Source: https://patents.google.com/patent/EP3190983A1/en
Timestamp: 2019-08-25 22:42:32
Document Index: 354228494

Matched Legal Cases: ['art 7', 'art 7', 'art 3', 'art 701', 'art 220', 'art 701', 'art 701', 'art 701', 'art 701', 'art 701', 'art 701', 'art 701', 'art 701', 'art 98', 'arts 94', 'art) 1334', 'art 1315', 'art 1315']

EP3190983A1 - A tongue advancer assembly for a tongue manipulation system - Google Patents
EP3190983A1
EP3190983A1 EP15770646.6A EP15770646A EP3190983A1 EP 3190983 A1 EP3190983 A1 EP 3190983A1 EP 15770646 A EP15770646 A EP 15770646A EP 3190983 A1 EP3190983 A1 EP 3190983A1
tongue advancer
EP15770646.6A
2014-08-21 Priority to US201462040106P priority Critical
2015-08-10 Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
2015-08-10 Priority to PCT/IB2015/056061 priority patent/WO2016027197A1/en
2017-07-19 Publication of EP3190983A1 publication Critical patent/EP3190983A1/en
210000000988 Bone and Bones Anatomy 0 Description 69
210000004373 Mandible Anatomy 0 Description 15
A tongue advancer assembly (305) for a tongue manipulation system, the tongue advancer assembly (305) comprising: a core mount (703) comprising a connection rod coupling configured to couple the tongue advancer assembly to a distal end of a connection rod (303); and a tongue advancer (701)configured to be coupled to the core mount (703).
(iii) a tether line which fixes the tongue advancer to the bone anchor. The bone anchor may feature a spool, enabling the surgeon to spool the tether into the bone anchor. This process is called adjustment and stabilizes the tongue as well as advances the tongue in the direction of the mandible (or prevents the tongue moving back), preventing blocking of the airway.
The pin may be configured to be welded to the core mount and form fit to the tongue advancer. In such embodiments the pin can be manufactured from the core mount material to enable a good weld. The pin may be configured to be welded to the tongue advancer and form fit to the core mount. In such embodiments the pin can be manufactured from the tongue advancer material to enable a good weld.
Fixing the core mount with the tongue advancer by a pin may comprise:
welding the pin to the core mount and form fitting the pin to the tongue advancer.
welding the pin to the tongue advancer and form fitting the pin to the core mount.
Figure 1 shows schematically an example trocar tool with implant cannula with respect to some embodiments;
Figure 2 shows schematically an implant tool with respect to some embodiments; Figures 3a-3c shows schematically cross-section or cutaway views of an implant tool with respect to some embodiments;
Figure 4 shows schematically an implant/removal assembly with respect to some embodiments;
Figures 5a-5b show schematically details of the connection rod part of the implant/removal assembly shown in Figure 4 with respect to some embodiments;
Figures 6a-6b show schematically connection rod screw coupling with the tongue advancer examples according to some embodiments;
Figures 7a-7d show schematically connection rod clamp coupling with the tongue advancer examples according to some embodiments;
Figure 8 shows an example tongue advancer according to some embodiments;
Figure 9 shows an example tongue advancer coupling to a tongue advancer tether according to some embodiments;
Figures 10a- 10b show further example tongue advancer to tongue advancer tether couplings according to some embodiments;
Figures 1 la- 1 lb show further example tongue advancer to tongue advancer tether knotted couplings according to some embodiments;
Figures 12a- 12b show an example implant assembly inserted into the implant tool according to some embodiments;
Figures 13a-13e show example adjustment tools according to some
Figure 14 shows an example connection tool according to some embodiments; Figure 15 shows a detail of a connection tool according to some embodiments; Figure 16 shows a detail of a blunt dissector end according to some embodiments;
Figure 17 show an example removal tool according to some embodiments;
Figure 18 shows a flow diagram of an example implant stage according to some embodiments;
Figure 19 shows a flow diagram of an example adjustment stage according to some embodiments; and
Figure 20 shows a flow diagram of an example removal stage according to some embodiments. DETAILED DESCRIPTION OF THE EMBODIMENTS
The concepts as described herein relate to tools specifically for the implantation and removal of the tongue advancer of the tongue manipulation devices.
Specifically the concepts as described herein relate to a connection rod or tube suitable for coupling at a first end to the tongue advancer and at the opposite end to a suitably designed implantation or removal tool.
Implantation: In the implantation stage, the bone anchor, tongue advancer and tether are installed by minimally invasive surgery. The system is not 'loaded' or stressed at implantation to enable the healing process.
Furthermore in order to simplify the understanding of the concepts described herein the operations or steps with respect to the implantation, adjustment and removal stages are described where possible in such a manner that tools are described or introduced in a sequential manner. It would be understood that in some embodiments of performing the operations or steps of each stage that it may be more logical to prepare all of the relevant tools or equipment prior to making a first incision (for example to reduce the time that the patient is under anaesthetic or is 'open') and as such the steps or operations as described herein are example step sequences only. The implantation stage, in order to install the tongue advancer and the bone anchor, utilize the trocar tool 1 and the implant cannula 3 such as shown in Figure 1, the implant tool 101 such as shown in Figure 2, the implant assembly 301 such as shown in Figure 4, the bone anchor, and the adjustment tool such as shown in Figure 13.
The operation of preparing the patient is shown in Figure 18 by step 1701.
With respect to Figure 1 an example trocar tool and implant cannula 3 is shown. The example trocar tool as shown in Figure 1 comprises a trocar 1 which in itself comprises a handle part 7 suitable for allowing the operator of the tool to grip the tool firmly and accurately. The trocar 1 furthermore comprises a trocar blade portion with a trocar tip 5 suitable for piercing and cutting a channel within soft tissue. The trocar blade portion and trocar tip 5 can be any suitable material such as surgical steel. The trocar 1 further comprises a coupling and/or latching section suitable for receiving an implant cannula 3. This can for example be an axis-symmetrical or axis-directional slot within the distal end of the trocar handle part 7. Furthermore the latching section can for example be implemented by an internal latching mechanism such as a lever with a profiled end configured to fit an associated profile on an implant cannula horn 11 when inserted into the trocar 1.
The implant cannula 3 as shown in Figure 1 comprises an implant cannula tube 13 and an implant cannula horn 11. The implant cannula tube 13 is a hollow tube which can be placed over the trocar blade portion and tip 5. The implant cannula tube 13 can be any suitable material, for example surgical steel, and is configured to provide a suitable stable channel within which the implantation of the implant can be performed.
The operation of coupling or connecting the cannula to the trocar tool is shown in Figure 18 by step 1703.
The operation of introducing the trocar in the incision is shown in Figure 18 by step 1705.
The operation of orientating the trocar to the desired tongue advancer implant location is shown in Figure 18 by step 1707.
The operation of moving the hand to the dorsal surface of the tongue is shown in Figure 18 by step 1709. The operator can then in some embodiments advance of the trocar towards the base of the tongue aiming at the overlap of the horizontal and vertical parts of the tongue. In some embodiments the overlap of the horizontal and vertical parts of the tongue can be determined by palpation of the tongue surface with the hand in the mouth.
The operation of advancing the trocar to the base of the tongue is shown in Figure 18 by step 1711.
The operation of advancing the trocar to the proximity of the surface of the tongue is shown in Figure 18 by step 1713.
The operation of separating and removing the cannula part 3 from the trocar tool 1 is shown in Figure 18 by step 1713.
With respect to Figure 2 an example implant (or implantation) tool 101 is shown. The implant tool 101 as shown in Figure 2 comprises a body 113 incorporating a handle part. The body 113 can be manufactured or formed from any suitable material, for example from an injection moulded plastic. The body 113 can in some embodiments have other components mounted from it. For example as shown in Figure 2 the body 113 is coupled or connected via an internal pivot point to a retraction lever 111. The retraction lever 111 in some embodiments as shown in Figure 2 is configured to be operable by the use of at least one finger when the operator of the tool is holding the implant tool and can be formed from a moulded plastic part. The body 113 can in some embodiments be further coupled to a safety lever or cover 107 which is pivoted at a second pivot point within the body 113 and is configured to cover or prevent the accidental pressing of a release mechanism in the example of a release button or trigger lever 109. The body 113 can in some embodiments be further coupled or connected to an implant assembly release mechanism in the form of a release button or trigger 109.
The body 113 can in some embodiments further comprise a coupling and/or latching section suitable for receiving the implant cannula 3. This can for example be an axis- symmetrical or axis-directional slot within the distal end of the implantation handle 113. Furthermore the latching section can for example be implemented by an internal latching mechanism such as a lever with a profiled end configured to fit an associated profile on an implant cannula horn 11 when inserted onto the implant tool body 113. The body 113 can in some embodiments comprise a release or cannula release button 105 or suitable latching release mechanism suitable for allowing the decoupling or disconnection between the implant tool 101 and the implant cannula 3.
The body 1 13 in some embodiments further is coupled to a loading tube 103. The loading tool 103 is a hollow tube which projects at least partially out of the implant tool 101 and is configured to fit inside of the implant cannula when the implant cannula 3 is attached to the body of the implant tool 101.
With respect to Figures 3a to 3c cross-sectional views of example implant tool 101 embodiments are shown. With respect to Figure 3a a first cross-sectional or cut away view of the implant tool 101 is shown. In the example cross sectional views the internal latching mechanism, release or cannula release button 105 or suitable latching release mechanism and safety lever or cover 107 are not shown in these examples to assist the understanding of the mechanism as described herein and operated by the release mechanism and the implant tool retraction mechanism.
The implant tool cross-section shows the loading tube 103 which extends internally within the body 113 and can be configured to act as a guide with respect to an implant assembly as it is pushed/pulled into the implant tool. The cross sectional view of the implant tool 101 furthermore shows the release mechanism comprising the trigger lever 109, which is pivoted at the trigger pivot point 205, and the retraction lever mechanism
comprising the retraction lever 111 and the retraction lever pivot point 203.
With respect to Figure 3b a detail of the cross-sectional view of the implant tool as shown in the Figure 3a is shown. The detail shows a loading mechanism comprising a first hook 215 coupled to the retraction lever mechanism and a second hook 217 which are both mounted such that they can pivot about respective points and hook or trap a ratchet groove feature on the implant assembly such that the implant assembly can move in one direction, an inwards direction, but is trapped and prevented from moving in an outwards direction. The loading mechanism in some embodiments therefore operates as a locking mechanism configured in a normal mode to permit the loading of an implant assembly in a direction inwards relative to the tool only. It would be understood that the term hook as used herein can define any suitable surface or profile enabling a hooking, gripping or catching of the implant assembly (or removal assembly).
Furthermore as shown in Figure 3b the release mechanism comprising the trigger lever 109, which is pivoted at the trigger pivot point 205 is coupled to a mechanism 219 which affects or disengages the first hook 215 and the second hook 217 from the ratchet groove feature on the implant assembly. Furthermore the cross-sectional view of the implant tool body 113 shows an implant load spring 201 or propulsion element. The implant tool 101 is configured to receive the implant assembly and as the implant assembly is loaded
(pulled/pushed) into the tool body to generate a suitable propulsive force (expulsive potential force). Although the following examples show a load spring it would be understood that in some embodiments any suitable propulsion element can be employed. Furthermore the propulsion element can in some embodiments be configured to be charged during the loading of the implant or removal assembly or charged at some point prior to the propelling of the implant or removal assembly. It would be understood that the release mechanism in some embodiments can indirectly enable the propulsion element to propel the implant or removal assembly from the implant or removal tool. The release button or mechanism can, for example, in some embodiments be configured to disable the normal mode of operation of the locking mechanism to permit the propulsion element to propel the implant assembly from the implant tool. However in some embodiments the release mechanism can be configured to directly enable the propulsion element to propel the implant or removal assembly from the implant or removal tool. For example in some embodiments the propulsion element can be latched or locked on being charged up and the release mechanism is then configured to unlock or unlatch the propulsion element directly.
With respect to Figure 3c a detail cross-sectional view of a further embodiment implant tool. In this example the first hook 215 as shown in Figures 3a and 3b is replaced by a latching mechanism 225. The latching mechanism 225 is configured to operate in a similar manner to the first hook as it co-operates with the second hook as part of a locking mechanism but is also configured to operate on the second hook as part of the release mechanism to unlatch the implant assembly as the release button is pressed. The release mechanism in some embodiments is configured to disable the loading mechanism to permit the propulsion element to propel the implant assembly from the implant tool (or in some embodiments the removal assembly from the removal tool).
Although with respect to Figures 3a to 3c a latching or locking mechanism is shown employing hooks, it would be understood that any other suitable implementation of a loading mechanism, or a locking mechanism as part of a loading mechanism can be employed to enable the loading of an implant or removal assembly. Furthermore the loading mechanism can in some embodiments operate with respect to the connection rod and form a suitable locking or ratchet mechanism permitting in a first, normal or loading mode the connection rod (or the implant or removal assembly as discussed herein) to be loaded into the implant tool. For example in some embodiments the insertion tool comprises a suitable gearwheel to operate on the connection rod. As a further example in some embodiments the insertion tool comprises a suitable clutch mechanism and uses friction to couple to the connection rod (which has an associated friction surface formed by suitable means). In other words although the examples shown in Figures 3a, 3b, and 3c describe a hook based loading mechanism further configured to perform as a locking mechanism any suitable apparatus configured to permit the connection rod (or similarly in the removal tool the removal sleeve and removal adaptor) to be loaded in a manner similar to that described herein can be employed.
As described herein the implant tool is configured to receive via the loading tube 103 the implant assembly. With respect to Figure 4 an example implant assembly 301 is shown. The implant assembly 301 can in some embodiments comprise a tongue advancer assembly (tongue advancer) 305 and a connection rod 303 (or ratchet or attachment sleeve). Furthermore Figure 4 can show an example removal assembly 1338 comprising the tongue advancer 305, the removal sleeve 1335 and the removal adaptor 1334. The example removal sleeve can in some embodiments comprise at a proximal end a coupling 1332 for coupling the proximal end of the removal sleeve to a distal end of the removal adaptor 1334.
As shown in Figure 4 the connection rod 303 comprises at the distal end a screw 307 or other suitable coupling means for coupling to the tongue advancer 305.
Furthermore the connection rod 303 comprises at the proximal end a groove pattern 309 or other coupling means for coupling with the implant tool (and especially the loading mechanism) as the connection rod 303 is inserted into the implant tool. The connection rod 303 in some embodiments is at least partially hollow and configured to receive the tongue advancer 305 and the tongue advancer tether at least partially within itself in order that the tongue advancer 305 can be implanted according to the embodiments as described herein. The connection rod may be formed from a single piece of material, and be machined to form the screw 307 and/or groove pattern 309, or in some embodiments the connection rod 303 is formed from separately machined parts which are joined or fixed together.
In some embodiments the connection rod 303 is at least partially hollow enabling the tongue advancer tether to be guided during implantation (and furthermore the similar tube in the form of the removal sleeve can be employed within the connection tool allowing the tube to be guided along the tether to the tongue advancer during removal). The outer diameter of the connection rod is configured to fit the inner diameter of the implant tool loading tube 103 to permit the tongue advancer to be pulled into the tube. In such
embodiments the tongue advancer fingers can be evenly straightened against the inner walls of the loading tube during the pulling in of the implant assembly to the implant tool and similarly enable an even unfolding of the anchor fingers during deployment.
As discussed below during removal surgery a channel can be created as the connection rod in the form of the removal sleeve approaches the tongue advancer.
Furthermore the coupling or connection or docking of the tongue advancer and the connection rod (or removal sleeve) should in some embodiments be controlled such that the tongue advancer is first controlled or approached with very limited force to avoid pushing it away. The coupling or connection to the tongue advancer in some embodiments should be performed with limited (pushing) force to avoid displacement of the tongue advancer.
Following the coupling of the tongue advancer to the connection rod or removal sleeve the tongue advancer should then be securely coupled to the rod which is pulled into the implant loading tube (or removal tool removal tube) by applying a pulling force.
With respect to Figure 5a a detail of the connection rod groove pattern 309 is shown. The groove pattern is shown having a series of grooves 403 which may be machined, pressed, moulded or otherwise formed. The grooves 403 comprise a variable profile or asymmetrical groove pattern where the proximal end 407 of the groove 403 is thinner than the distal end 405 of the groove 403. Figure 5a furthermore shows an example connection rod having a tapered proximal end to assist insertion into the implant tool.
With respect to Figure 5b a detail of the connection rod screw 307 is shown. The connection rod screw 307 is formed in some embodiments by a pitch 413 defined slots 411, which in some embodiments is a asymmetric C or U slot, cut into the connection rod and which form tab material parts which can be bent or pressed either outwards (to form an external screw thread) or inwards (to form an internal screw thread). The pressed slots form a discontinuous screw thread which can be configured to couple to a suitable screw tread on the tongue advancer. Although the coupling is shown as a discontinuous screw thread it would be understood that the screw thread can be a continuous screw thread.
It would be understood that the screw thread coupling or interface can in some embodiments comprise one or both screw threads having a continuous or only partly executed thread. For example a partial execution such as shown in Figure 5b may offer larger number of sharp edges to enable the scraping off of tissue from the associated other screw thread (such as in the case of removal) and therefore leave space to absorb any tissue scraped or left while attempting to attach the screw threads together.
With respect to Figures 6a and 6b example screw couplings or interface configurations between the connection rod 303 and the tongue advancer 305 are shown. The example shown in Figure 6a for example employs a screw couplings or interface
configuration wherein the tongue advancer 305 comprises an internal screw thread 501 and the connection rod 303 comprises an external screw thread 503. Whereas with respect to the example shown in Figure 6b the tongue advancer 305 comprises an external screw thread 511 and the connection rod 303 comprises an external screw thread 513
With respect to Figures 7a to 7d a suitable axisymmetric clamping interface is shown.
In the example shown in Figure 7a the connection rod 303, which is located at least partially within the loading tube 103 of the implant tool 101, comprises a first coupling arm or element 611. The coupling element 611 in some embodiments is configured with a profile having a profiled surface or clamp 613 suitable for locating a groove 615 on the tongue advancer 305.
Furthermore in some embodiments the coupling element is at rest or in normal operation biased in a direction away from the axial centre. Furthermore in such embodiments the loading tube 103 of the implant tool 101 (or any tube within which the connection rod is operating) may comprise a profile 609 which opens up in the tube's distal direction. In other words the tube internal diameter or radius increases towards the opening of the tube. This can for example, as shown in Figures 7a to 7d, be achieved by progressively thinning the tube wall thickness along the inside of the tube to the end of the tube.
Thus as the connection rod is moved in a outwards or distal motion as shown by arrow 601 the coupling element 611 opens up the clamping element 613 because of the profile 609 of the loading tube and enables the clamping element 613 to pass over the end of the tongue advancer 305 until the clamping element 613 is located substantially adjacent the tongue advancer 305 groove 615 such as shown in Figure 7b.
With respect to Figure 7b the loading tube 103 (or outer tube) can be moved in an outward or distal direction, shown by the arrow 603, relative to the connection rod 303 such that the clamping element 613 is pushed inwards by the profiling 609 of the loading tube causing the clamping element 613 to lock or latch the tongue advancer 305 by the groove 615 such as shown in Figure 7c.
With respect to Figure 7c the connection rod 303 is then moved in an inwards or proximal direction. The tongue advancer 305 which is clamped by the clamping elements 613 within the groove 615 is thus moved inwards or proximally such that the tongue advancer 305 can be pulled at least partially within a loading tube (or other suitable tube) such as shown in Figure 7d.
In some embodiments the groove 615 of the tongue advancer 305 is configured to run over the complete circumference of the tongue advancer, however it would be understood that in some embodiments the groove is discontinuously distributed about the circumference of the tongue advancer. In some embodiments the groove 615 is configured to have a clear blocking edge at the proximal side and sufficient tolerance at the distal side. In some embodiments the clamping elements have profiled or rounded ends to further assist the clamping elements to pass over the proximal end of the tongue advancer in the process of locating the groove 615.
With respect to Figure 8 an example tongue advancer assembly 305 according to some embodiments is shown. The tongue advancer assembly 305 (or tissue or tongue anchor) is configured to provide an anchoring function to the surrounding muscle tissue as well as a reliable connection to the bone anchor via a tether. Furthermore, the tongue advancer assembly 305 requires a suitable interface for connection to the implant tool (and furthermore to the removal tool) able to withstand high tension or pulling forces required to enable tongue advancer finger straightening and to therefore enable minimally invasive implantation and removal.
In the example shown in Figure 8 the tongue advancer assembly 305 comprises a main or tongue advancer part 701. In such embodiments it is beneficial to manufacture the main part 220 of the tongue advancer assembly 305 including the tongue advancer fingers from a material such as Nitinol which has the required mechanical characteristics in terms of bio implant performance and resilience of the anchor or finger parts. The tongue advancer fingers as part of the tongue advancer part 701 of the tongue advancer 305 can be a rod, tube or similar object shape with fingers which at rest fold about themselves. However machining of Nitinol or similar materials by standard production processes is difficult as these materials produce significant tool wear which therefore makes the production process expensive and requires higher efforts for controlling machines and process. Furthermore the fixation of the tether to the Nitinol or similar material is typically difficult at fixation in that weld or glue bond quality is usually poor.
In such embodiments as described herein the tongue advancer thus comprises a core mount 703 which is manufactured or constructed from different materials which do not require the feature of high elasticity. Furthermore in some embodiments the core mount 703 is fixed or coupled to the tongue advancer part 701 via a suitable coupling. For example the coupling shown in Figure 8 is a round connecting pin 705 which is configured to pass through suitable cooperating holes within the tongue advancer part 701 and within the core element 703. Although the coupling between the core mount 703 and the tongue advancer part 701 is shown fixed by the round connecting pin 705 it would be understood that any other suitable fixing or coupling could be implemented in other embodiments.
Furthermore the tongue advancer 305, and specifically in the example shown in Figure 8 the core mount 703, comprises a suitable connection rod interface in the form of a variable diameter external screw thread. However it would be understood that any suitable coupling or interface (such as external or internal screw thread such as shown in Figures 6a and 6b), ball, socket or groove (such as shown with respect to Figures 7a to 7d) can be employed in some embodiments.
With respect to Figure 9 the core mount (or core element) 703 and the tongue advancer tether 801 is shown in further detail. The core element 703 in some embodiments comprises a hollow tube like structure through which can pass a first loop 803 of the tether 801. The first loop 803 of the tether 801 can furthermore be fixed in position relative to the tongue advancer assembly 305 in some embodiments by the connecting pin 705 which is used to fix or couple the core element 703 to the tongue advancer part 701. In other words the tether 801 is fixed by the pin, which has the advantage that by design the tether does not come into contact with sharp objects or edges.
Although in the example shown herein the tether 801 is formed from a single central element with first loop 803 configured to attach to the tongue advancer and the second loop 805 for coupling with the bone anchor it would be understood that any suitable tether arrangement can be implemented or employed, such as for example a complete loop tether. With respect to Figures 10a and 10b example core mounts 703 according to some embodiments are shown in further detail. With respect to Figure 10a a first example core mount 703 is shown comprising an elongated slit 901 along the body of the core mount and at substantially 90° from the axis of the round pin 705. The elongated slit 901 permits the visual inspection of the mounting or fixing of the tether 801 and the tether first loop 803 and the pin 705 as the tether can be inspected visually for correct placement.
The pin 705 coupling the tongue advancer part 701 to the core mount 703 overcomes the need to weld the Nitinol or similar material of the anchor part 701 with the different and machineable material of the core mount 703. The pin 705 can in some embodiments reside in a hole of the core mount 703 and is fixed to the core mount by a shape or form fit. For example the form fit may be a round pin and round hole. The hole within the core mount 703 can be used in some embodiments to hold the pin 705 and in addition to the fixation in the core mount the pin can also reside in two holes of the Nitinol tube wall of the anchor part 701. In some embodiments the main stabilisation against the push and pull forces is by form fit also. In order to prevent the pin from working loose in some embodiments it is can be welded to the core mount 703 tube wall such as shown in Figure 10b. In some embodiments the pin is manufactured from Nitinol and welded to the anchor part wall.
With respect to Figure 10b a further example of a core mount 703 is shown. In this example the tether 801 passes into the core mount 703 and around a welded pin 703.
Although the tether 801 is shown herein fixed to the core mount 703 by the connection pin 705 it would be understood that any other suitable fixing could be employed. For example with respect to Figures 11a and 1 lb knotted tether fixation embodiments are shown. With respect to Figure 1 la a core mount 703 is shown having two interior channels 1001, 1003 through which a separate line 1011 1013 of the tether loop is passed and knotted to form a tether knot 1015 which secures the tether relative to the core mount 703. With respect to Figure 1 lb the core mount 703 is shown having a single channel 1021 through which both lines 1031, 1033 of the tether pass and which are knotted to form the tether knot 1035. It would be understood that in the single channel 1021 example that the knot 1035 has to be large enough to prevent slippage or slipping through the channel.
The core mount 703 in some embodiments can be formed from a single part or multiple parts that are connected together. The core mount can for example be manufactured from a suitable material such as stainless steel, titanium, durable plastic, or other
With respect to Figures 12a and 12b cross-sectional views of an example implant tool 101 is shown where the implant assembly 301 comprising the connection rod 303 has been inserted via the loading tube 103. The connection rod 303 as described herein comprises an interface 309 for coupling to the implant tool 101, in the form of grooves which co-operate with the first hook 215 and the second hook 217 and form a loading mechanism and specifically a locking or ratchet mechanism allowing the movement in an inwards direction only. Although in this example the loading mechanism is implemented by the use of hooks it would be understood that the term hook can define any suitable surface or profile enabling a hooking, gripping or catching of the implant assembly (or removal assembly). Similarly the term groove would be understood to mean any suitable co-operating surface or profile enabling the implant assembly to be hooked, gripped or caught.
In some embodiments as described herein the first hook 215 can be replaced by a gear wheel which is gearing into a gear rack on the connection rod. The gear wheel can be operated by a hand wheel by the operator and replaces the retraction lever mechanism. In some embodiments the hook/groove combination can be replaced by a clutch/rod
combination that relies on a friction coupling instead of a gear shape coupling.
The operation of inserting the implant assembly into the implant tool is shown in Figure 18 by step 1715.
The operation of retracting the tongue advancer into the implant tool until the tongue advancer fingers are completely inside the implant tool tube is shown in Figure 18 by step 1717.
The operation of inserting the loaded implant tool into the implanted cannula is shown in Figure 18 by step 1719.
The operation of performing a "final" check of the position of the cannula is shown in Figure 18 by step 1721.
In some embodiments the propulsion element such as the spring load element 201 of the implant tool 101 is charged with mechanical energy during the retraction of the implant assembly. The energy used to push or force the connection rod into the spring load element 201 can then be released in order to push or propel the implant along the loading tube. It would be understood that in some embodiments the propulsion element, such as for example the spring load element, can provide a force substantially in the range from 30 - 75 N to the connecting rod or removal sleeve and adaptor to propel it from the implant/removal tool. As described herein the propulsion element can be charged during loading, before loading or after loading. In other words a mechanism pre-charged relative to the operation of the release mechanism.
The procedure of operating a release mechanism and propelling the tongue advancer (or the connection rod with coupled tongue advancer) can be performed by lifting the safety cover or trigger guard 107 and pressing the trigger or release button 109. In some embodiments the trigger or release button 109 is configured to be coupled or connected to a hook release lever 219 which is configured to lift the first hook and the second hook from the connection rod grooves. The mechanical energy stored in the propulsion element such as the spring load propels or pushes the connection rod forward and the coupled tongue advancer out of the tool loading tube. The operation of deploying the tongue advancer into the tongue is shown in Figure 18 by step 1723.
The operation of repositioning (an optional step) is shown in Figure 18 by step
In some embodiments the implant tool 101 can comprise an ejection or implant counter and locking mechanism. The ejection or implant counter is configured to count the number of implantation and removal attempts. Furthermore the locking mechanism is configured to lock the implant tool after a determined number of implantation and removal attempts. For example the locking mechanism can in some embodiments be configured to lock the implant tool after determining three implantation and four removal attempts. The implant counter and locking mechanism can for example be used to prevent damage to a tongue advancer caused by being repeatedly implanted and removed. In such a manner the combination of the tools employed according to some embodiments allows a simple repositioning operation.
The operation of removing the implant tool 101 is shown in Figure 18 by step
The operation of exposing the tongue advancer tether by removing implant cannula and the connection rod is shown in Figure 18 by step 1729.
The operation of re-gloving is shown in Figure 18 by step 1731.
In some embodiments the operator can then connect or couple the bone anchor tether with the tongue advancer tether. In some embodiments this is performed by forming a flat symmetrical knot between the bone anchor tether and the tongue advancer tether.
However any other suitable fixation or coupling could be employed in some embodiments.
The operation of coupling or connecting the bone anchor tether with the tongue advancer tether is shown in Figure 18 by step 1733.
In some embodiments appropriate positions for holes for bone screws are marked on the mandible, the holes are drilled into the mandible and, the bone anchor attached to the mandible by use of bone screws. The attachment of the bone anchor to the mandible is shown in Figure 18 by step 1735.
Figure 13a to 13e shows an example of adjustment tool suitable to be used in embodiments where the bone anchor comprises a spool mechanism. In the following examples the bone anchor comprises a spool mechanism. However it would be understood that in some embodiments the bone anchor does not comprise a spool mechanism and the adjustment can be made in another known manner. Figure 13a shows the full tool assembly. It comprises a handle 90, a lock/unlock control section 92, an adjustment section 94 for controlling adjustment and an assembly of needles 96. This needle assembly 96 has at least two concentric parts, in the form of a smaller inner control shaft 98 which projects distally beyond the larger outer control shaft 100. They each terminate at a drive head.
The lock/unlock control section is shown in more detail in Figure 13b. It controls the rotation of the inner (longer) needle part. For example, a counter clockwise step is used for unlocking, and a clockwise step back is used for locking. The lock knob 92 and lock/unlock central needle part 98 are rigidly connected.
The second, outer needle 100 is a control shaft that can be rotated independently. Figure 13c shows the parts 94, 100 involved in tether line adjustment. The adjustment section is shown transparent to show that the inner hole of the adjustment knob and the outer diameter of the outer adjustment control shaft 100 connect to each other.
The components of the needle assembly 96 are shown in more detail in Figure 13d. There is an outer sleeve 102 at the outside of the needle assembly 96 which can rotate freely over the outer control shaft 100. The outer sleeve which terminates set back from the distal end of the outer control shaft 100 and it can be fixed with respect to the adjustment section 94. It serves two purposes. The first is that it remains in a fixed position in the channel of operation to avoid damage and irritation along the created access path in the human body while doing the adjustment. This can be achieved either by fixing the outer sleeve to the adjustment section 94 or by allowing it to rotated freely, in which case it will be held rotationally still by contact with the patient. The second is that its distal end provides a stop; the distance over which the inner lock control shaft 98 and outer control shaft 100 can be pushed into the corresponding bone anchor components is limited, thus protecting these components from damage due to excess of pushing force.
Figure 13e shows the tip of the needle assembly 96 in more detail. In this example, both the lock/unlock control shaft 98 and the outer control shaft 100 have an outer hexagonal shape. Their sizes match the hole dimensions of the corresponding bone anchor components. It can be seen from the two examples above that there are two rotating parts. The first can be the actual spool to wind tether, and the second can be the driver of a mechanism to block the spool. Both bodies can have the same axis of rotation, so that they have coaxial parts, and have non-circular holes for engagement with corresponding needle tips. The proximal one has a larger hole.
In some embodiments the adjustment tool and the lock tool is engaged into the lock interface of the bone anchor. This unlocks the bone anchor spool. The unlocking of the bone anchor is shown in Figure 18 by step 1737.
In some embodiments the adjustment interface of the engaged adjustment tool is engaged into the adjustment interface of the bone anchor. The length of the tether can be adjusted as desired and slack removed from the bone and tongue advancer tethers. The operation of removing slack from the tethers is shown in Figure 18 by step 1739.
The locking of the bone anchor is shown in Figure 18 by step 1741.
The closing of the incision is shown in Figure 18 by step 1743.
The operation of adjustment stage can thus be summarised by the following steps as shown with respect to Figure 19.
The operation of making an incision directly over the bone anchor funnel is shown in Figure 19 by step 1801.
The operation of engaging the lock tool and unlocking the bone anchor using the adjustment tool is shown in Figure 19 by step 1803.
The operation of engaging the adjustment tool and adjusting the length of the tether is shown in Figure 19 by step 1805.
The operation of engaging the lock tool into the lock interface of the bone anchor and locking the bone anchor is shown in Figure 19 by step 1807.
The operation of closing the incision is shown in Figure 19 by step 1809.
As discussed herein, in some embodiments, it is required to remove the bone anchor, tongue advancer and tether from the patient by minimally invasive surgery. The operations or steps with respect to the removal stage according to some embodiments are described with respect to Figure 20.
The operation of locating the bone anchor is shown in Figure 20 by step 1901. An incision is then made into the skin a few millimetres away from the bridge of the bone anchor.
The operation of making a first or initial incision is shown in Figure 20 by step
1903. Using the adjustment tool, such as shown in Figure 13a to 13e, the lock tool engages the lock interface of the bone anchor and unlocks the bone anchor. For example by turning the lock/unlock part of the adjustment tool in a counterclockwise direction until a stop or slight click is heard. In some embodiments this can feel like a quarter turn.
The unlocking of the bone anchor is shown in Figure 20 by step 1905.
The operation of unspooling the bone anchor tether is shown in Figure 20 by step 1907.
The operation of detaching the bone anchor from the mandible is shown in Figure 20 by step 1909.
The operation of presenting the exposed loop of the tongue advancer tether is shown in Figure 20 by step 1911.
With respect to Figure 14 an example connection tool is shown according to some embodiments. The connection tool 1301 can be considered to comprise four parts.
At least partially within the removal tube 1335 is located the removal sleeve or attachment sleeve (removal) 1335. The removal sleeve 1335 is configured to have at the distal end a coupling part suitable for coupling to the proximal end of the tongue advancer. For example in some embodiments the removal sleeve 1335 comprises a screw, clamp, a ball shaped coupling or connector (for coupling to a socket shaped coupling or connector on the tongue advancer), a socket shaped coupling or connector (for coupling to a ball shaped coupling or connector on the tongue advancer), or a gripping surface or profile or similar element for coupling to the tongue advancer. The removal sleeve 1335, in some
embodiments, therefore comprises at the distal end a structure similar to that described with the connection rod type structure. The removal sleeve 1335 in some embodiments can furthermore comprise a proximal coupling part such as a screw thread or clamping elements for coupling with a removal adaptor (or ratchet part) comprising features similar to the connection rod circular grooves (or other suitable means for forming a coupling or connection with the removal tool). The removal sleeve 1335 when coupled to the tongue advancer and to the removal adaptor (ratchet part) 1334 can be considered to form a removal assembly. The removal assembly can be configured to retract the tongue advancer within the removal tool. Furthermore the removal assembly is therefore similar to the implant assembly comprising a coupling of the connection rod and the tongue advancer for retracting the tongue advancer within the implant tool.
The tensioner 1321 can be any suitable means for applying tension to the tension rod and tension hook 1337, via the tension meter 1323. In the example shown in Figure 14 the tensioner 1321 is a handle suitable for pulling and applying a force is a direction away from the body of the tool. However the tensioner 1321 can be implemented as one of: an external retainer, a spooling spring, a linear spring, a mass or weight acting under gravity, a slider or a motor, such as a user controlled motor.
The tension meter 1323 can for example have three regions identifying the level of tension or force being applied. The first region which is displayed when the tension is first applied is an orange colour bar or block indicating a resting position or zero tension and further indicating when the tension is too low. The second region, a green colour bar or block, is displayed when the tension is correct. Thus at a desired tension the window displays the second region producing a fully green window. The third region, a red colour, is displayed such that when too much tension has been applied the window displays a red colour. It would be understood that ranges of tensions can vary according to the example implementation. For example a 'too low', 'desired' and 'too much' tension value can be based on the grade or type of tether line used. For example a 'too low' tension range (an orange colour bar is displayed) can be set for a range of values from 0-10 N. A 'desired' tension range (a green colour bar is displayed) can be set for a range of values from 5-25 N. A 'too much' tension range (a red colour bar is displayed) can be set for a range of values above IO N.
The operation of hooking or seating the loop of the tongue advancer tether line within the connection tool tension hook is shown in Figure 20 by step 1913.
The operation of tensioning the tether to the required amount is shown in Figure 20 by step 1915.
The operation of locating the implanted tongue advancer is shown in Figure 20 by step 1917.
With respect to Figure 15 a detail of the end of the connector tool as shown in Figure 14 is shown. In the example figure the removal tube 1333 is shown. Extending from within the removal tube is the removal sleeve 1335. The removal sleeve 1335 is configured to have at the distal end a coupling part suitable for coupling to the proximal end of the tongue advancer. For example in some embodiments the removal sleeve 1335 comprises a screw, clamp, a ball shaped coupling (for coupling to a socket shaped coupling on the tongue advancer), a socket shaped coupling (for coupling to a ball shaped coupling on the tongue advancer), or a gripping surface or profile for coupling to the tongue advancer. Furthermore extending from within the removal sleeve 1335 is the dissector 1336. The dissector 1336 comprises, as described herein, a tip configured to be suitable for cutting tissue. In other words the dissector comprises a sharpened or cutting edge. In order that when the tether line is followed at an oblique angle the tether line is not cut by the dissector 1336, in some embodiments the dissector comprises a flexible part or end configured to flex and prevent the tether line from contacting the dissector tip cutting edge. The flexible part or end can be manufactured from any suitable material. Furthermore extending from within the dissector 1336 is shown the tension hook 1337. The tension hook 1337 as described herein can be any suitable design suitable for coupling or connecting to the exposed tongue advancer tether line and applying a suitable tension to the tongue advancer tether line.
Furthermore with respect to Figure 16 a further example of a suitable tether protection device is shown. In the example shown in Figure 16 the dissector 1336 comprises a blunt dissector tip 1501 which in some embodiments can be located on the inside edge of the dissector tip and which is configured to separate the tether line and the cutting edge of the dissector where the tether line is followed at an oblique angle.
The operation of advancing the cannula along the tether into the tongue while maintaining tension on the tether is shown in Figure 20 by step 1919.
The coupling of the connection tool and the tongue advancer is shown in Figure 20 by step 1921.
In some embodiments therefore the removal sleeve 1335 is retained within the removal tube 1333 when the floating knob 1329 and the tensioning assembly 1311 is separated from the detachable removal cannula part 1315 and the body of the connection tool comprising the floating knob 1329 and the tensioning assembly 131 1 is moved away from the patient. Furthermore the tension rod detachable section is detached such that the tensioner 1321 and tension meter 1323 can be detached from the tension hook 1337 thus enabling the tensioning assembly 1311 to be moved while the tension hook and tether line is handled separately.
The separation of the connection tool into the detachable cannula part 1315 (including the removal assembly and tongue advancer) and the connection tool body
(including the tensioner 1321 and floating knob 1329 and the creation of a removal assembly is shown in Figure 20 by step 1923.
With respect to Figure 17 an example removal tool 1601 is shown. The removal tool 1601 as shown in Figure 17 comprises a body 1613 incorporating a handle part. The body 1613 can be manufactured or formed from any suitable material, for example from an injection moulded plastic. The body 1613 can in some embodiments have other components mounted from it. For example as shown in Figure 17 the body 1613 is coupled or connected via an internal pivot point to a retraction lever 1611. The retraction lever 1611 in some embodiments as shown in Figure 17 is configured to be operable by the use of at least one finger when the operator of the tool is holding the removal tool and can be formed from a moulded plastic part. The body 1613 can in some embodiments be further coupled to a safety lever or cover 1607 which is pivoted at a second pivot point within the body 1613 and is configured to cover or prevent the accidental pressing of a release button or trigger lever 1609. The body 1613 can in some embodiments be further coupled or connected to a removal assembly release button or trigger 1609.
It would be understood that in some embodiments the removal tool comprises features similar to the implant tool with respect to a loading mechanism configured to load a removal assembly comprising the tongue advancer and, a propulsion element configured to be charged during the loading of the removal assembly and a release mechanism
(implemented in some embodiments by the button release or trigger mechanism) configured to release the removal assembly comprising the tongue advancer. For example in some embodiments the removal tool 1601 comprises a loading mechanism comprising a first hook coupled to the retraction lever mechanism and a second hook which are both mounted such that they can pivot about respective points and hook or trap a ratchet groove feature on the removal assembly (and specifically the removal adaptor or ratchet part) such that the proximal end of the removal assembly can move in one direction, an inwards direction, but is trapped and prevented from moving in an outwards direction. The first hook is coupled or connected to the retraction lever mechanism such that, as the retraction lever is pulled towards the body of the removal tool, the first hook moves in an inwards direction relative to the body 1613. Furthermore the retraction mechanism comprises a propulsion element such as a biasing or spring load, which is charged on loading or retraction of the removal assembly into the removal tool. The propulsion element can, when the hooks are moved away from the grooves of the removal assembly, be configured to push or eject the removal assembly out of the removal tool. For example the hooks can be moved from the grooves of the removal assembly by a release or trigger mechanism actuated following pressing the release button or trigger lever 1609. The release button can for example be coupled to a suitable release mechanism to move the hooks away from the removal assembly and therefore disengage the hooks from the circular grooves.
The operation of coupling the removal tool to the removal assembly is shown in Figure 20 by step 1925.
The operation of retracting the tongue advancer and removal of the device assembly from the body is shown in Figure 20 by step 1927.
The operation of the checking the explanted tongue advancer is shown in Figure 20 by step 1929.
The operation of closing the incision is shown in Figure 20 by step 1931.
1. A tongue advancer assembly (305) for a tongue manipulation system, the tongue advancer assembly (305) comprising:
a core mount (703) comprising a connection rod coupling configured to couple the tongue advancer assembly to a distal end of a connection rod (303); and
a tongue advancer (701) configured to be coupled to the core mount (703).
2. The tongue advancer assembly (305) as claimed in claim 1, further comprising a fixing element configured to couple the core mount (703) and the tongue advancer (701).
3. The tongue advancer assembly (305) as claimed in claim 2, wherein the fixing element comprises a pin (705).
4. The tongue advancer assembly (305) as claimed in claim 3, further comprising a tongue advancer tether (801).
5. The tongue advancer assembly (305) as claimed in claim 4, wherein the tongue advancer tether (801) comprises a first loop (803), the first loop (803) configured to pass around the pin (705) to couple the tongue advancer tether (801) to the tongue advancer assembly (305).
6. The tongue advancer assembly (305) as claimed in any of claims 3 to 5, wherein the pin (705) is configured to be welded to the core mount (703) and form fit to the tongue advancer (701).
7. The tongue advancer assembly (305) as claimed in any of claims 3 to 5, wherein the pin (705) is configured to be welded to the tongue advancer (701) and form fit to the core mount (703).
8. The tongue advancer assembly (305) as claimed in any of claims 1 to 7, wherein the core mount (703) is configured to be a machineable from at least one of:
9. The tongue advancer assembly (305) as claimed in and of claims 1 to 7, wherein the core mount coupling comprises at least one of:
a screw thread (501, 511) configured to couple the tongue advancer assembly (305) to a connection rod (303) by a connection rod screw thread (503, 513);
a groove configured to couple the tongue advancer assembly (305) to a connection rod (303) by a connection rod clamping element (613);
a ball-shaped proximal end configured to couple the tongue advancer assembly (305) to a connection rod (303) by a connection rod clamping element (613).
10. The tongue advancer assembly (305) as claimed in any claim dependent on claim 4, wherein the core mount (703) comprises a slit (901) configured such that a tongue advancer tether (801) and connecting pin (705) locating the tongue advancer tether (801) can be observed through the slit (901).
the tongue advancer assembly (305) as claimed in claims 1 to 10; a connection rod (303) comprising:
a first coupling part (307) configured to couple the distal end of the connection rod to the tongue advancer assembly (305) core mount (703) connection rod coupling;
a second coupling part (309) configured to couple the proximal end of the connection rod to an implant tool (101) or a removal tool (1601), wherein
the connection rod is configured to transmit a tension or pulling force from the implant tool (101) or the removal tool (1601) to the tongue advancer assembly (305) such that the tongue advancer of the tongue advancer assembly is configured to be retracted within the implant tool (101) or removal tool (1601) respectively.
the tongue advancer assembly (305) as claimed in claims 1 to 10; a bone anchor; and
13. A method for providing a tongue advancer assembly (305) for a tongue manipulation system, comprising:
providing a core mount (703) comprising a connection rod coupling configured to couple the tongue advancer assembly to a distal end of a connection rod (303);
coupling a tongue advancer (701) to the core mount (703).
14. The method as claimed in claim 13, wherein coupling the tongue advancer (701) to the core mount (703) comprises fixing the core mount (703) to the tongue advancer (701).
15. The method as claimed in claim 14 wherein fixing the core mount (703) to the tongue advancer (701) comprises fixing the core mount with the tongue advancer (701) by a pin (705).
EP15770646.6A 2014-08-21 2015-08-10 A tongue advancer assembly for a tongue manipulation system Pending EP3190983A1 (en)
US201462040106P true 2014-08-21 2014-08-21
PCT/IB2015/056061 WO2016027197A1 (en) 2014-08-21 2015-08-10 A tongue advancer assembly for a tongue manipulation system
EP3190983A1 true EP3190983A1 (en) 2017-07-19
ID=54197013
EP15770646.6A Pending EP3190983A1 (en) 2014-08-21 2015-08-10 A tongue advancer assembly for a tongue manipulation system
US (1) US20170265853A1 (en)
EP (1) EP3190983A1 (en)
JP (1) JP2017528206A (en)
CN (1) CN106659496A (en)
WO (1) WO2016027197A1 (en)
2015-08-10 EP EP15770646.6A patent/EP3190983A1/en active Pending
2015-08-10 US US15/504,698 patent/US20170265853A1/en active Pending
2015-08-10 CN CN201580044839.8A patent/CN106659496A/en active Search and Examination
2015-08-10 WO PCT/IB2015/056061 patent/WO2016027197A1/en active Application Filing
2015-08-10 JP JP2017509690A patent/JP2017528206A/en active Pending
WO2016027197A1 (en) 2016-02-25
JP2017528206A (en) 2017-09-28
CN106659496A (en) 2017-05-10
US20170265853A1 (en) 2017-09-21
US20120022586A1 (en) 2012-01-26 Tissue closure device and method
US9636105B2 (en) 2017-05-02 Apparatus and methods for tissue closure