Nasal implants, delivery tools, systems, and methods of use
阅读说明:本技术 鼻部植入物、递送工具、系统及使用方法 (Nasal implants, delivery tools, systems, and methods of use ) 是由 M·H·罗森塔尔 S·J·巴伦 D·A·冈萨雷斯 P·阿罗拉 M·S·米里齐 P·拉蒂 于 2018-04-13 设计创作,主要内容包括:提供了具有平面型轮廓的鼻部植入物,所述平面型轮廓具有穿过平面型轮廓的部分的开放空间。鼻部植入物可以沿着鼻部植入物的一个或多个尺度(例如平面型轮廓的宽度和长度)是可压缩的。还提供了用于在鼻组织内展开鼻部植入物的递送工具。还提供了用于将鼻部植入物在患者的鼻组织内展开的方法。(A nasal implant is provided having a planar profile with an open space through portions of the planar profile. The nasal implant may be compressible along one or more dimensions of the nasal implant (e.g., the width and length of the planar profile). A delivery tool for deploying a nasal implant within nasal tissue is also provided. Methods for deploying a nasal implant within nasal tissue of a patient are also provided.)
1. A nasal implant, comprising:
a first portion; and
a second portion, wherein the first portion and the second portion together form a contour of the implant;
wherein the nasal implant is flexible at discrete locations along the contour; and
wherein the nasal implant as a whole is configured to be rigid along substantially all contours when a force is applied to the contours.
2. The nasal implant of claim 1, wherein at least a portion of the second portion is spaced apart from at least a portion of the first portion along the contour such that the first portion is compressible relative to the second portion.
3. The nasal implant of claim 1, wherein the nasal implant comprises a first plane comprising the first portion and a second plane that is substantially perpendicular to the first plane, and wherein the nasal implant is compressible in the first plane and flexible in the second plane.
4. The nasal implant of claim 1, wherein the profile is substantially planar.
5. The nasal implant of claim 1, wherein the profile comprises a curved planar profile.
6. The nasal implant of claim 1, wherein the profile is substantially flat.
7. The nasal implant of claim 1, wherein the first and second portions are substantially equal in size.
8. The nasal implant according to claim 1, wherein the first and second portions are substantially symmetrical.
9. The nasal implant of claim 1, wherein the profile has a coiled configuration.
10. The nasal implant of claim 1, wherein the profile has a circular shape.
11. The nasal implant of claim 1, wherein the profile has an elliptical shape.
12. The nasal implant of claim 1, wherein the profile has an annular shape.
13. The nasal implant of claim 1, wherein the profile has a substantially triangular shape.
14. The nasal implant of claim 1, wherein the first portion is a first elongate member and the second portion is a second elongate member, the first and second elongate members being connected together at a distal connection point and disconnected at a proximal end.
15. The nasal implant of claim 14, wherein the first and second elongated members are substantially straight.
16. The nasal implant according to claim 14, wherein the first and second elongate members each have one or more loops formed therein.
17. The nasal implant of claim 16, wherein the one or more rings are filled with a mesh or ribbed material.
18. The nasal implant of claim 14, wherein the first and second elongated members each have a plurality of ridges extending therearound.
19. The nasal implant of claim 1, wherein the implant has a width of 3-5mm, a height of 3mm or greater, and a thickness of 1mm or less.
20. The nasal implant of claim 1, wherein the nasal implant is configured to fit between the mucosa and dermis of the nasal sidewall.
21. The nasal implant of claim 1, wherein the nasal implant is configured to fit between the mucosa and the nasal septum.
22. The nasal implant of claim 1, wherein the profile comprises a body portion having a plurality of projections, each of the projections projecting from the body portion.
23. The nasal implant according to claim 22, wherein the plurality of projections comprises three or more projections.
24. The nasal implant of claim 1, wherein the distal end of the implant comprises a forked feature thereon.
25. The nasal implant of claim 24, wherein the forked feature is configured to receive a nasal bone therein.
26. The nasal implant of claim 1, wherein the implant comprises at least one open space therein, the open space comprising about 5% to about 20% of the surface area of the profile.
27. The nasal implant of claim 1, wherein the implant comprises at least one open space therein comprising about 20% or more of the surface area of the profile.
28. The nasal implant of claim 1, wherein the profile has about 2N mm2To about 500N mm2Bending stiffness of (2).
29. The nasal implant of claim 1, wherein the nasal implant comprises a first bioabsorbable material.
30. The nasal implant of claim 29, wherein the nasal implant consists essentially of the first bioabsorbable material.
31. The nasal implant of claim 29, wherein the nasal implant comprises a first bioabsorbable material having a first degradation profile and a second bioabsorbable material having a second degradation profile.
32. The nasal implant of claim 29, wherein the first bioabsorbable material is polydioxanone.
33. The nasal implant according to claim 31, wherein the second bioabsorbable material is selected from the group consisting of: PLA, PLLA and PLDLA.
34. The nasal implant of claim 31, wherein the first degradation profile is about 1 to 6 months.
35. The nasal implant of claim 31, wherein the second degradation profile is about 18 to 48 months.
36. The nasal implant of claim 1, wherein the implant comprises a plurality of flexible struts.
37. The nasal implant of claim 1, wherein the implant comprises a mesh material.
38. The nasal implant of claim 1, wherein the implant comprises a plurality of coil loops therein.
39. The nasal implant of claim 1, wherein the implant comprises a plurality of loop forming protrusions.
40. The nasal implant of claim 1, wherein the implant comprises a plurality of perforations therethrough.
41. A nasal implant, comprising:
a first portion; and
a second portion, wherein the first portion and the second portion together form a contour of the implant;
wherein at least a portion of the second portion is spaced apart from at least a portion of the first portion along the contour such that the first portion is compressible relative to the second portion; and
wherein the nasal implant as a whole is configured to be rigid along substantially all contours when a force is applied to the contours.
42. The nasal implant of claim 41, wherein the nasal implant comprises a first plane comprising a first portion and a second portion, and wherein the nasal implant is compressible in the first plane.
43. The nasal implant of claim 42, wherein the nasal implant comprises a second plane that is substantially perpendicular to the first plane, and wherein the nasal implant is flexible in the second plane.
44. The nasal implant of claim 41, wherein the profile is substantially planar.
45. The nasal implant of claim 41, wherein the profile comprises a curved planar profile.
46. The nasal implant of claim 41, wherein the profile is substantially flat.
47. The nasal implant according to claim 41, wherein the first and second portions are substantially equal in size.
48. The nasal implant according to claim 41, wherein the first and second portions are substantially symmetrical.
49. The nasal implant of claim 41, wherein the profile has a coiled configuration.
50. The nasal implant of claim 41, wherein the profile has a circular shape.
51. The nasal implant of claim 41, wherein the profile has an elliptical shape.
52. The nasal implant according to claim 41, wherein the profile has an annular shape.
53. The nasal implant of claim 41, wherein the profile has a substantially triangular shape.
54. The nasal implant of claim 41, wherein the first portion is a first elongate member and the second portion is a second elongate member, the first and second elongate members being connected together at a distal connection point and disconnected at a proximal end.
55. The nasal implant of claim 54, wherein the first and second elongated members are substantially straight.
56. The nasal implant according to claim 54, wherein the first and second elongate members each have one or more loops formed therein.
57. The nasal implant of claim 56, wherein the one or more rings are filled with a mesh or ribbed material.
58. The nasal implant of claim 54, further comprising a compressible hinge extending between the first and second elongate members.
59. The nasal implant of claim 41, wherein the implant has a width of 3-5mm, a height of 3mm or greater, and a thickness of 1mm or less.
60. The nasal implant of claim 41, wherein the nasal implant is configured to fit between the mucosa and dermis of the nasal sidewall.
61. The nasal implant according to claim 41, wherein the nasal implant is configured to fit between the mucosa and the nasal septum.
62. The nasal implant according to claim 41, wherein the profile includes a body portion having a plurality of projections each projecting from the body portion.
63. The nasal implant according to claim 62, wherein the plurality of projections comprises three or more projections.
64. The nasal implant of claim 41, wherein the distal end of the implant includes a forked feature thereon.
65. The nasal implant of claim 64, wherein the forked feature is configured to receive a nasal bone therein.
66. The nasal implant of claim 41, wherein the implant comprises at least one open space therein, the open space comprising about 5% to about 20% of the surface area of the profile.
67. The nasal implant of claim 41, wherein the implant comprises at least one open space therein comprising about 20% or more of the surface area of the profile.
68. The nasal implant of claim 41, wherein the profile has an approximate width of 2N mm2To about 500N mm2Bending stiffness of (2).
69. The nasal implant of claim 41, wherein the nasal implant comprises a first bioabsorbable material.
70. The nasal implant of claim 69, wherein the nasal implant consists essentially of the first bioabsorbable material.
71. The nasal implant of claim 69, wherein the nasal implant comprises a first bioabsorbable material having a first degradation profile and a second bioabsorbable material having a second degradation profile.
72. The nasal implant of claim 69, wherein the first bioabsorbable material is polydioxanone.
73. The nasal implant according to claim 71, wherein the second bioabsorbable material is selected from the group consisting of: PLA, PLLA and PLDLA.
74. The nasal implant of claim 71, wherein the first degradation profile is about 1 to 6 months.
75. The nasal implant of claim 71, wherein the second degradation profile is about 18 to 48 months.
76. The nasal implant of claim 41, wherein the nasal implant is substantially incompressible along a second plane perpendicular to a first plane including the first and second portions.
77. The nasal implant of claim 41, wherein the first portion and the second portion are configured to overlap one another when the implant is in a compressed configuration.
78. The nasal implant of claim 41, wherein the first portion and the second portion are configured to approximate each other when the implant is in a compressed configuration.
79. A delivery tool, comprising:
a handle portion having a hand grippable surface;
an elongate member having a proximal end and a distal end, the proximal end engaged with the handle portion, wherein the distal end comprises an implant chamber adapted to receive a nasal implant of any of claims 1-78, and an opening adapted to eject the nasal implant from the implant chamber.
80. The delivery tool of claim 79, wherein the opening is at the distal end of the elongate member and comprises a central axis of the elongate member.
81. The delivery tool of claim 79, wherein the opening is adjacent the distal end of the elongate member and is orthogonal to the central axis of the elongate member.
82. The delivery tool of claim 79, further comprising a cutting surface on the distal end of the elongate member.
83. The delivery tool of claim 82, wherein the cutting surface is at a distal-most end of the elongate member.
84. The delivery tool of claim 82, wherein the cutting surface comprises a scissor element having a blade at a lateral edge of the scissor such that the lateral edge is adapted to prepare a planar opening in nasal tissue when the lateral edge is moved away from a central axis of the elongate member.
85. A method for delivering a nasal implant, comprising:
creating a pocket within nasal tissue of a patient; and
placing the nasal implant of any one of claims 1-78 within the pouch.
86. The method of claim 85, wherein the pocket within the nasal tissue of the patient is between the mucosa and the dermis.
87. The method of claim 85, wherein the pocket in the nasal tissue of the patient is between the mucosa and the nasal septum.
88. The method of claim 85, wherein the pocket in the nasal tissue of the patient is between the dermis and the lateral cartilage.
89. The method of claim 85, further comprising suturing the nasal tissue after placing the nasal implant.
90. The method of claim 85, further comprising applying energy to a portion of nasal tissue adjacent to the pocket.
91. The method of any one of claims 85 to 90, further comprising carrying the nasal implant of any one of claims 1 to 78 with the delivery tool of any one of claims 79 to 83 and then placing the nasal implant by passing the nasal implant through an opening in an elongate member of the delivery tool.
92. The method of claim 91, wherein carrying comprises holding the nasal implant of any one of claims 1-78 in a compressed length and/or width.
Technical Field
Described herein are implants for placement in a body, tools for delivering implants, and systems and methods related to the use of implants and tools for placement in a body. More specifically, described herein are nasal implants, tools for delivering nasal implants, and systems and methods related to the use of such implants and tools.
Background
Nasal Valve Collapse (NVC) and sidewall insufficiency (LWI) are used to describe mechanical defects in nasal tissue and/or nasal airway cross-sectional area contributions to restrict airflow through the nasal valve region. Dynamic NVC is a significant contributor to Nasal Airway Obstruction (NAO), affecting the condition of individuals in the tens of millions.
There is a need for devices and delivery systems to improve the shape and/or structural integrity of the nasal sidewall in the area of the superior and inferior cartilages to help combat NVC and LWI. The superior and inferior cartilages are positioned to support the sidewall when inhaling, but may weaken due to reasons such as aging, trauma, and natural anatomy. These structures may also have been manipulated and damaged by previous surgery or removed altogether, resulting in weak nasal sidewalls that are prone to collapse during inhalation.
Surgical solutions for NVC and LWI have been previously described, including the placement of a nasal alar slat graft and an expanding graft, which utilize autografts harvested from the nasal septum, ear, or rib. Surgical techniques such as suture suspension have also been utilized which combine devices with invasive surgical techniques to provide support to the side wall. These procedures are complex and invasive, have significant cosmetic effects, and are highly dependent on the skill of the physician. Robust mechanical implants have also been developed to mitigate NVC and LWI. These implants include titanium or alternative metal implants that support the bridge of the nose and span the side walls, preformed permanent synthetic polymer implants similar to those required for the winged slat implants, and formable absorbable or permanent sheet products that can be configured by the physician as temporary support or splint structures for reshaping or repositioning cartilage, or as preformed implants. These options have shown promise, but have often resulted in tissue rejection and subsequent extrusion of synthetic materials. Complaints of undesirable cosmetic effects, foreign body sensation, pain and discomfort have also been reported.
Us patent publication 2016-0058556 describes minimally invasive options to address the above problems, including the use of needle-based delivery device methods, methods for delivering rod-shaped implant devices within the sidewall. This implant supports the lateral cartilage by bridging the cartilage and bony structures of the partial nasal anatomy. This solution provides a significant improvement when compared to previous non-self synthetic implant options (e.g., porous polyethylene, silicone, PGA, PDS, etc.), and the synthetic absorbable polymer structure may be reactive in the surrounding tissue. U.S. patent publication 2016-0058556 is applicable to many anatomical structures, but there may be some individuals who need a more robust mechanical solution. Patients who may need a more robust mechanical solution include patients with little to no cartilage to support. They may also include patients with narrow airways that require little or no dynamic motion of the side wall during inhalation.
Accordingly, there is a need for stronger implants for supporting the sidewalls. There is also a need for improved delivery systems for delivering nasal implants, and improved methods for delivering nasal implants.
Disclosure of Invention
The present invention relates to nasal implants that may be used to support portions of the nasal anatomy of a patient. Additionally, described herein are delivery tools and methods of delivering the nasal implants described herein to support nasal tissue.
Generally, in one embodiment, a nasal implant includes a first portion and a second portion. The first portion and the second portion together form the contour of the implant. The nasal implant is flexible at discrete locations along the profile, and the nasal implant as a whole is configured to be rigid along the profile when a force is applied to substantially all of the profile.
This and other embodiments may include one or more of the following features. At least a portion of the second portion may be spaced apart from at least a portion of the first portion along the contour such that the first portion is compressible relative to the second portion. The nasal implant includes a first plane that can include a first portion and a second portion, and a second plane that can be substantially perpendicular to the first plane, and the nasal implant can be compressible in the first plane and flexible in the second plane. The profile may be substantially planar. The profile may comprise a curved planar profile. The profile may be substantially flat. The first portion and the second portion may be substantially equal in size. The first portion and the second portion may be substantially symmetrical. The profile may have a coil configuration. The profile may have a circular shape. The contour may have an elliptical shape. The profile may have an annular shape. The profile may have a substantially triangular shape. The first portion may be a first elongated structureThe piece, and the second portion may be a second elongate member, and the first and second elongate members may be connected together at a distal connection point and disconnected at a proximal end. The first and second elongated members may be substantially straight. The first and second elongated members may each have one or more loops formed therein. One or more of the rings may be filled with a mesh or ribbed material. The first and second elongated members may each have a plurality of ridges extending therearound. The implant may have a width of 3-5mm, a height of 3mm or greater, and a thickness of 1mm or less. The nasal implant may be configured to fit between the mucosa and dermis of the nasal sidewall. The nasal implant may be configured to fit between the mucosa and the nasal septum. The profile may include a body portion having a plurality of projections that each project from the body portion. The plurality of protrusions may include three or more protrusions. The distal end of the implant may include a fork feature thereon. The forked feature may be configured to receive a nasal bone therein. The implant may include at least one open space therein, the open space comprising about 5% to about 20% of the surface area of the profile. The implant may include at least one open space therein, the open space comprising about 20% or more of the surface area of the profile. The profile may have about 2N mm2To about 500N mm2Bending stiffness of (2). The nasal implant may include a first bioabsorbable material. The nasal implant may consist essentially of the first bioabsorbable material. The nasal implant may include a first bioabsorbable material having a first degradation profile and a second bioabsorbable material having a second degradation profile. The first bioabsorbable material can be polydioxanone. The second bioabsorbable material may be selected from: PLA, PLLA and PLDLA. The first degradation curve may be about 1 to 6 months. The second degradation curve may be about 18 to 48 months. The implant may include a plurality of flexible struts. The implant may comprise a mesh material. The implant may include a plurality of coil loops therein. The implant may include a plurality of loop forming protrusions. The implant may include a plurality of perforations therethrough.
Generally, in one embodiment, a nasal implant includes a first portion and a second portion. The first portion and the second portion together form the contour of the implant. At least a portion of the second portion is spaced from at least a portion of the first portion along a contour such that the first portion is compressible relative to the second portion and the nasal implant is configured to be rigid along the contour as a whole when a force is applied to substantially all of the contour.
This and other embodiments may include one or more of the following features. The nasal implant can include a first plane including a first portion and a second portion, and the nasal implant can be compressible in the first plane. The nasal implant can include a second plane, which can be substantially perpendicular to the first plane, and the nasal implant can be flexible in the second plane. The profile may be substantially planar. The profile may comprise a curved planar profile. The profile may be substantially flat. The first portion and the second portion may be substantially equal in size. The first portion and the second portion may be substantially symmetrical. The profile may have a coil configuration. The profile may have a circular shape. The contour may have an elliptical shape. The profile may have an annular shape. The profile may have a substantially triangular shape. The first portion may be a first elongate member and the second portion may be a second elongate member, and the first and second elongate members may be connected together at a distal connection point and disconnected at a proximal end. The first and second elongated members may be substantially straight. The first and second elongated members may each have one or more loops formed therein. One or more of the rings may be filled with a mesh or ribbed material. The nasal implant can further include a compressible hinge extending between the first elongated member and the second elongated member. The implant may have a width of 3-5mm, a height of 3mm or greater, and a thickness of 1mm or less. The nasal implant may be configured to fit between the mucosa and dermis of the nasal sidewall. The nasal implant may be configured to fit between the mucosa and the nasal septum. The profile may include a pluralityA body portion of a plurality of projections, each projection projecting from the body portion. The plurality of protrusions may include three or more protrusions. The distal end of the implant may include a fork feature thereon. The forked feature may be configured to receive a nasal bone therein. The implant may include at least one open space therein, the open space comprising about 5% to about 20% of the surface area of the profile. The implant may include at least one open space therein, the open space comprising about 20% or more of the surface area of the profile. The profile may have about 2N mm2To about 500N mm2Bending stiffness of (2). The nasal implant may further include a first bioabsorbable material. The nasal implant may consist essentially of the first bioabsorbable material. The nasal implant may include a first bioabsorbable material having a first degradation profile and a second bioabsorbable material having a second degradation profile. The first bioabsorbable material can be polydioxanone. The second bioabsorbable material may be selected from: PLA, PLLA and PLDLA. The first degradation curve may be about 1 to 6 months. The second degradation curve may be about 18 to 48 months. The nasal implant can be substantially incompressible along a second plane perpendicular to a first plane including the first portion and the second portion. The first and second portions may be configured to overlap each other when the implant is in the compressed configuration. The first and second portions may be configured to approach each other when the implant is in the compressed configuration.
In general, in one embodiment, a delivery tool includes a handle portion having a hand graspable surface, and an elongated member having a proximal end and a distal end. The proximal end engages the handle portion. The distal end includes an implant cavity adapted to receive any nasal implant described herein, and an opening adapted to eject the nasal implant from the implant cavity.
This and other embodiments may include one or more of the following features. The opening may be at the distal end of the elongated member and may include a central axis of the elongated member. The opening may be adjacent the distal end of the elongate member and may be orthogonal to the central axis of the elongate member. The delivery tool may further comprise a cutting surface on the distal end of the elongate member. The cutting surface may be at the distal-most end of the elongate member. The cutting surface may include a scissor element having a blade at a lateral edge of the scissor such that the lateral edge is adapted to prepare a planar opening in the nasal tissue when the lateral edge is moved away from the central axis of the elongate member.
In general, in one embodiment, a method for delivering a nasal implant includes creating a pocket within nasal tissue of a patient and placing a nasal implant as described herein within the pocket.
This and other embodiments may include one or more of the following features. The pocket within the nasal tissue of the patient may be between the mucosa and the dermis. The pocket within the nasal tissue of the patient may be between the mucosa and the nasal septum. The pocket within the patient's nasal tissue may be between the dermis and the lateral cartilage. The method may further comprise suturing the nasal tissue after placing the nasal implant. The method may further include applying energy to a portion of the nasal tissue adjacent to the pocket. The method can further include carrying the nasal implant with either delivery tool and then placing the nasal implant by passing the nasal implant through an opening in an elongated member of the delivery tool. Carrying may include holding the nasal implant in a compressed length and/or width.
Drawings
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
fig. 1 shows the nasal anatomy.
Figures 2A-2B show views of nasal valve collapse.
Figures 3A-3D illustrate an exemplary nasal implant having a substantially triangular profile.
Fig. 4 illustrates an exemplary crimped nasal implant.
Fig. 5A-5B illustrate an exemplary annuloplasty nasal implant.
Fig. 6A-6B illustrate a nasal implant including a protrusion. Figures 6C-6D illustrate various positions for the nasal implant shown in figure 6B.
Fig. 7A-7F illustrate an exemplary nasal implant.
Fig. 8A-8M illustrate an exemplary nasal implant.
Fig. 9A-9C illustrate an exemplary annuloplasty nasal implant.
Fig. 10A-10D illustrate various steps for placing a nasal implant within nasal tissue of a patient.
Fig. 11A-11B illustrate an exemplary delivery tool that can be used to deliver the implants described herein.
Fig. 12A-12B illustrate an exemplary delivery tool that can be used to deliver the implants described herein.
Fig. 13A-13D illustrate an exemplary nasal implant.
Fig. 14 illustrates an exemplary tool configured to prepare a pocket in the nasal anatomy.
Fig. 15 illustrates flexing of the distal end of the delivery tool.
Fig. 16 illustrates an exemplary delivery tool that can be used to deliver the implants described herein.
Figures 17A-17F illustrate an exemplary nasal implant having a pair of elongate members hinged together. Fig. 17G illustrates placement of an implant similar to 17A-17F in the nasal anatomy.
Fig. 18 shows an exemplary tool configured to prepare a pocket in the nasal anatomy.
Figures 19A-19D illustrate an exemplary nasal implant having two wide legs hinged together. Figure 19E illustrates placement of a nasal implant, such as the one shown in figures 19A-19D, in the nasal anatomy.
Fig. 20A-20B illustrate an exemplary mesh nasal implant.
Fig. 21 shows another exemplary mesh implant.
Fig. 22 shows a distal end of an exemplary delivery tool for a nasal implant as described herein.
Fig. 23A-23B show an exemplary tool configured to prepare a pocket in the nasal anatomy.
Fig. 24 shows an exemplary nasal implant.
Fig. 25 shows an exemplary nasal implant.
Fig. 26 shows an exemplary nasal implant.
Fig. 27 shows an exemplary nasal implant.
28A-28B illustrate an exemplary nasal implant.
Fig. 29A-29D show cross-sections of exemplary delivery device cannulas.
Fig. 30 shows an exemplary nasal implant.
FIGS. 31A-31D illustrate an exemplary nasal implant.
Fig. 32A-32C show an exemplary tool configured to prepare a pocket in the nasal anatomy.
Fig. 33 shows an exemplary nasal implant with a collapsible hinge.
Fig. 34A-34C illustrate an exemplary nasal implant.
Fig. 35 shows an exemplary nasal implant.
Fig. 36 shows an exemplary nasal implant.
Fig. 37 shows an exemplary nasal implant.
Fig. 38 shows an exemplary nasal implant.
Fig. 39 shows an exemplary nasal implant.
Fig. 40 shows an exemplary nasal implant.
Fig. 41 shows an exemplary placement of the distal prong feature within the nasal anatomy.
Fig. 42A-42C illustrate an exemplary tool configured to create pockets in the nasal anatomy.
43A-43C illustrate the relative positioning of a nasal implant as described herein within the nasal anatomy.
44A-44B illustrate an exemplary distal prong feature for a nasal implant. Fig. 44A shows a front view of the fork feature, while fig. 44B shows a side view of the fork feature.
45A-45B illustrate additional exemplary distal prong features for nasal implants. Fig. 45A shows a front view of the fork feature, while 45B shows a side view of the fork feature.
Fig. 46 shows additional exemplary distal prong features for a nasal implant.
Fig. 47A-47B illustrate additional exemplary distal prong features for nasal implants. Fig. 47A shows a front view of the fork feature, while fig. 47B shows a side view of the fork feature.
Detailed Description
Various nasal implants, delivery tools, and methods for delivering nasal implants are described herein. The nasal implants described herein may advantageously provide a reliable and safe solution for patients with NVC or LWI. Further, the nasal implant may advantageously have little to no impact on the overall aesthetics of the nose. The delivery devices and methods described herein may also provide for easier delivery methods and less invasive delivery of implants. The nasal implants, delivery tools and methods described herein may be advantageously used in an operating room or office procedure (office procedure) using general or local anesthesia.
Fig. 1 is an isometric view of the nasal anatomy with the dermis removed. Figures 2A-2B show bottom views of the nose where the nostrils on the right side show some nasal collapse during inhalation compared to the dashed lines showing the nasal structure before/after inhalation. The nasal valve collapse shown in fig. 2A-2B may be caused by various factors that may contribute to the reduction in the cross-sectional area of the nasal valve during inhalation, as well as the negative pressure generated by the nasal airway during inhalation. As described herein, nasal implants can help correct such nasal valve collapse. For example, the nasal implant may provide extensive support of the nasal sidewall in a configuration that may be preferentially flexible to accommodate natural nasal manipulation, particularly in the most mobile or flexible nasal anatomy, but prevents the internal medial collapse of the nasal wall upon inhalation.
The implants described herein can be sufficiently flexible to allow patient comfort during natural facial movements or manual nasal manipulation, particularly in the head/compression direction of the anatomy (e.g., rubbing the nose, blowing, and/or cleaning). The flexibility of the implants described herein may also allow for the natural static curvature imparted by the surrounding natural anatomical geometry, but also be sufficiently rigid to prevent sidewall collapse imparted during inspiration. The implants described herein may be capable of bending laterally (outwardly) from their natural position, but not in the medial direction (nasal collapse direction) or significantly less. The implants described herein can further be maximally rigid enough to physically alter the shape of the nose in both static and dynamic inhalation states, or minimally rigid enough to minimize nasal valve collapse in dynamic inhalation states.
The implants described herein can be placed in various orientations relative to the targeted nasal anatomy. For example, the implant may be configured to be placed adjacent to the upper and/or lower cartilage and/or maxilla/nasal bone, e.g., medial or lateral to the cartilage structure and bone. The implant may also be placed in the side wall in the usual position of the superior and/or inferior nasal cartilage, in particular in cases where these cartilage structures are not present, for example in post-traumatic or post-operative patients. As shown by the
Various nasal implant configurations are described herein. In one exemplary embodiment, the nasal implant can have a profile formed by a first side of the nasal implant. The profile may have a first length and a first width. The implant may include a second side opposite the first side, and the profile may include a second side. The contour may include at least one open space between the first side and the second side. The implant may have a thickness between the first side and the second side. The first length, the first width, and the thickness between the first side and the second side can be configured such that the nasal implant fits within nasal tissue of a patient. The nasal implant may be flexible along the contour. The nasal implant may be preferentially compressible and preferentially flexible. The nasal implant may include parallel planes generally parallel to the first and second sides, and perpendicular planes generally perpendicular to the first and second sides. The nasal implant may be compressible in a vertical plane and flexible in a parallel direction. The nasal implant may be compressible along a first length and a first width.
In some embodiments, the first side and the second side have substantially the same dimensions. In some embodiments, the first side and the second side are substantially symmetrical. In some embodiments, the first side and the second side are asymmetric. The first length, the first width, and the thickness between the first side and the second side may be configured such that the nasal implant or a portion of the nasal implant fits between the mucosa and dermis of the nasal sidewall, e.g., medial or lateral to the lateral cartilaginous structure. The first length, the first width, and the thickness between the first side and the second side can be configured such that the nasal implant fits between the mucosa of the nasal tissue and the nasal septum. The first length, the first width, and the thickness between the first side and the second side can be configured such that the nasal implant fits between the mucosa and dermis of the nasal sidewall. In some embodiments, the nasal implant is substantially incompressible along a thickness between the first side and the second side. In other embodiments, the nasal implant may be compressible along the thickness.
The nasal implants described herein can include a variety of different profiles, shapes, and configurations. In some embodiments, the profile of the nasal implant is substantially planar. In some embodiments, the profile is substantially flat. For example, the flat profile may comprise a spiral configuration, such as an elliptical spiral structure, or a triangular shape with an open interior. As another example, the flat profile may include a body portion having a plurality of projections that each project from the body portion. In some embodiments, the plurality of protrusions may include three or more protrusions, for example four or more protrusions. In some embodiments, the protrusions have a finger-like configuration. In some embodiments, the profile comprises a curved planar profile. In some embodiments, the profile has a coil configuration. In some embodiments, the profile has a circular shape. In some embodiments, the contour has an elliptical shape. In some embodiments, the profile has a circular shape. Additional profiles are described herein and shown in the drawings.
In some embodiments, the implants described herein can be bioabsorbable. The material properties of the bioabsorbable implant change over a period of time. Thus, a bioabsorbable implant can be configured to have any material property, such as those described herein, in vivo for a period of time or after exposure to bodily fluids.
In some embodiments, the implants described herein can include a plurality of bioabsorbable materials having different mechanical properties and degradation profiles. For example, the planar profile of the implant may be defined by a first bioabsorbable material forming a structural component of the planar profile, and a second bioabsorbable material including a protrusion from the structural component. The first bioabsorbable material may have a first degradation profile and the second bioabsorbable material may have a second degradation profile. When the nasal implant is initially implanted, the structural component may provide more rigid support to the nasal tissue immediately after implantation, but may degrade more rapidly than the protrusions. A longer degradation profile may allow the protrusion to provide support to nasal tissue after initial healing and degradation of structural components. In some embodiments, the protrusions may have a fibrous, hairy configuration. In some embodiments, the structural component may have a coil shape. In some embodiments, the first degradation profile may be faster than the second degradation profile. In some embodiments, the second degradation profile may be faster than the first degradation profile. The degradation curve may be any of the biodegradation curves described herein.
In some embodiments, the nasal implants described herein comprise multiple different materials. For example, a nasal implant may include a structural portion having a longer degradation profile and higher mechanical strength, and a second material having a faster degradation profile and lower mechanical strength than the structural material. In one example, the structural portion may be encapsulated by a thin film of the second material. The membrane may fix the structural elements in position relative to each other. The membrane may make it easier to manipulate the nasal implant in the delivery tool and during implantation into nasal tissue. The membrane may improve the ability to fold the implant and compress the implant to allow insertion through or by a tool. As described herein, multiple portions of an implant may be selectively absorbable and may have varying degradation profiles.
In some embodiments, the contours of the nasal implants described herein can include a plurality of openings to provide fluid flow or transfer across or across the nasal implant. Allowing fluid flow may promote healthy cartilage tissue because cartilage does not have a dedicated blood supply, but instead relies on blood flow from adjacent tissue. In some embodiments, the nasal implant profile can include a plurality of open spaces between the first side and the second side. The open space may be in the form of perforations, holes, large openings, etc. In some instances, there may be an open space between the individual outer perimeters that has suitable structural integrity. For example, the perimeter may have a rectangular, circular, oval, triangular configuration, and may include a single opening within the interior of the perimeter. In some embodiments, the openings or open spaces may comprise about 20% or more of the surface area of the profile. In other embodiments, the opening or open space may be as low as 5% of the surface area of the implant profile. In some embodiments, the opening or open space between the first side and the second side comprises from about 5% to about 20% of the contour surface area. The size, shape, contour, and configuration of the opening or open space can be customized to provide a desired amount of support to the nasal tissue. In some cases, the nasal implant may be selected such that the size, shape, contour, or configuration of the opening or open space may be matched to achieve a desired or predetermined ratio to the sidewall volume.
The nasal implant described herein can be designed to minimize inflammatory and/or foreign body responses to the nasal implant once it has been implanted in the body. For example, the amount of material used in the implant may be reduced to reduce the inflammatory response and/or foreign body response.
The profile of the nasal implant described herein may have about 2N mm2To about 500N mm2Bending stiffness of (2). Different regions of the implant may have material properties such as strength, flexibility, stiffness or bending stiffness. In some embodiments, the implant may have one or more material properties selected to approximate or mimic material properties of a bodily structure. For example, the bending stiffness of the nasal implant may be the same or close to the bending stiffness of nasal tissue, such as cartilage. As described below, some nasal cartilage has an elastic modulus measured between 5 and 32 MPa. The elastic modulus of the implant or portion of the implant may have an elastic modulus between 5 and 32MPa, or greater than 2, 4, 5, 10, 15, 20, 25, 30, 32, 35, 40, or 50MPa, or less than 2, 4, 5, 10, 15, 20, 25, 30, 32, 35, 40, or 50MPa, or any value in between, for example 2 to 50MPa or 10 to 30 MPa. The bending stiffness of some slatted grafts formed from septal cartilage has been determined to be between 50 and 130N mm2Or 50-140N mm2And the bending stiffness of the implant or parts of the implant may also be in this range. The bending stiffness of the implant may also be greater or less than this. For example, other support structures within the body may work with the implant to provide additional support and require a lesser amount of support from the implant, or the supporting tissue may also be weaker and may require greater support from the implant. ImplantThe implant or part of the implant may have a bending stiffness of more than 10N mm2Greater than 30N mm2Greater than 50N mm2Greater than 75N mm2Greater than 100N mm2Greater than 150N mm2Greater than 200N mm2Greater than 300N mm2Greater than 400N mm2Or less than 600N mm2Less than 500N mm2Less than 420N mm2Less than 400N mm2Less than 300N mm2Less than 200N mm2Less than 130N mm2Less than 100N mm2Or less than 50N mm2. For example, the implant or portion of the implant may have a thickness in the range of 10 to 590N mm2(ii) a 30 to 450N mm2;60-250N*mm2;75-200N*mm2(ii) a 50 to 130N mm2(ii) a Or 9 to 130N mm2Bending stiffness in between. In some embodiments, the implant may have a bending stiffness of less than about 130N mm2Part (c) of (a). In some embodiments, the implant may have a bending stiffness of about 10 to about 130N mm2Part (c) of (a). In some embodiments, the implant may have a bending stiffness of about 50 to about 130N mm2Part (c) of (a).
The nasal implants described herein may be provided in multiple shapes, or may be shapeable by the physician to accommodate various anatomical structures or degrees of collapse. Some configurations may be modified to increase mechanical integrity. This may be accomplished, for example, by selectively reducing the space between the various components of the implant design, overlapping portions of the implant, or stacking multiple implants to increase the thickness in the preferential area. Preferential flexibility may also be achieved by selectively locking portions of the implant to one another to resist bending. In some embodiments, the implant may include multiple layers that may change the overall stiffness of the implant or stiffness in certain areas and in certain orientations when rotated or repositioned relative to each other. The implants described herein may be capable of receiving various volumes of fluid prior to implantation or in situ to modify shape and/or mechanical properties. The implants described herein can be modified to receive fluids, which can include bioactive agents or pharmaceutical compounds, to achieve a desired tissue response.
In some embodiments, an implant as described herein may be in the form of a mesh, fabric, or braid that can be freely moved in an orthogonal direction from its flat-state footprint by a selected distance with minimal force, and cannot be further offset from this predetermined distance. Such implants may include flexible or rigid frames of various geometries for mesh, fabric, or braid that may be secured to the surrounding anatomy or tissue. The frame may include features to aid in such fixation, such as barbs, suture eyelets, or extension members with tissue engagement features. The nasal implant may have an open structure to allow blood flow to adjacent tissue, such as cartilage.
The implant cross-section may include multiple longitudinal elements having the same or different dimensions, for example, the elements closest to the center of the implant footprint may be thicker or wider to provide greater rigidity, while the outermost elements may be thinner or narrower to provide greater flexibility. This example provides more rigid mechanics at areas where support from collapse is most likely needed, while providing more atraumatic transition to the surrounding tissue structure where less support is needed.
The implant may be constructed of various polymer configurations throughout or selectively within the implant footprint to allow for various mechanical properties and/or to promote various physiological responses and interactions in/with the surrounding tissue. The nasal implant may be manufactured from a variety of different biocompatible materials. In some embodiments, the nasal implant comprises a first bioabsorbable material. In some embodiments, the nasal implant consists essentially of the first bioabsorbable material. The nasal implant may be made from multiple different materials, such as multiple bioabsorbable materials and combinations of bioabsorbable and non-bioabsorbable materials. In some embodiments, the nasal implant may comprise a non-bioabsorbable material alone or in addition to one or more absorbable materials.
In embodiments in which the nasal implant is biodegradable, the degradation characteristics of the implant can be tailored based on the selection of the material and optional coating of the nasal implant. In some embodiments, the nasal implant includes a first bioabsorbable material having a first degradation profile and a second bioabsorbable material having a second degradation profile. The first degradation profile may be more rapid to promote a rapid inflammatory response to help form a protective capsule around the implant that can quickly secure the implant into a targeted location within the nasal tissue. The second degradation profile may have a slower degradation profile and may provide more durable mechanical support. In some embodiments, the second material may be a non-degradable material. The first degradation curve and the optional second degradation curve may be about 2-10 weeks at the low end and 3-5 years on the top end. The 2-10 week curves are similar to conventional wound closure and sutures, while the 3-5 year curves are typical of facial skull plates, suture anchors, cartilage replacement. Alternatively, the implant may be non-biodegradable and thus permanent.
In some embodiments, the nasal implants described herein can include a hollow portion, or one or more internal implant chambers that can receive fluid. Fluid may be provided to or removed from the hollow portion or internal implant chamber to alter one or more of the shape, profile and stiffness of the nasal implant. An example of a fluid that can modify the structural properties of a nasal implant is saline or other biocompatible fluid. In some embodiments, the fluid may include a drug or bioactive agent that may be provided to the hollow portion or one or more internal implant chambers. The fluid may be provided to the nasal implant prior to implantation, or may be provided to the nasal implant in situ after the nasal implant has been placed within the nasal tissue. In one example, a delivery tool for a nasal implant can include a reservoir containing a fluid, and a fluid path between the reservoir and the nasal implant, such that a desired amount of fluid can be provided in situ or removed from the nasal implant. The hollow portion or one or more internal implant chambers may also be designed to receive fluid in situ from a source separate from the delivery tool. For example, a needle or syringe may be used to provide fluid to the nasal implant in situ.
In some embodiments, an implant or feature on an implant described herein can include a shape memory material. In some variations, the implant comprises a biocompatible, bioabsorbable material, such as a bioabsorbable polymer. Bioabsorbable or biodegradable implants can provide structure and support to body tissues such as nasal tissues. A portion or all of the implant may be degraded (also referred to as biodegradable) in vivo into small portions, and may be bioabsorbable. If the implant includes a bioabsorbable portion and a non-bioabsorbable portion, the methods as described herein may include both biodegrading and bioabsorbable implants or only portions of implants. Bioabsorption can be promoted by tissues and organs. Bioabsorbable tissues and organs can include bodily fluids such as blood, lymph, mucus, saliva, and the like. Bacteria may also aid in the bioabsorbable material. The implant may be made partially or completely of one or more biocompatible biodegradable materials, such as naturally occurring or synthetic polymers. The biodegradable implant may be made from: poly (lactide); poly (glycolide); poly (lactide-co-glycolide); poly (lactic acid); poly (glycolic acid); poly (lactic-co-glycolic acid); poly (lactide)/poly (ethylene glycol) copolymers; poly (glycolide)/poly (ethylene glycol) copolymers; poly (lactide-co-glycolide)/poly (ethylene glycol) copolymers; poly (lactic acid)/poly (ethylene glycol) copolymers; poly (glycolic acid)/poly (ethylene glycol) copolymers; poly (lactic-co-glycolic acid)/poly (ethylene glycol) copolymers; poly (caprolactone); poly (caprolactone)/poly (ethylene glycol) copolymers; poly (ortho esters); poly (phosphazenes); poly (hydroxybutyrate) or copolymers including poly (hydroxybutyrate); poly (lactide-caprolactone); a polycarbonate; a polyester amide; a polyanhydride; poly (dioxanone) (PDO); poly (alkylene alkylate); copolymers of polyethylene glycol and polyorthoesters; biodegradable polyurethanes; poly (amino acids); a polyether ester; a polyacetal; polycyanoacrylates; poly (oxyethylene)/poly (oxypropylene) copolymers, or blends or copolymers thereof. In some examples, the implant comprises poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA) or both. In some examples, the implant is a 90:10, 80:20, 70:30, 60:40, 50:50PLLA/PDLA copolymer, or between any of these values. In some examples, the implant is 70:30, +/-10% PLLA/PDLA copolymer. In some examples, the implant is 70:30, +/-10% PLLA/PDLLA.
An implant as described herein may include an additional bioactive agent or material, such as an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducing agent, a decongestant, a drug, a growth factor, a microparticle, a mucolytic agent, a radiopaque material, a steroid, or a vitamin. Such materials may be attached to, adhered to, coated onto, or incorporated within the implant. Such materials may be inserted into body tissue along with an implant. Such materials may be injected into the implant. The material may be provided to a balloon or hollow portion of the nasal implant that is configured to receive fluid from an external source, such as a syringe or needle. The hollow portion of the implant or balloon may be configured such that it infuses the active agent into the surrounding tissue at a predetermined rate. The implant can be configured to include multiple hollow portions that each can include an opening or structure on the outer surface of the implant that can receive an injection of the active agent in situ for the designed lifetime of the nasal implant without significant structural compromise. Such materials may be needed at different times and may be time sensitive or time released. For example, an anti-inflammatory agent may be useful immediately after implantation to prevent too much early inflammation and pain, but may be undesirable during the later stages of scarring and healing, as it may interfere with the healing process providing new tissue to provide support to the tissue. For example, the implant may be configured to release a cartilage growth inducing agent, such as a fibroblast growth factor (FGF; e.g., basic fibroblast growth factor or FGF2) or a transforming growth factor (TGF; e.g., TGF β 1), after several days or weeks, in order to prevent an inappropriate or unwanted response from occurring at an early stage. Alternatively, the implant may include an active agent or material that is expected to promote inflammation at an early stage of delivery to promote scar formation, which provides the desired permanent changes to the surrounding tissue and sidewall structure. This may be accomplished by selectively incorporating a rapidly absorbable material in direct contact with the surrounding tissue at an early stage of implantation to promote a more aggressive foreign body response for an initial predetermined period of about 2-12 weeks.
The implants disclosed herein may include multiple materials to tailor the rigidity, external stiffness/softness of the implant, biocompatibility and absorption profile of the implant. In some embodiments, the implant may include an internal structure that is degradable by the hydrophobic external coating. Degradable materials can be degraded in vivo by hydrolysis. Degradation can be slowed by coating the degradable material with a coating, such as a hydrophobic coating, to control or modulate the degradation of the implant. The hydrophobic coating may delay the entry of water and subsequently the hydrolysis of the degradable portion of the implant. An example of a hydrophobic material that may be used is polycaprolactone, which is an absorbable material that is hydrophobic, crystalline, and highly elastic, making it well suited for coatings. The coating may be applied with a specifically selected solvent blend to minimize the impact on the underlying polymer structure. In some embodiments, a non-absorbable biocompatible coating, such as silicone, epoxy acrylate, or ParyleneTMMay be used to slow the absorption of water into the underlying polymer.
In some embodiments, the biodegradation rate, profile, and/or period of the implant can be modulated. For example, a variety of coatings, both absorbable and non-absorbable, may be applied to the underlying implant structure that has shown the necessary mechanical properties for supporting the superior and inferior nasal cartilage. There are many possible coatings including polycaprolactone, silicone, fluoropolymers, vinyl alcohol, acrylates, and the like. In some embodiments, the coating may be ParyleneTM. Exemplary hydrophobic coating compound ParyleneTM(poly (dichloro-p-xylene)) has the following form:
ParyleneTMn is the basic member of the family and is generally the most moisture permeable. ParyleneTMC and D are commonly used for moisture barrier properties. The current form of Parylene due to the typical pinhole-free coating propertiesTMHave been used primarily as a complete moisture barrier for electronic products and medical implants. In some cases, ParyleneTMCan be used as a controlled release agent for releasing drugs from materials beneath the coating. For example, the drug may be located in ParyleneTMIn a layer or material underlying the coating. In other forms of coating, ParyleneTMIt may also be used to add lubricious coatings on guidewires and catheters. In the present disclosure, ParyleneTMUsed differently from conventional applications. In one embodiment, the semi-permeable nature of very thin coatings may be advantageously used to control the ingress of water through the thin coating and into contact with the underlying implant structure. The rate of biodegradation of the implant can be controlled by selecting and controlling the coating (e.g., Parylene)TMCoating) thickness and conformability. For ParyleneTMThe conformal coating process of (a) is well established and allows control of the thickness of the coating on the implant substrate. To facilitate passage through ParyleneTMSome water transport of the coating and initiation of hydrolytic degradation, the implant may be coated at a thickness in the range of about 0.1 to about 10 microns, preferably in the range of 0.1 to 5 microns, to allow for a semi-permeable design. The design of the semipermeable coating allows for selective adjustment of the absorption rate of the implant, with the degree of permeation being determined by the thickness and conformability of the coating.
In nasal implant embodiments in which a hydrophobic coating is used, the thickness of the hydrophobic coating can be selected to modify the absorption profile of the implant. In some embodiments, the hydrophobic coating may have a thickness of about 0.1 microns to about 10 microns. In some embodiments, the hydrophobic coating may have a thickness of about 0.1 microns to about 5 microns. In some embodiments, the hydrophobic coating may have a thickness of about 0.1 microns to about 1 micron. In some embodiments, the hydrophobic coating has a thickness of less than 10 microns. In some embodiments, the hydrophobic coating has a thickness of less than 5 microns. In some embodiments, the hydrophobic coating has a thickness of less than 1 micron. The thickness of the coating can be selected to control the rate at which water enters through the coating and into the core of the implant. The hydrophobic coating may be applied to the entire outer surface of the implant or to portions of the outer surface of the implant. In some embodiments, a hydrophobic coating is applied to a central rod portion of the implant. In another embodiment, a hydrophobic coating is applied to the implant except at the ends. For example, the proximal end or tip may be uncoated to serve as a site for water entry. The conformability of the hydrophobic coating can also be selected to alter the absorption profile of the implant. In some embodiments, the conformability of the hydrophobic coating is selected to control the rate of water entry into the implant core through the hydrophobic coating. In some embodiments, the hydrophobic coating has a patterned conformability with the coated portions and the open portions. The patterned hydrophobic coating may be applied over the entire outer surface of the implant or over portions of the implant. In some embodiments, the hydrophobic coating may have a porous structure. In some embodiments, the hydrophobic coating may have a laminate structure made of multiple materials. For example, in some embodiments, a combination of bioabsorbable and non-bioabsorbable layers can be used to modulate the degradation rate or profile of the implant after implantation in nasal tissue.
When a coating is used on the nasal implants described herein, the coating can be applied using various processes, such as vapor deposition, dip coating, spray coating, sputter coating, brush coating, and the like. In some embodiments, the coating is bioabsorbable. In the case of polycaprolactone, the coating itself is hydrophobic and bioabsorbable, allowing for complete resorption over a period of time. Using dip coating methods, coating thicknesses of 0.1 to 10 microns can be achieved for the desired results. In addition, the same effect can be achieved by depositing 0.001 to 20 wt% of polycaprolactone on the implant substrate. Polycaprolactone is readily soluble in mixtures of various solvents including, but not limited to, cycloalkanes, organic esters, chloroform and other such organic solvents.
The rate of degradation profile of the implants and/or portions of implants described herein can be selectively adjusted such that the lifetime of the implant core or implant base polymer substrate can be increased by up to 20-fold. The desired biodegradation profile may comprise a period of time of less than about 48 months. The desired biodegradation profile may comprise a period of time of less than about 36 months. The desired biodegradation profile may comprise a period of time of less than about 24 months. The desired biodegradation profile may comprise a period of time of less than about 18 months. The desired biodegradation profile may comprise a period of time of less than about 12 months. The desired biodegradation profile may comprise a period of time of less than about 9 months. The desired biodegradation profile may comprise a period of time of less than about 6 months. The desired biodegradation profile may comprise a period of time of less than about 3 months. The desired biodegradation profile may comprise a period of time of less than about 1 month. The degradation profile may include a period of 12-18 months.
Also described herein are delivery methods and tools for use with the nasal implants described herein. In some cases, the implants described herein can be delivered using a customized delivery tool. For example, the customized delivery tool may include a handle portion having a hand-graspable surface, and an elongated member having a proximal end and a distal end, wherein the proximal end is engaged with the handle portion. The distal end can include an implant cavity adapted to receive any of the nasal implants described herein, and an opening adapted to eject the nasal implant from the implant cavity. The opening may be at the distal end of the elongated member and include a central axis of the elongated member. The opening may be adjacent the distal end of the elongate member and orthogonal to the central axis of the elongate member. The delivery tool may further comprise a cutting surface on the distal end of the elongate member. The cutting surface may be at the distal-most end of the elongate member. The cutting surface may include a scissor element having a blade at a lateral edge of the scissor such that the lateral edge is adapted to prepare a planar opening in the nasal tissue when the lateral edge is moved away from the central axis of the elongate member. The cutting surfaces may be used to separate nasal tissue to form or enlarge pockets along a plane for placement of the implant. For example, the delivery tool may have a cutting surface similar to a pair of tendon cutters having sharp side edges that can be opened to separate and cut tissue in a desired plane.
In some embodiments, a delivery tool for a nasal implant as described herein can include an energy source, an energizing surface of the tool adapted to receive energy from the energy source, and a controller adapted to control the energy between the energy source and the energizing surface of the tool. Examples of energy sources include one or more of cryogenic, ultrasound, and Radio Frequency (RF). In one aspect, an energy source may be used to interact with nasal tissue. The energized surface may be adapted to provide energy to a portion of nasal tissue to facilitate a physiological response. In another aspect, an energy source can be used to interact with the nasal implant to initiate or change the shape and characteristics of the nasal implant. The energizing surface can be adapted to energize a portion of the nasal implant to change the shape of the nasal implant.
In some embodiments, a delivery tool for a nasal implant as described herein can include a distal portion having an element in fluid communication with an implant and a proximal handle. Such fluid communication elements may be used to selectively enlarge or reduce the size of the implant, with the injection or removal of fluid from the internal implant chambers described herein. For example, the delivery tool can include a fluid source, a fluid injection port adapted to provide fluid into a portion of the nasal implant, and a fluid communication path between the fluid source and the fluid injection port. The delivery tool may further include a fluid controller configured to control fluid flow between the fluid source and the nasal implant to change a shape of at least a portion of the nasal implant.
A delivery device as described herein may also include controls on the proximal handle to accomplish any of the tasks described herein. For example, the control can include one or more of a trigger, a slider, or a roller to advance the insertion element to push the implant from the distal portion into the target tissue region. The delivery tool may be a single tool or a group of tools.
In some embodiments, a delivery tool as described herein may include a structure for expanding an internal pocket, such as a balloon, to apply pressure between layers of tissue and delaminate or dissect the layers from one another. If a balloon-like dilator is used at the distal end region to create the pocket, the proximal handle may also include a connection to a pressure source or piston-like mechanism to create pressure using a fluid, such as a liquid, air, or other gas. The lumen may connect a pressure generating source at the proximal handle to the balloon at the distal end. A braided or coiled structure may also be used to create the balloon-like expansion, which may expand to a larger diameter as the length is reduced. This may be accomplished by using a structure at the distal end of the tool, such as a telescoping rod, that is selectively connected to the distal and proximal ends of the braid or coil member and that is movable relative to each other to expand or collapse the braid or coil. Another example of a structure that may be used to modify nasal tissue to separate the tissue includes a semi-rigid loop material that may be deployed from an opening in the distal end of the delivery tool. For example, a wire or other similar material can be pushed out of a distal opening in a delivery tool such that a loop is formed, which can expand such that it dissects and separates nasal tissue along a flat plane corresponding to the loop.
Methods for delivering the nasal implant are also described herein. In some cases, the methods for placing the implants described herein can be minimally invasive. In other embodiments, the methods for delivering a nasal implant may be more invasive than minimally invasive surgery, but less invasive than open surgical techniques. Thus, in some embodiments, the methods may be between minimally invasive and open surgical techniques.
In some embodiments, a method of delivering a nasal implant can include creating a pocket within nasal tissue of a patient and placing any of the nasal implants described herein within the pocket. The pocket within the nasal tissue of the patient may be between the mucosa and the dermis. The pocket in the patient's nasal tissue may be between the septum and the lateral cartilage. The pocket in the nasal tissue of the patient may be between the mucosa and the nasal septum. The pocket within the nasal tissue of the patient may be between the dermis and the lateral cartilage. The method can include carrying any of the nasal implants described herein with any of the delivery tools described herein, and subsequently placing the nasal implant by passing the nasal implant through an opening in an elongate member of the delivery tool. The nasal implant may be carried by maintaining the nasal implant in a compressed state, e.g., having a compressed length and/or width. The method may further comprise suturing the nasal tissue after placing the nasal implant.
In some embodiments, a method of delivering an implant includes delivering the implant in a folded state through a small incision and expanding in situ to fill a larger pocket or tissue anatomical plane. Nasal implants may be self-expanding or require more active or manual expansion methods. The expanded nasal implant may include shapes such as a spiral, selectively bridged concentric circles, overlapping filament nesting, scalloped rings, flat stent patterns, louvers, balloons, and the like. An expandable nasal implant may include any of the mechanical or specific geometric designs discussed above to provide selective flexibility when in an expanded state. The ability of these implants to expand from a compressed state may be primarily a result of the flexibility of the polymer used to make the implant in combination with the geometry of the implant. For example, an implant configuration that includes a spaced filament type design may only require a reduction in the spacing between the filaments and some of the bends in the filaments to achieve the folded state. Other designs, such as substantially circular implants, may require the ability to flex into a more oval shape to reduce the size in a preferred direction.
In some embodiments, the method can include changing the shape of the nasal implant prior to placing the nasal implant within the pocket. In one aspect, the application of energy is used to change the shape of the nasal implant. Examples of applying energy include applying one or more of cryogenics, ultrasound, and Radio Frequency (RF) to a nasal implant. Thus, in some embodiments, the method may include applying energy to a portion of nasal tissue adjacent to the pocket. Additionally, in some embodiments, the method can include injecting a fluid into a portion of the nasal implant to change a shape of at least a portion of the nasal implant. In one aspect, the injection of fluid is completed before the nasal implant is placed within the bag. In one aspect, the injection of the fluid is done in situ.
Thus, described herein are implants that, when delivered, provide extensive support of the nasal sidewall. The implants described herein can be substantially planar. For example, the implant may be 3-5mm wide, 3mm or more in height, and 1mm or less in thickness. The implant may be preferentially flexible to conform to the natural nasal contours while being sufficiently rigid overall to prevent the interior sides of the nasal walls from collapsing upon inhalation. Additionally, in at least some embodiments, the nasal implants described herein can be compressible and expandable (e.g., via elastic expansion) for delivery.
In general, the implants described herein can be placed within the nasal anatomy, as shown in fig. 43A-43C. That is, as shown in fig. 43A, the implant may be placed along the trajectory of
Various positions of
Fig. 4 illustrates another exemplary nasal implant 180. Implant 180 has a rounded rectangular or substantially circular profile formed from a helical wire (which may be made of metal, polymer, or any other material described herein). The helical configuration of implant 180 is formed from four turns of wire. Further, the helical configuration may include spaces 444 between two or more adjacent loops of wire. As with
Fig. 5A-5B illustrate additional exemplary
Fig. 9A-
Fig. 6A-6B illustrate additional exemplary
Fig. 13A-
Fig. 37 shows an implant similar to
Fig. 7A-7F illustrate additional exemplary
Fig. 8A-8M illustrate various examples of nasal implants having similar features and/or characteristics as other implants described herein. Fig. 8A shows an
Fig. 17A-17F illustrate exemplary
As shown in fig. 17C-17D,
Placement of implant 1700 (which may be similar to any of
Fig. 33 shows an implant 3310 that is similar to
Fig. 34A-
Fig. 19A-19D illustrate additional exemplary
The
Fig. 31A-31D show exemplary
Fig. 20A-21 show an
Fig. 24-25
Fig. 26-27 show additional
Fig. 28A-28B show
Fig. 30 shows another
Fig. 35-36 show additional
Fig. 38-40 show additional
Any of the implants described herein can include prongs or barb features on the distal end thereof for engagement with the nasal anatomy. For example, referring to fig. 44A-44B, the
It should be understood that any feature described herein with respect to one embodiment may be substituted for or combined with any feature described herein with respect to any other embodiment. Additionally, it should be understood that the relative placement of implants described herein with respect to one implant embodiment may be used with any of the other embodiments described herein.
Fig. 10A-10D illustrate exemplary steps for placing a nasal implant as described herein. The steps shown in fig. 10A-10D are more invasive than minimally invasive surgery (e.g., where the implant is delivered with a needle), but less invasive than open surgical techniques for delivering nasal implants (e.g., surgical delivery of slatted and expanded grafts). Fig. 10A-10B illustrate that a
Fig. 16 shows an
Fig. 11A-11B illustrate examples of embodiments of
Fig. 12A-12B illustrate aspects of embodiments of
The distal end of another
Referring to fig. 15, in some embodiments, the distal end 1515 of the
In some embodiments, specialized tools can be used to create pockets in the nasal anatomy for placement of implants therein. For example, fig. 14 shows an exemplary tool 1400 for forming a pocket in the nasal wall. The tool 1400 includes a cannula or catheter body 1416 having a balloon 1414 on its distal tip. The balloon 1414 may be tapered from proximal to distal to create a pocket as the balloon 1414 is inflated within the nasal anatomy. The catheter body 1416 may include a port 1418 for supplying gas or fluid to inflate the balloon 1414. Further, the distal and proximal seals 1419a, b may ensure that air or fluid in the balloon 1414 does not leak.
Another
Another
Another exemplary tool 3200 for creating a pocket in the nasal wall is shown in fig. 32A-32C. The
Another
When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it can be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applied to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".
Spatially relative terms, such as "below," "lower," "above," "upper," and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "below … …" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for illustrative purposes only, unless explicitly stated otherwise.
Although the terms "first" and "second" may be used herein to describe various features/elements, these features/elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element, without departing from the teachings of the present invention.
As used herein in the specification and claims, including as used in the examples, and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or "approximately", even if the term does not expressly appear. When describing magnitudes and/or positions, the phrase "about" or "approximately" may be used to indicate that the stated values and/or positions are within a reasonably expected range of values and/or positions. For example, a numerical value can have a value that is +/-0.1% of the value (or range of values), +/-1% of the value (or range of values), +/-2% of the value (or range of values), +/-5% of the value (or range of values), +/-10% of the value (or range of values), and the like. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
While various illustrative embodiments have been described above, any of a variety of changes may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various described method steps are performed may often be varied in alternative embodiments, while in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description is provided primarily for the purpose of illustration and should not be construed as limiting the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show by way of illustration, and not limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention" merely for convenience and without intending to limit the scope of this application to any single invention or inventive concept if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
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