 905 is relatively rigid, and the proximal end of elongate member 905 is joined to the distal face of handle 902. Footplate 904 and additional elongate member 905 act to prevent the proximal movement of nasal packing 907 when actuator 906 is translated in the proximal direction in the event that tines 902 provide sufficient inward force to hold on to packing material 907 during proximal translation. The proximal face of packing material 907 contacts the distal face of footplate 904 as tines 902 are retracted proximally, preventing further proximal motion of packing material 907 and enabling tines 902 to slide clear of nasal packing 907. The width of footplate 904 (as shown in section B-B) may be line to line with the inner surfaces of tines 902. Alternatively (not shown), the width of footplate 904 may extend such that tines 902 are partially or completely enclosed within the distal face of footplate 904. In these cases, cutouts or thru holes of sufficient size, location, and clearance to allow tines 902 to translate freely in the proximal and distal directions are incorporated into footplate 904. As shown in FIG. 9A, the height of footplate 904 is preferably large enough to present a sufficiently large obstacle to the proximal movement of packing material 907. However, the overall size of footplate 907 should preferably not exceed the cross sectional area of packing material 907 to enable adequate maneuverability of the device in the nasal cavity. Packing material 907 may be any of those previously described herein, but may preferably be a xerogel formulated as disclosed in co-pending U.S. patent application 61/259,564, the disclosure of which is incorporate by reference in its entirety.
[0074] FIG. 10 depicts an embodiment of the invention 1000 in a top cross-sectional view and a transverse cross section through section A-A. Embodiment 1000 comprises an elongate member 1001, flange 1003, extension line 1004, connection port 1005, expandable member 1006, and packing material 1008. Elongate member 1001 further comprises injection ports 1002. Flange 1003 is joined to elongate member 1001. The distal end of extension line 1004 is joined to the proximal end of elongate member 1001 and the proximal end of extension line 1004 is joined to the distal end of connection port 1005. Expandable member 1006 is disposed about the distal portion of elongate member 1001 and sealed to elongate member 1001 at joint 1007. Packing material 1008 is disposed about expandable member 1006. In this embodiment, packing material 1008 further comprises joint line 1009. Packing material 1008 may be any of those previously described herein, but may preferably be a xerogel formulated as disclosed in co-pending U.S. patent application 61/259,564, the disclosure of which is incorporate by reference in its entirety.
[0075] FIGS. 11A and 11B depicts top and side views, respectively, of an embodiment of the invention 1100. FIG. 11C depicts a cross-sectional side view of the embodiment of the invention. Embodiment 1100 comprises a handle 1101, an elongate member 1102, a shuttle 1103, an actuator 1104, and a packing material 1105. Packing material 1105 may be any of those previously described herein, but may preferably be a xerogel formulated as disclosed in co-pending U.S. patent application 61/259,564, the disclosure of which is incorporate by reference in its entirety. Shuttle 1103 further comprises tines 1106 and a post 1111. In this embodiment there are two tines 1106, however it should be clear to one of skill in the art that shuttle 1103 may comprise any number of tines or means of holding packing material 1105. Handle 1101 further comprises a ridged and/or contoured section 1107. Elongate member 1102 further comprises at least one lumen 1108, a channel 1109 extending a portion of the length of elongate member 1102 and, in this example, positioned on the bottom elongate member 1102, and a cap 1116 joined to the distal end of elongate member 1102. It should be clear to one of skill in the art that the shape, length, orientation with respect to the elongate member 1102, and the width of channel 1109 may be varied to accommodate differing specific designs of the embodiment of the invention. Cap 1116 is joined to the distal end of elongate member 1102 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Alternatively, cap 1116 may be an integral part of the elongate member 1102 that is formed or cut using processes known in the art such as stamping, laser cutting and the like and folded in to the lumen opening of the elongate member 1102. The proximal end of elongate member 1102 is joined to the distal end of handle 1101 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Handle 1101 further comprises an internal space 1110 that is in communication with lumen 1108 of elongate member 1102. Link member 1112 is slidably disposed within lumen 1108 of elongate member 1102 and extends into the internal space 1110 of handle 1101. The distal end of link member 1112 is joined to post 1111 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Link member 1112 is flexible to enable translation of link member 1112 through the S-shaped distal portion of handle 1101. The proximal end of link member 1112 is joined to disk 1113 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Spring 1114 is disposed within internal space 1110 of handle 1101 and about the proximal portion of link member 1112. Spring 1114 is compressed such that the proximal end of spring 1114 abuts the distal face of disk 1113. Spring 1114 is prevented from expanding to its unloaded length by the interaction between the proximal latch 1117 of actuator 1104 and the proximal face of disk 1113. Actuator 1104 is biased into a position such that proximal latch 1117 restricts the proximal motion of disk 1113.
[0076] FIGS. 12A and 12B show side and cross-sectional views of the embodiment of the invention 1100 after the distal portion of actuator 1104 has been depressed. The action of depressing the distal portion of actuator 1104 with sufficient force to overcome the resisting force of spring 1115 raises the proximal latch 1117 of actuator 1104. When the proximal latch 1117 is moved out of contact with the proximal face of disk 1113, spring 1114 expands to its unloaded position (i.e. the proximal end of spring 1114 translates proximally within internal space 1110) and drives disk 1113 to the proximal portion of internal space 1110. The proximal motion of disk 1113 is transmitted through link member 1112 to post 1111, and to shuttle 1103. The proximal motion of shuttle 1103 relative to elongate member 1102 pulls tines 1106 and packing material 1105 in the proximal direction. The proximal end of packing material 1105 contacts the distal face of cap 1116 and the distal end of elongate member 1102, halting the proximal motion of packing material 1105. Tines 1106 continue to translate in the proximal direction, releasing packing material 1105 from device 1100. While the embodiment of the invention shown in FIGS. 11 and 12 is intended for single use, it should be clear to one of skill in the art that a re-usable embodiment may be fabricated by providing a means to push disk 1113 in the distal direction such that actuator 1104 may be re-set in its original position. In such an embodiment, link member 1112 may preferably be fabricated from a material, or in such a manner, that it is both flexible and can support compressive loads such that distal translation of disk 1113 results in distal translation of shuttle 1103. For example, stainless steel formed into a coiled coil (such as found in cardiovascular guidewires) or a nickel-titanium alloy may preferably be chosen. Re-useable alternatives to the aforementioned embodiment of the invention may preferably be manufactured from materials that are resistant to multiple rounds of sterilization (e.g. steam autoclaving). Alternatively (not shown), apparatus 1100 can be configured such that the spring 1114 is located at the proximal side of disk 1113 wherein its proximal end is affixed or anchored to the proximal end of handle 1101. Load to the spring 1114 is applied by stretching the distal end until disk 1113 engages to latch 1117 of actuator 1104. Other types of spring 1114 known in the art may also be used such as constant force spring, elastic rubber and the like.
[0077] Apparatus 1100 may also have additional features such as an adjustable elongate member 1102 wherein the elongate member 1102 can be rotated along its longitudinal central axis (not shown). This feature allows adjustment of the packing material 1105 to vary its position relative to the handle 1101 wherein the vertical plane between these two components can be set at an angle relative to each other.
[0078] FIG. 13A illustrates an alternative embodiment of the device of the invention 1200 comprising a handle 1201, an elongate member 1202, a shuttle 1203, an actuator 1204, and a packing material 1205. Packing material 1205 may be any of those previously described herein, but may preferably be a xerogel formulated as disclosed in co-pending U.S. patent application 61/259,564, the disclosure of which is incorporate by reference in its entirety. Handle 1201 further comprises a ridged and/or contoured section 1206. The materials of fabrication and means of joining the components of embodiment of the invention 1200 that are common to those of embodiment of the invention 1100 are identical to those previously described for embodiment of the invention 1100. Components of embodiment of the invention 1200 that are unique to embodiment of the invention 1200, such as shuttle 1203, are described in sufficient detail such that one of skill in the art can comprehend their assembly and function. For example, shuttle 1203 may be fabricated from metallic or non-metallic materials known to the art including, but not limited to, aliphatic polyamides, fluorinated ethylene propylene, nylon, perfluoroalkoxy (e.g. Teflon), polyether block amide (Pebax), polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyurethane, polyvinylchloride, polysulfone, stainless steel, nickel, titanium, aluminum, brass, copper, polycarbonate, acrylic, polyoxymethylene (Delrin), combinations, copolymers, and/or alloys thereof, and the like. Section A-A depicts an end-on view of a proximal slice of shuttle 1203 and packing material 1205. As seen in section A-A, shuttle 1203 is generally U-shaped in cross-section and sized to contain packing material 1205. Shuttle 1203 may preferably be sized to apply a compressive load on the outer surfaces of packing material 1205. The outer top edges of shuttle 1203 may be formed such that they are folded-in or curved-in (not shown) wherein the gap or opening between the top opposite edges is less than the widest gap or opening between the walls below the top edge. The internal surfaces of shuttle 1203 (i.e. those that contact the outer surfaces of packing material 1205) may have features (not shown) that secure the packing material 1205 and prevent from inadvertent dislodgement from the shuttle 1203 prior to deployment. For example, these features may include, but are not limited to, texturing, beading, protrusions such as detents, barbs, and the like, ridges, areas of differing material properties such as dimples fabricated from a lower durometer material than the majority of shuttle 1203, combinations thereof, and the like. Section B-B depicts an end-on view of the distal portion of elongate member 1202, further comprising a cap 1207. Cap 1207 may be fabricated from metallic or non-metallic materials known to the art including, but not limited to, aliphatic polyamides, fluorinated ethylene propylene, nylon, perfluoroalkoxy (e.g. Teflon), polyether block amide (Pebax), polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyurethane, polyvinylchloride, polysulfone, stainless steel, nickel, titanium, aluminum, brass, copper, polycarbonate, acrylic, polyoxymethylene (Delrin), combinations, copolymers, and/or alloys thereof, and the like. Cap 1207 may be joined to the distal end of elongate member 1202 using means known to the art including, but not limited to, adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Alternatively, cap 1207 may be an integral part of the elongate member 1202 that is formed or cut using processes known in the art such as stamping, laser cutting and the like and folded in to the lumen opening of the elongate member 1202. Cap 1207 further comprises an opening 1208 that is sized and shaped to slidably accept shuttle 1203 as shown in section B-B.
[0079] FIGS. 14A and 14B depict embodiment of the invention 1200 with actuator 1204 in the neutral and depressed states, respectively. As can be seen in FIG. 14A, elongate member 1202 further comprises a lumen 1209 and is joined to the distal end of handle 1201 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Handle 1201 further comprises an internal space 1211 that is in communication with lumen 1209 of elongate member 1202. Link member 1210 is slidably disposed within lumen 1209 of elongate member 1202 and extends into the internal space 1211 of handle 1201. The distal end of link member 1210 is joined to the proximal end of shuttle 1203 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Link member 1210 is flexible to enable translation of link member 1210 through the S-shaped distal portion of handle 1201. The proximal end of link member 1210 is joined to disk 1212 using means known to the art, including but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, combinations thereof, and the like. Spring 1213 is disposed within internal space 1211 of handle 1201 and about the proximal portion of link member 1210. Spring 1213 is compressed such that the proximal end of spring 1213 abuts the distal face of disk 1212. Spring 1213 is prevented from expanding to its unloaded length by the interaction between the proximal latch 1215 of the actuator 1204 and the proximal face of disk 1212. Actuator 1204 is biased into a position such that the proximal latch 1215 restricts the proximal motion of disk 1212 by spring 1214.
[0080] As shown in FIG. 14B, the action of depressing the distal portion of actuator 1204 with sufficient force to overcome the resisting force of spring 1214 raises the proximal latch 1215 of actuator 1204. When the proximal latch 1215 is moved out of contact with the proximal face of disk 1212, spring 1213 expands to its unloaded position (i.e. the proximal end of spring 1213 translates proximally within internal space 1211) and drives disk 1212 to the proximal portion of internal space 1211. The proximal motion of disk 1212 is transmitted through link member 1210 to shuttle 1203. The proximal motion of shuttle 1203 relative to elongate member 1202 pulls packing material 1205 in the proximal direction. The proximal end of packing material 1205 contacts the distal face of cap 1207 and the distal end of elongate member 1202, halting the proximal motion of packing material 1205. Shuttle 1203 continues to translate in the proximal direction, releasing packing material 1205 from device 1200. Alternatively (not shown), apparatus 1200 can be configured such that the spring 1213 is located at the proximal side of disk 1212 wherein its proximal end is affixed or anchored to the proximal end of handle 1101. Load to the spring 1213 is applied by stretching the distal end until disk 1212 engages to latch 1215 of actuator 1204. Other types of spring 1213 known in the art may also be used such as constant force spring, elastic rubber and the like. The previously described considerations for embodying a re-usable version of the device of the invention 1100 apply to device of the invention 1200 as well.
[0081] Apparatus 1200 may also have added feature such as an adjustable elongate member 1202 wherein the elongate member 1202 can be rotated along its longitudinal central axis (not shown). This feature allows adjustment of the packing material 1205 to vary its position relative to the handle 1201 wherein the vertical plane between these two components can be set at an angle relative to each other.
[0082] FIGS. 15A-15C depict an alternative means for releasing or delivering a packing material into the nasal cavity. In these figures, force applied in the proximal direction is denoted by a heavy black arrow; the means of applying such force may be those previously disclosed in this specification or any other means within the art. FIG. 15A depicts a shuttle assemble comprised of a primary tine 1301 and a secondary tine 1302, an elongate member 1303, a cap 1304, a packing material 1305, and a link member 1306. Packing material 1305 may be any of those previously described herein, but may preferably be a xerogel formulated as disclosed in co-pending U.S. patent application 61/259,564, the disclosure of which is incorporate by reference in its entirety. Primary tine 1301 further comprises a primary flange 1307 and secondary flange 1308, while secondary tine 1302 further comprises tertiary flange 1309. Elongate member 1303 further comprises a lumen 1310. Primary and secondary tines 1301 and 1302, and primary, secondary, and tertiary flanges 1307, 1308, and 1309 may be fabricated from metallic or non-metallic materials known to the art, including but not limited to aliphatic polyamides, fluorinated ethylene propylene, nylon, perfluoroalkoxy (e.g. Teflon), polyether block amide (Pebax), polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyurethane, polyvinylchloride, polysulfone, stainless steel, nickel, titanium, aluminum, brass, copper, polycarbonate, acrylic, polyoxymethylene (Delrin combinations, copolymers, and/or alloys thereof, and the like. As previously discussed for embodiment of the invention 1200, the internal surfaces of the distal portions of primary tine 1301 and secondary tine 1302 may further comprise features that secures the packing material 1305 and prevent from inadvertent dislodgement from primary and secondary tines 1301 and 1302, respectively, prior to deployment. Primary flange 1307 and secondary flange 1308 may be joined to primary tine 1301 using means known to the art including, but not limited to, adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, cold working, combinations thereof, and the like. Tertiary flange 1309 may be joined to secondary tine 1302 using means known to the art including, but not limited to, adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, cold working, combinations thereof, and the like. Alternatively, flanges 1307, 1308, and 1309 may be an inherent feature of their respective tines 1301 or 1302. For example, a tine may be formed by bending a length of stainless steel such that a flange is formed in the body of the tine. Elongate member 1303 may be fabricated from metallic or non-metallic materials known in the art including, but not limited to aliphatic polyamides, fluorinated ethylene propylene, nylon, perfluoroalkoxy (e.g. Teflon), polyether block amide (Pebax), polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyurethane, polyvinylchloride, polysulfone, stainless steel, nickel, titanium, aluminum, brass, copper, polycarbonate, acrylic, polyoxymethylene (Delrin), combinations and/or alloys thereof, and the like. Cap 1304 may be fabricated from materials known in the art including, but not limited to aliphatic polyamides, fluorinated ethylene propylene, nylon, perfluoroalkoxy (e.g. Teflon), polyether block amide (Pebax), polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyurethane, polyvinylchloride, polysulfone, stainless steel, nickel, titanium, aluminum, brass, copper, polycarbonate, acrylic, polyoxymethylene (Delrin), combinations and/or alloys thereof, and the like and joined to the distal end of elongate member 1303 using means known to the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, cold working, combinations thereof, and the like. Alternatively, cap 1304 may be an integral part of the elongate member 1303 that is formed or cut using processes known in the art such as stamping, laser cutting and the like and folded in to the lumen opening of the elongate member 1303. Link member 1306 may be fabricated from materials known to the art including, but not limited to aliphatic polyamides, fluorinated ethylene propylene, nylon, perfluoroalkoxy (e.g. Teflon), polyether block amide (Pebax), polyetheretherketone (PEEK), polyethylene, polytetrafluoroethylene (PTFE), polypropylene, polyurethane, polyvinylchloride, polysulfone, stainless steel, nickel, titanium, aluminum, brass, copper, polycarbonate, acrylic, polyoxymethylene (Delrin), combinations and/or alloys thereof, and the like. The distal end of link member 1302 may be joined to the proximal portion of secondary flange 1308 using means known to the art including, but not limited to adhesive bonding, welding, ultrasonic welding, overmolding, threading and tapping, mechanical fixation, friction or interference fits, cold working, combinations thereof, and the like. Primary tine 1301 and secondary tine 1302 are slidably disposed within lumen 1310 of elongate member 1303 and arranged such that the distal ends of primary tine 1301 and secondary tine 1302 extend distally beyond the distal end of elongate member 1303.
[0083] FIGS. 15B and 15C illustrate the action of the components as force is applied to link member 1306 in the proximal direction. The proximal translation of link member 1306 within the lumen 1310 of elongate member 1303 is transmitted to primary tine 1301, which in turn translates in the proximal direction until the proximal face of primary flange 1307 contacts the distal face of tertiary flange 1309. At this point, the distal portion of primary tine 1301 has retracted away from packing material 1305 and into the lumen 1310 of elongate member 1303. Further application of force in the proximal direction to link member 1306 continues to pull primary tine 1302 and secondary tine 1302 in the proximal direction, retracting distal portion of secondary tine 1302 away from packing material 1305 and into the lumen 1310 of elongate member 1303. Any proximal motion of packing material 1305 that may occur during the proximal translation of link member 1306 is halted due to interference with the distal face of cap 1304 and/or the distal end of elongate member 1303. Though this example is provided with two tines, it should be clear to one of skill in the art that any number or arrangement of tines, or sequence in retracting any number or arrangement of tines, is contemplated.
