BONE GRAFT INJECTION OSTEOTOME
20180085200 ยท 2018-03-29
Assignee
Inventors
- Ilan UCHITEL (Kefar Saba, IL)
- Adi ALPHANDARY (Hod Hasharon, IL)
- Gideon Fostick (Givat Shmuel, IL)
- Yossi GROSS (Moshav Mazor, IL)
- Zev Sohn (Ginot Shomron, IL)
Cpc classification
A61C3/02
HUMAN NECESSITIES
A61B17/8811
HUMAN NECESSITIES
A61B17/8827
HUMAN NECESSITIES
A61B17/8816
HUMAN NECESSITIES
A61B17/8822
HUMAN NECESSITIES
A61C17/14
HUMAN NECESSITIES
A61B2017/8813
HUMAN NECESSITIES
International classification
A61C8/00
HUMAN NECESSITIES
Abstract
A composition delivery source (300) includes a chamber (302), a solid-liquid composition delivery tube (314), a mixing tube (316), and a liquid-supply tube (318). A filter (304) divides the chamber (302) into a liquid compartment (306) and a solid-liquid composition compartment (308). The solid-liquid composition delivery tube (314) is in fluid communication with the solid-liquid composition compartment (308). The mixing tube (316) is in fluid communication with the liquid compartment (306) and the solid-liquid composition compartment (308). The liquid-supply tube (318) is in fluid communication with the liquid compartment (306) and a liquid solution container (366). A pump unit (301) is provided that includes a mixing pump (322), which is arranged to cause flow in the mixing tube (316); and a liquid-supply pump (324), which is arranged to cause flow in the liquid-supply tube (318). Other embodiments are also described.
Claims
1. Apparatus for use with solid particles and a liquid container containing a physiological liquid solution, the apparatus comprising: (1) a composition delivery source, which comprises: (a) a chamber, which: (i) comprises a filter, which is disposed within the chamber so as to divide the chamber into a liquid compartment and a solid-liquid composition compartment, and (ii) is shaped so as to define (A) one or more liquid ports in fluid communication with the liquid compartment, and (B) one or more solid-liquid composition ports in fluid communication with the solid-liquid composition compartment; (b) a solid-liquid composition delivery tube, which is in fluid communication with at least one of the one or more solid-liquid composition ports; (c) a mixing tube, which is in fluid communication with at least one of the one or more liquid ports and at least one of the one or more solid-liquid composition ports; and (d) a liquid-supply tube, which is in fluid communication with at least one of the one or more liquid ports, and is coupled in fluid communication with an interior of the liquid solution container; and (2) a pump unit, which comprises: (a) a mixing pump, which is arranged to cause flow in the mixing tube; and (b) a liquid-supply pump, which is arranged to cause flow in the liquid-supply tube.
2. The apparatus according to claim 1, wherein the solid particles are solid bone graft particles, and wherein the apparatus is for use with the solid bone graft particles.
3. The apparatus according to claim 1, further comprising the solid particles, wherein the filter is configured to inhibit passage of the solid particles and allow passage of the physiological liquid solution.
4. The apparatus according to claim 1, wherein the mixing pump is arranged to cause, in the mixing tube, flow that raises the solid particles in a puff into the physiological liquid solution in the solid-liquid composition compartment.
5. The apparatus according to claim 1, wherein a closest distance between the one or more solid-liquid composition ports and the filter equals at least 75% of a distance between the filter and a point on an interior of a wall of the solid-liquid composition compartment farthest from the filter.
6. The apparatus according to claim 1, wherein the mixing tube (a) merges with the liquid-supply tube at an exit junction, and (b) is in fluid communication with the at least one of the one or more liquid ports via a portion of the liquid-supply tube.
7. The apparatus according to claim 1, wherein the liquid-supply tube (a) merges with the mixing tube at an exit junction, and (b) is in fluid communication with the at least one of the one or more liquid ports via a portion of the mixing tube.
8. The apparatus according to claim 1, wherein the chamber is shaped so as to define exactly one liquid port in fluid communication with the liquid compartment, and wherein the chamber is shaped so as to define exactly one solid-liquid composition port in fluid communication with the solid-liquid composition compartment.
9. The apparatus according to any one of claims 1-8, wherein the pump unit further comprises control circuitry, which is configured to repeatedly: (a) assume a mixing activation state, in which the control circuitry activates the mixing pump to mix the solid particles and the physiological liquid solution in the solid-liquid composition compartment to form a solid-liquid composition, by pumping the physiological liquid solution through the mixing tube and into the solid-liquid composition compartment, and (b) assume a particle-delivery activation state, wherein the control circuitry, during at least a portion of the particle-delivery activation state, activates the liquid-supply pump to apply positive pressure to pump the solid-liquid composition from the solid-liquid composition compartment into the solid-liquid composition delivery tube.
10. The apparatus according to claim 9, wherein the control circuitry is configured to assume the mixing activation state and the particle-delivery activation state at the same time.
11. The apparatus according to claim 9, wherein the control circuitry is configured in assume the mixing activation state and the particle-delivery activation state at partially-overlapping times.
12. The apparatus according to claim 9, wherein the control circuitry is configured to assume the mixing activation state and the particle-delivery activation state at non-overlapping times.
13. The apparatus according to claim 9, wherein the control circuitry is configured to, when in the particle-delivery activation state, activate the liquid-supply pump to apply the positive pressure to pump the physiological liquid solution (a) from the liquid solution container, (b) through the liquid-supply tube, (c) into the liquid compartment, (d) through the filter, (e) into the solid-liquid composition compartment, (f) from the solid-liquid composition compartment, and (g) to the solid-liquid composition delivery tube.
14. The apparatus according to claim 9, wherein the control circuitry is configured, during each of one or more negative-positive particle delivery cycles of the particle-delivery activation state, to assume: a negative particle-delivery activation sub-state, in which the control circuitry activates the liquid-supply pump to apply negative pressure to pump liquid from the solid-liquid composition delivery tube toward the liquid compartment via the solid-liquid composition compartment, and a positive particle-delivery activation sub-state, in which the control circuitry activates the liquid-supply pump to apply the positive pressure to pump the solid-liquid composition from the solid-liquid composition compartment into the solid-liquid composition delivery tube, wherein a direction of pumping of the liquid-supply pump in the positive particle-delivery activation sub-state is opposite a direction of pumping of the liquid-supply pump in the negative particle-delivery activation sub-state.
15. The apparatus according to claim 14, wherein the control circuitry is configured to assume the mixing activation state and the particle-delivery activation state at non-overlapping times.
16. The apparatus according to claim 14, wherein the control circuitry is configured to assume the mixing activation state and the negative particle-delivery activation sub-state at partially-overlapping times.
17. The apparatus according to claim 14, wherein the control circuitry is configured to assume the particle-delivery activation state in a plurality of particle-delivery-state cycles, and to begin the particle-delivery activation state in each of the particle-delivery-state cycles with the negative particle-delivery activation sub-state.
18. The apparatus according to claim 14, wherein the control circuitry is configured to provide a plurality of the negative-positive particle delivery cycles during the particle-delivery activation state.
19. The apparatus according to claim 14, wherein the control circuitry is configured to, when in the negative particle-delivery activation sub-state, activate the liquid-supply pump to pump the liquid from the solid-liquid composition delivery tube, into the solid-liquid composition compartment, and into the liquid compartment.
20. The apparatus according to claim 14, wherein the liquid-supply pump is a liquid-supply peristaltic pump, which comprises a rotor, wherein the liquid-supply peristaltic pump is capable of (a) pumping fluid at an average rate throughout a full 360-degree revolution of the rotor at a certain speed, and (b) pumping fluid at a maximum rate during portions of the full 360-degree revolution at the certain speed, the maximum rate greater than the average rate, and wherein the control circuitry is configured, when in both the positive and the negative particle-delivery activation sub-states, to activate the liquid-supply peristaltic pump to (a) rotate the rotor, at the certain speed, a partial revolution equal to a fraction of the full 360-degree revolution of the rotor, the fraction less than 1, and (b) pump, throughout the partial revolution, the fluid at the maximum rate.
21. The apparatus according to claim 14, wherein the liquid-supply pump is a liquid-supply peristaltic pump, which comprises a rotor, and wherein the control circuitry is configured: when in the positive particle-delivery activation sub-state, to activate the liquid-supply peristaltic pump to rotate the rotor, in a first rotational direction, a first partial revolution equal to a fraction of a full 360-degree revolution of the rotor, the fraction less than 1, and when in the negative particle-delivery activation sub-state, to activate the liquid-supply peristaltic pump to rotate the rotor, in a second rotational direction opposite the first rotational direction, a second partial revolution equal to the fraction of the full 360-degree revolution of the rotor.
22. The apparatus according to claim 14, wherein the liquid-supply pump is a liquid-supply peristaltic pump, which comprises a rotor, and wherein the control circuitry is configured, when in the positive particle-delivery activation sub-state, to activate the liquid-supply peristaltic pump to: rotate the rotor a partial revolution equal to a fraction of a full 360-degree revolution of the rotor, the fraction less than 1, and pump, throughout the partial revolution, a volume of fluid that is greater than the product of the fraction and a volume of fluid pumpable throughout the full 360-degree revolution of the rotor.
23. The apparatus according to claim 9, wherein the liquid-supply pump is a liquid-supply peristaltic pump, which comprises a rotor.
24. The apparatus according to claim 23, wherein the control circuitry is configured to assume the particle-delivery activation state a plurality of times in alternation with mixing activation states, and to begin each of the particle-delivery activation states with the rotor at a same rotational position.
25. The apparatus according to claim 9, wherein the mixing pump is a mixing peristaltic pump, which comprises a rotor.
26. The apparatus according to claim 25, wherein the mixing peristaltic pump comprises a total number of rollers equal to at least two, and wherein the control circuitry is configured to assume the mixing activation state a plurality of times in alternation with particle-delivery activation states, and to begin the mixing activation states with the rotor at respective starting rotational positions, which are identical to one another or rotationally offset from one another by the product of (a) 360 degrees divided by the total number of rollers and (b) a positive integer.
27. The apparatus according to claim 25, wherein the mixing peristaltic pump comprises (a) a pump casing that is shaped so as to define a partial-circle mixing tube channel in which the mixing tube is disposed, and (b) an odd total number of rollers, the odd total number equal to at least one, and wherein the control circuitry is configured to assume the mixing activation state a plurality of times in alternation with particle-delivery activation states, and to begin each of the mixing activation states with an aligned total number of the rollers rotationally aligned with the mixing tube channel, the aligned total number equal to more than half of the odd total number.
28. The apparatus according to claim 27, wherein the odd total number equals at least three.
29. The apparatus according to any one of claims 1-8, wherein the chamber comprises a receptacle component and a cover component, wherein the cover component (a) comprises the filter, and (b) is shaped so as to define (i) a cap and (ii) a bone-graft container having an opening that (x) faces away from the cap and (y) is farther from the cap than the filter is from the cap, and wherein the receptacle component and the cover component are shaped so as to be reversibly coupleable with each another to form a watertight seal, with the bone-graft container disposed within the receptacle component.
30. The apparatus according to any one of claims 1-8, wherein the mixing pump and the liquid-supply pump are respective peristaltic pumps.
31. The apparatus according to any one of claims 1-8, wherein the mixing tube (a) merges with the solid-liquid composition delivery tube at a return junction, and (b) is in fluid communication with the at least one of the one or more solid-liquid composition ports via a portion of the solid-liquid composition delivery tube.
32. The apparatus according to any one of claims 1-8, wherein the mixing tube (a) merges with the solid-liquid composition delivery tube at a return junction, and (b) is in fluid communication with the at least one of the one or more solid-liquid composition ports via a portion of the solid-liquid composition delivery tube.
33. The apparatus according to claim 32, wherein the chamber comprises a receptacle component and a cover component, which is shaped so as to define a cap, wherein the return junction is disposed along a longitudinal portion of the solid-liquid composition delivery tube and around a circumferential portion of the solid-liquid composition delivery tube, wherein the longitudinal portion includes a point that is closest to the cap when the cap is coupled to the receptacle component, and wherein the circumferential portion includes the point.
34. The apparatus according to any one of claims 1-8, wherein the apparatus further comprises a shaft unit, which comprises a shaft delivery tube in fluid communication with a distal end of the solid-liquid composition delivery tube.
35. The apparatus according to claim 34, wherein the shaft unit further comprises a removable depth limiting element, which is configured to limit a depth of insertion of the shaft delivery tube into a bore through a bone when the shaft delivery tube is inserted into the bore.
36. The apparatus according to claim 35, wherein the shaft unit comprises a shaft delivery tube, wherein the shaft unit further comprises a sealing element disposed around an external surface of the shaft delivery tube, and wherein the depth limiting element is removable from the shaft unit without removal of the sealing element.
37. Apparatus for use with solid particles and a liquid container containing a physiological liquid solution, the apparatus comprising a composition delivery source, which comprises: (a) a chamber, which: (i) comprises a filter, which is disposed within the chamber so as to divide the chamber into a liquid compartment and a solid-liquid composition compartment, and (ii) is shaped so as to define (A) one or more liquid ports in fluid communication with the liquid compartment, and (B) one or more solid-liquid composition ports in fluid communication with the solid-liquid composition compartment; (b) a solid-liquid composition delivery tube, which is in fluid communication with at least one of the one or more solid-liquid composition ports; (c) a nixing tube, which is in fluid communication with at least one of the one or more liquid ports and at least one of the one or more solid-liquid composition ports; and (d) a liquid-supply tube, which is in fluid communication with at least one of the one or more liquid ports, and is coupled in fluid communication with an interior of the liquid solution container.
38. Apparatus for use with solid particles and a liquid container containing a physiological liquid solution, the apparatus comprising a pump unit, which comprises: (a) a mixing pump; (b) a liquid-supply pump; and (c) control circuitry, which is configured to repeatedly: (i) assume a mixing activation state, in which the control circuitry activates the mixing pump, and (ii) assume a particle-delivery activation state, wherein the control circuitry is configured, during each of one or more negative-positive particle delivery cycles of the particle-delivery activation state, to assume: a negative particle-delivery activation sub-state, in which the control circuitry activates the liquid-supply pump apply negative pressure to pump in a first direction, and thereafter, a positive particle-delivery activation sub-state, in which the control circuitry activates the liquid-supply pump to apply positive pressure to pump in a second direction opposite the first direction.
39. Apparatus for use with solid particles and a physiological liquid solution, the apparatus comprising: a composition delivery source, which comprises: (a) a chamber, which is shaped so as to define one or more liquid ports and one or more solid-liquid composition ports; (b) a solid-liquid composition delivery tube, which is in fluid communication with at least one of the one or more solid-liquid composition ports; and (c) a mixing tube, which is in fluid communication with at least one of the one or more liquid ports and at least one of the one or more solid-liquid composition ports; and a pump unit, which comprises a mixing pump, which is arranged to cause, in the mixing tube, flow that raises the solid particles in a puff into the physiological liquid solution in the chamber.
40. Apparatus comprising a surgical tool for use with solid particles and a physiological liquid solution, the surgical tool comprising: a shaft unit, which is shaped so as to define a delivery lumen, and a distal opening, which is disposed within 10 mm of a distal end of the shaft unit, in fluid communication with the delivery lumen; a composition source, which is coupled in fluid communication with the delivery lumen, and which is configured to provide a solid-liquid composition of the solid particles and the physiological liquid solution; and a pump, which is configured to pump the solid-liquid composition through the distal opening via the delivery lumen.
41. The apparatus according to claim 40, wherein the surgical tool is configured as an oral surgical tool.
42. The apparatus according to claim 40, wherein the pump is configured to pump the solid-liquid composition at a pulsating hydraulic pressure that periodically varies between positive arid negative.
43. The apparatus according to claim 42, wherein the pump is configured to pump the solid-liquid composition through the distal opening via the delivery lumen during a plurality of positive-pressure periods that alternate with a plurality of negative-pressure periods, and to set an average duration of the positive-pressure periods to be less than or equal to an average duration of the negative-pressure periods.
44. The apparatus according to claim 43, wherein the pump is configured to set the average duration of the positive-pressure periods to be equal to the average duration of the negative-pressure periods.
45. The apparatus according to claim 40, wherein the pump is configured to pump the solid-liquid composition at a pulsating positive hydraulic pressure.
46. The apparatus according to any one of claims 40-45, wherein the composition source comprises a combining unit, which is configured to provide the solid-liquid composition by combining the solid particles with the physiological liquid solution.
47. The apparatus according to claim 46, wherein the combining unit comprises a mixing unit, which is configured to provide the solid-liquid composition by mixing the solid particles with the physiological liquid solution.
48. The apparatus according to any one of claims 40-45, wherein the solid particles arc solid bone graft particles, and wherein the surgical tool is for use with the solid bone graft particles.
49. Apparatus comprising a surgical tool for use with solid particles and a physiological liquid solution, the surgical tool comprising: exactly one shaft unit, which is shaped so as to define a delivery lumen and a drainage lumen; a distal opening, which is disposed within 10 mm of a distal end of the shaft unit, in fluid communication with the delivery lumen; a composition source, which is coupled in fluid communication with the delivery lumen, and which is configured to provide a solid-liquid composition of the solid particles and the physiological liquid solution; and a filter, which is disposed in fluid communication with the drainage lumen, and which is configured to inhibit passage of the solid particles of the solid-liquid composition and allow passage of the physiological liquid solution of the solid-liquid composition.
50. The apparatus according to claim 49, wherein the filter is disposed within 10 mm of the distal end of the shaft unit.
51. The apparatus according to claim 49, wherein the filter is disposed around an axis of the distal opening.
52. The apparatus according to claim 49, wherein the drainage lumen is disposed alongside the delivery lumen in the shaft unit.
53. The apparatus according to claim 49, wherein the filter disposed around the delivery lumen in the shaft unit.
54. The apparatus according to claim 49, further comprising a pump, which is configured to clear the solid particles that accumulate on the filter during drainage of the physiological liquid solution through the filter, by periodically applying a positive pressure to the drainage lumen.
55. The apparatus according to claim 49, wherein the filter is shaped so as to define a plurality of slits having a width narrower than the solid particles.
56. The apparatus according to claim 49, wherein the surgical tool is configured to move the distal opening and the shaft unit with respect to each other.
57. The apparatus according to claim 56, wherein the surgical tool further comprises a filter clearing element, which is fixed to the distal opening, and is configured to clear the solid particles that accumulate on the filter during drainage of the physiological liquid solution through the filter.
58. The apparatus according to claim 56, wherein the surgical tool is configured to rotate the distal opening and the shaft unit with respect to each other.
59. The apparatus according to claim 49, wherein the surgical tool further comprises a filter clearing element, which is configured to clear the solid particles that accumulate on the filter during drainage of the physiological liquid solution through the filter.
60. Apparatus comprising a surgical tool for use with solid particles and a physiological liquid solution, the surgical tool comprising: exactly one shaft unit, which is shaped so as to define a delivery lumen and a drainage lumen; a distal opening, which is disposed within 10 mm of a distal end of the shaft unit, in fluid communication with the delivery lumen; a composition source, which is coupled in fluid communication with the delivery lumen, and which is configured to provide a solid-liquid composition of the solid particles and the physiological liquid solution; and a plurality of elements disposed around and outside the delivery lumen for facilitating (a) inhibiting passage of the solid particles of the solid-liquid composition to the drainage lumen, and (b) allowing passage of the physiological liquid solution of the solid-liquid composition to the drainage lumen.
61. Apparatus comprising a surgical tool for use with solid particles and a physiological liquid solution, the surgical tool comprising: exactly one shaft unit, which (a) is shaped so as to define a drainage lumen, and (b) comprises a delivery shaft, which is shaped so as to define (i) a delivery lumen, and (ii) a plurality of rib elements that extend radially outward from an external surface of the delivery shaft; a distal opening, which is disposed within 10 mm of a distal end of the shaft unit, in fluid communication with the delivery lumen; and a composition source, which is coupled in fluid communication with the delivery lumen, and which is configured to provide a solid-liquid composition of the solid particles and the physiological liquid solution.
62. The apparatus according to claim 61, wherein the rib elements extend an average distance of between 0.1 and 2 mm radially outward from the external surface of the delivery shaft.
63. The apparatus according to claim 61, wherein the rib elements extend longitudinally along the external surface of the delivery shaft for an average distance of at least 1 mm.
64. The apparatus according to claim 61, wherein the surgical tool further comprises a depth limiting element, which is configured to limit a depth of insertion of the shaft unit into a bore through a bone when the shaft unit is inserted into the bore.
65. The apparatus according to claim 64, wherein the depth limiting element is removably attached to the shaft unit.
66. The apparatus according to claim 64, wherein the depth limiting element is shaped so as to define a portion of the drainage lumen between at least a portion of an internal surface of the depth limiting element and a portion of the external surface of the delivery shaft.
67. The apparatus according to any one of claims 49, 60, and 61, wherein the surgical tool is configured as an oral surgical tool.
68. The apparatus according to any one of claims 49, 60, and 61, wherein the solid particles are solid bone graft particles, and wherein the surgical tool is for use with the solid bone graft particles.
69. The apparatus according to any one of claims 49, 60, and 61, wherein the drainage lumen is disposed around the delivery lumen in the shaft unit.
70. The apparatus according to any one of claims 49, 60, and 61, wherein the surgical tool further comprises a suction source, which is coupled in fluid communication with the drainage lumen.
71. The apparatus according to any one of claims 49, 60, and 61, for use with a suction source, wherein the drainage lumen is coupleable in fluid communication with the suction source.
72. The apparatus according to any one of claims 49, 60, and 61, wherein the surgical tool further comprises a depth limiting element, which is configured to limit a depth of insertion of the shaft unit into a bore through a bone when the shaft unit is inserted into the bore.
73. The apparatus according to any one of claims 49, 60, and 61, wherein the composition source comprises a combining feeder unit, which is configured to provide the solid-liquid composition by combining the solid particles with the physiological liquid solution.
74. The apparatus according to claim 73, wherein the combining feeder unit comprises a mixing feeder unit, which is configured to provide the solid-liquid composition by mixing the solid particles with the physiological liquid solution.
75. The apparatus according to any one of claims 49, 60, and 61, wherein the surgical tool is configured to automatically apply motion to the shaft unit selected from the group consisting of: vibrational motion, rotational motion, oscillatory motion, axial back-and-forth motion, and lateral side-to-side motion.
76. The apparatus according to any one of claims 49, 60, and 61, further comprising a pump, which is configured to pump the solid-liquid composition through the distal opening via the delivery lumen.
77. The apparatus according to claim 76, wherein the pump is configured to pump the solid-liquid composition at a pulsating positive hydraulic pressure.
78. The apparatus according to claim 76, wherein the pump is configured to pump the solid-liquid composition at a pulsating hydraulic pressure that periodically varies between positive and negative.
79. The apparatus according to any one of claims 49, 60, and 61, wherein the surgical tool further comprises a solid-particle container, which contains the solid particles for combining with the physiological liquid solution.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF APPLICATIONS
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[0780] Surgical tool 20 further comprises a handheld bone graft injector unit 32. For some applications, injector unit 32 is implemented as an attachment to a separate handheld motor 24, such as shown in
[0781] Surgical tool 20 is configured to be used with bone graft particles 34 and a physiological liquid solution 36, such as saline solution or blood. For some applications, the bone graft particles comprise natural bone mineral particles (either xenograft or allograft), synthetic particles, demineralized bone matrix, an autograft, or bioactive composites. To this end, surgical tool 20 comprises a composition source 38, which is configured to provide a solid-liquid composition 39 (labeled in
[0782] For some applications, surgical tool 20 (e.g., injector unit 32 thereof) further comprises a solid-particle container 37, which contains bone graft particles 34 for combining with physiological liquid solution 36. For example, solid-particle container 37 may have a volume of at least 0.2 ml, no more than 20 ml, and/or between 0.2 and 20 ml. Optionally, solid-particle container 37, in addition to bone graft particles 34, contains some physiological liquid solution 36, which may enable combining of bone graft particles 34 and physiological liquid solution 36 in solid-particle container 37, such as described hereinbelow with reference to
[0783] For some applications, external control unit 22 is configured to display one or more of the following: (a) bone graft volume injected, (b) bone graft volume remaining, (c) pressure of solid-liquid composition 39, and/or (d) total volume injected (bone graft plus physiological liquid solution).
[0784] Reference is now made to
[0785] In the configurations shown in
[0786] In the configuration shown in
[0787] Injector unit 32 comprises a shaft unit 40, such as exactly one shaft unit 40, which is shaped so as to define a delivery lumen 42 and a drainage lumen 44. Shaft unit 40 comprises one or more shafts (including, for example, a delivery shaft 56, which defines delivery lumen 42), which may be arranged concentrically and/or alongside one another. Composition source 38 is coupled in fluid communication with delivery lumen 42, such as via a feeder tube 35, which optionally is flexible and/or transmits torque. Delivery lumen 42 and drainage lumen 44 are typically not in fluid communication with each other within shaft unit 40. Typically, a largest circle circumscribed by a cross-section of delivery lumen 42 has a diameter of at least 1 mm, such as at least 1.5 mm, and/or no more than 7 mm, such as no more than 4 mm (the cross-section is perpendicular to a longitudinal axis of the delivery lumen).
[0788] Injector unit 32 further comprises a distal opening 46, which is typically disposed within 10 mm of a distal end 48 of shaft unit 40 (e.g., within 5 mm of the distal end, such as at the distal end), in fluid communication with delivery lumen 42. For some applications, distal opening 46 comprises a nozzle, for controlling the direction and/or flow rate of the distribution of solid-liquid composition 39. The nozzle may be shaped so as to define one or more lateral or distal openings. As used in the present application, including in the claims, distal end 48 of shaft unit 40 means the distal-most point(s) of the shaft unit.
[0789] For some applications, such as shown in
[0790] To this end, for some applications, such as shown in
[0791] For some applications, filter 50, distal opening 46, and/or solid-particle container 37 are detachable from surgical tool 20 and/or disposable.
[0792] For other applications, such as shown in
[0793] As mentioned above, for some applications, composition source 38 comprises combining feeder unit 60, which is configured to provide solid-liquid composition 39 by combining bone graft particles 34 with physiological liquid solution 36. For some applications, combining feeder unit 60 comprises a mixing feeder unit 62, which is configured to provide solid-liquid composition 39 by mixing bone graft particles 34 with physiological liquid solution 36. Several possible configurations of mixing feeder unit 62 are described hereinbelow with reference to
[0794] As described hereinbelow with reference to
[0795] To enable such injection, for some applications surgical tool 20 further comprises a pump, which is configured to pump solid-liquid composition 39 through distal opening 46 via delivery lumen 42. For some applications, such as those in which injector unit 32 is implemented as an attachment to separate handheld motor 24 (such as shown in
[0796] For some applications, the pump is configured to pump solid-liquid composition 39 at a pulsating positive hydraulic pressure. Such pulsation may help distribute solid-liquid composition 39 in the cavity, and/or inhibit clogging of filter 50, such as described hereinbelow. For some applications, the pump is configured to pump solid-liquid composition 39 at a pulsating hydraulic pressure that periodically varies between positive and negative (optionally, the negative pressure is applied a smaller portion of the time than is the positive pressure). Such pulsation may help inhibit clogging of filter 50, such as described hereinbelow. For some applications, the pump is configured to pump solid-liquid composition 39 through distal opening 46 via delivery lumen 42 during a plurality of positive-pressure periods that alternate with a plurality of negative-pressure periods, and to set an average duration of the positive-pressure periods to be less than or equal to an average duration of the negative-pressure periods. For some applications, the pump is configured to set the average duration of the positive-pressure periods to be equal to the average duration of the negative-pressure periods. This technique typically allows time for at least a portion (e.g., most or nearly all) of bone graft particles 34 to settle in cavity 90 before liquid of solid-liquid composition 39 is withdrawn, thereby allowing for accumulation of bone graft particles 34 in cavity 90.
[0797] For some applications, surgical tool 20 further comprises a suction source 49 (labeled in
[0798] For some applications, surgical tool 20 (e.g., injector unit 32 thereof, such as shaft unit 40) is configured to inhibit clogging of filter 50 by bone graft particles 34 as physiological liquid solution 36 drains through filter 50. For some applications, surgical tool 20 (e.g., injector unit 32 thereof, such as shaft unit 40) is configured to move distal opening 46 and shaft unit 40 with respect to each other (for applications in which distal opening 46 comprises the nozzle, the nozzle and shaft unit 40 with respect to each other), for example during delivery of solid-liquid composition 39. For example, surgical tool 20 (e.g., injector unit 32 thereof, such as shaft unit 40) may be configured to: [0799] rotate distal opening 46 and shaft unit 40 with respect to each other; the rotation may be either full or partial, and/or unidirectional and/or bidirectional; for some applications, surgical tool 20 (e.g., injector unit 32 thereof) is configured to rotate distal opening 46 while holding shaft unit 40 rotationally immobile, while for other applications, surgical tool 20 (e.g., injector unit 32 thereof) is configured to rotate shaft unit 40 while holding distal opening 46 rotationally immobile; [0800] move distal opening 46 and shaft unit 40 side-to-side with respect to each other; [0801] move distal opening 46 and shaft unit 40 axially back-and-forth with respect to each other; and/or [0802] vibrate distal opening 46 and shaft unit 40 side-to-side with respect to each other; and/or
[0803] Alternatively or additionally, for some applications, surgical tool 20 (e.g., injector unit 32 thereof) is configured to automatically apply motion to shaft unit 40 selected from the group consisting of: vibrational motion, rotational motion, oscillatory motion, axial back-and-forth motion, and lateral side-to-side motion. Further alternatively or additionally, for some applications, surgical tool 20 (e.g., injector unit 32 thereof) is configured to vibrate solid-liquid composition 39 in delivery lumen 42.
[0804] For some applications, in order to provide any of the above-mentioned motions, surgical tool 20 uses electromagnetic power or pneumatic power.
[0805] For some applications, surgical tool 20 (e.g., injector unit 32 thereof, such as shaft unit 40) is configured such that flow of solid-liquid composition 39 causes distal opening 46 and shaft unit 40 to move with respect to each other. Alternatively or additionally, for some applications, surgical tool 20 (e.g., injector unit 32 thereof, such as shaft unit 40) is configured such that flow of filtered physiological liquid solution 36 causes distal opening 46 and shaft unit 40 to move with respect to each other.
[0806] For some applications, such as shown in
[0807] For some applications, such as shown in
[0808] Reference is now made to
[0809] For some applications, surgical tool 20 (e.g., injector unit 32 thereof) is configured to move filter clearing element 70 with respect to filter 50. For example, surgical tool 20 (e.g., injector unit 32 thereof) may be configured to (a) rotate filter clearing element 70 (the rotation may be either full or partial, and/or unidirectional and/or bidirectional); and/or (b) axially move filter clearing element 70.
[0810] For some applications, such as shown in
[0811] For some applications, such as shown in
[0812] For some applications, such as shown in
[0813] Reference is now made to
[0814] A bore 86 (e.g., exactly one bore) is formed through bone 82 from a first side of the bone to a second side of the bone. A Schneiderian membrane 88 is raised to form a cavity 90 between the second side of the bone and Schneiderian membrane 88, such as using hydraulic pressure or mechanical elevation.
[0815] Reference is still made to
[0816] For some applications, such as shown in
[0817] For other applications, such as shown in
[0818] For some applications, inserting shaft unit 40 comprises positioning distal opening 46 at a location at a distance from the second side of the bone, the distance equal to at least 50% (e.g., at least 75%) of a height of cavity 90 directly above bore 86, and solid-liquid composition is injected (e.g., pumped) while distal opening 46 is positioned at the location. For some applications, distal opening 46 is positioned at between 2 and 12 mm (e.g., 4 and 6 mm) from Schneiderian membrane 88 at a roof of cavity 90 directly above bore 86. For some applications, distal opening 46 is disposed at distal end 48 of shaft unit 40, and positioning distal opening 46 comprises positioning distal end 48 of shaft unit 40 at the location. For some applications, raising Schneiderian membrane 88 comprises injecting physiological solution through delivery lumen 42 after inserting shaft unit 40 into bore 86.
[0819] Alternatively, the surgeon injects solid-liquid composition 39 to lift membrane 88, thereby combining the lift and bone graft injection steps into a single step. Further alternatively, the surgeon uses surgical tool 20 to inject physiological solution, e.g., saline solution, to raise the membrane.
[0820] After solid-liquid composition 39 is injected, an implant is implanted at least partially within cavity 90, either during the same procedure or after bone grows into bone graft particles 34 in cavity 90. After bone grows into bone graft particles 34, a dental appliance, such as a crown, is coupled to the implant.
[0821] Reference is now made to
[0822] Reference is now made to
[0823] For some applications, shaft unit 140 is shaped so as to define exactly one lumen 142. For other applications, shaft unit 140 is shaped so as to define a plurality of lumens that are in fluid communication with one another in shaft unit 140. Typically, a largest circle circumscribed by a cross-section of lumen 142 has a diameter of at least 1 mm, such as at least 1.5 mm, and/or no more than 7 mm, such as no more than 4 mm (the cross-section is perpendicular to a longitudinal axis of the lumen).
[0824] Injector unit 132 further comprises a one-way filter 150, which is disposed in fluid communication with lumen 142, and which is configured to: [0825] allow passage, in a proximal-to-distal direction ((schematically indicated by an arrow 151 in
[0828] For some applications, surgical tool 120 (e.g., injector unit 132 thereof) comprises a one-way filter valve 152 that comprises one-way filter 150. One-way filter valve 152 is in fluid communication with lumen 142. For example, one-way filter valve 152 may comprise a leaf valve 154, which comprises one or more leafs 156. For example, leafs 156 may comprise mesh 158 having openings smaller than bone graft particles 34, or may be shaped so as to define a plurality of slits having a width narrower than bone graft particles 34. For some applications, one-way filter 150 is disposed within 10 mm of distal end 148 of shaft unit 140.
[0829] Composition source 38 is coupled in fluid communication with lumen 142, such as via a feeder tube 135. For some applications, surgical tool 20 is shaped so as to define a suction port 160, and one-way filter 150 is in selective fluid communication with suction source 49 via suction port 160. For some applications, suction port 160 is disposed at a site 162 along a fluid path between one-way filter 150 and composition source 38, and surgical tool 20 (e.g., injector unit 32 thereof) further comprises a source one-way valve 166, which is disposed along the fluid path proximal to site 162 at which suction port 160 is disposed.
[0830] For some applications, the pump (e.g., pump 27 of external control unit 22, or pump 43 of injector unit 132) is configured to pump solid-liquid composition 39 through distal opening 146 via lumen 142. For some applications, the pump is configured to pump solid-liquid composition 39 with an on-off duty cycle. For some applications, suction port 160 is configured to assume an open state when the pump is off, and a closed state when the pump is on. For some applications, suction source 49 is configured to apply suction when the pump is off, and not apply the suction when the pump is on.
[0831] To inhibit suctioning of bone graft particles 34 through suction port 160, for some applications, source one-way valve 166 is configured to open at a higher pressure gradient than the pressure gradient at which one-way filter valve 152 opens (the injection pressure is typically substantially higher than the suction vacuum). Alternatively or additionally, application of the suction is synchronized with application of the pressure, so that the suction is off when the solid-liquid composition 39 is injected and vice versa.
[0832] For some applications, surgical tool 120 is used in conjunction with a minimally-invasive sinus lift surgical procedure for implanting a dental implant. Other than as described below, the procedure is similar to the procedure described hereinabove with reference to
[0833] For some applications, injecting and draining comprise alternatingly injecting (as shown in
[0834] An implant is implanted, as described hereinabove with reference to
[0835] For some applications, distal end 148 of shaft unit 140 is disposed no more distal than a distal-most surface of sealing element 54, such as described hereinabove with reference to
[0836] Reference is again made to
[0837]
[0838]
[0839]
[0840]
[0841]
[0842]
[0843]
[0844]
[0845]
[0846]
[0847]
[0848]
[0849] Reference is now made to
[0850] Osteotome 200 is shaped so as to define: [0851] a lumen 210 through osteotome 200. A distal end 212 of lumen 210 opens through a distal opening 214 disposed within 10 mm of a distal end 216 of osteotome 200, such as within 5 nun of distal end 216, e.g., at distal end 216. A proximal end 218 of lumen 210 opens through a proximal opening 220 disposed at least 5 mm proximal to distal opening 214. For some applications, proximal opening 220 is disposed within 10 mm of a proximal end 222 of osteotome 200, such as within 5 mm of proximal end 222, e.g., at proximal end 222, [0852] a lateral external surface 230, at least a portion of which is shaped so as to define a screw thread 232 that (a) has a distal thread end 234 that is disposed within 10 mm of distal end 216 of osteotome 200, such as within 5 mm of distal end 216, e.g., within 1 mm of distal end 216, and (b) comprises one or more raised helical ribs 236 going around osteotome 200, and [0853] one or more longitudinal drainage slots 250, which extend along at least respective longitudinal portions 252 of osteotome 200 having respective longitudinal lengths L of at least 5 mm, such as at least 8 mm, e.g., at least 10 mm, such as at least 12 mm, measured parallel to a central longitudinal axis 253 of osteotome 200 (typically, the longitudinal lengths L are no more than 20 mm).
[0854] As used in the present application, including in the claims, distal end 216 of osteotome 200 means the distal-most point(s) of the osteotome. Similarly, proximal end 222 of osteotome 200 means the proximal-most point(s) of the osteotome.
[0855] Typically, a largest circle circumscribed by a cross-section of lumen 210 has a diameter of at least 1 mm, such as at least 1.5 mm, and or no more than 7 mm, such as no more than 4 mm (the cross-section is perpendicular to central longitudinal axis 253).
[0856] For some applications, the longitudinal lengths L of the respective longitudinal portions 252 are at least 2 mm greater than a thickness of bone 82 adjacently surrounding bore 86. This provides for 1 mm of longitudinal draining slots on the top and the bottom of the bone.
[0857]
[0858] For some applications, such as in configurations 200B and 200D shown in
[0859] For some applications, screw thread 232 is multi-start, i.e., is shaped to define more than one start, as is known in the screw art. For example, screw thread 232 may be double-start (as shown in
[0860] For some applications, respective average widths of the one or more longitudinal drainage slots 250 are no more than 3 mm, such as no more than 2 mm, e.g., no more than 1.5 mm or 1 mm. Typically, the widths of the one or more longitudinal drainage slots 250 are selected to be smaller than the bone graft particles 34, in order to filter the bone graft particles 34 (i.e., inhibit their passage through the drainage slots).
[0861] For some applications, respective average depths or the one or more longitudinal drainage slots 250, measured with respect to an outermost portion of screw thread 232 (i.e., locally with respect to the outermost portion of the screw thread; the width of the screw thread may vary therealong), are at least 10% greater than an average depth of screw thread 232, and/or at least 0.1 mm (such as at least 0.3 mm, e.g., at least 0.5 mm) greater than the average depth of screw thread 232, and/or at least 0.4 mm from the outermost portion of screw thread 232. (Typically, the average thread depth of screw thread 232 is at least 0.1 mm, such as at least 0.3 mm.)
[0862] For some applications, such as in configurations 200A and 200B shown in
[0863] For other applications, such as in configurations 200C and 200D shown in
[0864] Typically, osteotome 200 is configured to be used with bone graft particles 34 and physiological liquid solution 36, as described hereinabove. During use, osteotome 200 is inserted, from a first side of bone 82, into bore 86, such that distal opening 214 is disposed in the bore or in a cavity adjacent to the second side of the bone. A solid-liquid composition 39 of bone graft particles 34 and physiological liquid solution 36 is provided from composition source 38 that is coupled in fluid communication with lumen 210. Solid-liquid composition 39 is injected through lumen 210 and distal opening 214 into cavity 90, such that (a) a portion of physiological liquid solution 36 drains through the one or more longitudinal drainage slots 250, and (b) the one or more longitudinal drainage slots 250 inhibit passage of bone graft particles 34 of solid-liquid composition 39 such that the bone graft particles 34 accumulate in cavity 90.
[0865] For some applications, osteotome 200 is configured as a dental osteotome, and bone 82 is a bone of a jaw. For some applications, cavity 90 is between the second side of bone 82 and a membrane, such as Schneiderian membrane 88. Typically, before inserting osteotome 200, the membrane is raised to form cavity 90 between the second side of bone 82 and membrane 88.
[0866] Typically, proximal end 222 of osteotome 200 is shaped so as to define a coupling interface, such as a male or female coupling interface, which, for example, may be shaped so as to define a male or female polygon having four or more sides, such as five or more sides, or six or more sides, e.g., exactly four, five, or six sides. The surgeon may use a conventional dental wrench or dental drill to engage the coupling interface and rotate the osteotome.
[0867] Reference is now made to
[0868] The procedure begins as described hereinabove with reference to
[0869] As shown in
[0870] Although the surgical tools and methods described herein have been generally described for sinus lift dental applications, these tools and methods may additionally be used for other dental applications, such as ridge augmentation (in both the maxilla and mandible) (such as by injecting the solid-liquid composition between the gingiva and the bone crest), or sinus floor elevation. In addition, these tools and methods may additionally be used for non-dental applications, such as orthopedic applications. For orthopedic applications, bone graft particles 34 may have a larger average particle size, e.g., up to 7 mm.
[0871] Reference is now made to
[0872] Reference is now made to
[0873] Reference is now made to
[0874] Reference is made to
[0875] Reference is still made to
[0876] Composition delivery source 300 further comprises: [0877] a solid-liquid composition delivery tube 314, which is in fluid communication with at least one of the one or more solid-liquid composition ports 312; [0878] a mixing tube 316, which is in fluid communication with at least one of the one or more liquid ports 310 and at least one of the one or more solid-liquid composition ports 312; and [0879] a liquid-supply tube 318, which is in fluid communication with at least one of the one or more liquid ports 310, and is coupled in fluid communication with an interior of liquid solution container 366.
[0880] Pump unit 301 comprises: [0881] a mixing pump 322, which is arranged to cause flow in mixing tube 316, typically unidirectionally; and [0882] a liquid-supply pump 324, which is arranged to cause flow in liquid-supply tube 318, typically oscillating (bidirectional) flow.
[0883] It is noted that mixing tube 316 is considered to be in fluid communication with the at least one of the one or more liquid ports 310 and the at least one of the one or more solid-liquid composition polls 312 even though mixing tube 316 is intermittently not in such fluid communication because of the operation of liquid-supply pump 324, as described hereinbelow. Similarly, it is noted that liquid-supply tube 318 is considered to be in fluid communication with the at least one of the one or more liquid ports 310 and to be coupled in fluid communication with the interior of liquid solution container 366 even though liquid-supply tube 318 is intermittently not in such fluid communication because of the operation of mixing pump 322, as described hereinbelow.
[0884] For some applications, each of the tubes comprises one or more tube segments that are coupled together to form the complete tube, such as for applications in which the pumps do not comprise peristaltic pumps and respective tube segments are coupled to an inlet and an outlet of a pump.
[0885] For some applications, as shown in
[0886] For some applications, as shown in
[0887] For some applications, a proximal end 330 of solid-liquid composition delivery tube 314 is in fluid communication with the at least one of the one or more solid-liquid composition ports 312, and a distance D1 (labeled in
[0888] For some applications, an internal cross-sectional area of solid-liquid composition delivery tube 314 perpendicular to an axis of solid-liquid composition delivery tube 314 is non-decreasing from return junction 328 to a distal end of solid-liquid composition delivery tube 314. Typically, solid-liquid composition 339 (described hereinbelow with reference to
[0889] Reference is still made to
[0890] Reference is still made to
[0891] For some applications, shaft unit 340 further comprises a removable depth limiting element 384, which is configured to limit a depth of insertion of shaft delivery tube 380 into a bore through a bone when shaft delivery tube 380 is inserted into the bore, such as described hereinbelow with reference to
[0892] For some applications, shaft delivery tube 380 further comprises a sealing element 386 disposed around an external surface of shaft delivery tube 380, and configured to form a liquid-tight seal with (a) a channel of a screw, such as such as described hereinbelow with reference to
[0893] Reference is still made to
[0894] Reference is still made to
[0895] For some applications, pump unit 301 further comprises control circuitry 332. Typically, pump unit 301 further comprises a power supply, electronics, a user interface 335 for controlling bone graft injection system 320, and/or a foot control 333 for controlling pump unit 301. For other applications, pump unit 301 does not necessarily comprise any circuitry, and the rotation and relative timing of rotation of the pumps are achieved mechanically (i.e., non-electronically), e.g., by connecting both pumps to a common axle.
[0896] Reference is now made to
[0897] In some applications of the present application, bone graft injection system 320 is configured to repeatedly (a) mix solid bone graft particles 334 and physiological liquid solution 336 in solid-liquid composition compartment 308 to form a solid-liquid composition 339 and (b) pump solid-liquid composition 339 into cavity 90 under a membrane, such as a Schneiderian membrane 88. For some applications, in order to perform the mixing, bone graft injection system 320 pumps filtered liquid from liquid compartment 306 into the bottom of solid-liquid composition compartment 308, which raises solid bone graft particles 334 in a puff 399 into physiological liquid solution 336 higher in solid-liquid composition compartment 308. Because volume in chamber 302 is conserved as fluid is pumped out of liquid compartment 306, the pumped fluid reenters chamber 302 (rather than entering the portion of solid-liquid composition delivery tube 314 beyond return junction 328 in the opposite direction of chamber 302 (to the right in
[0898] Typically, this mixing is repeated periodically, because solid bone graft particles 334 very quickly settle and separate from physiological liquid solution 336 (generally nearly all of the particles settle within 500 ms). Typically, the immediately following particle-delivery activation state 344 occurs (a) before most of solid bone graft particles 334 settle and separate from physiological liquid solution 336 and/or (b) even after solid bone graft particles 334 have settled (in which case typically the solid bone graft particles 334 that settled near the one or more solid-liquid composition ports 312, and/or bone graft particles puffed by the pulsating transfer itself).
[0899]
[0900] For some applications, in order to perform the mixing and pumping described immediately above, control circuitry 332 is configured to repeatedly (typically, in a plurality of cycles): [0901] assume a mixing activation state 342, as shown in
[0903] Typically, in order to perform the mixing during mixing activation state 342, the physiological liquid solution pumped into solid-liquid composition compartment 308 raises solid bone graft particles 334 in a puff 399 into physiological liquid solution 336 in the compartment.
[0904] As mentioned above, control circuitry 332 is typically configured to repeatedly, in a plurality of cycles, assume mixing activation state 342 and particle-delivery activation state 344. For some applications, control circuitry 332 is configured to repeatedly assume mixing activation state 342 and particle-delivery activation state 344 over a period time period having a duration of at least 30 second, no more than 600 seconds, and/or between 30 and 600 seconds.
[0905] For some applications, control circuitry 332 is configured to assume mixing activation state 342 and particle-delivery activation state 344 at non-overlapping times, such as illustrated in
[0906] For some applications, control circuitry 332 is configured to repeatedly, in alternation, (a) assume mixing activation state 342 for between 100 and 1200 ms, such as between 200 and 800 ms, e.g., 400 ms, and (b) assume particle-delivery activation state 344. For some applications, control circuitry 332 is configured to repeatedly, in alternation, (a) assume mixing activation state 342 for between 100 and 1200 ms, and (b) assume particle-delivery activation state 344 for between 150 and 3000 ms, such as between 1000 and 2000 ms, e.g., 1400 ms.
[0907] Typically, control circuitry 332 is configured to, when in particle-delivery activation state 344, activate liquid-supply pump 324 to apply the positive pressure to pump physiological liquid solution 336 (a) from liquid solution container 366, (b) through liquid-supply tube 318, (c) into liquid compartment 306, (d) through filter 304, (e) into solid-liquid composition compartment 308, (f) from solid-liquid composition compartment 308, and (g) to solid-liquid composition delivery tube 314.
[0908] In some applications of the present invention, control circuitry 332 is configured, during each of one or more negative-positive particle delivery cycles 346 of particle-delivery activation state 344, to assume: [0909] a negative particle-delivery activation sub-state 348, as shown in
[0911] In other words, control circuitry 332 is configured to cause liquid-supply pump 324 to oscillate during each of one or more negative-positive particle delivery cycles 346.
[0912] During positive particle-delivery activation sub-state 350, solid-liquid composition 339 is injected into cavity 90. Solid bone graft particles 334 of solid-liquid composition 339 typically quickly settle toward the bottom of cavity 90 (generally within 100 ms). As a result, physiological liquid solution 336, substantially without solid bone graft particles 334, remains near distal opening 383 of shaft delivery tube 380. During the immediately following negative particle-delivery activation sub-state 348, mostly this physiological liquid solution 336 remaining near distal opening 383, rather than the settled solid bone graft particles 334, is pumped back into solid-liquid composition delivery tube 314. This non-return of solid bone graft particles 334 may be aided by positioning distal opening 383 near the roof of cavity 90, as described hereinbelow with reference to blow-up C of
[0913] For some applications, at least a portion of solid-liquid composition 339 that is pumped out of chamber 302 in a given positive particle-delivery activation sub-state 350 exits distal opening 383 into cavity 90 before the completion of the given positive particle-delivery activation sub-state 350, such as at least 50%, e.g., at least 80%, such as 100%. For some applications, control circuitry 332 is configured to pump, throughout positive particle-delivery activation sub-state 350, a volume of solid-liquid composition 339 that is greater than a combined volume of solid-liquid composition delivery tube 314 and shaft delivery tube 380, such as equal to at least 100% of the combined volume, and/or less than 700% of the combined volume.
[0914] For some applications, control circuitry 332 is configured to assume particle-delivery activation state 344 in a plurality of particle-delivery-state cycles, and to begin particle-delivery activation state 344 in each of the particle-delivery-state cycles with negative particle-delivery activation sub-state 348. Beginning with the negative particle-delivery activation sub-state 348 reduces the risk of accidentally overfilling cavity 90 with solid-liquid composition 339, which might burst Schneiderian membrane 88.
[0915] For some applications, as mentioned above, control circuitry 332 is configured to assume mixing activation state 342 and particle-delivery activation state 344 at non-overlapping times.
[0916] For some applications, control circuitry 332 is configured to provide a plurality of the negative-positive particle delivery cycles 346 during particle-delivery activation state 344. For some applications, control circuitry 332 is configured to provide up to 10 of the negative-positive particle delivery cycles 346 during particle-delivery activation state 344, such as between 3 and 6 cycles 346, e.g., 4 cycles 346.
[0917] For some applications, control circuitry 332 is configured to assume negative particle-delivery activation sub-state 348 for between 25 and 300 ms, such as between 100 and 200 ms, e.g., 175 ms, during each of the one or more negative-positive particle delivery cycles 346. For some applications, control circuitry 332 is configured to assume negative particle-delivery activation sub-state 348 for between 25 and 100 ms during each of the one or more negative-positive particle delivery cycles 346
[0918] For some applications, control circuitry 332 is configured to assume positive particle-delivery activation sub-state 350 for between 25 and 300 ms, such as between 100 and 200 ms, e.g., 175 ms, during each of the one or more negative-positive particle delivery cycles 346. For some applications, control circuitry 332 is configured to assume positive particle-delivery activation sub-state 350 for between 25 and 100 ms during each of the one or more negative-positive particle delivery cycles 346.
[0919] For some applications, control circuitry 332 is configured to assume negative particle-delivery activation sub-state 348 for between 25 and 300 ms during each of the one or more negative-positive particle delivery cycles 346, and to assume positive particle-delivery activation sub-state 350 for between 25 and 300 ms during each of the one or more negative-positive particle delivery cycles 346.
[0920] For some applications, control circuitry 332 is configured to assume negative particle-delivery activation sub-state 348 for a first duration during each of the one or more negative-positive particle delivery cycles 346, and to assume positive particle-delivery activation sub-state 350 for a second duration during each of the one or more negative-positive particle delivery cycles 346, the second duration equal to between 80% and 120% of the first duration, such as between 90% and 110% of the first duration.
[0921] For some applications, control circuitry 332 is configured to, when in negative particle-delivery activation sub-state 348, activate liquid-supply pump 324 to pump the liquid from solid-liquid composition delivery tube 314, into solid-liquid composition compartment 308, and into liquid compartment 306.
[0922] Reference is made to
[0923] Mixing peristaltic pump 352A comprises a pump casing 360A that is shaped so as to define a partial-circle mixing tube channel 362A in which a portion of mixing tube 316 is disposed. Similarly, liquid-supply peristaltic pump 352B comprises a pump casing 360B that is shaped so as to define a partial-circle liquid-supply tube channel 362B in which a portion of liquid-supply tube 318 is disposed. For some applications, the portions of the tubes disposed in the partial-circle liquid-supply tube channels comprise silicone, which may be more flexible than the material that other portions of the tubes comprise. Alternatively or additionally, for some applications, the portions of the tubes disposed in the partial-circle liquid-supply tube channels may have larger diameters than the diameters of the other portions of the tubes. These larger diameters may increase the pumping rate. The smaller diameters of the other portions of the tubes may reduce the total volume of fluid in the system, which may reduce the volume of fluid needed to operate the system. Typically, mixing peristaltic pump 352A rotates unidirectionally, e.g., clockwise in
[0924] For some applications, mixing peristaltic pump 352A and the portion of mixing tube 316 disposed within mixing tube channel 362A are configured such that mixing peristaltic pump 352A pumps at least 2 cc, no more than 4 cc, and/or between 2 and 4 cc of fluid per full revolution, such as 2.7 cc. For some of these applications, the portion of mixing tube 316 disposed within mixing tube channel 362A has an inner diameter of at least 3.2 mm, no more than 9.6 mm, and/or between 3.2 and 9.6 mm, e.g., 6.4 mm.
[0925] For some applications, liquid-supply peristaltic pump 352B and the portion of liquid-supply tube 318 disposed within liquid-supply tube channel 362B are configured such that liquid-supply peristaltic pump 352B pumps at least 2 cc, no more than 4 cc, and/or between 2 and 4 cc of fluid per full revolution, such as 2.7 cc. For some of these applications, the portion of liquid-supply tube 318 disposed within liquid-supply tube channel 362B has an inner diameter of at least 3.2 mm, no more than 9.6 mm, and/or between 3.2 and 9.6 mm, e.g., 6.4 mm.
[0926] When a roller 358 is fully engaged and closes off a tube, the roller pushes a certain amount of liquid as it rotates. As the leading roller begins to disengage from the tube, the next roller behind the leading roller continues the pushing. However, since the leading roller is disengaging from the tube, the leading roller allows the tube to open up and hold a larger volume of liquid. This absorption of liquid not pushed out of the pump reduces flow. There are no voids anywhere in the tube. A reverse effect occurs as the next roller begins engaging the tube. Maximum flow is achieved during the period in which the leading roller is fully engaged with tube. This is the range in which the oscillating liquid-supply peristaltic pump 352B works. In a closed system, such as described herein, the amount of liquid in the pillows in liquid-supply peristaltic pump 352B is minimal when the most rollers are engaged with the tube. If exactly three rollers are provided, this minimum occurs, for example, when two of the rollers are symmetrically located at 10 o'clock and 2 o'clock. For some applications, this is the starting rotational position of mixing pump peristaltic pump 352A, since maximum liquid is in cavity 90 under Schneiderian membrane 88.
[0927] Liquid-supply peristaltic pump 352B is capable of (a) pumping fluid at an average rate throughout a full 360-degree revolution of rotor 354B at a certain speed, and (b) pumping fluid at a maximum rate during portions of the full 360-degree revolution at the certain speed. The maximum rate is greater than the average rate. For some applications, control circuitry 332 is configured, when in both positive and negative particle-delivery activation sub-states 350 and 348, to activate liquid-supply peristaltic pump 352B to (a) rotate rotor 354B, at the certain speed, a partial revolution equal to a fraction of the full 360-degree revolution of rotor 354B, the fraction less than 1, and (b) pump, throughout the partial revolution, the fluid at the maximum rate.
[0928] For some applications, control circuitry 332 is configured: [0929] when in positive particle-delivery activation sub-state 350, to activate liquid-supply peristaltic pump 352B to rotate the rotor 354B, in a first rotational direction RD.sub.1 (e.g., clockwise in
[0931] This technique for rotating rotor 354B results in liquid-supply peristaltic pump 352B producing a net output of zero, while maximizing both the positive and negative flow, because one of rollers 358B is always squeezing, and thus occluding, liquid-supply tube 318 (and thus pumping).
[0932] For some applications, control circuitry 332 is configured, throughout positive particle-delivery activation sub-state 350, to activate liquid-supply peristaltic pump 352B to: [0933] rotate rotor 354B a partial revolution equal to a fraction of a full 360-degree revolution of rotor 354B, the fraction less than the quotient of 1 divided by the total number of rollers 358B, or, for example, less than or equal to the quotient of 0.5 divided by the total number of rollers 358B (for example, in
For some applications, in order to achieve this volume of fluid pumping, control circuitry 332 is configured to rotationally position rotor 354B such that a lead one of rollers 358B is rotationally aligned with (fully squeezing) mixing tube channel 362A (and is thus operative) throughout positive particle-delivery activation sub-state 350 (the lead roller is the forward-most roller rotationally aligned with partial-circle mixing tube channel 362A; one or more additional rollers may also be rotationally aligned with the tube channel, trailing the lead roller). For example, if the upstream entrance to mixing tube channel 362A is disposed at 9 o'clock and the downstream exit of mixing tube channel 362A is disposed at 3 o'clock (as shown in
[0935] As used in the present application, including in the claims, throughout a time period (e.g., a particular state or sub-state) means from the beginning to the end of the time period (e.g., an occurrence of the state or sub-state). As mentioned above, each of the states and sub-states typically occur a plurality of non-contiguous times during operation of bone graft injection system 320.
[0936] For some applications, mixing peristaltic pump 352A comprises a total number of rollers 358A equal to at least two, and control circuitry 332 is configured to assume mixing activation state 342 a plurality of times in alternation with particle-delivery activation states 344, and to begin mixing activation states 342 with rotor 354A at respective starting rotational positions, which are identical to one another or rotationally offset from one another by the product of (a) 360 degrees divided by the total number of rollers 358A and (b) a positive integer (i.e., 1 or greater). For example, for configurations in which mixing peristaltic pump 352A comprises exactly three rollers 358A, such as shown in
[0937] For some applications, mixing peristaltic pump 352A comprises an odd total number of rollers 358A, the odd total number equal to at least one (e.g., at least three), and control circuitry 332 is configured to assume mixing activation state 342 a plurality of times in alternation with particle-delivery activation states 344, and to begin each of mixing activation states 342 with an aligned total number of rollers 358A rotationally aligned with mixing tube channel 362A, the aligned total number equal to more than half of the odd total number. (Thus, in the case in which mixing peristaltic pump 352A comprises exactly three rollers 358A, as shown in
[0938] For some applications, control circuitry 332 is configured, when in mixing activation state 342, to rotate mixing peristaltic pump 352A between and 3 revolutions, such as one revolution, such as for applications in which mixing peristaltic pump 352A comprises exactly three rollers 358A. More generally, for some applications, control circuitry 332 is configured, when in mixing activation state 342, to rotate mixing peristaltic pump 352A between (a) a number of revolutions and (b) 3 revolutions, the number of revolutions equal to the quotient of 1 divided by the number of rollers 358A. For some applications, control circuitry 332 is configured, when in mixing activation state 342, to rotate mixing peristaltic pump 352A at a rate of at least 50 rpm (revolutions per minute), no more than 600 rpm, and/or between 50 and 600 rpm, e.g., 150 rpm. This rapid rotation helps generate the puff 399 described hereinabove with reference to
[0939] For some applications, control circuitry 332 is configured: [0940] when in positive particle-delivery activation sub-state 350, to activate liquid-supply pump 324 to pump a volume of between 0.1 and 2 cc of fluid (e.g., between 0.2 and 0.9 cc, such as between 0.3 and 0.6 cc), and [0941] when in negative particle-delivery activation sub-state 348, to activate liquid-supply pump 324 to pump the volume of fluid.
[0942] Alternatively or additionally, for some applications, control circuitry 332 and mixing pump 322 are configured such that throughout mixing activation state 342 (i.e., during each occurrence of mixing activation state 342 in configurations in which mixing activation state 342 occurs more than once in alternation with particle-delivery activation state 344), pump 322 pumps between 0.5 and 9 cc of physiological liquid solution 336, such as between 1.8 and 3.9 cc of physiological liquid solution 336.
[0943] For some applications, control circuitry 332 is configured to assume particle-delivery activation state 344 a plurality of times in alternation with mixing activation states 342, and to begin each of particle-delivery activation states 344 with rotor 354B at a same rotational position.
[0944] For some applications, control circuitry 332 and liquid-supply pump 324 are configured such that during at least a portion of positive particle-delivery activation sub-state 350, liquid-supply pump 324 pumps physiological liquid solution 336 at a rate of at least 3 cc/sec, such as at least 7 cc/sec. Alternatively or additionally, for some applications, control circuitry 332 and liquid-supply pump 324 are configured such that during at least a portion of the negative particle-delivery activation sub-state 348, liquid-supply pump 324 pumps physiological liquid solution 336 at a rate of at least 3 cc/sec, such as at least 7 cc/sec. Further alternatively or additionally, for some applications, control circuitry 332 and mixing pump 322 are configured such that during at least a portion of mixing activation state 342 mixing pump 322 pumps physiological liquid solution 336 at a rate of at least 3 cc/sec, such as at least 7 cc/sec.
[0945] For some applications, control circuitry 332 is configured to, before repeatedly assuming mixing and particle-delivery activation states 342 and 344, assume a filling state, in which control circuitry 332 activates liquid-supply pump 324 to apply positive pressure to pump a volume of physiological liquid solution 336 from solid-liquid composition compartment 308 into solid-liquid composition delivery tube 314, the volume equal to between 0.5 and 3 cc.
[0946] For some applications, control circuitry 332 is configured to assume mixing activation slate 342 and particle-delivery activation state 344 at partially-overlapping times. For some of these applications, control circuitry 332 is configured to assume negative particle-delivery activation sub-state 348 and particle-delivery activation state 344 at partially-overlapping times. For example, control circuitry 332 may be configured to: [0947] begin negative particle-delivery activation sub-state 348 toward the end of mixing activation state 342 (e.g., within the last 30% of mixing activation state 342), [0948] complete negative particle-delivery activation sub-state 348 either simultaneously with the completion of mixing activation state 342, or after the completion of mixing activation state 342, and [0949] begin positive particle-delivery activation sub-state 350 upon the completion of negative particle-delivery activation sub-state 348, typically immediately upon the completion of negative particle-delivery activation sub-state 348.
[0950] For some applications, control circuitry 332 is configured to assume mixing activation state 342 and particle-delivery activation state 344 at the same time.
[0951] Reference is now made to
[0952] Before receptacle component 370 and cover component 372 are coupled to each another, bone-graft container 376 contains solid bone graft particles 334. For some applications, such as when bone-graft container 376 is provided pre-loaded with solid bone graft particles 334, bone-graft container 376 further comprises a temporary cap (not shown). For some applications, bone-graft container 376 is placed upside-down on a surface, such that opening 378 is facing up. The temporary cap, if provided, is removed. Receptacle component 370 of chamber 302 is coupled to bone-graft container 376 while bone-graft container 376 remains upside-down. Typically, chamber 302 is turned over to its upright operational position only after bone graft injection system 320 has filled the chamber with physiological liquid solution 336 in the filling state described above.
[0953] For some applications, bone-graft container 376 has a volume of between 0.2 and 6 ml. Alternatively or additionally, for some applications, chamber 302 has a volume of between 0.2 and 20 ml. Further alternatively or additionally, for some applications, a volume of bone-graft container 376 equals at least 10% of and/or less than 50% of a volume of chamber 302, such as less than 33%, e.g., less than 20% of the volume of chamber 302.
[0954] Reference is now made to
[0955] For some applications, user interface 335 of bone graft injection system 320 includes one or more of the following user controls (which may comprise, for example, buttons), for performing the following functions during use of bone graft injection system 320 in a bone augmentation procedure: [0956] a load user control, which instructs control circuitry 332 to fill all of the tubes of bone graft injection system 320 with physiological liquid solution 336, during the filling state described above with reference to
[0962] For some applications, a method of using bone graft injection system 320 comprises inserting, from a first (lower) side of maxillary bone 82 of a jaw, shaft delivery tube 380 of shaft unit 340 of bone graft injection system 320 into bore 86 that passes through maxillary bone 82 from the first (lower) side to the second (upper) side of maxillary bone 82, such that distal opening 383 of shaft delivery tube 380 is disposed in bore 86 or in cavity 90 that is (a) adjacent to the second side of maxillary bone 82 and (b) between the second side of maxillary bone 82 and Schneiderian membrane 88. (As mentioned hereinbelow, distal opening 383 is in fluid communication with shaft delivery tube 380.) For some applications, distal opening 383 is disposed at tho distal end of shaft delivery tube 380, and positioning distal opening 383 comprises positioning the distal end of shaft delivery tube 380 at the location.
[0963] For some applications, a screw 400 that defines a channel is screwed into bore 86 before insertion of shaft delivery tube 380, and shaft delivery tube 380 is inserted into bore 86 by being inserted into the channel of screw 400. Optionally, saline solution was previously injected through the channel of the screw in order to raise Schneiderian membrane 88. For some applications, a seal (e.g., comprising an o-ring) is provided between the wall of the channel and an external surface of shaft delivery tube 380. Alternatively or additionally, a seal is provided against the first (lower) side of first maxillary bone 82.
[0964] The method typically further comprises positioning distal opening 383 near a roof 406 of cavity 90. For example, distal opening 383 may be positioned at a solid-liquid-composition-delivery location 402 at a distance D5 from the second side of maxillary bone 82, the distance D5 equal to at least 50% (e.g., at least 75%) of a height H of cavity 90 directly above bore 86. Alternatively or additionally, for some applications, distal opening 383 is positioned at a distance D6 between 2 and 12 mm, such as between 4 and 6 mm from Schneiderian membrane 88 at roof 406 of cavity 90 directly above bore 86. Providing such spacing between distal opening 383 and Schneiderian membrane 88 may prevent solid-liquid composition 339 from rebounding off the membrane directly back into distal opening 383 before solid bone graft particles 334 can settle in the cavity.
[0965] The method further comprises providing solid-liquid composition 339 from a solid-liquid composition source, such as chamber 302 and other elements of bone graft injection system 320 that are coupled in fluid communication with shaft delivery tube 380, typically by activating pump unit 301, such as by activating control circuitry 332. While distal opening 383 is positioned at solid-liquid-composition-delivery location 402, solid-liquid composition 339 is injected through distal opening 383 via shaft delivery tube 380. Typically, while solid-liquid composition 339 is injected, chamber 302 is oriented such that liquid compartment 306 is above solid-liquid composition compartment 308. Typically, when chamber 302 is oriented such that liquid compartment 306 is above solid-liquid composition compartment 308: (a) the one or more solid-liquid composition ports 312 are disposed no more than a distance from a bottom of solid-liquid composition compartment 308, the distance equal to 25% of a vertical height of solid-liquid composition compartment 308, and/or (b) the one or more solid-liquid composition ports 312 are located through a side wall of solid-liquid composition compartment 308. Typically, while solid-liquid composition 339 is injected, solid-liquid composition delivery tube 314 is oriented within 45 degrees of horizontal, such as within 15 degrees of horizontal, e.g., horizontally. (As used in the present application, including in the claims, horizontal means horizontal with respect to the Earth, i.e., perpendicular to a vertical line directed to the center of gravity of the Earth, e.g., as ascertained using a plumb-line.)
[0966] For some applications, the method further comprises raising Schneiderian membrane 88 by injecting physiological liquid solution 336 through shaft delivery tube 380, such as shown in blow-up B of
[0967] For some applications, distal opening 383 is positioned at liquid-delivery location 404 while removable depth limiting element 384 is attached to shaft delivery tube 380. Removable depth limiting element 384 limits advancement of shaft delivery lube 380 through bore 86. Positioning distal opening 383 at solid-liquid-composition-delivery location 402 comprises removing depth limiting element 384 from shaft delivery tube 380, and subsequently advancing shaft delivery tube 380 through bore 86 until distal opening 383 reaches solid-liquid-composition-delivery location 402, such as shown in blow-up C of
[0968] For some applications, injecting solid-liquid composition 339 comprises pumping solid-liquid composition 339 through distal opening 383 via shaft delivery tube 380 at a pulsating hydraulic pressure that periodically varies between positive and negative.
[0969] For some applications, bone graft injection system 320 is used to perform the techniques described hereinabove with reference to
[0970] Although the techniques described herein have been generally described for use with bone graft particles, these techniques may also be used with other solid particles, such as, as for example, drug-releasing solid particles or solid drug particles.
[0971] The scope of the present invention includes embodiments described in the following patents and patent application publications, which are assigned to the assignee of the present application and are incorporated herein by reference. In an embodiment, techniques and apparatus described in one or more of the following patents or patent application publications are combined with techniques and apparatus described herein: [0972] U.S. Pat. No. 7,934,929 to Better et al. [0973] U.S. Pat. No. 8,029,284 to Better et al. [0974] U.S. Pat. No. 8,662,891 to Uchitel et al. [0975] U.S. Pat. No. 8,388,343 to Better et al. [0976] U.S. Pat. No. 8,702,423 to Better et al. [0977] PCT Publication WO 2010/035270 to Better et al. [0978] PCT Publication WO 2010/146573 to Better et al. [0979] PCT Publication WO 2014/199332 to Fostick et al.
[0980] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.