TUBE DEPLOYING SYSTEM

A tube deploying system includes a nose assembly having a distal cutting edge and a tube. The distal cutting edge is configured to be manually advanced to pierce a membrane of a patient. A handle of the system includes a pull mechanism having a slider and a pull block and an actuation member having a distal end that couples to the distal cutting edge and a proximal end that couples to the pull block. The slider is manually operated to move the pull mechanism from a non-pulled configuration to a pulled configuration. In the pulled configuration, the pull block pulls the actuation member such that the distal cutting edge is retracted to deploy the tube.

SUMMARY

A tube deploying system includes a nose assembly having a distal cutting edge and a tube. The distal cutting edge is configured to be manually advanced to pierce a membrane of a patient. A handle of the system includes a pull mechanism having a slider and a pull block and an actuation member. The actuation member has a distal end that couples to the distal cutting edge and a proximal end that couples to the pull block. The slider is manually operated to move the pull mechanism from a non-pulled configuration to a pulled configuration. In the pulled configuration, the pull block pulls the actuation member such that the distal cutting edge is retracted to deploy the tube.

A pull mechanism on a tube deploying system includes a slider having a trigger portion that is manually operated to move the pull mechanism from a non-pulled configuration to a pulled configuration. The trigger portion of the slider includes a first peaked zone, a second peaked zone that has a height that is greater than a height of the first peaked zone and a valleyed zone located between the first peaked zone and the second peaked zone. The valleyed zone has a height that is less than the height of the first peaked zone and the height of the second peaked zone. The trigger portion further includes a rear guide zone located behind the second peaked zone. The first peaked zone, the second peaked zone and the valleyed zone include a plurality of raised features and the rear guide zone is free of the plurality of raised features.

A method of deploying a tube in a membrane includes providing a nose assembly that includes a nose portion, an elongated portion, a distal cutting edge and a tube. At least some of the elongated portion, the distal cutting edge and the tube are manually advanced in an orifice of a patient, a membrane of the patient is pierced with the distal cutting edge and a trigger portion on a slider of a pull mechanism is manually moved to pull an actuation member having a distal end coupled to the distal cutting edge to retract the distal cutting edge and to deploy the tube. The slider is configured to rotate a pivot arm about a fixed pivot point. The pivot arm is coupled to a pull block that is connected to a proximal end of the actuation member.

DETAILED DESCRIPTION

The tube deploying systems described herein combine the steps of making an incision in a membrane, such as a myringotomy in a tympanic membrane or eardrum, positioning a tube (e.g., ventilation tube such as a pressure equalization (PE) tube or tympanostomy tube that may have a variety of different geometries including cylindrical, rectangular or other types of cross sections) and placing or inserting the tube in a patient's membrane in a single system. In the embodiments described, each tube deploying system includes a nose assembly connected to a handle and a pull mechanism that both protrudes from the handle and is housed in the handle. Backlash is clearance or lost motion in a mechanical system caused by gaps between the parts. In other words, backlash is the maximum distance or angle that any part in the mechanical system may move in one direction without applying any sort of appreciable force onto the next or sequential part in the mechanical system. The tube deploying system described below includes an overall mechanical design that minimizes backlash. Because a clinician often blindly grasps the described tube deploying systems to use, the haptics of the described tube deploying systems, both in the mechanisms and on their surfaces, are important for user functionality.

FIG. 1is a front perspective view of a tube deploying system100having a cutting sheath slot115that faces in a first direction according to an embodiment.FIG. 2is back perspective view of tube deploying system100but with a cutting sheath slot115facing in an opposing second direction according to an embodiment.FIG. 3is a right side view ofFIG. 1,FIG. 4is a left side view ofFIG. 1,FIG. 5is a front view ofFIG. 1,FIG. 6is a back view ofFIG. 1,FIG. 7is a top view ofFIG. 1,FIG. 8is a bottom view ofFIG. 1andFIG. 9is an exploded view ofFIG. 1. Tube deploying system100includes a nose assembly102coupled to a handle104and a pull mechanism106that partially protrudes from handle104as well as is partially housed within the interior of handle104.

FIG. 10is front perspective view,FIG. 11is a back perspective view andFIG. 12is a back view of nose assembly102. Nose assembly102includes a nose portion122, an elongated portion120extending from nose portion122and a sheath assembly112. In this embodiment, elongated portion120is a hollow positioning rod and sheath assembly112includes a hollow cutting sheath116having a distal cutting edge119. In the illustrated embodiment, distal cutting edge119includes a beveled cutting edge. Portions of the hollow cutting sheath116surround a distal end126(FIG. 13) of elongated portion120. Hollow cutting sheath116also at least partially houses a tube114configured to be placed in or deployed across a membrane of a patient.

FIG. 13is a section view taken through the section line indicated inFIG. 12. In the embodiments illustrated inFIGS. 1-13, nose portion122is overmolded at or nearer to a proximal end124(FIGS. 11, 12 and 13) of positioning rod120. Positioning rod120includes a slot128(FIG. 9) that extends from distal end126of positioning rod120to a terminating end129of slot128. Terminating end129is located between distal end126of positioning rod120and proximal end124, which is overmolded by nose122.

An actuation member118(FIGS. 9 and 13) having a distal end132(FIG. 13) is coupled to cutting sheath116, extends internally within cutting sheath116, extends through slot128in positioning rod120and extends internal to and along positioning rod120into nose portion122. Tube114is at least partially surrounded by cutting sheath116while a portion of tube114protrudes through slot115in cutting sheath116. The portion of tube114that protrudes through slot115provides a visualization tab to the clinician placing the tube in a membrane of a patient.

As illustrated inFIG. 9, handle104includes a first side housing130and a second side housing132. Each of first side housing130and second side housing132includes an area135(FIGS. 2, 3, 9) and an area137(FIGS. 1 and 4), respectively, of molded texture. This molded texture is different from other surfaces of first and second side housings130and132to enable haptic differentiation. The molded texture of areas135and137may be in the shape of undercuts and scoops to provide haptic feedback for correct finger positioning. The molded texture may also provide points of resistance to prevent system100from sliding forward or backward in the clinician's hand during use. Together, first side housing130and second side housing132couple together to internally house at least a portion of pull mechanism106. In one embodiment, handle104is connected to nose portion122with snap-on members131and133(FIG. 9). Snap-on members131and133prevent relative left to right and right to left twisting. An interlock element139(FIGS. 9-13) reduces the chance of the nose twisting up when a downward force to make an incision is applied by the clinician. Snap-on members131and133and interlock element139combine to form a multipoint stable attachment between nose assembly102and handle104. It should be realized that snap-on members131and133could be interlock elements and interlock element139could be a snap-on member. In addition, handle104is configured to receive removable locking pin108and removable assembly clip110. Removable assembly clip110allows for the assembly of first and second side housings130and132as well as the disassembly of first and second side housings130and132. Pull mechanism106, removable locking pin108and removable assembly clip110will be discussed in more detail below.

FIG. 14is a front perspective view of tube deploying system200having a cutting sheath slot that faces in a first direction according to an embodiment.FIG. 15is a back perspective view of tube deploying system200but with a cutting sheath slot215facing in a second direction that opposes the first direction according to an embodiment.FIG. 16is a right side view,FIG. 17is a left side view,FIG. 18is a front view,FIG. 19is a back view,FIG. 20is a top view,FIG. 21is a bottom view andFIG. 22is an exploded view of tube deploying system200. System200includes a nose assembly202coupled to the a handle204Pull mechanism206of system200partially protrudes from handle204and is at least partially housed within the interior of handle204. Handle204is connected to nose assembly202with snap-on members231and233(FIG. 22). Snap-on members231and233prevent relative left to right and right to left twisting. Interlock element239(FIGS. 22-27) reduces the chance of the nose twisting up when a downward force to make an incision is applied by the clinician. Snap-on members231and233and interlock element239combine to form a multipoint stable attachment between nose assembly202and handle204. It should be realized that snap-on members231and233could be interlock elements and interlock element239could be a snap-on member. Handle204of system200, like handle104of system100, may be configured to receive a removable locking pin (not shown) and removable assembly clip210. Removable assembly clip210allows for the assembly of first and second side housings230and232of handle204as well as the disassembly of first and second side housings230and232. In one embodiment, clip210may be an elastomeric material that expands to be placed over the proximal end of first and second side housings230and232and contracts to hold first and second side housings230and232together. However, clip210may be a resilient removable clip, or system200may not include a clip and alternatively include a feature that allows first and second side housings230and232to be pushed together. Pull mechanism206, as previously mentioned, will be discussed in more detail below.

FIG. 23is a front perspective view of nose assembly202.FIG. 24is a front perspective view of a nose222of nose assembly202.FIG. 25is a back perspective view andFIG. 26is a back view of nose assembly202.FIG. 27is a section view taken through the section line inFIG. 26. Nose assembly202includes a nose222and a sheath assembly212. Nose222has an elongated portion234(FIG. 24) and a nose portion236(FIG. 24). Elongated portion234extends distally from nose portion236. Sheath assembly212includes a hollow cutting sheath216and a tube214at least partially surrounded by hollow cutting sheath216and configured to be placed in or deployed across a membrane of a patient.

In the embodiments illustrated inFIGS. 14-27, elongated portion234and nose portion236of nose222are made of a single molded part and hollow cutting sheath216surrounds a distal end226of elongated portion234as well as surrounds a section of elongated portion234of nose222. Elongated portion234includes two different widths. A first section238of elongated portion234includes a first width that extends from distal end226to a travel stop242. First section238provides a zone for the travel of cutting sheath216. A second section240of elongated portion234includes a second width that extends from travel stop242to where elongated portion234ends. In another embodiment, second width of portion234may be a variable width. For example, a width that gets larger towards the proximal end to add strength. The change in width from the first width in first section238to the second width in second section240provides the stop for hollow cutting sheath216. Second section240provides a zone where an external wrap, such as shrink tubing, can be applied. Travel stop242will be described in more detail upon discussion of the operation of tube deploying system200. In the molded embodiments illustrated inFIGS. 14-22, nose222includes a channel244that extends from distal end226of elongated portion234to the back of nose portion236. The portion of channel244that extends in elongated portion234is an open channel, slot or groove that acts as a guide for an actuation member218. Channel244extends to distal end226of elongated portion234to allow for clearance of a weld joint, such as a butt joint, between141b

218and cutting sheath216. The portion of channel244that extends in nose portion236is an enclosed channel or passage having an outlet245(FIGS. 25-27). Actuation member218includes a distal end232(FIG. 27) that couples to a proximal end246(FIG. 27) of cutting sheath216, extends in and through the portion of channel244that is the open channel or slot in elongated portion234of nose222and continues in the portion of channel244that is the enclosed channel in nose portion236of nose222. In one embodiment of system200, channel244allows actuation member218to be a rectangular or flat wire (as opposed to a round wire, like the round wire actuation member118of system100) so as to maximize wire cross section while minimizing the amount of cross section of nose222that must be removed to create the passageway for actuation member218, which allows nose222to retain structural integrity. In another embodiment, it is possible that channel244is only deep enough to act as a guide and a portion of actuation member244extends above or outside of channel244. Tube214is at least partially surrounded by cutting sheath216while a portion of tube214protrudes through a slot215in cutting sheath216. The portion of tube214that protrudes through slot215(FIGS. 15 and 17) provides a visualization landmark to the clinician placing the tube in or deploying the tube across the membrane of a patient. External wrap248, such as shrink wrap or similar, is wrapped around elongated portion234of nose222in second section240to retain actuation member218in the open groove of channel244at all times including when actuation member218is actuated, which will be discussed in detail below.

FIG. 28is a front perspective view of a nose322according to another embodiment of a nose assembly. Nose322is made of a single molded part and includes an elongated portion334and a nose portion336. Nose322may be substituted for nose222in nose assembly202. Elongated portion334extends distally from nose portion336. Hollow cutting sheath216may be configured to surround a distal end326of elongated portion334as well as is configured to surround a section of elongated portion334as was discussed in the figures related to nose222. Elongated portion334includes three different widths. A first section338of elongated portion334includes a first width that extends from distal end326to a travel stop342. A second section339of elongated portion334includes a second width that extends from travel stop342to a third section340. Third section340includes a third width and extends from second section339to where elongated portion334ends and nose portion336begins. The change in width from the first width in first section338to the second width in second section339provides travel stop342for a hollow cutting sheath. The change in width from the third width in third section340to the second width in second section339provides a notch for external wrap248placement. Such a notch keeps external wrap248from adding too much thickness in elongated portion334that might block line of sight to tube214during placement and deployment.

Nose322includes a channel344that extends from distal end326to the back of nose portion336. The portion of channel344that extends in elongated portion334is an open channel or slot. The portion of channel344that extends in nose portion336is an enclosed channel. Channel344is configured to house and hold an actuation member, such as actuation member218that is connected to or butt welded to cutting sheath216.

FIG. 29is a right front perspective view,FIG. 30is a left front perspective view andFIG. 31is a back view of a nose422according to yet another embodiment of a nose assembly.FIG. 32is a section view taken through the line indicated inFIG. 31. Nose422is made of a single molded part and includes an elongated portion434and a nose portion436. Nose422may be substituted for nose222in nose assembly202. Elongated portion434extends distally from nose portion436. Hollow cutting sheath216may be configured to surround a distal end426of elongated portion434as well as configured to surround a section of elongated portion434of nose422as was discussed in the figures related to nose222. Elongated portion434includes a first section438that extends from distal end426to a travel stop442. A second section440extends from travel stop442to where elongated portion434ends and nose portion436begins.

Nose422includes a channel444that extends from distal end426to the back of nose portion436. The portion of channel444that extends in first section438of elongated portion434is a straight open channel or slot. At second section440, channel444includes a side pass through into the open channel or slot of first section438. This arrangement supports an actuation member, such as actuation member218, in channel444without requiring any additional element to constrain the actuation member to the channel, such as external wrap248. The portion of channel444that extends in nose portion436is an enclosed channel. As previously described in other embodiments, channel444is configured to house and hold an actuation member, such as actuation member218, which is connected to or butt welded to cutting sheath216.

FIG. 33illustrates a first user grip position on a handle of a tube deploying system. AlthoughFIG. 33illustrates tube deploying system100shown inFIGS. 1-9, it should be realized that other tube deploying system embodiments are capable of being held with the first user grip position because each described system includes a handle104and pull mechanism106. The first user grip position is a “pencil grip.” As illustrated handle104is cradled in a user's hand like how one would cradle a pencil. The forward section of handle104is held between the user's thumb and middle finger, while the user's index finger engages with pull mechanism106. The index finger will be the finger that will activate pull mechanism106.

FIG. 34illustrates a second user grip position on a handle of a tube deploying system. AlthoughFIG. 34illustrates tube deploying system100shown inFIGS. 1-9, it should be realized that other tube deploying system embodiments are capable being held with the second user grip position because each described tube deploying system includes a handle104and pull mechanism106. The second user grip position is a “backhand pencil grip” (or “chopstick grip”). As illustrated, handle104is cradled in a user's hand like how one would cradle a chopstick. The forward section of handle104rests between the user's index finger and the user's middle finger, while the user's thumb engages with pull mechanism106. The thumb will be the finger that will activate pull mechanism106.

FIGS. 35ais a perspective view of second side housing132of handle104with pull mechanism106in a non-pulled configuration and coupled to actuation member118,218.FIG. 35bis an alternative embodiment ofFIG. 35a.FIG. 36is an enlarged view of a portion ofFIG. 35aandFIG. 37is a perspective view of first side housing130of handle104with pull mechanism106in a non-pulled configuration and coupled to actuation member118,218. As previously mentioned, handle104, including pull mechanism106, can be used with any of the embodiments of nose assemblies. Therefore, the illustrated actuation member can be of any of the described embodiments of nose assemblies. InFIGS. 35a, 35b,36and37, pull mechanism106includes a slider150and a pull block152. InFIGS. 35a,36and37slider150and pull block152are separate components along with a separate pivot arm154. InFIG. 35b, however, slider150and pull block152are integral and therefore there is no need for pivot arm154. Slider150includes an exterior or trigger portion149(FIG. 36) that is located outside of and protrudes from first and second side housings when coupled together. Trigger or exterior portion149is manually operated to move pull mechanism106from a non-pulled configuration to a pulled configuration. Trigger or exterior portion149is zoned to allow a user to tactically position their finger or thumb into locations for manual operation of pull mechanism106. In other words, trigger149is zoned to receive a user's finger or thumb for manual operation. The different zones provide haptic feedback to a user on where their finger or thumb is located and also provide multiple potential finger locations per user preference. Slider150also includes an interior portion151. Interior portion151protrudes into the interior of coupled first and second side housings130and132to provide structure for interfacing with pull block152and pivot arm154in theFIGS. 35a,36and37embodiment or for integrating with pull block152in theFIG. 35bembodiment.

Exterior or trigger portion149of slider150includes a first peaked zone or region156, a second peaked zone or region160, a valleyed zone or region158between first peaked zone156and second peaked zone160and a guide zone or region162located behind or to the rear of second peaked zone160. Under one embodiment, second peaked zone160includes a height above housings130and132that is greater than a height of first peaked zone156. Whereas, valleyed zone158includes a height above housings130and132that is less than the heights of first peaked zone156and second peaked zone160. First peaked zone156, valleyed zone158and second peaked zone160include a plurality of raised features or ribs, while rear guide zone or region162is free of ribs and includes a smooth, backward sloping surface. The plurality of raised features provide finger or thumb locations and the smooth, backward sloping surface of rear guide zone162allows a user to slide their finger or thumb along the smooth, backward sloping surface to reach the plurality of raised features for finger or thumb position locations. First peaked zone156includes a rib164. Valleyed zone158includes ribs166a, b, c, dande.Second peaked zone160includes rib168. Under one user fingering positioning, a distal phalanx portion of a user's index finger rests in valleyed zone158with the distal tip of the index finger being located behind rib164as is illustrated inFIG. 33. Under another user fingering position, the distal tip of the user's index finger engages with rib164of first peaked zone156. Under yet another user fingering position, a distal phalanx portion of the user's thumb rests in valleyed zone158with the side of the distal phalanx portion located at or behind rib164of first peaked zone as is illustrated inFIG. 34. The multitude and variety of ribs and zones of trigger portion149of slider150provides multiple variations of user fingering positions for manual operation of pull mechanism106. First peaked zone156, valleyed zone158, or second peaked zone160may all serve as contact areas for an actuating thumb or finger, which maximizes the target size for locating trigger portion149and accounting for differences in hand size and grip styles.

Pull block152includes an actuation member pathway170and an anchoring well172. As illustrated inFIGS. 35a-band37, actuation member118,218transitions from nose assembly102,202into housing104by exiting channel144,244at back of nose122,222. Handle104includes interior structures to support actuation member118,218between where actuation member118,218exits channel144,244and where actuation member118,218is secured to pull block152. Actuation member118,218follows and is placed in pathway170and the proximal end of actuation member118,218is coupled to or secured to pull block152in anchoring well172with, for example, an adhesive. In other embodiments, anchoring well may be a shaped well for retaining a pin to pinch the actuation member118,218between the retaining pin and pull block152and bind actuation member118,218and pull block152together. In other embodiments, anchoring well172may hold actuation member118,218in a retention configuration. The interior of first side housing130and the interior of second side housing132, for example, each include a wire guide141aand141b,respectively, that when fitted together prevents actuation member118,218from buckling between channel144,244and pull block152when compressive force is applied to actuation member118,218, for example, when cutting sheath116,216is used to pierce the membrane.

InFIGS. 35a,36and37, pull block152also includes a pull arm174that protrudes backwardly and has a pin175at the end of the pull arm174. Pivot arm154includes a slot176that mates with pin175of pull arm174and an end pin177that engages with the interior portion151of slider150. Pivot arm154is rotatably coupled to a fixed swivel or pivot point178. The structure that provides swivel or pivot point178may be formed as part of either first or second side housings130or132of handle104or if a pin on pivot arm154and a deboss in the housing is used, it could be formed from both first and second side housings130and132and a pivot arm pin. InFIGS. 35a,36and37, interior portion151of slider150includes a contact surface180that rigidly holds pull block152in place when in a full forward position or as illustrated inFIGS. 35a,36and37, in a non-pulled configuration. In the non-pulled configuration, contact surface180is in direct contact with a backlash surface181of pull block152. This full forward position or non-pulled configuration is further enforced by removable locking pin108being in place behind trigger portion149of slider150. Removable locking pin108prevents pre-deployment of slider150during shipping or by a user. Overall, the full forward, non-pulled configuration where contact surface180of slider150rigidly holds pull block152in place and removes backlash during incision of the membrane. During incision, slider150is to be in a non-pulled configuration.

To operate the tube deploying system discussed above, tube deploying system100,200is carefully removed from its packaging. Removable locking pin108prevents accidental movement of slider150so that tube deploying system100,200may be inspected to make sure tube deploying system100,200is not damaged. In addition, it is verified that tube114,214is properly loaded within cutting sheath116,216and that the portion of tube114,214that protrudes through slot115,215in cutting sheath116,216is visible. When ready to use, removable locking pin108is removed as illustrated inFIG. 38.

The clinician or user grips handle104with one hand by tactile positioning of their fingers and/or thumb on slider150without moving slider150so as to be ready for deployment of tube114,214from TTS100,200. As described above, the clinician may hold tube deploying system100,200with the “pencil grip” as illustrated inFIG. 33, the “chopstick grip” as illustrated inFIG. 34or other variations of these grips where the clinician is able to stabilize the operating hand holding tube deploying system100,200to an ear speculum or to the patient. The clinician or user may use other parts of tube deploying system100,200to grip or to stabilize. For example, nose122,222includes a wing feature123(FIGS. 10-13),223(FIGS. 23-27). Wing feature123,223is a rib that is formed continuously around the sides and top of nose122and allows the clinician or user to push forward with their fingers on nose assembly102,202without slipping down nose122,222.

Under visualization, for example through an operating microscope or endoscope, the clinician or user manually advances or inserts nose assembly102,202down the ear canal such that distal cutting edge119,219of cutting sheath116,216pierces and incises the membrane. The clinician or user advances nose assembly102,202until medial flange of tube114,214is through the membrane and the portion of tube114,214that protrudes through slot115,215in cutting sheath116,216is visible lateral to the membrane or marker band117,217on cutting sheath116,216is located proximal to the membrane. In one embodiment, marker band117,217is a laser mark. A laser marker adds no width to cutting sheath116,216and therefore functions only as a visual aid. In another embodiment, marker band117,217is a printed mark. A printed marker may be made colored and therefore functions to enhance visualization. In yet another embodiment, marker band117,217may be an adhesive element or added metal element. Such an additive adds width to cutting sheath116,216and therefore functions as both a visual aid, a mechanical feature to provide haptic feedback, or a mechanical stop. The length of marker band117along cutting sheath116,216may vary depending on the tube to be deployed.

The clinician or user then moves slider150located on handle104backwards away from the cutting edge119,219of cutting sheath116,216to retract cutting sheath116,216and leave tube114,214positioned across the membrane. Slider150is continued to be moved through its full range of motion to fully retract cutting sheath116,216and until pull mechanism106is located in a pulled configuration as illustrated inFIG. 39. In the embodiments illustrated inFIGS. 14-32, a fully retracted cutting sheath216will butt up against stop242,342,442.

FIG. 39is a perspective view of theFIGS. 35a,36and37embodiment with first side housing130of handle104including locking pin108exploded and pull mechanism106in a pulled configuration. In particular, slider150is moved fully backwards from the non-pulled configuration to the pulled configuration, which causes end pin177(not illustrated inFIG. 39, but as previously discussed and illustrated, is directly coupled to interior portion151of slider150) of pivot arm154to rotate pivot arm154about swivel or pivot point178. This rotation of pivot arm154causes pull arm152at pin175to pull backwards and therefore pull actuation member118,218along with pull block152to retract distal cutting edge119,219and deploy tube114,214. Actuation member118,218is coupled to cutting sheath116,216and retracts cutting sheath116,216. It should be realized that there may be variations in pivot arm154in terms of length and location of where pin177interfaces with slider150. For example, in the illustrated embodiment, trigger149of slider150travels approximately 1.5 times further than distal cutting edge119,219. However, other ratios are possible including a 1:1 ratio between slider150and distal cutting edge119,219.

Once tube114,214is deployed in the membrane and free of cutting sheath116,216, TTS100,200is removed from the ear canal and disposed of appropriately. To facilitate proper waste disposal, the entirety of tube deploying system100,200would be considered to be sharps waste if all kept together. Sharps waste is a form of biomedical waste that is composed of “sharps,” which includes any device or object used to puncture or lacerate a membrane. Sharps waste is classified as biohazardous waste and must be carefully handled. By breaking tube deploying system100,200down into sharps waste and normal waste, the quantity of sharps waste can be reduced.FIGS. 40-42illustrate a process of disassembling embodiments of a handle and specifically exemplifying the disassembly of a nose of a nose assembly from the handle so as to reduce the amount of sharps waste.

InFIG. 40, removable assembly clip110is removed from handle104and is no longer considered to be sharps waste. InFIG. 41, the embodiment of handle104does not include removable assembly clip110, but does include first side housing130and second side housing132, which are separated from pull mechanism106and nose assembly102. In particular, snap-on feature131on first side housing130is freed from through hole125on nose122and snap-on feature133on second side housing132is freed from through hole127on nose122. In addition, swivel point178on second side housing132is freed from pivot arm154of pull mechanism106. Because first side housing130and second side housing132are separated from pull mechanism106and nose assembly102, first side housing130and second side housing132are no longer considered to be sharps waste. InFIG. 42, pivot arm154is separated from pull block152and slider150. With this action, pivot arm154and slider150are free from pull block152and nose assembly102and no longer considered to be sharps waste. The remaining nose assembly102and pull block152are now disposed of in sharps waste, which is a reduction in sharps waste compared to when tube deploying system100was entirely assembled.

Although elements have been shown or described as separate embodiments above, portions of each embodiment may be combined with all or part of other embodiments described above. Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.