Tube Deployment System

Abstract

A tube deployment system (100, 200) includes a nasal assembly (102, 202) having a distal cutting blade (119, 219) and a tube (114, 214). The distal cutting blade (119, 219) is configured to be manually advanced to puncture a patient's membrane. A handle (104, 204) of the system (100, 200) includes: a pulling mechanism (106, 206) having a slider (150) and a pull block (152); and an actuating member (118, 218) having a distal end (132, 232) coupled to the distal cutting blade (119, 219) and a proximal end coupled to the pull block (152). The slider (150) is manually operated to move the pulling mechanism (106, 206) from a non-tensioned structure to a tensioned structure. In the tension structure, the pull block (152) pulls the actuating member (118, 218) to retract the distal cutting edge (119, 219) to unfold the tube (114, 214).

Description

[0001] Cross-references to related applications

[0002] This application is based on and claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 132,562, filed on December 31, 2020, the contents of which are incorporated herein by reference in their entirety. Summary of the Invention

[0003] A tube deployment system includes a nasal assembly having a distal cutting blade and a tube. The distal cutting blade is configured to be manually advanced to puncture a patient's membrane. The system's handle includes a pulling mechanism and an actuating member. The pulling mechanism has a slider and a pull block. The actuating member has a distal end coupled to the distal cutting blade and a proximal end coupled to the pull block. The slider is manually operated to move the pulling mechanism from a non-tensioned configuration to a tensioned configuration. In the tensioned configuration, the pull block pulls the actuating member, causing the distal cutting blade to retract and deploy the tube.

[0004] The pulling mechanism on the tube deployment system includes a slider with a trigger portion that is manually operated to move the pulling mechanism from a non-tensioned structure to a tensioned structure. The trigger portion of the slider includes a first peak-shaped region, a second peak-shaped region with a height greater than the first peak-shaped region, and a valley-shaped region located between the first and second peak-shaped regions. The height of the valley-shaped region is less than the height of the first and second peak-shaped regions. The trigger portion also includes a rear guide region located behind the second peak-shaped region. The first, second, and valley-shaped regions include multiple protruding features, while the rear guide region does not have multiple protruding features.

[0005] A method of deploying a tube within a membrane includes providing a nasal assembly comprising a nasal portion, an elongated portion, a distal cutting blade, and a tube. At least some of the elongated portion, the distal cutting blade, and the tube are manually advanced into a patient's orifice, the distal cutting blade piercing the patient's membrane, and a trigger portion on a slider of a pulling mechanism is manually moved to pull an actuating member having a distal end coupled to the distal cutting blade, causing the distal cutting blade to retract and the tube to deploy. The slider is configured to rotate a pivot arm about a fixed pivot point. The pivot arm is coupled to a pull block, which is connected to the proximal end of the actuating member.

[0006] This "Summary" is provided to introduce a selection of concepts in a simplified form, which will be further described in the "Detailed Description" below. This "Summary" is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to embodiments that address any or all the shortcomings pointed out in the background art. Attached Figure Description

[0007] Figure 1 This is a front perspective view of a tube unfolding system according to one embodiment, in which the cutting sheath groove faces a first direction.

[0008] Figure 2 According to one embodiment Figure 1 The diagram shows a rear perspective view of the tube unfolding system, but with the cutting sleeve groove facing the second direction.

[0009] Figure 3 yes Figure 1 The right view.

[0010] Figure 4 yes Figure 1 The left view.

[0011] Figure 5 yes Figure 1 Front view.

[0012] Figure 6 yes Figure 1 Rear view.

[0013] Figure 7 yes Figure 1 Top view.

[0014] Figure 8 yes Figure 1 A bottom view.

[0015] Figure 9 yes Figure 1 The exploded diagram.

[0016] Figure 10 yes Figure 1 and Figure 3-9 Front perspective view of the nose component.

[0017] Figure 11 yes Figure 10 The rear perspective view.

[0018] Figure 12 yes Figure 10 and Figure 11 Rear view.

[0019] Figure 13 It is along Figure 12 The sectional view shown is taken by the section lines shown.

[0020] Figure 14 This is a front perspective view of another tube unfolding system according to one embodiment, in which the cutting sheath groove faces a first direction.

[0021] Figure 15 According to one embodiment Figure 14 The diagram shows a rear perspective view of the tube unfolding system, but with the cutting sleeve groove facing the second direction.

[0022] Figure 16 yes Figure 14 The right view.

[0023] Figure 17 yes Figure 14 The left view.

[0024] Figure 18 yes Figure 14 Front view.

[0025] Figure 19 yes Figure 14 Rear view.

[0026] Figure 20 yes Figure 14 Top view.

[0027] Figure 21 yes Figure 14 A bottom view.

[0028] Figure 22 yes Figure 14 The exploded diagram.

[0029] Figure 23 yes Figure 14 and Figure 16-22 Front perspective view of the nose component.

[0030] Figure 24 yes Figure 23 Front perspective view of the nose component of the nose assembly.

[0031] Figure 25 yes Figure 23 Rear perspective view of the nose component.

[0032] Figure 26 yes Figure 23 Rear view of the nose component.

[0033] Figure 27 It is along Figure 26 A sectional view taken from the section lines.

[0034] Figure 28 This is a front perspective view of the nose component of another embodiment of the nose assembly.

[0035] Figure 29 This is a right front perspective view of a nose component according to yet another embodiment of a nose assembly.

[0036] Figure 30 yes Figure 29 Left front perspective view of the nose-shaped part.

[0037] Figure 31 yes Figure 29 and Figure 30 Rear view of the nose-shaped component.

[0038] Figure 32 It is along Figure 31 A sectional view taken from the section lines.

[0039] Figure 33 The first user grip position is shown on the handle of the tube deployment system.

[0040] Figure 34 The second user grip position is shown on the handle of the tube deployment system.

[0041] Figure 35a This is a perspective view of the second side housing of the handle, wherein an embodiment of the pulling mechanism is in an unstretched configuration and connected to the actuating member.

[0042] Figure 35b It is a perspective view of the second side housing of the handle, wherein another embodiment of the pulling mechanism is in an unstretched configuration and connected to the actuating member.

[0043] Figure 36 yes Figure 35a A magnified side view of the second side housing of the handle.

[0044] Figure 37 This is a perspective view of the first side housing of the handle, in which the pulling mechanism is in an unstretched configuration and connected to the actuating member.

[0045] Figure 38 yes Figure 35a A perspective view showing no actuating components and the locking pin removed.

[0046] Figure 39 yes Figure 35a A perspective view of the second side housing of the handle, wherein the locking pin is removed and the pulling mechanism is in a tensioned configuration.

[0047] Figures 40-42 The process of removing the handle and detaching the nose assembly from the handle is shown to reduce the amount of sharps waste and / or allow for easier disposal and recycling. Detailed Implementation

[0048] The tube deployment system described herein combines the steps of making an incision in the membrane, such as a myringotomy in the tympanic membrane or eardrum, positioning the tube (e.g., a ventilation tube, such as a pressure equalization (PE) tube or a tympanostomy tube, which can have various geometries, including cylindrical, rectangular, or other types of cross-sections), and placing or inserting the tube into the patient's membrane in a single system. In the described embodiments, each tube deployment system includes a nose assembly connected to a handle and a pulling mechanism, both of which protrude from and are housed within the handle. Backlash is the gap or free movement caused by the spacing between parts in a mechanical system. In other words, backlash is the maximum distance or angle by which any part in a mechanical system can move in one direction without exerting any kind of noticeable force on the next or subsequent part in that mechanical system. The tube deployment systems described below include an overall mechanical design that minimizes backlash. Because clinicians often grope around to use the described tube deployment systems, the tactile feel of the described tube deployment systems—both in the mechanism and on their surfaces—is important for user functionality.

[0049] Figure 1 This is a front perspective view of a tube unfolding system 100 having a cutting sheath groove 115 facing a first direction, according to one embodiment. Figure 2 This is a rear perspective view of a tube unfolding system 100 according to one embodiment, but the cut sheath groove 115 faces the opposite second direction. Figure 3 yes Figure 1 The right view, Figure 4 yes Figure 1 Left view, Figure 5 yes Figure 1 Front view, Figure 6 yes Figure 1 Rear view, Figure 7 yes Figure 1 Top view, Figure 8 yes Figure 1 The bottom view, and Figure 9 yes Figure 1 Exploded view. The tube deployment system 100 includes a nose assembly 102 coupled to a handle 104 and a pulling mechanism 106 that protrudes partially from the handle 104 and is partially housed within the handle 104.

[0050] Figure 10 It is a front perspective view. Figure 11 It is a rear perspective view. Figure 12This is a rear view of the nose assembly 102. The nose assembly 102 includes a nose portion 122, an elongated portion 120 extending from the nose portion 122, and a sheath assembly 112. In this embodiment, the elongated portion 120 is a hollow positioning rod, and the sheath assembly 112 includes a hollow cutting sheath 116 having a distal cutting edge 119. In the illustrated embodiment, the distal cutting edge 119 includes a beveled cutting edge. Multiple portions of the hollow cutting sheath 116 surround the distal end 126 of the elongated portion 120. Figure 13 The hollow cut sheath 116 also at least partially houses the tube 114, which is configured to be placed in or spread across the patient's membrane.

[0051] Figure 13 It is along Figure 12 The sectional view shown is taken by the section lines. Figures 1-13 In the embodiment shown, the nose-shaped member 122 is located at the proximal end 124 of the positioning rod 120. Figure 11 , Figure 12 and Figure 13 The positioning rod 120 is molded at or near the location of the groove 128. Figure 9 The groove 128 extends from the distal end 126 of the positioning rod 120 to the terminal 129 of the groove 128. The terminal 129 is located between the distal end 126 and the proximal end 124 of the positioning rod 120, the proximal end 124 being molded over the nose-shaped member 122.

[0052] With remote 132 ( Figure 13 Actuating component 118 Figure 9 and 13 The tube 114 is attached to the cutting sheath 116, extends within the cutting sheath 116, extends through a slot 128 in the positioning rod 120, extends within the positioning rod 120, and extends along the positioning rod 120 into the nose member 122. The tube 114 is at least partially surrounded by the cutting sheath 116, while a portion of the tube 114 protrudes through a slot 115 in the cutting sheath 116. The portion of the tube 114 protruding through the slot 115 provides a visual label for the clinician placing the tube into the patient's membrane.

[0053] like Figure 9 As shown, the handle 104 includes a first side housing 130 and a second side housing 132. Each of the first side housing 130 and the second side housing 132 respectively includes a molded textured area 135. Figure 2 , Figure 3 , Figure 9 ) and area 137 ( Figure 1 and Figure 4The molded texture differs from the other surfaces of the first side housing 130 and the second side housing 132 to achieve tactile differentiation. The molded texture of regions 135 and 137 may be undercut and scoop shapes to provide tactile feedback for correct finger positioning. The molded texture may also provide resistance points to prevent the system 100 from sliding forward or backward in the clinician's hand during use. The first side housing 130 and the second side housing 132 are coupled together to internally accommodate at least a portion of the pull mechanism 106. In one embodiment, the handle 104 is connected to the nose member 122 using snap-fit ​​members 131 and 133. Figure 9 The locking components 131 and 133 prevent relative twisting from left to right and from right to left. When the clinician applies a downward force to form an incision, the interlocking element 139 (…) Figures 9-13 This reduces the chance of the nose component twisting upwards. The snap-fit ​​members 131, 133 and interlocking element 139 combine to form a multi-point stable attachment between the nose assembly 102 and the handle 104. It should be appreciated that snap-fit ​​members 131 and 133 can be interlocking elements, and interlocking element 139 can be a snap-fit ​​member. Additionally, the handle 104 is configured to receive a removable locking pin 108 and a removable assembly clip 110. The removable assembly clip 110 allows for the assembly of the first side housing 130 and the second side housing 132, as well as the disassembly of the first side housing 130 and the second side housing 132. The pull mechanism 106, the removable locking pin 108, and the removable assembly clip 110 will be discussed in more detail below.

[0054] Figure 14 This is a front perspective view of a tube unfolding system 200 with the cutting sheath groove facing a first direction, according to one embodiment. Figure 15 This is a rear perspective view of a tube unfolding system 200 according to one embodiment, but the cut sheath groove 215 faces a second direction opposite to the first direction. Figure 16 It is the right view. Figure 17 It is the left view. Figure 18 This is the front view. Figure 19 This is the rear view. Figure 20 It is a top view. Figure 21 It is a bottom view, and Figure 22 This is an exploded view of the tube deployment system 200. System 200 includes a nose assembly 202 coupled to a handle 204. A pulling mechanism 206 of system 200 partially protrudes from and is at least partially received within the handle 204. The handle 204 is connected to the nose assembly 202 via snap-fit ​​members 231 and 233. Figure 22 The locking components 231 and 233 prevent relative twisting from left to right and from right to left. Interlocking element 239 (…) activates when the clinician applies a downward force to form an incision. Figures 22-27This reduces the chance of the nose component twisting upwards. Snap-fit ​​members 231, 233 and interlocking element 239 combine to form a multi-point stable attachment between the nose assembly 202 and the handle 204. It should be appreciated that snap-fit ​​members 231 and 233 can be interlocking elements, and interlocking element 239 can be a snap-fit ​​member. The handle 204 of system 200, like the handle 104 of system 100, can be configured to receive a removable locking pin (not shown) and a removable assembly clip 210. The removable assembly clip 210 allows for the assembly and disassembly of the first side housing 230 and the second side housing 232 of the handle 204. In one embodiment, the clip 210 can be an elastomeric material that expands to rest on the proximal ends of the first side housing 230 and the second side housing 232 and contracts to hold the first side housing 230 and the second side housing 232 together. However, the clip 210 may be a resiliently removable clip, or the system 200 may not include a clip and may optionally include features that allow the first side housing 230 and the second side housing 232 to be pressed together. The pulling mechanism 206 as described above will be discussed in more detail below.

[0055] Figure 23 This is a front perspective view of the nose assembly 202. Figure 24 This is a front perspective view of the nose component 222 of the nose assembly 202. Figure 25 It is a rear perspective view, and Figure 26 This is a rear view of the nose assembly 202.

[0056] Figure 27 It is along Figure 26 The cross-sectional view is taken from the section line in the figure. The nose assembly 202 includes a nose-shaped member 222 and a sheath assembly 212. The nose-shaped member 222 has an elongated portion 234. Figure 24 ) and nasal part 236 ( Figure 24 The elongated portion 234 extends distally from the nasal portion 236. The sheath assembly 212 includes a hollow-cut sheath 216 and a tube 214, which is at least partially surrounded by the hollow-cut sheath 216 and configured to be placed in or spread across the patient's membrane.

[0057] exist Figures 14-27In the illustrated embodiment, the elongated portion 234 and nose portion 236 of the nose member 222 are made from a single molded part, and the hollow cutting sheath 216 surrounds the distal end 226 of the elongated portion 234 and a portion of the elongated portion 234 surrounding the nose member 222. The elongated portion 234 includes two different widths. A first segment 238 of the elongated portion 234 includes a first width extending from the distal end 226 to the travel stop 242. The first segment 238 provides a region for the travel of the cutting sheath 216. A second segment 240 of the elongated portion 234 includes a second width extending from the travel stop 242 to the termination of the elongated portion 234. In another embodiment, the second width of the portion 234 may be a variable width. For example, the width increases towards the proximal end to increase strength. The variation in width from the first width in the first segment 238 to the second width in the second segment 240 provides a stop for the hollow cutting sheath 216. The second section 240 provides an area where external coverings (such as shrink tubing) can be applied. The travel stop 242 will be described in more detail when discussing the operation of the tube deployment system 200. Figures 14-22 In the molded embodiment shown, the nose member 222 includes a channel 244 extending from the distal end 226 of the elongated portion 234 to the rear portion of the nose portion 236. The portion of the channel 244 extending in the elongated portion 234 is an open channel, slot, or groove that serves as a guide for the actuating member 218. The channel 244 extends to the distal end 226 of the elongated portion 234 to allow for a gap in the welded joint (such as a butt joint) between 141b 218 and the cutting sheath 216.

[0058] The portion of channel 244 extending in the nasal portion 236 is a closed channel or passageway with an outlet 245. Figures 25-27 The actuating component 218 includes a distal end 232 ( Figure 27 The distal end is connected to the proximal end 246 of the cutting sheath 216. Figure 27The tube 218 extends into and through the open channel or slot portion of the elongated portion 234 of the channel 244, which serves as the nose portion 222, and is continuous in the closed channel portion of the channel 244, which serves as the nose portion 236 of the nose portion 222. In one embodiment of system 200, channel 244 allows actuating member 218 to be a rectangular or flat wire (as opposed to round wire, similar to the round wire actuating member 118 of system 100) to maximize the wire cross-section while minimizing the amount of cross-section that the nose portion 222 must be removed to form the channel for actuating member 218, which allows the nose portion 222 to maintain structural integrity. In another embodiment, channel 244 may be only deep enough to act as a guide, and a portion of actuating member 244 extends above or outside channel 244. Tube 214 is at least partially surrounded by cut sheath 216, while a portion of tube 214 protrudes through slot 215 in cut sheath 216. The portion of tube 214 protruding through slot 215 ( Figure 15 and Figure 17 This provides a visual guide for clinicians to place the tube within or across the patient's membrane. An external wrapping 248 (such as a shrink wrapping or the like) is wrapped around the elongated portion 234 of the nose-like member 222 in the second section 240 to always (including when the actuating member 218 is actuated) retain the actuating member 218 in the open groove of the channel 244, which will be discussed in detail below.

[0059] Figure 28This is a front perspective view of a nose member 322 according to another embodiment of the nose assembly. The nose member 322 is made of a single molded part and includes an elongated portion 334 and a nose portion 336. The nose member 322 may replace the nose member 222 in the nose assembly 202. The elongated portion 334 extends distally from the nose portion 336. A hollow cut sheath 216 may be configured to surround the distal end 326 of the elongated portion 334 and to surround a portion of the elongated portion 334, as discussed in the accompanying drawings relating to the nose member 222. The elongated portion 334 includes three different widths. A first segment 338 of the elongated portion 334 includes a first width extending from the distal end 326 to a travel stop 342. A second segment 339 of the elongated portion 334 includes a second width extending from the travel stop 342 to a third segment 340. The third section 340 includes a third width and extends from the second section 339 to the end of the elongated portion 334 and the beginning of the nose-like part 336. The width variation from the first width in the first section 338 to the second width in the second section 339 provides a travel stop 342 for the hollow cut sheath. The width variation from the third width in the third section 340 to the second width in the second section 339 provides a notch for placing the outer covering 248. This notch prevents the outer covering 248 from adding excessive thickness in the elongated portion 334, which could obstruct the view of the tube 214 during placement and deployment.

[0060] The nose member 322 includes a channel 344 extending from the distal end 326 to the rear portion of the nose member 336. The portion of the channel 344 extending in the elongated portion 334 is an open channel or groove. The portion of the channel 344 extending in the nose member 336 is a closed channel. The channel 344 is configured to receive and retain an actuating member, such as an actuating member 218 connected to or butt-welded to the cutting sheath 216.

[0061] Figure 29 It is a right front perspective view. Figure 30 It is a left front perspective view, and Figure 31 This is a rear view of a nose member 422 according to yet another embodiment of a nose assembly. Figure 32 It is along Figure 31The diagram shows a cross-sectional view taken by a line cut. The nose-shaped member 422 is made of a single molded part and includes an elongated portion 434 and a nose portion 436. The nose-shaped member 422 may replace the nose-shaped member 222 in the nose assembly 202. The elongated portion 434 extends distally from the nose portion 436. A hollow cut sheath 216 may be configured to surround the distal end 426 of the elongated portion 434 and to surround a segment of the elongated portion 434 of the nose-shaped member 422, as discussed in the accompanying drawings relating to the nose-shaped member 222. The elongated portion 434 includes a first segment 438 extending from the distal end 426 to a travel stop 442. A second segment 440 extends from the travel stop 442 to a position where the elongated portion 434 ends and the nose portion 436 begins.

[0062] The nose member 422 includes a channel 444 extending from the distal end 426 to the rear portion of the nose portion 436. The portion of the channel 444 extending in a first section 438 of the elongated portion 434 is a straight, open channel or groove. At a second section 440, the channel 444 includes a side channel leading into the open channel or groove of the first section 438. This arrangement supports an actuating member (e.g., actuating member 218) within the channel 444 without requiring any additional elements (e.g., external covering 248) to confine the actuating member to the channel. The portion of the channel 444 extending in the nose portion 436 is a closed channel. As previously described in other embodiments, the channel 444 is configured to receive and retain an actuating member, such as actuating member 218, which is attached to or butt-welded to the cutting sheath 216.

[0063] Figure 33 The image shows the first user grip position on the handle of the tube deployment system. Although Figure 33 It shows Figures 1-9 The tube deployment system 100 is shown, but it should be recognized that other tube deployment system embodiments can be held using a first user grip position, as each described system includes a handle 104 and a pull mechanism 106. The first user grip position is a "pen grip." As shown, the handle 104 is held in the user's hand, as if holding a pen. The front section of the handle 104 is held between the user's thumb and middle finger, while the user's index finger engages with the pull mechanism 106. The index finger will be the finger that actuates the pull mechanism 106.

[0064] Figure 34 The second user grip position is shown on the handle of the tube deployment system. Although Figure 34 It shows Figures 1-9The tube deployment system 100 is shown, but it should be recognized that other tube deployment system embodiments can be held using a second user grip position because each described tube deployment system includes a handle 104 and a pulling mechanism 106. The second user grip position is a "reverse pen grip" (or "chopstick grip"). As shown, the handle 104 is held in the user's hand, just as one would hold a chopstick. The front section of the handle 104 rests between the user's index and middle fingers, while the user's thumb engages with the pulling mechanism 106. The thumb will be the finger that actuates the pulling mechanism 106.

[0065] Figure 35a This is a perspective view of the second side housing 132 of the handle 104, wherein the pulling mechanism 106 is in an unstretched configuration and is connected to the actuating members 118, 218. Figure 35b yes Figure 35a Alternative embodiments. Figure 36 yes Figure 35a A magnified image of a portion, and Figure 37 This is a perspective view of the first side housing 130 of the handle 104, wherein the pulling mechanism 106 is in an unstretched configuration and coupled to the actuating members 118, 218. As previously described, the handle 104 including the pulling mechanism 106 can be used with any embodiment of the nose assembly. Therefore, the actuating member shown can be any of the described embodiments of the nose assembly. Figure 35a , Figure 35b , Figure 36 and Figure 37 In the middle, the pulling mechanism 106 includes a slider 150 and a pulling block 152. Figure 35a , Figure 36 and Figure 37 In this configuration, the slider 150 and pull block 152, along with the separate pivot arm 154, are separate components. However, in... Figure 35b In this configuration, the slider 150 and the pull block 152 are integrated, thus eliminating the need for a pivot arm 154. The slider 150 includes an outer portion or trigger portion 149. Figure 36When the first and second side housings are joined together, the outer portion or trigger portion 149 is located outside and protrudes from both the first and second side housings. The trigger portion or outer portion 149 is manually operated to move the pull mechanism 106 from the unpulled configuration to the pulled configuration. The trigger portion or outer portion 149 is partitioned to allow the user to strategically position their thumb or other fingers for manual operation of the pull mechanism 106. In other words, the trigger portion 149 is partitioned to receive the user's thumb or other fingers for manual operation. Different areas provide the user with tactile feedback regarding the location of their thumb or other fingers, and also provide multiple potential finger positions based on user preference. The slider 150 also includes an inner portion 151. The inner portion 151 protrudes into the interior of the joined first and second side housings 130 to provide a structure for... Figure 35a , Figure 36 and Figure 37 In the embodiments, the pull block 152 and the pivot arm 154 engage, or are used to engage with Figure 35b In the embodiment, the pull block 152 is integrally formed.

[0066] The outer portion or trigger portion 149 of the slider 150 includes a first peak-shaped region or area 156, a second peak-shaped region or area 160, a valley-shaped region or area 158 between the first peak-shaped region 156 and the second peak-shaped region 160, and a guide region or area 162 located behind or at the rear of the second peak-shaped region 160. In one embodiment, the second peak-shaped region 160 includes a height above the housings 130 and 132 that is greater than the height of the first peak-shaped region 156. However, the valley-shaped region 158 includes a height above the housings 130 and 132 that is less than the height of the first peak-shaped region 156 and the second peak-shaped region 160. The first peak-shaped region 156, the valley-shaped region 158, and the second peak-shaped region 160 include multiple raised features or ribs, while the rear guide region or area 162 has no ribs and includes a smooth, rearwardly sloping surface. Multiple raised features provide positions for the thumb or other fingers, and the smooth, rearwardly sloping surface of the rear guide region 162 allows the user to slide their thumb or other fingers along the smooth, rearwardly sloping surface to reach the portions of the multiple raised features for the thumb or other fingers. A first peak-shaped region 156 includes ribs 164. A valley-shaped region 158 includes ribs 166a, b, c, d, and e. A second peak-shaped region 160 includes rib 168. In a user-defined finger placement configuration, the distal phalanx portion of the user's index finger rests in the valley-shaped region 158, while the distal tip of the index finger lies behind rib 164, as... Figure 33As shown. In another user finger positioning configuration, the distal end of the user's index finger engages with the rib 164 of the first peak-shaped region 156. In yet another user finger positioning configuration, the distal phalanx portion of the user's thumb rests in the valley-shaped region 158, and the lateral side of the distal phalanx portion is located at or behind the rib 164 of the first peak-shaped region, as shown. Figure 34 As shown. The numerous and multiple ribs and regions of the trigger portion 149 of the slider 150 provide a variety of variations in user finger positioning for manual operation of the pull mechanism 106. The first peak region 156, the valley region 158, or the second peak region 160 can all be used as contact areas for actuating the thumb or fingers other than the thumb, which maximizes the target size for positioning the trigger portion 149 while taking into account differences in hand size and grip style.

[0067] The pull block 152 includes an actuation component path 170 and an anchoring well 172. For example... Figures 35a-35b and Figure 37 As shown, actuating members 118, 218 transition from nose assemblies 102, 202 into housing 104 by exiting channels 144, 244 at the rear of nose members 122, 222. Handle 104 includes internal structures to support actuating members 118, 218 between positions where they exit channels 144, 244 and positions where they are secured to pull block 152. Actuating members 118, 218 follow and are positioned within path 170, and proximal ends of actuating members 118, 218 are coupled to or secured to pull block 152 in anchoring well 172 using, for example, an adhesive. In other embodiments, the anchoring well may be a shaped well for retaining a pin to clamp actuating members 118, 218 between the retaining pin and pull block 152, and to bind actuating members 118, 218 and pull block 152 together. In other embodiments, the anchor well 172 may retain the actuating members 118, 218 in a retaining configuration. For example, the interiors of the first side housing 130 and the second side housing 132 respectively include wire guides 141a and 141b that, when assembled together, prevent the actuating members 118, 218 from bending between the channels 144, 244 and the pull block 152 when compressive forces are applied to the actuating members 118, 218 (e.g., when the cutting sheaths 116, 216 are used to puncture the membrane).

[0068] exist Figure 35a , Figure 36 and Figure 37In the handle 104, the pull block 152 also includes a rearwardly projecting pull arm 174, and has a pin 175 at its end. The pivot arm 154 includes a groove 176 that mates with the pin 175 of the pull arm 174 and an end pin 177 that engages with the inner portion 151 of the slider 150. The pivot arm 154 is rotatably connected to a fixed rotation point or pivot point 178. The structure providing the rotation point or pivot point 178 can be formed as part of the first side housing 130 or the second side housing 132 of the handle 104; or, if using the pin on the pivot arm 154 and the recess in the housing, it can be formed by both the first side housing 130 and the second side housing 132, as well as the pivot arm pin. Figure 35a , Figure 36 and Figure 37 In the middle, the inner portion 151 of the slider 150 includes a contact surface 180; when in the fully forward position or as Figure 35a , Figure 36 and Figure 37 As shown, the contact surface 180 rigidly holds the pull block 152 in place in its unstretched configuration. In the unstretched configuration, the contact surface 180 is in direct contact with the clearance surface 181 of the pull block 152. This fully forward position or unstretched configuration is further reinforced by a removable locking pin 108 located in place behind the trigger portion 149 of the slider 150. The removable locking pin 108 prevents the slider 150 from being pre-deployed during transport or by the user. Overall, in the fully forward unstretched configuration, the contact surface 180 of the slider 150 rigidly holds the pull block 152 in place and eliminates clearance during membrane cutting. During cutting, the slider 150 is in its unstretched configuration.

[0069] To operate the aforementioned tube deployment system, the tube deployment systems 100 and 200 are carefully removed from their packaging. A removable locking pin 108 prevents accidental movement of the slider 150, allowing inspection of the tube deployment systems 100 and 200 to ensure they are not damaged. Additionally, it is verified that the tubes 114 and 214 are correctly loaded within the cutting sleeves 116 and 216, and that the portions of the tubes 114 and 214 protruding through the slots 115 and 215 in the cutting sleeves 116 and 216 are visible. When ready for use, the removable locking pin 108 is removed, as... Figure 38 As shown.

[0070] Clinicians or users hold the handle 104 with one hand by positioning their fingers (excluding the thumb) and / or thumb tactile sensation on the slider 150, without moving the slider 150, in order to prepare to deploy the tubes 114, 214 from the TTS 100, 200. As described above, clinicians can utilize, for example... Figure 33 The "pen grip" shown, as Figure 34The "chopstick grip" shown, or other variations of these grips, are used to hold the tube deployment system 100, 200, wherein the clinician can stably hold the operated handheld tube deployment system 100, 200 to an ear speculum or patient. The clinician or user may use other parts of the tube deployment system 100, 200 for gripping or stabilization. For example, the nose-like components 122, 222 include wing features 123 (… Figures 10-13 ), 223 Figures 23-27 Wing features 123, 223 are ribs continuously formed around the sides and top of the nose member 122, and allow clinicians or users to push forward on the nose components 102, 202 with their fingers without slipping off the nose members 122, 222.

[0071] In a visualized setting, such as using a surgical microscope or endoscope, a clinician or user manually advances or inserts the nasal components 102, 202 along the ear canal, causing the distal cutting edges 119, 219 of the cutting sheaths 116, 216 to pierce and cut the membrane. The clinician or user advances the nasal components 102, 202 until the central flange of the tubes 114, 214 penetrates the membrane, and the portion of the tubes 114, 214 protruding through the grooves 115, 215 in the cutting sheaths 116, 216 is visible on the side of the membrane, or the marking bands 117, 217 on the cutting sheaths 116, 216 are located near the membrane. In one embodiment, the marking bands 117, 217 are laser markings. Laser markings do not increase the width of the cutting sheaths 116, 216 and therefore only serve a visual aid. In another embodiment, the marking bands 117, 217 are printed markings. Printed markings can be made in color, thus enhancing visualization. In yet another embodiment, the marking strips 117, 217 may be adhesive elements or additional metal elements. Such attachments increase the width of the cutting sleeves 116, 216 and thus function as visual aids, mechanical features providing tactile feedback, or mechanical stops. The length of the marking strip 117 along the cutting sleeves 116, 216 can vary depending on the tube to be unfolded.

[0072] The clinician or user then moves the slider 150 on the handle 104 backward away from the cutting edges 119, 219 of the cutting sleeves 116, 216, so that the cutting sleeves 116, 216 retract and the tubes 114, 214 are positioned across the membrane. The slider 150 continues to move through its entire range of motion so that the cutting sleeves 116, 216 are fully retracted and until the pulling mechanism 106 is in tension configuration, as... Figure 39 As shown. In Figures 14-32 In the embodiment shown, the fully retracted cutting sleeve 216 will abut against the stops 242, 342, 442.

[0073] Figure 39 yes Figure 35a , Figure 36 and Figure 37 A perspective view showing that the first side housing 130 of the handle 104 includes a disassembled locking pin 108 and a pulling mechanism 106 in a tension configuration. Specifically, the slider 150 has moved fully rearward from the untensioned configuration to the tension configuration, which causes the end pin 177 of the pivot arm 154 (not in) Figure 39 As shown, but as discussed and illustrated above, the internal portion 151 directly connected to the slider 150 causes the pivot arm 154 to rotate about the pivot point or pivot point 178. This rotation of the pivot arm 154 causes the pull arm 152 at the pin 175 to pull back, and thus pull the actuating members 118, 218 and the pull block 152 to retract the distal cutting edges 119, 219 and extend the tubes 114, 214. The actuating members 118, 218 are connected to the cutting sleeves 116, 216 and retract the cutting sleeves 116, 216. It should be appreciated that the pivot arm 154 can vary in the length and position of the engagement between the pin 177 and the slider 150. For example, in the illustrated embodiment, the trigger portion 149 of the slider 150 travels approximately 1.5 times further than the distal cutting edges 119, 219. However, other ratios are also possible, including a 1:1 ratio between the slider 150 and the distal cutting blades 119, 219.

[0074] Once tubes 114 and 214 are deployed within the membrane and detached from the cutting sheaths 116 and 216, TTS 100 and 200 are removed from the ear canal and disposed of appropriately. For proper waste disposal, the entire tube deployment system 100 and 200 would be considered sharps waste if kept together. Sharps waste is a type of biomedical waste consisting of "sharp objects," including any device or object used to puncture or tear a membrane. Sharps waste is classified as biohazardous waste and must be handled with care. By separating the tube deployment system 100 and 200 into sharps waste and general waste, the amount of sharps waste can be reduced. Figures 40-42 The disassembly process of an embodiment of the handle is shown, and specifically illustrated by removing the nose-shaped part of the nose assembly from the handle to reduce the amount of sharps waste.

[0075] exist Figure 40 In this configuration, the removable assembly clip 110 is removed from the handle 104 and is no longer considered sharps waste. Figure 41In this embodiment, the handle 104 does not include the removable assembly clip 110, but includes a first side housing 130 and a second side housing 132, which are separate from the pulling mechanism 106 and the nose assembly 102. Specifically, the snap-fit ​​feature 131 on the first side housing 130 disengages from the through hole 125 on the nose member 122, and the snap-fit ​​feature 133 on the second side housing 132 disengages from the through hole 127 on the nose member 122. Additionally, the rotation point 178 on the second side housing 132 disengages from the pivot arm 154 of the pulling mechanism 106. Because the first side housing 130 and the second side housing 132 are separate from the pulling mechanism 106 and the nose assembly 102, the first side housing 130 and the second side housing 132 are no longer considered sharps waste. Figure 42 In this configuration, the pivot arm 154 is separated from the pull block 152 and the slider 150. This action detaches the pivot arm 154 and slider 150 from the pull block 152 and the nose assembly 102, and they are no longer considered sharps waste. The remaining nose assembly 102 and pull block 152 are now disposed of as sharps waste; this reduces sharps waste compared to when the tube deployment system 100 is fully assembled.

[0076] Although the elements have been shown or described above as individual embodiments, multiple portions of each embodiment may be combined with all or part of the other embodiments described above. While the subject matter has been described in language specific to structural features and / or methodological actions, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are disclosed as exemplary forms for implementing the claims.

Claims

1. A tube deployment system, comprising: A nasal assembly including a distal cutting blade and a tube, wherein the distal cutting blade is configured to be manually advanced to puncture a patient's membrane; A handle, coupled to the nose assembly and internally housing at least a portion of a pulling mechanism, the pulling mechanism having a slider and a pull block, the pull block being separate from the slider, wherein the slider has: The external portion, located outside the housing of the handle and protruding from the housing of the handle, and An internal portion, located inside the handle, wherein the internal portion of the slider has a contact surface, and wherein the pull block has a clearance surface; and An actuating member having a distal end connected to the distal cutting blade and a proximal end connected to the pull block; Wherein, when the pulling mechanism is in an unstretched configuration, the slider is in a fully forward position, such that the contact surface of the inner portion of the slider directly contacts the clearance surface of the pull block, and is configured to rigidly hold the pull block in the fully forward position; and The slider is manually operated into a tension configuration by being able to slide completely backward relative to the handle, and the slider is configured to pull the pull block and the actuating member, causing the distal cutting edge to retract to unfold the tube, wherein, in the tension configuration, the contact surface of the inner portion of the slider disengages from the clearance surface of the pull block.

2. The tube deployment system as described in claim 1, wherein, The pulling mechanism further includes a pivot arm that is separate from the slider and the pull block and is rotatable about a fixed pivot point, and is directly connected to the pull block and the slider. In the tensioned configuration, the slider causes the pivot arm to rotate about the fixed pivot point to pull the pull block and the actuating member, causing the distal cutting edge to retract to unfold the tube.

3. The tube deployment system as described in claim 1, wherein, The mechanical gain between the manually operated slider and the retraction of the distal cutting edge ranges from 1:1 to 1.5:

1.

4. The tube deployment system as described in claim 1, wherein, The outer portion of the slider includes a trigger portion configured to receive a user's thumb or a finger other than the thumb. The trigger portion includes a first peak-shaped region, a second peak-shaped region located between the proximal end of the handle and the first peak-shaped region, a valley-shaped region located between the first peak-shaped region and the second peak-shaped region, and a rear guide region located between the second peak-shaped region and the proximal end of the handle.

5. The tube deployment system as described in claim 4, wherein, The first peak-shaped region, the second peak-shaped region, and the valley-shaped region include multiple protruding features, while the rear guide region does not have the multiple protruding features.

6. The tube deployment system as claimed in claim 4, wherein, The height of the second peak region is greater than the height of the first peak region.

7. The tube deployment system as claimed in claim 6, wherein, The height of the valley-shaped region is less than the height of the first peak-shaped region and the height of the second peak-shaped region.

8. A tube deployment system, comprising: A nasal assembly comprising a nasal portion, an elongated portion, a distal cutting edge, and a tube, wherein some of the elongated portion, the distal cutting edge, and the tube are configured to be manually advanced into a patient's orifice, such that the distal cutting edge pierces the patient's membrane. A handle having a proximal end and a distal end connected to the nose assembly, wherein the handle accommodates a pull block, the pull block being connected to the slider at a contact surface of the slider and at different pin-fixed couplings; The actuating member has: The distal end, which is connected to the distal cutting edge, and The proximal end is connected to the pull block; The slider has an external portion located outside and protruding from the handle, and an internal portion located inside the handle. The internal portion of the slider is configured to hold the pull block in place at the contact surface. When the external portion of the slider is manually operated, the internal portion of the slider is configured to disengage at the contact surface, causing a pivot arm located inside the housing of the handle and connected to the pull block at a pin-fixed coupling to rotate about a fixed pivot point to pull the pull block, which is connected to the proximal end of the actuating member to retract the distal cutting blade and unfold the tube.

9. The tube deployment system as claimed in claim 8, wherein, The outer portion of the slider is configured to receive the user's thumb or a finger other than the thumb.

10. The tube deployment system as claimed in claim 9, wherein, The outer portion of the slider includes a first peak-shaped region, a second peak-shaped region located between the proximal end of the handle and the first peak-shaped region, a valley-shaped region located between the first peak-shaped region and the second peak-shaped region, and a rear guide region located between the proximal end of the handle and the second peak-shaped region.

11. The tube deployment system of claim 10, wherein, The height of the second peak region is greater than the height of the first peak region.

12. The tube deployment system of claim 11, wherein, The height of the valley-shaped region is less than the height of the first peak-shaped region and the height of the second peak-shaped region.

13. The tube deployment system of claim 8, further comprising a removable locking pin located behind the outer portion of the slider, wherein, The removable locking pin is configured to prevent the slider from moving before the nasal assembly is advanced into the patient's orifice.

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