Curable material dispensing system, and methods of operating and packaging the same

Abstract

To provide a system for dispensing a curable material.SOLUTION: A lead screw 62 rotatably fixed to a first control surface 60 includes external threads. A locking nut 90 includes internal threads threadably engaging the external threads. An engagement feature of the locking nut is adapted to be selectively engaged with an actuator having a second control surface. The threads provide for rotation of the locking nut about a translation axis when the actuator is in a disengaged position. Rotation of the locking nut permits a lead screw to move proximally along the axis and the compressed curable material to at least partially decompress within a dispensing volume. The threads further provide for distal advancement of the lead screw along the translation axis when the actuator is in an engaged position rotatably fixing the locking nut about the axis. Methods for operating and packaging the curable material dispensing system are also disclosed.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This patent application is a continuation of U.S. Provisional Patent Application No. 62 / 656,000, filed April 11, 2018. No. 33, the contents of which are incorporated by reference. and are hereby incorporated in their entirety. [Background technology]

[0002] In some surgical procedures, hardenable materials are placed within bone structures. In surgical procedures, an access cannula is guided through the cortical bone of the vertebra into the cancellous region of the vertebral body. A dispensing system is connected to this access cannula. The dispensing system is then operated. The curable material is then dispensed through the access cannula into the cavernous region. The system has several drawbacks. Summary of the Invention

[0003] In some instances, the system configured to dispense the curable material includes a dispensing cavity. a chamber defining a space between the dispensing space and a distal outlet communicating the hardenable material with the dispensing space; The first control surface includes a chamber configured to dispense through the first control surface. a lead screw configured to receive a primary input from the first control surface portion, the lead screw being rotatable relative to the first control surface portion; The lead screw is fixed to the proximal end, the distal end, and the a male screw thread at least partially disposed thereon and a parallel thread defined between the proximal end and the distal end; The plunger is connected to the feed screw and is disposed within the dispensing space. The plunger moves along a translation axis in response to the first control surface receiving a primary input. The locking member is configured to be advanced distally by the locking member to compress the curable material within the dispensing space. The lead screw includes an internal thread that mates with the external thread of the lead screw and an engagement feature. The actuator also includes a second control surface portion. and the locking nut engagement feature to an engaged position, thereby locking the actuator and the locking nut. configured to receive a secondary input from the user to disengage the engagement feature to the disengaged position. The female threads on the locking nut and the male threads on the lead screw are aligned with the actuator in the disengaged position. When the plunger is moved along the translation axis, the locking nut rotates. the compressed curable material to move proximally along the The pressure is at least partially reduced.

[0004] In some instances, the system configured to dispense the curable material includes a housing and a chamber connected to the housing. The chamber is adapted to dispense a curable material. The first control surface is coupled to the housing and defines a dispensing space configured to The lead screw is configured to receive a primary input from a user. The lead screw has a proximal end, a distal end, and a and a male thread at least partially disposed between the proximal end and the distal end. The plunger is coupled to the distal end of the lead screw. The lead screw also includes a lock nut having internal threads that mate with the external threads of the lead screw and an engagement feature. The actuator is coupled to the housing and includes a second control surface portion. The locking nut engages the actuator and the locking nut in an engaged position. A secondary input is required from the user to disengage the engagement features of the locking nut and the locking rod to the disengaged position. The locking nut is configured to receive the housing when the actuator is in the engaged position. a locking nut rotatably secured to the locking ring to prevent rotation of the locking nut about the translation axis; This allows the female threads of the locking nut and the male threads of the lead screw to align with the first control surface. Distal movement of the lead screw and plunger along the translation axis in response to receiving an input. The device is configured to provide an advancement and compress the curable material within the dispensing space.

[0005] In some instances, the system configured to dispense the curable material includes a housing and a chamber connected to the housing. The chamber is adapted to dispense a curable material. The first control surface is coupled to the housing and defines a dispensing space configured to The system is configured to receive a primary input from a user. The lead screw rotates relative to the first control surface portion and also includes a locking nut having an internal thread. The lead screw is rotatably fixed to the proximal end, the distal end, and the space between the proximal end and the distal end. and a flat end defined between the proximal end and the distal end. The engagement of the male threads of the lead screw with the female threads of the locking nut provides a first control. a lead screw along a translation axis in response to the surface receiving a primary input in a first direction; and configured to cause the movement of the curable material within the dispensing space to compress the curable material within the dispensing space. A one-way mechanism operably connects the first control surface portion to the housing. The one-way mechanism includes a first control surface configured to receive a first input torque less than a torque threshold. a first control surface portion configured to allow distal advancement of the lead screw in response to receiving a second input; The torque threshold is set to 0.5 V. ... and a first control in a second direction opposite to the first direction about the translation axis in response to the The face is configured to allow rotation of the face to translate the lead screw proximally.

[0006] In some instances, the system configured to dispense the curable material comprises dispensing the curable material The lead screw includes a chamber defining a dispensing space configured to dispense a first The lead screw is rotatably fixed to the control surface. The lead screw has a proximal end, a distal end, and a proximal end. a male thread disposed at least partially between the proximal end and the distal end; and a translation axis defined between the locking nut and the lead screw. The female thread of the locking nut and the male thread of the lead screw are greater than 50% The locking nut is compressed within the dispensing space and is determined by the thread efficiency. The feed rotates around a translation axis in response to the proximal force applied by the hardening material. The screw is configured to translate proximally along a translation axis.

[0007] In some instances, the system configured to dispense the curable material comprises dispensing the curable material The first control surface portion includes a chamber defining a dispensing space configured to dispense The lead screw is configured to receive a primary input from a user. The lead screw is configured to move relative to the first control surface portion. The lead screw has a proximal end, a distal end, and a pair of ends. and a male thread at least partially disposed between the proximal end and the distal end. The lead screw moves in response to the first control surface receiving a primary input. The device is configured to advance distally along a translation axis to compress the curable material within the dispensing cavity. The locking nut has female threads that mate with the male threads of the lead screw. The female thread of the lead screw and the male thread of the lead screw move along the translation axis without the lead screw rotating. Proximal translation causes rotation of the lock nut about the translation axis. and allowing the compressed curable material to at least partially decompress within the dispensing space. It is configured to:

[0008] In some instances, the method of operating a curable material dispensing system includes: and moving a second control surface from a disengaged position to an engaged position in addition to the first control surface. The second control surface portion is held in the engaged position against a force applied by a biasing member. With the second control surface portion in the engaged position, a primary input is applied to the first control surface portion, transmitting The screw is moved distally along the translation axis to compress the curable material within the dispensing cavity. The secondary input applied to the second control surface is removed, and the second control surface is biased by the biasing member. The second control surface is moved from the engaged position to the disengaged position. This results in proximal translation of the screw along its translation axis, causing the compressed hardenable material to enter the dispensing cavity. This allows for at least partial decompression within the time period.

[0009] In some instances, the method of operating the curable material dispensing system comprises: a locking nut biased by a force applied by a biasing member to engage the locking nut; In a state where the first control surface portion is fixed so as to be rotatable about a translation axis, a primary input is applied to the first control surface portion. The threaded engagement causes the distal portion of the lead screw to move along the translation axis of the lead screw. This causes translation of the force exerted by the biasing member, compressing the curable material within the dispensing space. A secondary input force sufficient to overcome the applied force is applied to the second control surface portion, causing the actuator to Move the locking nut away from the locking nut and rotate the locking nut around the translation axis. Engagement and rotation of the locking nut causes proximal movement along the translation axis of the lead screw. and allowing the compressed curable material to be at least partially decompressed within the dispensing space. This makes it possible to do so.

[0010] In some instances, the method of operating a curable material dispensing system includes dispensing a curable material from the curable material dispensing system. providing a package having dimensions sufficient to accommodate the system. A curable material dispensing system is provided that includes a dispensing space coupled to a housing and a A flexible tube rotatably connected to the rotary coupling and an elbow coupling connected to the rotary coupling. An extension tube having a body is provided, the elbow of the extension tube being located at the distal end of the dispensing space. , thereby providing fluid communication between the flexible tubing and the dispensing space. The tube is articulated about the elbow joint relative to the dispensing space into the packaging configuration. The flexible tube and the dispensing space are substantially parallel to each other, and the flexible tube has an elbow joint. The dispensing space is then placed against the body. An extension tube is disposed within the package.

[0011] The present disclosure may be better understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which: If it is understood, it will become clear quickly. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a perspective view of a curable material dispensing system removably coupled to a mixing and compression system. [Figure 2] FIG. 1 is a perspective view of a curable material dispensing system. [Figure 3] 3 is a cross-sectional view of the curable material dispensing system of FIG. 2 taken along section line 3-3 with the actuator in a disengaged position. [Figure 4] FIG. 1 illustrates a cross-sectional view of a curable material dispensing system with an actuator in an engaged position. [Figure 5] FIG. 10 is a cross-sectional view of the curable material dispensing system with the lead screw advanced distally to compress and / or dispense the curable material. [Figure 6] FIG. 1 is an exploded view of the curable material dispensing system. [Figure 7] FIG. 1 is a perspective view of a curable material dispensing system with the actuator and housing removed. [Figure 8] 8 is a perspective cross-sectional view of the curable material dispensing system of FIG. 7 taken along section line 8-8. [Figure 9] FIG. 1 is a perspective view of a handle defining a first control surface portion, the handle including a one-way torque mechanism feature. [Figure 10] FIG. [Figure 11] FIG. [Figure 12] FIG. 10 is a bottom perspective view of an actuator with a second control surface portion. [Figure 13] FIG. 12 is a front perspective view of the overcome one-way mechanism. [Figure 14] FIG. 13 is a rear perspective view of the overcome one-way mechanism. [Figure 15]3 is a detailed perspective view of the portion within box 15-15 in the curable material dispensing system of FIG. 2. FIG. [Figure 16] FIG. 10 illustrates a curable material dispensing system with the extension tube in a deployed configuration during use. [Figure 17] 1 is a schematic diagram of a curable material dispensing system, a mixing and compression system, and an extension tube in a packaged configuration disposed within a package. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0013] 1-6 illustrate a system 30 configured to dispense a curable material. The stem 30 defines a dispensing space 34 configured to receive and dispense a curable material. The curable material may be, for example, a powder copolymer and a liquid monomer. In some instances, the cement may be formed by mixing the cement. The compressor 32 is connected to the premixer 30 via a mixing and compression system 31 to which the system 30 is removably connected. The present invention relates to a method for manufacturing a compacted hardenable material. System 31 is disclosed in commonly owned International Patent Application Publication No. 2008 / 08045329. The contents of this document are incorporated herein in their entirety by reference. Alternatively, chamber 32 may receive powdered copolymer and / or liquid monomer, followed by The contents of the dispensing space 34 are mixed prior to dispensing the curable material in a manner described below. An exemplary configuration suitable for mixing the curable material within the dispensing space 34 is shown below. Components are disclosed in commonly owned U.S. Patents 6,547,432, 6,736,537, and 7 ,134,782, 7,306,361, and 7,320,540. All of these documents are incorporated herein in their entirety by reference. This shall be the case.

[0014] At the start of a surgical procedure, the inventors of the present application discovered that a known system was installed in the surgical room. We know that known systems take up more valuable space than necessary in the surgical setting. It is necessary to incorporate a flexible tube that is ultimately connected to the access cannula in the operating room. This further wastes time and resources that could be allocated to other surgical tasks. Also, during surgery, x-rays are used to visualize the hardening material within the bone structure. Fluoroscopy may be used. In this case, known dispensing systems have a The surgeon may place the dispensing system around the surgical site to avoid the radiation associated with fluoroscopic imaging. It does not provide the surgeon with sufficient maneuverability to move the Perhaps most importantly, for a variety of reasons, surgeons may wish to administer curable materials during surgery. For example, if an excessive amount of high-pressure hardening material is introduced into the body, Many known dispensing systems have not addressed this issue. This is insufficient because compressed hardening materials tend to move along the path of least resistance, i.e. That is, the pressure is at least partially reduced outside the system and into the patient. This concept, known as a "drool," allows for a clear connection between the dispensing space and the surgical site. Until the pressure gradient between the 5, the exemplary chamber 32 is a distal end 36 and a distal outlet 38 located at least substantially opposite the proximal end 36. The distal outlet 38 communicates with the dispensing space 34. The chamber 32 is shown in FIGS. As shown, it may have an elongated substantially tubular shape, but the design or exterior of the system 30 may vary. The endoscopic device may have any suitable size and shape based on the requirements of the intended application.

[0015] The chamber 32 includes an inlet port 40 that is at least initially in fluid communication with the dispensing space 34. The inlet port 40 is adapted to be removably connected to the mixing and compression system 31. The curable material entering the dispensing space 34 through the inlet port 40 passes through a transfer stage 44. During the transfer phase, the inlet port 40 is in fluid communication with the dispensing space 34 and the distal outlet 38. Referring to FIG. 15, the inlet port 40 is located at the neck portion extending from the chamber 32. 53. Neck portion 53 defines an opening 55 that communicates with dispensing space 34. The neck portion 53 is tubular and has at least one radially outwardly extending rib 57. FIG. 15 shows two ribs 57 arranged in a generally spiral shape. and inlet port 40 in cooperation with complementary features of discharge assembly 33 of compression system 31. and connect the inlet port 40 to the (part number not provided) outlet port of the mixing and compression system 31. The seal body 59 is configured to be at least partially disposed within the neck portion 53 and to sealingly engage the port. The seal body 59 is at least partially disposed. The seal body 59 includes a coupling feature 71. Feature 71 engages a complementary interlocking feature in neck portion 53 to axially retain seal body 59. 15 illustrates the coupling feature 71 as a deflectable finger. The fingers are shown as elastically deflectable portions that engage complementary interlocking features 73 at least partially. The seal body 59 is configured to engage with an opening formed in the neck portion 53. When coupled to the seal body 59, a lumen 75 extending through the seal body 59 selectively communicates with the dispensing space 45. This will happen.

[0016] 2-5, the curable material is dispensed from the distal outlet 38 in a manner described below. Meanwhile, the sealing interface 43 between the plunger 42 and the chamber 32 is The distal movement moves the inlet port 40 distally, and the inlet port 40 then The sealing interface 43 is no longer in fluid communication with the injection space 34 and the distal outlet 38. A sealing interface 43 is defined between the outer surface of the plunger 42 and the inner surface of the chamber 32. The seal may be defined by a seal (not shown) connected to the jar 42. O-rings or other compression elements (uncoated or coated with anti-friction material) The seal may be a seal body or a dynamic seal body. The feather seal provides a sealing force proportional to the force applied to it. As the ranger 42 moves relative to the chamber 32, friction at the sealing interface 43 The temperature drops to near zero while sealing the hardenable material distal to the jar 42. The sealing interface 43 , whether or not defined by individual seal bodies, with minimal friction. The seal is configured to maintain a seal between the jar 42 and the chamber 32. Among the additional benefits, minimal friction at the sealing interface 43 facilitates the operation of the curable material delivery system 30. This facilitates back-driveability and improves feedback to the surgeon during movement.

[0017] A chamber fixture 44 is provided for, among other things, securing the chamber 32 to the housing 50. , connected to chamber 32 at or near proximal end 36 of chamber 32. The chamber fixture 44 is formed integrally with the chamber 32. The support members 45 are arranged facing each other and extending outward in the direction of the arrow. , within correspondingly shaped grooves 54 (one shown in FIG. 6) defined in housing 50. The support members 45 facing each other are configured to be seated in a proximal-distal direction. 32 to a position proximal to the proximal end 38 of the chamber 32, and At least a portion of the cavity 47 is defined which is sized to accommodate several components of the The cavity 47 is laterally bounded by the support members 47 facing each other. and is bounded proximally by a proximal ring 49. Furthermore, cavity 47 , and is distally bounded by the proximal end 36 of the chamber 32. The side that does not have the supporting members 45 facing each other is open. At least one of the openings 51 is provided. The opening 51 is adapted to receive the actuator 120. Dimensioned to receive mating feature 123, thereby allowing for placement within cavity 47. A locking nut 90 will be engaged to the actuator 120 in a manner to be described below.

[0018] The distal coupling 46 of the chamber 32 is detachably attached to an extension tube 190 (see FIG. 16) described below. The extension tube 190 is configured to be removably connected to a configured to be coupled to a surgical instrument, e.g., an access cannula, for penetrating a bony structure; The distal coupling 46 is detachable from the elbow coupling 192 of the extension tube 190 of the present disclosure. Luer fittings, bayonet mounts, or other suitable It may be a suitable connector or the distal end of a known tubular device.

[0019] The chamber 32 is configured to allow the curable material (and plunger 42) within the dispensing space 34 to flow through the surgical site. and at least partially formed from a translucent or transparent material to allow for visualization to the physician. The amount of curable material in the dispensing space 34 and / or the amount of material dispensed from the dispensing space 34 may be adjusted. The amount of curable material dispensed, specifically the movement of plunger 42 within dispensing space 34, To inform the surgeon of the amount of curable material based on the distance determined by the Marks may be provided on the outer surface 52 of the chamber 32. The marks may be (e.g., cubic centimeters). Preferably, the scale has a number corresponding to the volume of the dispensing space 34 (expressed in inches).

[0020] Referring to FIG. 5, plunger 42 is slidably disposed within dispensing cavity 34. The plunger 42 moves distally (D) and proximally (P) within the dispensing chamber 34. Specifically, the plunger 42 advances distally into the dispensing chamber 34. The hardenable material (CM) is propelled and / or compressed, thereby The plunger 4 is configured to expel at least a portion of the material from the distal outlet 38. To facilitate distal advancement of the curable material dispensing system 30, the curable material dispensing system 30 may be configured to receive a a first control surface portion 60 configured to receive a next input; and a second control surface portion 60 operable to 3 and 5, the plunger The lead screw 62 is connected to the lead screw 62, for example, at or near the distal end 64 of the lead screw 62. The lead screw 62 is rotatably fixed to the first control surface portion 60. In a manner described below, a primary input, e.g., a first input torque, is applied in a first direction. When pressure is applied to the control surface 60, the lead screw 62 rotates, and accordingly, the dispensing chamber 34 At this point, the plunger 42 advances in the distal direction. Conversely, a second input moves in the opposite direction to the first. When a force is applied to the first control surface portion 60 in the second direction, the lead screw 62 rotates, which In response, the plunger 42 moves proximally within the dispensing chamber 34. The plunger 42 is rotated in a manner that reduces friction between the plunger 42 and the lead screw 62. It is also conceivable that the plunger 42 and the lead screw 62 are rotated relative to each other. During proximal movement of plunger 42, for example, by reducing friction between This can facilitate the reverse driveability of the system 30 in the

[0021] 3-5 and 8, the lead screw 62 has a distal end 64 and a distal end 64. The lead screw 62 has an opposite proximal end 66. A translation axis (TA) is provided at the proximal end 66 of the lead screw 62. The first control surface portion 60 is defined between the first end 4 and the distal end 66. The first control surface portion 60 is associated with a handle 68. The handle 68 has a proximal end 70, a distal end 72, and a proximal end 74 of the handle 68. and a lumen 74 extending at least partially between the proximal end 70 and the distal end 72. The lumen 74 extends from the interior 56 of the housing 50 along the translation axis to the handle 68. As best shown in FIGS. 3 to 5, the feed The proximal end 66 of the screw 62 is disposed within the lumen 74. The handle 68 is The handle 68 further includes a drive feature 76 that defines at least a portion of the handle 68. The drive feature 76 is adapted to engage a driven feature 78 of the lead screw 62 that is complementary to the drive feature 76. whereby the lead screw 62 is rotated relative to the first control surface portion 60 of the handle 68. 9, for example, the drive feature 76 is rotatably secured to the handle 68. It defines a rectangular lumen extending at least partially between a proximal end 70 and a distal end 72. Drive feature 76 further includes a groove 77 that at least partially defines lumen 74. The driven feature 78 is defined by the proximal end 66 of the lead screw 62. The distal end 66 is at least substantially rectangular and sized to fit within the lumen 74 of the handle 68. The driven feature 78 extends longitudinally along the lead screw 62 (e.g., and further comprising at least one ridge 79 (e.g., defined by a chord of the lead screw 62). The drive feature 76 and the driven feature 78 are interfacing features between the lead screw 62 and the handle 68. The handle 68 is rotated relative to the first control surface portion 60 along the translation axis. The leadscrews 62 are engaged with each other to allow axial movement of the leadscrew 62.

[0022] The handle 68 includes a shaft 80 and a grip portion 82 connected to the shaft 80. Gripping portion 82 at least partially defines first control surface portion 60. FIG. A gripping portion 82 is located on the proximal side of the shaft 80 and extends radially outward from the shaft 80. The gripping portion 82 is sized to be grasped by one hand of the surgeon during actuation. The first control surface portion 60 is disposed annularly around the gripping portion 82. At least the first control surface portion 60 of the grip portion 82 is provided with first and second control surfaces 60. A highly tacky material is used to prevent the hand from inadvertently slipping while applying input torque. (e.g., rubber). The control surface 60 may include indentations and / or ridges to enhance grip during use. A first rotational direction (not shown) is provided to provide guidance to the surgeon. Markings may be placed on the handle 68 to indicate the orientation.

[0023] When the lead screw 62 is rotatably fixed to the first control surface portion 60, the first and second Applying an input torque to the first control surface portion 60 causes the handle 60 to rotate and thus Rotation of the lead screw 62 can be effected. However, the plunger along the translation axis A lead screw coupled to plunger 42 moves plunger 42 distally and proximally. 62. Corresponding distal and proximal translations of the axial translation axis are required. To facilitate distal movement of plunger 42 and lead screw 62, a curable material dispenser The system 30 includes a locking nut 90 having internal threads 92. With particular reference to FIG. 9, the internal threads 92 of the lock nut 90 engage the proximal end 64 and the distal end 66 of the lead screw 62. The locking nut 9 is threadedly engaged with the external threads 94 of the lead screw 62 that extend at least partially therebetween. 0 is disposed within the interior 56 of the housing 50 and is coaxial with the translation axis. The lock nut 90 includes an opening 96 configured to receive the lead screw 62. The feed screw 94 extends through the opening 96 of the locking nut 90 coaxially with the female thread 92 of the locking nut 90. Thread 62 is shown with female threads 92 mating with male threads 94 of lead screw 62. The female threads 92 of the locking nut 90 engage with the male threads 94 of the lead screw 62, forming a first When the control surface 60 receives a first input torque from a user, the lead screw 62 (and plunger 42) advances distally relative to lock nut 90. The female thread 92 of the 0 extends around the entire circumference of the opening 96 (i.e., 360°). However, the male thread 94 may be partially threaded (e.g., 90°, 180°, 270°, etc.). ) extending over less than the entire circumference of the lead screw 62. Note that one or more ridges 79 may be present on the portion of the lead screw 62 that does not have external threads 94. Alternatively, the female threads 92 and / or the male threads 94 may each extend between 36 It may extend over a full 360° circumference or over less than 360° circumference. It may be possible.

[0024] 8, 10, and 13 show a hub 100 and a ring gear connected to the hub 100. The hub 100 defines an opening 96. , with internal threads 92 disposed around opening 96. Hub 100 is connected to ring gear 1 The opening 96 is located within a recess defined by a hub 100. and sized to receive the lead screw 62. The locking nut 90 is made of a polymer The substrate may be formed from any suitable material including copper, metal, combinations thereof, and the like.

[0025] The curable material dispensing system 30 selects rotation of the lock nut 90 about the translation axis. The lead screw 62 is then effectively blocked, so that rotation of the lead screw 62 advances the lead screw 62 distally. Conversely, when the locking nut 90 is rotatable about a translation axis, , (due to the characteristics of the female thread 92 and the male thread), the rotation of the lead screw 62 2 and lock nut 90, thereby rotating the feed screw 2 against the lock nut 90. This results in only a minimal advancement of the screw 62. When rotation of 90 is prevented, the female threads 92 of the locking nut 90 and the male threads of the lead screw 62 94, rotation of the leadscrew 62 rotates the leadscrew relative to the locking nut 90. Distal advancement of the locking nut 90 relative to the housing 50 occurs. When rotation is prevented, the female threads 92 of the locking nut 90 and the male threads 94 of the lead screw 62 Due to the threaded engagement between the lead screw 62, rotation of the lead screw 62 rotates the lead screw 62 relative to the housing 50. 2 distal advancement occurs.

[0026] To selectively prevent rotation of the lock nut 90 about the translation axis, 90 includes an engagement feature 98. As will be described below, the engagement feature 98 is ) to prevent rotation of the lock nut 90 about the translation axis. The engagement feature 98 includes a plurality of teeth 118. 8 extends radially from the ring gear 102 and, more specifically, the rear of the locking nut 90. These teeth 118 are arranged annularly around the locking gear 102. Disposed around the distal ring 104 and / or the proximal ring 105 forming the ring gear 112 Alternatively, the engagement feature may be a notch, protrusion, or the like.

[0027] 3 and 4, the system 30 engages the engagement feature 98 of the lock nut 90. and an actuator 120 configured to selectively engage. 120 includes a second control surface portion 122 configured to receive a secondary input from a user. The actuator 120 has an engagement feature that is complementary to the engagement feature 98 of the locking nut 90. 14, the tooth 124 is further provided with a complementary tooth 123, e.g., a tooth 124. The actuator 120 is a lever 126 pivotally connected to the housing 50. The illustrated lever 126 is generally rectangular and accepts secondary inputs from the user. 1. The control surface 120 defines a second control surface portion 122 facing away from the housing 50 for Typically, the actuator 120 may be a button, a toggle switch, a slider, etc. .

[0028] The teeth 124 are connected to the actuator 120 and are arranged to face the locking nut 90. The teeth 124 are located substantially opposite the control surface portion 122 of the locking nut 90. The teeth 118 are arranged in a complementary manner to the arcuate portions of the teeth 118 that extend annularly around the actuator. The housing 5 may be connected by a method other than a pivotal connection, for example, a slidable connection. It is further contemplated that the actuator 120 may be movably coupled to the locking mechanism. In the engaged position, the complementary engagement feature 123 Engagement feature 98 of lock nut 90 to inhibit rotation of lock nut 90 about the translation axis. For example, teeth 124 of actuator 120 intersect with teeth 118 of locking nut 90. Since the actuator 120 is connected to the housing 50, the actuator When the motor 120 is in the engaged position, the locking nut 90 is rotatable relative to the housing 50. In the disengaged position, the teeth 124 of the actuator 120 engage the locking nut 90. When the actuator 120 is in the disengaged position, the locking The nut 90 rotates relative to the housing 50 about a translation axis. A secondary input applied to portion 122 moves actuator 120 between the engaged and disengaged positions. For example, lever 126 is initially in the disengaged position shown in FIG. While supporting the housing 50, the user applies a secondary input, e.g., a downward force, to the lever 126. The lever 126 pivots relative to the housing 50, thereby applying pressure to the actuator. The teeth 124 of the motor 120 move toward the teeth 118 of the locking nut 90. They thread together, thereby defining the engagement position of the actuator 120 .

[0029] The system 30 includes a biasing member 128 operably coupled to the actuator 120. The biasing member 128 biases the actuator 120 to the disengaged position. The actuator 120 is fitted with a coil spring configured to engage a recess 129 on the bottom side of the actuator 120. 9 shows the biasing member 128 consisting of the actuator 120 in the engaged position. 4, the coil spring is connected to the actuator 120 and the housing 50. Thus, the biasing member 128 urges the lever 126 away from the housing 50. As a result, the force exerted by the biasing member 128 When a secondary input exceeding the biasing force is applied to the second control surface portion 122, the actuator 12 0 moves from the disengaged position to the engaged position. Conversely, when the secondary input is removed from the second control surface portion 122, When engaged, the biasing member 128 moves the actuator 120 from the engaged position to the disengaged position. Alternatively, the biasing member 128 is configured to bias the actuator 120 toward the disengaged position. The clamping force may be a torsion spring, spring clip, constant force spring, or other suitable mechanism.

[0030] Alternatively, a biasing member may be coupled to bias the actuator 20 to the engaged position, and a second A secondary input applied to the control surface portion 122 of the actuator 120 moves the actuator 120 from the engaged position to the disengaged position. In this example, a configuration in which the The engagement feature 98 of the locking nut 90 may, for example, be The teeth are designed to engage with teeth (not shown) located on the side opposite the The second control surface portion 122 is adapted to engage with the engagement feature 98 when no further input is applied to the second control surface portion 122. The actuator 120 is positioned away from the lock nut 90 (for example, Furthermore, the actuator 120 is biased toward the locking nut 90. The second control surface portion 122 is operably connected to the teeth located on the opposing side. Upon application of the force, the actuator 120 moves toward the housing 50, thereby , disengaging the teeth from the engagement feature 98 against the biasing force applied by the biasing member. The nut 90 is no longer constrained by the teeth that are rotatably fixed relative to the housing 50. and rotation about a translation axis for reasons described throughout this disclosure. It becomes possible.

[0031] When the actuator 120 is in the engaged position, a primary input is applied to the first control surface portion 60. When the lead screw 62 is engaged with the locking nut 90, the lead screw 62 moves about the translation axis. This results in rotation of the lead screw 62 and distal translation of the lead screw 62 along the translation axis. Distal movement of lead screw 62 moves plunger 42 distally within dispensing chamber 34. The curable material in the dispensing space 34 is compressed and / or pushed out of the distal outlet 3 8. Exemplary surgical procedures for use with the curable material dispensing system 30 include: That is, in the case of vertebroplasty, the curable material is dispensed into the extension tube 190 and introduced into the cortical bone. The inserted access cannula is guided into the cancellous region of the vertebral body.

[0032] Additionally, for various reasons, for example, a surgeon may wish to deliver a curable material to the cancellous region of a vertebral body. As mentioned above, one example of a bad practice is It is known that excessive amounts of hardening material can be introduced into the vertebral body. Despite this, many known systems produce "drupe" and require additional hardening agents. Many advantageous features of the system 30 of the present disclosure include: One feature is that the lead screw 62 (and plunger 42) moves proximally to increase the dispensing volume. The primary objective of the present invention is to minimize or eliminate drool from the distal exit 38 of the endoscopic catheter 34. As such, the female threads 92 of the locking nut 90 and the male threads 94 of the lead screw 62 are actuated. When the actuator 120 is in the disengaged position, the lock nut 90 is rotated about the translation axis. The rotation of the locking nut 90 causes the plunger 42 to move in a parallel direction. The distal outlet 38 is movable proximally along the axis of movement, as opposed to applying a vacuum via the distal outlet 38. and at least partially decompressing the compressed hardenable material within the dispensing space 34. More is possible.

[0033] Referring again to FIG. 4, the system 30 with the actuator 120 in the engaged position is Specifically, a lever 126 is located adjacent to the housing 50 and serves as a second control. The actuator 120 has a tooth 122 that is substantially flush with the housing 50. 24 engages teeth 118 of lock nut 90, thereby locking lock nut 90 against the housing. As previously mentioned, the first control surface portion 60 is fixed to the first control surface portion 60. Application of an input torque of 1 causes rotation of the leadscrew 62 relative to the locking nut 90, thereby increasing the feed rate. Further advancement occurs in the distal direction (D) along the translation axis (TA) of the lead screw 62. Distal advancement of plunger 62 advances plunger 42 distally, and in response The curable material (CM) is compressed in the dispensing space 34 (see FIG. 5). Under dynamic conditions, the curable material can be applied at 200 psi (pounds per square inch), 500 psi, and 1 It is recommended that the material be compressed to 000 psi, 3000 psi, or 5000 psi or higher. Compression of the material exerts a force on plunger 42 in the proximal direction (P) along the translation axis. can be.

[0034] If the surgeon desires to immediately stop delivery of hardenable material from dispensing space 34, If so, simply remove the secondary input applied to the second control surface portion 122. The biasing member 128 biases the actuator 120 away from the housing 50, thus preventing engagement. When the secondary input is removed, the teeth of the actuator 120 are biased from the engaged position to the disengaged position. 124 automatically disengages from the teeth 118 of the engagement feature 98 of the lock nut 90. The set 90 is rotated by an actuator 120 fixed to the housing 50. The object is no longer constrained and is able to rotate about the translation axis.

[0035] Rotation of the locking nut 90 about the translation axis causes the lead screw 62 to rotate about the translation axis. The lead screw 62 is movable proximally along the The force applied to plunger 42 from the compressed hardenable material causes the plunger 42 to move along the translation axis. The lead screw 62 translates proximally without rotating. This is because the lock nut 90 does not translate but rotates around the translation axis. It is also possible that some translation of the lock nut 90 may be provided or occur. The proximal translation of the lead screw 62 contacts the compressed curable material. The accessible dispensing space 34 expands. In other words, the chamber 34 is expanded distal to the plunger 42. The portion of the dispensing space 34 defined within the member 32 expands. at least partially within the enlarged portion of the dispensing space 34 accessible to the curable material. Additionally, in many cases, the diameter of the chamber 32 is larger than the diameter of the distal outlet 38. Therefore, even a minimal movement of the plunger 42 in the proximal direction will result in a large amount of fluid in the dispensing space 34. In other words, the compressed curable material is compressed into the distal In contrast to when exiting the outlet 38, the fluid encounters little resistance within the expanded portion of the dispensing space 42. In view of the viscosity of the partially compressed curable material, the curable material may be compressed to the dispensing space 34. The pressure is reduced sufficiently to reduce the pressure gradient between the surgical site and the hardenable material. The note system 30 minimizes or eliminates the possibility of drool.

[0036] Movement of the lead screw 62 in the proximal direction is achieved by the engagement of the female threads 92 of the locking nut 90 with the lead screw 62. 2. In other words, the female threads of the locking nut 90 92 and the external threads 94 of the lead screw 62 are configured to provide a back-driveable system. A back-driveable system is defined by a screw efficiency greater than 50%. The locking nut 90 has an internal thread 92 and the lead screw 62 has an external thread 94. If the thread efficiency is, for example, the pitch of the threads 92 and 94, the friction between the threads 92 and 94, If it is less than 50% based on friction, etc., the system 30 is not back-driveable and the locking nuts are The screw 90 is driven by a lead screw 62 which is biased proximally by a compressed hardenable material. In other words, the compressed hardening material prevents the The proximal force applied to plunger 42 and lead screw 62 is given by Equation 1 below: The torque applied to the locking nut 9 is greater than the rearward drive torque (Tb) of the system 30, which is expressed as is added to 0.

number

[0037] In addition to minimizing or eliminating drubbing, the lead screw of the system 30 includes screw efficiency. The 62 design provides several additional benefits, which are described below. First, the compressed rigid The force (e.g., back pressure) exerted on plunger 42 by the reactive material causes system 30 This is efficiently transmitted to the surgeon's hand, specifically to the first control surface portion 60. This improves the surgeon's sense of touch and allows for accurate visualization of the fluid dispensed from the dispensing space 34 during use of the system 30. In other words, the amount of friction in the system 30 is further improved. Losses are minimized, thereby achieving more precise control. A first input torque to the first control surface portion causes a predictably accurate amount of fluid to be dispensed from the dispensing section 34. Second, efficiency does not come at the expense of the improved tactile sensation afforded to the surgeon. The mechanical advantages of the system 30, among others, limit surgeon fatigue and provide robustness. The benefits of avoiding lost surgical time that can compromise non-surgical systems are substantially preserved. Third, the protected mechanical advantage of the system 30 allows the surgeon to apply input torque. The compressed hardenable material is rapidly delivered to the patient (i.e., "fast start"). In other words, the lead screw 62 is a well-known shaft with significant friction losses. A slight rotation of the stem allows the same amount of curable material to be dispensed into the patient. In one example, it is about 0.8 to 1.0 cm 3 The hardening material loses sufficient mechanical advantage The lead screw is delivered for every 360° of rotation of the first control surface portion 60 without any movement. In known systems, the amount of curable material delivered per 360° rotation is 0.5 cm 3 otherwise limited to less than 1000kJ / s by friction losses associated with high pitch lead screws. Requires undesirably high input power from the surgeon, with associated fatigue and work time The female threads 92 of the locking nut 90 and the male threads 94 of the lead screw 62 are , may be modified to change the characteristics of the rapid start, if desired. Similarly, lubricants and / or coatings may be applied to the lead screws 62 and / or 64 to improve quick start characteristics. Alternatively, it may be applied to the locking nut 90 .

[0038] In particular, during the retraction of the system 30, the plunger 42 and the lead screw 62 move proximally. When moving, the lock nut 90 may be limited or eliminated from translation along the translation axis. Specifically, limiting or eliminating translation of lock nut 90 along the translation axis is desirable. This allows the lock nut 90 to move more efficiently about the translation axis for the reasons previously discussed. Therefore, one or more locking nuts 90 located adjacent to or against the locking nuts 90 will rotate. It is conceivable that the bearing 65 may comprise a plurality of bushings 63 and / or one or more bearings 65. 6 and 8 show a system 30 comprising two bushings 63 with bearings 65. The bearing 65 is a thrust bearing located adjacent to the two bushings 63. Suitable means for reducing friction other than those mentioned above, such as ball bearings, needle bearings, lubricants, coatings, etc. The tolerances between the bushing 63, the bearing 65, and the proximal ring 48 are Designed to minimize or eliminate proximal translation of lock nut 90 along the axis of translation and bearing 65 is configured to facilitate rotation of lock nut 90 about the translation axis. It has been completed.

[0039] The plunger 42 releases the compressed hardenable material within the dispensing cavity 34. When urged proximally along the translation axis by a force applied to 42, an axial force is transmitted. The force is transmitted to the locking nut 90 which is threaded onto the lead screw 62 and the chamber fixture 4. At least a portion of the proximal ring 49, in particular the proximal ring 49, defines a load bearing surface 67 and is compressed. associated with the significant forces transmitted from the applied hardenable material to the leadscrew 62 and locking nut 90. The chamber is configured to be subjected to stress, strain, fatigue, wear, etc. The fixture 44 is sized to receive the locking nut 90, the bushing 63, and / or the bearing 65. The locking nut 90, the bushing 63, and the locking nut 90 define a regular cavity 47. The axial force is applied to the locking nut 90, the bushing 63, and the locking nut 90. and bearings 65 to a load bearing surface 67 fixed to the chamber 32 and supporting members 4 facing each other. 5. In such an instance, the housing 50 is considered not to support the load. Therefore, it is possible to use less rigid materials and / or less complex manufacturing processes. Specifically, the cavity 47 that accommodates the locking nut 90 may be formed by effectively integrated within chamber 32 (via opposing support members 45), so that When the chamber 32 is connected to the housing 50, the compressed hardenable material is compressed into the lead screw. The forces transmitted to 62 and locking nut 90 are absorbed or dissipated within chamber 32 itself.

[0040] Other suitable designs for the chamber 32, chamber fixture 44, and / or housing 50 are also contemplated. In one example, the second control surface portion 122 may be operatively coupled to the chamber 32 (rather than the housing 50) and to the second control surface portion 122. The coupled engagement features 98 are adapted to engage the teeth 118 of the lock nut 90 as previously described. In such an example, (e.g., at the pivot point of the lever 126) Any load on the second control surface portion 122 is absorbed or dissipated within the chamber 32 itself; It will not be supported by the housing 50.

[0041] As detailed above, the curable material dispensing system 30 is configured to operate when the actuator 120 is in the engaged position. When in the position, the first control surface portion 60 receives a primary input (e.g., a first input signal to the steering wheel 68). When the plunger 42 receives the torque, the plunger 42 advances distally in response. This allows the surgeon to apply a secondary input with one hand to the second control surface portion 122, thereby actuating the actuator. While maintaining the rotor 120 in the engaged position, with the other hand, apply a first input torque to the first control surface portion 60. For various reasons, the surgeon may wish to place the first hand on the first control surface. 60. In most cases, the surgeon continues to apply the first input torque. To replace the hand, the first hand would be removed from the first control surface. The surgeon then performs the surgical procedure with one hand while supporting the system 30 with a second hand. However, the lead screw 62 and locking nut may need to be removed. Based on the manner in which the rearward drive of the actuator 90 can be performed (while maintaining the actuator 120 in the engaged position), When the temporary input is removed from the first control surface portion 60, the compressed solidified material in the dispensing space 34 is released. The elastic material rotates (and moves proximally) the plunger 42 and lead screw 62, which In response to this, the first control surface portion 60 is rotated. When 120 is in the engaged position, threads 92, 94 cause lead screw 62 to engage with the housing The rotation of the locking nut 90 is threadedly engaged with the locking nut 90, which is rotatably fixed to the locking nut 50. Rotation of lead screw 62 at impairs distal advancement of plunger 42, The surgeon is reluctant to do so and must return plunger 42 to its original position before continuing with the procedure. To overcome this drawback, the curable material dispensing system 30 includes a one-way torque mechanism. It has 130.

[0042] Referring to FIGS. 2 to 5, 9, 14, and 15, the one-way torque mechanism 130 is The one-way torque mechanism 130 is operably coupled to the first control surface 60. Allows rotation of the face 60 in a first direction (e.g., R1 in FIG. 2) about a translation axis. 2) about the translation axis of the first control surface portion 60. More specifically, the one-way torque mechanism 13 is configured to substantially prevent rotation. 0 indicates that the lead screw 62 is rotating while a first input torque in a first direction is applied to the handle 68. and when the first input torque is removed, the proximal advancement of the lead screw 62 is As a result, the surgeon is free to rotate the handle 68 in a first direction. , advance plunger 42 distally a desired amount, and then release the distal end of plunger 42. The handle 68 can be re-grasped without compromising directional advancement and / or surgical procedure. Other procedures can be performed.

[0043] The one-way torque mechanism 130 includes a ratchet member such as a ratchet ring 132 and a small Preferably, the ratchet mechanism has at most one pawl 134. The pawl 134 is attached to the handle 6. 9 is seated in a recess 136 defined by a flange 137 connected to the casing 8. , shows lugs 138 extending radially outward from the shaft 80 of the handle 68. The lug 138 is disposed coaxially with the translation axis. The lug 138 is attached to the proximal end of the handle 68. The shaft 80 may be provided at any suitable location between the first end 70 and the distal end 72. There may be more than one recess 136, for example, two recesses 136 located on either side of the lug 138. The claw 134 is at least partially seated within the recess 136. A biasing element 144 is provided to bias the handle 68 and the pawl 134. A biasing element 144, such as a coil spring or a torsion spring, is operably connected to the The claws 134 are biased radially outward, thereby causing the claws 134 to contact the outer periphery of the lug 138. 132. The ratchet ring 132 is then exposed beyond the recess 134 and engaged with the ratchet ring 132 as described below.

[0044] The ratchet ring 132 is disposed coaxially with the translation axis and engages with the lug 138 of the handle 68. The ratchet ring 132 is aligned coaxially with the lug 138. More specifically, the lug 138 is oriented toward the claw 134 seated within the lug 138. 9 and 14. When the ratchet ring 132 is rotated, the inner surface 146 and the claw portion 134 connected to the lug 138 are in contact with each other. 13 and 14. The control surface portion 60 is operatively connected to the first control surface portion 60 at the interface between the first control surface portion 60 and the second control surface portion 60. 14, the ratchet ring 132 has an inner surface 146 opposite an outer surface 148. , defines the proximal portion 150 of the ratchet ring 132. The inner surface 146 of the piston ring 132 is provided with ratchet teeth 152 circumferentially disposed about the inner surface 146. Each of the ratchet teeth 152 is asymmetrical and has a rear end facing a first direction (R1) and a rear end facing a second direction (R2). The first input torque in the first direction is defined by a tip pointing in a second direction (R2). When the handle 68 and the claws 13 connected to the handle 68 are pressed against the main control surface 60, 4 rotates in a first direction about a translation axis. The pawl 134 biased toward the tip of the ratchet tooth 152 comes into contact with the tip of one of the ratchet teeth 152. Due to the shape of the inner surface 146 (e.g., a sloped surface), the claws 134 are urged away from the inner surface 146. When biased, the biasing element 144 moves the pawl 134 past each of the ratchet teeth 152. The locking nut 90 is fixed so as to be rotatable about a translation axis. Assuming that the first control surface portion 60 rotates with relatively little resistance, , the lead screw 62 will advance distally.

[0045] When a second input torque is applied to main control surface 60 in a second direction, handle 68 The pawl 134 connected to the handle 68 is positioned so that the pawl 134 is in contact with one of the ratchet teeth 152. The ratchet 152 rotates in a second direction about the translation axis until it engages the rear end. The rear end of the claw portion 134 and the tip of the claw portion 134 are provided with a mechanism that allows the main control surface portion 60 to overcome the obstacle (described later). tightly together so that they cannot rotate further in the second direction (if not already in place) Thus, the one-way torque mechanism 130 is configured to engage the first control surface portion 6 0 translation axis in a first direction, and the translation of the first control surface portion 60 The second input is configured to substantially prevent rotation in a second direction about the drive axis. The force torque is exerted proximally by the influence of the compressed curable material within the dispensing space 34. It should be understood that this occurs due to the lead screw 62 being connected to the one-way torque mechanism 13. 0 is the main control (when the locking nut 90 is fixed for rotation about the translation axis) The lead screw 62 rotatably fixed to the face 60 is prevented from moving proximally.

[0046] Upon activation of the curable material dispensing system 30, an audible indication and / or tactile feedback is provided. The one-way torque mechanism 130 allows the surgeon to hear the surgeon holding the handle. The device is configured to provide an impact that can be felt by the surgeon's hand and / or the impact can be felt by the surgeon's hand. In one non-limiting example, the biasing element 144 may urge the pawl 134 against the ratchet ring 132. The pawl 134 is biased toward the inner surface 146 of the ratchet ring 1 in the first direction. When the biasing element 144 passes over the rear end of each of the pawls 52, the biasing element 144 elastically deforms, thereby A slight gap is momentarily created between the ratchet teeth 134 and the inner surface 146. The rear end of 152 is a "plateau" against the inner surface 146 of the ratchet ring 132. The biasing element 144 is elastically deformed at the rear end, and the biasing element 144 is shaped like a Immediately afterwards, the claw portion 134 presses against the inner surface 146, quickly closing the gap that has been created. This impact between 146 provides an audible indication and tactile feedback to the surgeon. In this case, the pawl 134 and the ratchet ring 132 may be made of a material such as metal or plastic. The ratchet ring 132 may be formed of a When the claw 134 strikes the claw 146, it produces a "click." , by the appropriate force felt by the surgeon's hand holding the handle 68, the ratchet It is preferable that the impact is made on the inner surface of the ring 132 .

[0047] With further reference to FIG. 14, the ratchet teeth 152 are formed on the inner surface 1 of the ratchet ring 152. 46. ​​As a result, the first The angular displacement of the rotation of the control surface portion 60 corresponds to each of a series of audible indications and / or tactile feedback. If the locking nut 64 is rotated while applying the first input torque to the first control surface 60, If 90 is fixed for rotation about a translation axis, evenly spaced ratchet The angular displacement corresponding to each of the teeth 152 is the angular displacement of the lead screw 62 and plunger 64 along the translation axis. 42. Further, the feed along the translation axis is related to a certain distance of distal advancement. A certain distance of distal advancement of the screw 62 and plunger 42 is required to remove the dispensed material from the dispensing space 34. The amount of compressed hardenable material that is compressed may be associated with a certain amount of hardenable material that is compressed. For example, a series of audible indications and / or The tactile feedback indicates the amount of 0.05 cc, 0.10 cc, or 100 cc dispensed from the dispensing cavity 34. c, 0.25cc, 0.50cc, or 1.0cc. A series of audible indications and The constant amount associated with each of the haptic feedback and / or the haptic feedback may be determined, at least in part, by the laser. circumferential spacing between the teeth 152 of the locking nut 90 and the male threads 92 of the lead screw 62 The pitch of the screw thread 94 is based on the pitch of the screw thread 94. If the chamber 32 is made of a transparent material, The movement of the plunger 42 is visualized through the chamber 32, allowing the hardenable material to be The audible indication and / or tactile feedback associated with the quantification may be used to allow the surgeon to By providing additional means configured to evaluate the amount of curable material dispensed from become.

[0048] Alternatively, the one-way torque mechanism 130 may rotate the pawl 134 against the inner surface 11 of the ratchet ring 132. 46. ​​In this case, the biasing element 144 may not be provided. The following material is used: the pawl 134 moves past each of the ratchet teeth 152, In the first direction, the ratchet teeth 152 move past the rear ends of the ratchet teeth 152, and in the second direction, so that it returns to its original shape after passing the rear end of the ratchet teeth 152 (contacting the inner surface 146). , a resilient material configured to deflect under force from ratchet teeth 152, a semi-rigid material, and The ratchet ring may be made of a material such as a rubber and / or a shape memory material (e.g., nitinol). The ring may have alternative shapes and forms other than those shown, for example, polygonal shapes. It should also be understood that in some instances, the one-way torque mechanism 130 may be The clutch may have a drive wheel configured to engage the wheel. Other configurations that provide unidirectional rotation between structures may be incorporated into the systems of the present disclosure. .

[0049] As described in detail above, the curable material dispensing system 30 is configured to position, the proximal movement of the lead screw 62 along the translation axis is accordingly A biasing member 128 biases the second control surface 122 against the locking nut 9. 0 (i.e., the second bias is applied to move the actuator to the release position). In this example, the lever 126 or control surface is a so-called "dead-time Simply releasing lever 126 acts as a "dead man's switch." Additionally, for various reasons, surgeons may wish to: For example, the movement of the lead screw 62 along the translation axis in relation to the opening of the "dead man switch" It may be desired to provide a proximal translation. It is typically the screw that provides the proximal movement of the two, rather than the one-way torque mechanism 130. It will be easy to see that it is Mount Ji 92, 94.

[0050] The curable material dispensing system 30 includes a surmountable one-way mechanism 160. The one-way mechanism 160 operably couples the first control surface portion 60 and the housing 50 together. The overcomeable one-way mechanism 160 is configured to provide a torque threshold value when the first control surface portion 60 exceeds the torque threshold value. 2 torque input, the lead screw 62 is accordingly allowed to move proximally. Additionally, the overcomeable one-way mechanism 160 prevents the second input torque from exceeding the torque threshold. When the lead screw 32 is in the axial direction, the lead screw 32 is prevented from moving proximally. 0 indicates that the lead screw 62 is moved proximally by the influence of the compressed hardenable material within the dispensing space 34. When biased to the side (e.g., when the surgeon displaces his / her hand), the second direction of the handle by the surgeon who intends to apply sufficient torque to the main control surface 60 while preventing rotation. to allow rotation of the handle 68 in a second direction, resulting in proximal translation of the lead screw 62. The torque threshold is set as described below (collectively referred to as 172). ) The clutch mechanism is based primarily on the frictional relationship between the female threads 92 and the male threads 94. It should be understood that this may also be based on friction, the force exerted by the compressed hardenable material, and the like. As a result, the torque threshold is increased, specifically, by the rearwardly driven, proximally biased lead screw 62. The torque threshold is set so that the typical torque applied to the handle 68 from the The latch mechanism 172 is designed to have a predetermined length.

[0051] The surmountable one-way mechanism 160 applies a first torque less than the torque threshold to the first control surface portion 60. The lead screw 62 is configured to allow distal advancement in response to an input torque of In other words, in the first direction, the handle 68 (for example, when the claw 143 is in the first 152 in the second direction), which is required for rotation of the handle 68 in the second direction. It can be easily rotated with a torque that is relatively smaller than the required torque. As the material is gradually compressed within the dispensing space 34, the force from the compressed hardenable material The first input torque required to advance the lead screw 62 distally is a torque threshold It should be understood that the increase is greater than

[0052] 3-5, 13, and 14, the overcomeable one-way mechanism 160 is In other words, the one-way torque mechanism 130 8. The one-way mechanism 160 shown in FIG. The torque mechanism 130 has a frictional relationship with the chamber fixture 44 which is fixed relative to the housing 50. The clutch mechanism 172 is defined at the friction interface (e.g., one-way torque The clutch mechanism 130 slides relative to the chamber fixture 44. is sufficient torque (above the torque threshold) for the ratchet ring 132 to overcome the frictional relationship. operatively coupled to the first control surface portion 60 in a first and second direction when receiving a lock input. This allows the rotation of the ratchet ring 132 (connected to the ratchet ring 132).

[0053] The ratchet ring 132 has an outer surface that defines a proximal portion 150 of the ratchet ring 132. The ratchet ring 132 has an inner surface 146 opposite a proximal portion 150. The distal portion 151 also includes a distal portion 151 coupled to the proximal portion 152 along a translation axis. Like the proximal portion 150, the distal portion 151 is located distal to the proximal portion 150. , 13, 15, the ring-shaped inner annular surface 174 and the outer annular surface 17 6. The outer annular surface 176 of the distal portion 151 is defined by the chamber fixture 44. and defines a clutch mechanism 172. Increasing the frictional relationship allows for a desired torque to be achieved. To achieve the threshold friction, one or more friction elements 180 are coupled to the outer annular surface 176. The proximal ring 49 of the spring 44 is provided at the interface between the spring 44 and the inner surface of the proximal ring 49 (FIGS. 3 to 5 and 6). 8). In other words, if a relatively large frictional relationship is associated with the clutch mechanism 172, If so, the surgeon applies a second input torque to the first control surface portion 60 that is greater than the frictional relationship. 13 and 14, and the lead screw 62 must be moved proximally along the translation axis. FIG. 14 shows a friction element consisting of an O-ring disposed within a recess in the outer annular surface 176 of the distal portion 151. Two or more O-rings may be provided. The O-rings are fixed to the chamber. It has a thickness somewhat greater than the depth of the recess in order to contact the inner surface of the fixture 44 .

[0054] The clutch mechanism 172 is configured to apply first and second torque inputs that each exceed a torque threshold. configured to allow rotation of the first control surface portion 60 in first and second directions in response to and the one-way torque mechanism 130 allows rotation of the first control surface portion 60 in a first direction; configured to prevent rotation of the first control surface portion 60 in a second direction about the translation axis. Therefore, the one-way torque mechanism 130 and the clutch mechanism 17 are functionally integrated. 2, the first control surface portion 60 is configured to operate the first control surface portion 60 when the first input torque is less than the torque threshold value. It can be rotated in any direction.

[0055] The relative force of the compressed hardenable material within the dispensing cavity 34 and the movement of the claw 134 in a first direction The force of the biasing member 128 biasing the pawl 134 when it exceeds the ratchet teeth 152 at A first input torque of a first magnitude must be applied to the main control surface 60 to overcome the resultant force. The first input torque of the second magnitude is the torque associated with the clutch mechanism 172. The first magnitude is smaller than the second magnitude. The frictional engagement that defines mechanism 172 never occurs when handle 68 is rotated in a first direction. The pawl 134 is not overcome by the ratchet teeth 152 because it moves more easily past the ratchet teeth 152. However, in the second direction, the tip of the claw portion 134 The end tightly engages the ratchet teeth 152, further increasing the magnitude of the second input torque. The second input torque is applied from the handle 68 to the pawl 134. The force is then effectively transmitted to the ratchet teeth 152 of the ratchet ring 132. If the magnitude of the input torque is further increased, eventually the second input torque will become the torque The threshold is exceeded, thereby overcoming the frictional engagement of the clutch mechanism 172 and causing the ratchet ring 132 rotates relative to the chamber fixture 44 and therefore relative to the housing 50. The torque threshold is set to two to three times the first torque input required to rotate the steering wheel 68 in the first direction. When the lock nut 90 is in the engaged position, the torque threshold A second input torque exceeding the value causes the lead screw 62 to rotate proximally relative to the lock nut 90. The foregoing disclosure indicates that the surmountable one-way mechanism 160 advantageously moves the torque below a threshold. A first input torque of 0.150 results in distal advancement of the lead screw 62, and a torque below the torque threshold. and prevents proximal movement of the lead screw 62 by a full second torque input, exceeding the torque threshold. a second torque input configured to allow proximal movement of the lead screw 62. As a result, the actuator 120 is engaged with the locking nut 90. The surgeon can then rotate the handle 60 relatively easily in a first direction to separate the The plunger 42 can be advanced distally within the injection cavity 32. , their hands may be removed from the handle to replace it (or for any other reason). However, at this time, the overcomeable one-way mechanism 160 prevents rotation of the handle 68 in the second direction. The surgeon can prevent the second control surface from rotating in two ways. By eliminating the secondary input torque to the portion 122 and / or by overcoming the frictional relationship. By rotating the handle 68 in the second direction with a relatively large force, the plan The jar 42 can be moved proximally.

[0056] In an alternative embodiment, at least a portion of the overcomeable one-way mechanism 160 is attached to the housing 50. For example, the surmountable one-way mechanism 160 may be rotatably fixed relative to the housing. Alternatively, the friction ring may be rotatably fixed to the ring 50. One control surface portion 60 is movable (e.g., rotatable) relative to the friction ring. In an alternative embodiment, the rear ends of the ratchet teeth 152 and the leading ends of the pawls 134 may be releasably engaged. The second torque input may be complementary shaped to provide a torque and causing rotation of the primary control surface portion 60 in the second direction when the threshold is exceeded. good.

[0057] Given the foregoing description of the curable material dispensing system 30, a method of operating the system 30 is described below. The following description will be given with reference to FIG. 16. The system 30 uses a first hand (FH) and a second hand (SH). The first hand (FH) and the second hand (SH) are operated by a surgeon with a palmar view. (P) and the index finger (I), middle finger (M), and thumb (T) extending from the palm (P). (See FIG. 21.) The housing 50 is supported by the palm of the surgeon's second hand. A secondary input is applied to the second control surface portion 122 to move the control surface portion 122 from the disengaged position to the engaged position. 122. The secondary input is applied to the second hand while the second hand is supporting the housing 50. For example, the finger, middle finger, and / or thumb of the second hand may be used while the other hand is touching the other hand. The actuator 120 moves to engage the lock nut 90 and rotates the lock nut about a translation axis. The second control surface portion 122 is provided with a biasing member 128 to prevent rotation of the seat 90. While the primary control surface 60 is being supported by the first hand, the primary control surface 60 is maintained in the engaged position against the force of the first hand. The second control surface portion 122 is supported by the index finger, middle finger, and / or thumb of the second hand. do.

[0058] A primary input is applied to the first control surface portion 60 while the second control surface portion is held in the engaged position. The primary input may be rotation by the index finger, middle finger, and / or thumb of the first hand; The first control surface portion 60 is rotated in a first direction about a translation axis by a forward torque mechanism. This allows the lead screw 62 to move distally with relative ease. Distal movement of the lead screw 62 along the translation axis causes a The hardenable material in the second control surface portion 122 is then compressed. Secondary input is excluded. Specifically, when the first control surface 60 is supported by the first hand, While supporting the housing 50 with the palm of the second hand, the index finger, middle finger, and / or the thumb may be moved away from the second control surface portion 122. The biasing member 128 may The actuator 120 moves the surface 122 elastically from the engagement position to the disengagement position. 10. The locking nut 90 is then released from the locking nut 90. This causes the locking nut to move about the translation axis. 62 along the translation axis in the proximal direction, causing the compressed The material is allowed to be at least partially decompressed within the dispensing space 34 .

[0059] According to another exemplary method of curable material dispensing system 30, actuator 120: Initially, the lock nut 90 is biased into engagement by the force applied by the biasing member 128. In other words, the locking mechanism is actuated without a secondary input being applied to the second control surface portion 122. The locking nut 90 is fixed so as to be rotatable about a translation axis. In the state where the primary input is rotatably fixed by the actuator 120 in the position A force is applied to the first control surface portion 60. A secondary input is then applied to the second control surface portion However, this secondary input exceeds the force applied to the biasing member 128 and causes the actuator 120 to This allows the lock nut 90 to move along the translation axis. 62. The lead screw 62 is then rotatable about the axis of translation, causing proximal translation along the axis of translation of the lead screw 62. and at least partially decompressing the compressed hardenable material within the dispensing space 34. The secondary input is removed from the second control surface portion 122, and then the biasing member 128 The actuator 120 returns to the engagement position with the locking nut 90. The threaded engagement between the female threads 92 and the male threads 94 of the lead screw provides a distal translation of the lead screw along the translation axis. This causes a translation of the curable material in the dispensing space 34, compressing the curable material. The curable material is dispensed from a distal outlet 38 of the chamber 32 which communicates with a dispensing space 43 .

[0060] Referring again to FIG. 16 and with further reference to FIG. 1, as previously mentioned, the extension tube The extension tube 190 is connected to the distal coupling 46 of the chamber 32. The surgical instrument is connected to a surgical instrument fixed within the patient, e.g., an access cannula that penetrates a bony structure. The extension tube 190 is configured as follows. The extension tube 190 is connected to an elbow-shaped joint 192. and a flexible tube 194 rotatably and / or pivotably connected to the flexible tube 194. The soft tube 194 may be made of flexible piping, but may be made of piping having appropriate rigidity. It is also contemplated that the components of the extension tube 190 may be rigid in compression. It should further be understood that the nozzle may be configured to withstand the pressures associated with dispensing the chemical material. For example, the extension tube 190 can be used with 200 psi (pounds per square inch), 500 psi, and 1 Constructed to withstand pressures of 1000 psi, 3000 psi, or 5000 psi or greater are.

[0061] The elbow coupling 192 is removably coupled to the distal coupling 46 of the curable dispensing system 30. When the elbow connector 102 is connected to the distal connector 46, 1, elbow 192 is in fluid communication with distal outlet 38 and dispensing cavity 34 of system 30. The elbow 192 may comprise a relatively short, tubular or hollow rigid structure. Tubing 194 provides a fluid connection between the flexible tubing 194 and dispense chamber 34 of the system. It is connected to elbow 192 to achieve communication.

[0062] As shown in FIG. 16, the elbow 192 includes a flexible tube 194 and a first axis A1. The pivot joint 200 is configured to articulate about the elbow joint 192. articulates flexible tube 194 relative to elbow 192 about second axis A2. The second axis A2 is preferably perpendicular to the first axis A1. Thus, the aforementioned flexible tube 194 is related to the system 30 in at least two degrees of freedom. It is capable of articulating (for example, pivoting about a first axis A1 and a second axis A2) The extension tube 190 is connected to a flexible tube 194. The device further includes a cannula assembly 206. The cannula assembly 206 is secured within the patient. configured to be removably coupled to an attached surgical instrument, e.g., an access cannula. This places the bone structure in fluid communication with the dispensing chamber 34 of the system 30. For example, during vertebroplasty, the hardenable material may extend the extension tube 190 and access cannula. The cannula assembly 206 is inserted through the cannula assembly 206 and dispensed into the cancellous region of the vertebral body. The third axis A3 is configured to rotate around the third axis A3. Tubing 190 rigidly secures curable material dispensing system 30 within the patient. It is possible to articulate with respect to the surgical instrument in at least three degrees of freedom (e.g., A first axis A1 is rotatable about a second axis A2, and a third axis A3 is rotatable about a third axis A4. A3). Furthermore, the flexibility of the flexible tube 194 allows for additional A "quasi" degree of freedom is achieved (i.e., the surgeon has "true" autonomy). Although it is not a flexural joint (e.g., a linear joint), the bending of the flexible tube 194 allows the system 3 0 relative to the surgical instrument). The extension tube 190 of the present disclosure The advantage is that the patient and the surgical instruments can be moved without placing undue stress on the surgical instruments rigidly fixed within the patient. It can provide the surgeon with improved control over the surgical site. In fluoroscopic procedures, surgeons can easily see the system while avoiding unnecessary exposure to radiation. The fluid communication between the endoscopic tube 30 and the interior of the bone structure can be well maintained. The several degrees of freedom afforded by the probe 190 allow the surgeon to The screen allows you to step away from the surgical area while maintaining control of the system 30. be.

[0063] A further advantage of the extension tube 190 of the present disclosure is that it simplifies packaging, shipping, and / or In known systems, flexible tubing is inserted into the dispensing system immediately prior to use. This will need to be done with other tasks associated with the surgery. Instead, flexible tubing is pre-attached to the dispensing system, which wastes time and resources. If so, the package must be large enough to accommodate the structure. Storage of such dispensing systems in a closed container can, for example, take up excessive space in the storage compartment. In any case, the dispensing system with the flexible tubing is A significant portion of the tabletop space, and more specifically, a significant portion of the sterile field The extension tube 190 of the present disclosure encloses the curable material dispensing system 30 and occupies a space of about FIG. 17 shows a system and / or method for packaging a rigid body 210. Schematic of chemical material dispensing system 30, mixing and compression system 31, and extension tubing 190. 5, the distal coupling 46 is oriented on a translation axis. It can be seen that the chamber 32 is inclined at an angle, specifically 90°. Similarly, elbow 192, as its name suggests, is a flexible tube 19 4 is inclined at an angle to the connection interface between elbow connector 192 and distal connector 46. 1 and 17, such a configuration allows the flexible tube 194 ( The chamber 32 of the curable material dispensing system 30 and the flexible tube 194 are arranged substantially parallel to each other. The extension tube 190 and the rigid Material dispensing system 30 is unnecessarily large to accommodate a flexible tubing 194 of sufficient length. The assemblies are connected to each other before packaging and are tightly nested within the package 210. It would be good to do so.

[0064] The curable material dispensing system 30 is prepared, and the elbow 192 is attached to the distal end of the chamber 32. body 46, thereby providing a fluid connection between the cannula coupling 206 and the dispensing space 34. The extension tube 190 is positioned such that the chamber 32 and elbow 192 are substantially parallel to each other. The flexible tube 194 is generally parallel to the elbow 196, and is spaced apart from the dispensing space 34. This deployed configuration is shown in Figure 16. In this configuration, elbow 192 and flexible tube 194 are offset from one another. The tube 194 is articulated about an elbow 196 from the deployed configuration to the aforementioned packed configuration. In the packaged configuration, the elbow 192 and flexible tube 194 are substantially parallel. The flexible tube 194 is positioned toward the dispensing space 34 relative to the elbow 196. The packaged configuration is shown in Figure 1. In the packaged configuration, the flexible tube 194 is attached to the housing 5 0. Then, the curable material dispensing system 30 in its packaged form and the extension The tubing 190 is adapted to accommodate the curable material dispensing system 30 and the extension tubing 190. The package 210 is placed in a package of sufficient size. The package 210 is filled with a sterilizing agent and hardened. The extension tube 190 is also provided with a flexible material dispensing system 30 that allows contact with various surfaces. The packaging body 210 is preferably a plastic housing that accommodates the sterility of the curable material dispensing system and extension tubing 30 (e.g., It is preferable that the container be configured to maintain airtightness.

[0065] The extension tube 190 is preferably maintained in its packaged form after being removed from the package 210. The curable material dispensing system 30 is operated with the extension tube 190 kept in the packaged state. By placing it in the room, several benefits are achieved: Whether placed on a back table or a Mayo stand, the curable material dispensing system The system 30 is placed in a very small space within the sterile field, specifically, It takes up very little space where other surgical instruments and items (which may be necessary) are placed. Furthermore, in practice, known systems often require a back table and a Mayo stand. The flexible tube is placed over the table or stand, allowing it to extend beyond the perimeter. If any part of the tube extends outside the sterile field, the risk of contact with non-sterile items increases and the operating room becomes unusable. Increased risk of being accidentally knocked off a table or stand by a moving person The curable material dispensing system 30 with the extension tube 190 of the present disclosure attached thereto is the aforementioned During a surgical procedure, once dispensing chamber 34 receives the hardenable material, When the system 30 is ready for use, the extension tube 190 is unfolded from its packaging. It is advisable to quickly transition to this form.

[0066] As discussed throughout this disclosure, one of the many advantages of system 30 is the In some cases, the purpose of the present invention is to minimize or eliminate the possibility of drubbing. It may be desirable to provide a secondary mechanism to minimize or eliminate The curable material delivery system 30 includes a flow diverter and a drool accumulator (described below). Examples of suitable flow dividers and drool accumulators are: , commonly owned international patent application no. PCT / US2018 / filed February 22, 2018 No. 019211, the contents of which are incorporated herein by reference. The flow divider and drool accumulator shall be connected to the extension tube 19. The first diverter outlet is connected to a location opposite chamber 32 of the first diverter outlet. An aspiration catheter positioned within the patient (e.g., penetrating a bone structure) for selective delivery to a target site. a reservoir configured to be coupled to the second flow diverter outlet; A valve is provided and configured to selectively operate between the first and second configurations. In the first configuration, fluid communication is established between the dispensing space 34 and the reservoir, and the dispensing The fluid communication between the inlet space 34 and the first diverter outlet is interrupted. In this configuration, fluid communication is established between the dispensing space 34 and the first diverter outlet, and the dispensing space 34 If the drain accumulator is If it is desired to direct the curable material contained within the device to the target site, A jar or other mechanism is adapted to be activated by the user. In the present invention, a system for dispensing a curable material includes a chamber defining a dispensing space, the chamber is configured to dispense the curable material through a distal outlet in fluid communication with the dispensing space. a chamber; a first control surface configured to receive a primary input from a user; a lead screw rotatably fixed to the first control surface, the lead screw having a proximal end and a distal end; an external thread disposed at least partially between the proximal end and the distal end; a lead screw having a translation axis defined between the lead screw and a distal end thereof; a plunger disposed within the dispensing space, the plunger configured to: In response, the actuator advances distally along the translation axis to compress the curable material within the dispensing space. a plunger; and an extension tube connected to the chamber, an extension tube defining a lumen in fluid communication with the dispensing space; and an inlet connected to the extension tube through the first diverter outlet; and a second diverter outlet. a flow diverter, the first and second flow diverter outlets each in fluid communication with a lumen of the extension tube; The flow diverter is in fluid communication with a delivery cannula configured to direct the curable material to the target site. a flow diverter configured to be coupled to the flow diverter; and a flow diverter configured to receive a remaining amount of the curable material. a dremel accumulator defining a reservoir formed by a second dispenser outlet and a and a drool accumulator defining a reservoir in fluid communication with the reservoir.

[0067] The foregoing description is not intended to be exhaustive or to define the present invention in any particular manner. The terminology used is not intended to be limiting. It is intended to be illustrative rather than representative. Many modifications and variations are possible and the invention may be practiced otherwise than as specifically described. It may be implemented.

Claims

1. 1. A system configured to dispense a curable material, comprising: a chamber defining a dispensing space, said dispensing space being adapted to dispense said curable material into said dispensing space; a chamber configured to dispense through a distal outlet in communication with the chamber; a first control surface configured to receive a primary input from a user; a lead screw rotatably fixed to the first control surface, the lead screw having a proximal end and a distal end; a distal end and an external thread disposed at least partially between the proximal end and the distal end. and a translation axis defined between the proximal end and the distal end. 、 a plunger coupled to the lead screw, the plunger being disposed within the dispensing space; In response to receiving the primary input, one control surface portion moves distally forward along the translation axis. and configured to compress the curable material within the dispensing space. Jar and a lock nut having internal threads that mate with the external threads of the lead screw and an engagement feature; An actuator having a second control surface portion, the second control surface portion comprising: and engaging the actuator and the locking nut in an engaged position, receiving a secondary input from the user to disengage the lock nut engagement feature to a disengaged position; an actuator and Equipped with The female thread of the locking nut and the male thread of the lead screw are providing rotation of the lock nut about the translation axis when in a disengaged position; allowing the plunger to move proximally along the translation axis; The curable material is at least partially depressurized within the dispensing space. The system is configured as follows:

2. a housing connecting the first and second control surfaces; The locking nut is secured to the housing when the actuator is in the engaged position. and the lead screw is fixed to the parallel movement axis via the locking nut. The system of claim 1 , wherein the system is configured to be advanced distally along a

3. a biasing member operably connected to the housing and the actuator; 、 The biasing member is configured to bias the actuator to the disengaged position.

3. The system of claim 2.

4. the engagement features being teeth arranged annularly around the locking nut; The actuator is configured to move in an arcuate fashion to selectively engage the annular teeth of the engagement feature. A system according to any one of claims 1 to 3, having complementary teeth arranged therein.

5. a lever defining the second control surface; The lever is pivotally connected to the housing; The biasing member is configured to bias the lever pivotally away from the housing. The system of claim 3 .

6. further comprising a biasing member operably coupled to the actuator; When the secondary input from the user to the lever is not present, the biasing member configured to bias the actuator pivotally away from the housing; 6. The system of claim 2, 3, or 5, wherein

7. The locking nut has a hub with the female thread and a toothed portion connected to the hub. and a ring gear, The ring gear is fixed to the hub so as to be rotatable relative to the hub. The system according to any one of claims 1 to 5.

8. the first control surface further comprises a handle; the handle having a lumen extending at least partially therethrough; the lumen is configured to slidably receive a proximal end of the lead screw. A system according to any one of claims 1 to 7.

9. the handle further includes a drive feature defining at least a portion of the lumen; The lead screw includes a bearing located at least partially between the proximal end and the distal end. further comprising a drive feature; The driven feature acts in a complementary manner to the drive feature of the handle and and transmitting the primary input from the first control surface portion to the driven feature. The system of claim 8 , wherein the system is configured to transmit the force to a thread.

10. The handle is disposed coaxially with the translation axis and is partially extendable from the interior of the housing.

9. The system of claim 8, wherein the

11. a one-way torque mechanism operably coupled to the first control surface; The one-way torque mechanism has a first control surface portion receiving the primary input comprising a first input. a first direction about the translation axis in the first control surface portion in response to the movement of the first control surface portion; and rotating the lead screw distally to advance the lead screw from the first control surface portion. and configured to prevent proximal movement of the lead screw upon removal of an input torque of one of the leadscrews. The system according to any one of claims 1 to 10,

12. a housing to which the first control surface is movably coupled; The one-way torque mechanism is movable while providing a frictional relationship with the housing. and defining a clutch mechanism, whereby the first control surface portion a second torque input from the user that exceeds a torque threshold sufficient to overcome the frictional relationship; the first control surface in a second direction opposite the first direction in response to receiving the The system of claim 11 , wherein the rotation of the part is enabled.

13. the one-way torque mechanism further comprises a ratchet mechanism; The ratchet mechanism includes: a ratchet ring arranged coaxially with the translation axis, the ratchet teeth being aligned with the ratchet ring; a ratchet ring circumferentially disposed around the inner surface of the ratchet ring; a pawl coupled to the first control surface and configured to engage with a ratchet tooth of the ratchet ring; a pawl configured to engage the lead screw and prevent proximal movement of the lead screw; 13. The system according to claim 11 or 12, comprising:

14. The ratchet mechanism includes a biasing mechanism configured to bias the pawl toward the inner surface. Further equipped with elements, The biasing element is configured to bias the first control surface portion in the first direction about the translation axis. In a rotating state, the pawl moves past one of the ratchet teeth of the ratchet ring. and configured to elastically deform when the claw portion is brought into contact with the inner surface. and returning the sensor, thereby providing an audible indication and / or tactile feedback to the user. The system of claim 13 further configured to:

15. the ratchet teeth are evenly spaced circumferentially around the inner surface; The front of the first control surface portion between the circumferentially equally spaced ratchet teeth The angular displacement in the first direction about the translation axis is The distance of distal advancement of the screw and the plunger is related to the distance of the distal advancement of the plunger.

15. The system according to claim 13 or 14.

16. in distal movement of the lead screw and the plunger along the translation axis. The fixed distance relates to a fixed amount of the compressed curable material dispensed from the dispensing space.

16. The system of claim 15,

17. a housing to which the first control surface is movably coupled; The first control surface portion is movable while creating a frictional relationship with the housing. and a clutch mechanism is defined, whereby the first control surface portion is a second torque input from the user that exceeds a torque threshold sufficient to overcome the frictional relationship; and, in response to receiving the signal, permitting rotation of the first control surface portion in the second direction. A system according to any one of claims 1 to 16.

18. a housing to which the first control surface is movably coupled; an overcomeable one-way mechanism operatively connecting the first control surface and the housing; Furthermore, The surmountable one-way mechanism may be configured to cause the first control surface portion to engage a first input torque less than a torque threshold. a first rotation about the translation axis in response to receiving the primary input comprising a force torque; and allowing distal advancement of the lead screw by rotation of the first control surface in a direction and a torque threshold value that is opposite to the first input torque and that is greater than the first control surface portion. In response to receiving a second input torque, the rotational axis moves in a direction opposite to the first direction about the translation axis. and rotating the first control surface portion in a second direction of the pair to move the lead screw proximally. The system of any one of claims 1 to 17, configured to enable:

19. The female threads of the locking nut and the male threads of the lead screw are threaded to a thread efficiency of greater than 50%. A system according to any one of claims 1 to 18, defined by

20. 1. A system configured to dispense a curable material, comprising: Housing and a dispensing space coupled to the housing and configured to dispense the curable material; a chamber for determining the temperature; a first control coupled to the housing and configured to receive a primary input from a user; The mask and a lead screw rotatably fixed to the first control surface, the lead screw having a proximal end and a distal end; a distal end and an external thread disposed at least partially between the proximal end and the distal end. and a translation axis defined between the proximal end and the distal end. 、 a plunger coupled to a distal end of the lead screw; a lock nut having internal threads that mate with the external threads of the lead screw and an engagement feature; an actuator coupled to the housing and having a second control surface portion, The two control surfaces engage the actuator and the locking nut engagement features in the engaged position. to disengage the engagement features of the actuator and the locking nut to a disengaged position. an actuator configured to receive a secondary input from a user; Equipped with The locking nut is secured to the housing when the actuator is in the engaged position. and preventing rotation of the locking nut about the translation axis. This allows the female thread of the locking nut and the male thread of the lead screw to align with the first In response to the control surface receiving the primary input, the lead screw moves along the translation axis. and causing distal advancement of the plunger to dispense the curable material into the dispensing space. The system is configured to compress the

21. a biasing member operably coupled to the housing and the second control surface; 、 The biasing member is configured to bias the second control surface portion to the disengaged position.

21. The system of claim 20.

22. The female thread of the locking nut and the male thread of the lead screw are such that the second control surface portion When in the disengaged position, the lead screw and the plunger move proximally along the translation axis. causing rotation of the lock nut about the translation axis as the lock nut moves to the side; allowing the compressed curable material to at least partially decompress within the dispensing space.

22. The system of claim 20 or 21, configured to:

23. The actuator is pivotally coupled to the housing and has a second control surface.

23. The system according to any one of claims 20 to 22, wherein the lever is a lever.

24. the engagement features being teeth arranged annularly around the locking nut; The lever has complementary teeth configured to engage the annular teeth of the locking nut.

24. The system of claim 23,

25. a one-way torque mechanism operably coupled to the first control surface; The one-way torque mechanism is configured such that the first control surface receives the primary input comprising a first input. a first control surface portion in a first direction about the translation axis in response to the movement of the first control surface portion; and rotating the lead screw distally to advance the lead screw from the first control surface portion. and configured to prevent proximal movement of the lead screw upon removal of an input torque of one of the leadscrews. The system according to any one of claims 20 to 24,

26. a housing to which the first control surface is movably coupled; The one-way torque mechanism is movable while providing a frictional relationship with the housing. and defining a clutch mechanism, whereby the first control surface portion a second torque input from the user that exceeds a torque threshold sufficient to overcome the frictional relationship; the first control surface in a second direction opposite the first direction in response to receiving the The system of any one of claims 20 to 24, wherein the system allows rotation of the part.

27. 1. A system configured to dispense a curable material, comprising: Housing and a dispensing space coupled to the housing and configured to dispense the curable material; a chamber for determining the temperature; a first control coupled to the housing and configured to receive a primary input from a user; The mask and a lock nut disposed within the housing and having an internal thread; a lead screw rotatably fixed to the first control surface, the lead screw being a proximal end, a distal end, and a stent disposed at least partially between the proximal end and the distal end. a translation axis defined between the proximal end and the distal end, The engagement of the male thread of the lead screw with the female thread of the locking nut causes the first control surface portion to In response to receiving the primary input in the direction of and compressing the curable material within the dispensing space. lead screw and a surmountable one-way mechanism operatively connecting the first control surface portion and the housing; The overcomeable one-way mechanism is configured to: distal advancement of the lead screw in response to receiving the primary input comprising an input torque. and wherein the first control surface portion is at least equal to the torque threshold in a direction opposite to the first input torque. a second input torque at least equal to the first input torque, the feeder screw by rotating the first control surface portion in a second direction opposite to the first direction; a surmountable one-way mechanism configured to allow proximal movement of the A system that includes:

28. The overcome one-way mechanism operably connects the first control surface portion and the housing. a one-way torque mechanism for connecting the The one-way torque mechanism allows rotation of the first control surface portion about the translation axis. and rotating the first control surface portion in the second direction about the translation axis. configured to prevent The one-way torque mechanism is movable while providing a frictional relationship with the housing. and defining a clutch mechanism, whereby the first control surface portion the second torque from the user exceeding a torque threshold sufficient to overcome the frictional relationship; In response to receiving an input, the first control surface portion is allowed to rotate in the second direction.

28. The system of claim 27,

29. the one-way torque mechanism further comprises a ratchet mechanism; The ratchet mechanism includes: a ratchet ring arranged coaxially with the translation axis, the ratchet teeth being on an inner surface thereof; a ratchet ring circumferentially disposed therearound; a claw connected to the first control surface, the claw configured to move parallel to the first control surface; a ratchet of the ratchet ring to prevent rotation in the second direction about the axis; a claw portion configured to engage with the mating teeth; 29. The system of claim 28, comprising:

30. The ratchet mechanism further includes a biasing element that biases the pawl toward the inner surface. 、 The biasing element is configured to bias the first control surface portion in the first direction about the translation axis. In a rotating state, the pawl moves past one of the ratchet teeth of the ratchet ring. The claw portion is configured to elastically deform when moved, and the claw portion is configured to elastically contact the inner surface. and optionally returning the sensor to the user, thereby providing an audible indication and / or tactile feedback to the user.

30. The system of claim 29, further configured to:

31. The one-way torque mechanism includes a pawl and a ratchet tooth configured to receive the pawl. [0023] The present invention further includes a ratchet mechanism having The ratchet mechanism is configured such that the pawl exceeds one of the ratchet teeth in the first direction. and providing audible and / or tactile feedback to the user as the user moves through the The system according to any one of claims 27 to 30,

32. the ratchet teeth are evenly spaced circumferentially around the inner surface; The front of the first control surface portion between the circumferentially equally spaced ratchet teeth The angular displacement in the first direction about the translation axis is 30. The system of claim 29, wherein the distance of distal travel of the screw is associated with a fixed distance. Tem.

33. The constant distance of distal movement of the lead screw along the translation axis is associated with a fixed amount of the compressed curable material dispensed from the dispensing space. Item 33. The system described in item 32.

34. 1. A system configured to dispense a curable material, comprising: a chamber defining a dispensing space configured to dispense the curable material; a lead screw rotatably fixed to the first control surface, the lead screw having a proximal end and a distal end; a male screw thread disposed at least partially between the proximal end and the distal end; a lead screw having a translation axis defined between the proximal end and the distal end; a locking nut having a female thread that threadably engages with the male thread of the lead screw, and the male thread of the lead screw are defined by a thread efficiency of greater than 50%. This allows the locking nut to contact the compressed hardenable material within the dispensing space. Therefore, the lead screw rotates around the translation axis in response to the applied proximal force. a locking nut configured to translate proximally along the translation axis; A system that includes:

35. The lead screw substantially rotates as it translates proximally along the translation axis.

35. The system of claim 34, wherein the system is configured not to

36. 1. A system configured to dispense a curable material, comprising: a chamber defining a dispensing space configured to dispense the curable material; a first control surface configured to receive a primary input from a user; a lead screw rotatably fixed to the first control surface, the lead screw having a proximal end and a distal end; a distal end and an external thread disposed at least partially between the proximal end and the distal end. and a translation axis defined between the proximal end and the distal end, the surface portion advances distally along the translation axis in response to receiving the primary input; a lead screw configured to compress the curable material within the dispensing space; a locking nut having a female thread that threadably engages with the male thread of the lead screw, The female thread of the lead screw and the male thread of the lead screw are arranged to allow the lead screw to move in parallel without rotating. and moving the locking nut in response to translation along the translation axis. and rotating the compressed hardenable material around a center of gravity such that the compressed hardenable material moves within the dispensing space at least a locking nut configured to allow partial decompression; A system that includes:

37. a first control surface portion, a second control surface portion, a dispensing space, a biasing member, and the first control surface portion a lead screw coupled to the dispensing chamber and at least partially disposed within the dispensing chamber; 1. A method of operating a material dispensing system, comprising: A secondary input is applied to the second control surface portion to move the second control surface portion from the disengaged position to the engaged position. a moving step; retaining the second control surface portion in the engaged position against a force applied by the biasing member and With the second control surface portion in the engaged position, a primary input is applied to the first control surface portion. and moving the lead screw distally along a translation axis to move the lead screw distally within the dispensing space. compressing the hardenable material; The biasing member biases the second control surface portion, excluding the secondary input applied to the second control surface portion. moving the control surface portion of the second With the control surface in the disengaged position, the feed screw moves along the translation axis. and causing the compressed curable material to move less within the dispensing space. and a step allowing partial depressurization. A method comprising:

38. the curable material dispensing system further comprising a one-way torque mechanism; The step of applying the primary input comprises: applying a first input torque to the first control surface portion, a mechanism for moving the translation axis of the first control surface portion in response to the input torque; a step that allows the distal movement of the lead screw by rotation in the first direction about the center of the lead screw; Pu and, Removing the first input torque applied to the first control surface portion, preventing proximal movement of the lead screw with a one-way torque mechanism; 38. The method of claim 37, further comprising:

39. The curable material dispensing system further comprises a housing; The lead screw is in a frictional relationship with the housing, thereby forming a clutch mechanism. Determined, The method further comprises applying a second torque input in an opposite direction to the first input torque to the first control. applying a force to a surface by the clutch mechanism and the one-way torque mechanism, forward in the second direction until the applied second torque input exceeds a torque threshold.

39. The method of claim 38, further comprising the step of preventing rotation of the first control surface portion.

40. The step of applying the primary input to the first control surface portion includes applying the primary input to the first control surface portion with a second hand. While holding the second control surface portion in the engaged position, a first hand applies the primary input.

40. The method of claim 39, further comprising the step of:

41. The step of holding the second control surface portion in the engaged position with the second hand comprises: While supporting the first control surface portion with the palm of the second hand, the index finger and / or the index finger of the second hand or a middle finger, holding the second control surface portion in the engaged position.

41. The method of claim 40.

42. The step of holding the second control surface portion in the engaged position with the second hand comprises: While supporting the first control surface with the palm of a second hand, the thumb of a second hand holds the second control surface.

42. The method of claim 40 or 41, further comprising the step of: retaining the control surface portion in the engaged position. How to do it.

43. a first control surface portion; a second control surface portion; and an actuator coupled to the second control surface portion. a dispensing space; a biasing member; and a first control surface portion connected to the dispensing space. and a female screw thread that is threadably engaged with the male screw thread of the lead screw. and a locking nut for locking the locking nut, the locking nut comprising: The actuator engages the locking nut with the force provided by the biasing member. The locking nut is urged to engage with the locking nut, and the locking nut is fixed so as to be rotatable about a translation axis. applying a primary input to the first control surface portion in a state , causing distal translation of the lead screw along the translation axis, compressing the hardenable material within the injection cavity; a secondary input sufficient to overcome the force applied by the biasing member to the second control a surface portion and a movement of the actuator to disengage the locking nut; Providing rotation of the locking nut about a translation axis, Engagement and rotation of the lead screw causes a proximal movement of the lead screw along the translation axis. a translational movement of the compressed curable material at least partially within the dispensing space; Steps A method comprising:

44. 1. A method of packaging a curable material dispensing system, comprising: providing a package having dimensions sufficient to accommodate said curable material dispensing system; Top and The curable material dispensing system includes a housing and a dispensing space connected to the housing. providing a stem; a flexible tube rotatably connected to the rotary coupler; and an elbow-shaped tube connected to the rotary coupler. providing an extension tube comprising: The elbow of the extension tube is connected to the distal end of the dispensing space, thereby providing fluid communication between the flexible tubing and the dispensing space; The flexible tube is arranged in a packaged form with the elbow-shaped connector at the center in the dispensing space. In the packaging form, the flexible tube and the dispensing space are substantially The flexible tubes are generally parallel to each other and extend in the direction of the dispensing space relative to the elbow joint. a step, The curable dispensing system and the extension tube in the packaged form are then placing it inside the body; A method comprising:

45. The articulating step includes articulating the flexible tube from the packaged configuration to the deployed configuration. and a step of moving the flexible tube in the deployed state. are substantially parallel to each other, and the flexible tube is 45. The method of claim 44, further comprising the step of: spaced apart.

46. placing the flexible tube adjacent to the housing in the packaged configuration; 46. ​​The method of claim 44 or 45, further comprising:

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