Expansion device for bone expansion and medical device for bone expansion
09839461 · 2017-12-12
Inventors
Cpc classification
F04C2270/0421
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
International classification
Abstract
The invention relates to an expansion device for bone expansion, wherein the expansion device has a proximal end and a distal end, between which ends the expansion device extends in a longitudinal direction, and extending apparatuses, which succeed one another in the longitudinal direction, wherein the extension apparatuses can be extended in order to exert force on a bone.
Claims
1. A method comprising: inserting an expansion device into a crevice of a bone, wherein the expansion device has a plurality of expansion chambers arranged along a longitudinal direction of the expansion device; expanding the expansion chambers to exert a radial force on the bone; controlling the expanding in accordance with the principle of callus distraction such that the expanding occurs over a plurality of days.
2. The method according to claim 1, wherein the expanding comprises expanding the expansion chambers uniformly.
3. The method according to claim 1, wherein the expanding comprises expanding the expansion chambers non-uniformly.
4. The method according to claim 1, wherein the expanding comprises filling the expansion chambers with a liquid.
5. The method according to claim 1, wherein the expanding comprises expanding the expansion chambers continuously over the plurality of days.
6. The method according to claim 1, wherein the expanding comprises expanding the expansion chambers stepwise over the plurality of days.
Description
(1) Preferred embodiments of the expansion device and of the medical apparatus are explained in the following with the aid of the attached figures.
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FIRST EMBODIMENT
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(14) The medical apparatus 100 comprises, in addition to the expansion device 110 according to the invention, a line 140 and an actuator 150 in the form of a pump, wherein the expansion device 110 is connected to the pump 150 via the line 140.
(15) The expansion device 110 shown in
(16) The encasing element 120 is produced from a flexible material, for example from a polyolefin-based elastomer, a silicone which is suitable for medical uses or generally from a resilient polymer. The encasing element 120 can expand together with the chambers 121, 122, 123 during the expansion described in the following.
(17) The X direction shown in
(18) The encasing element 120 likewise extends along this X direction shown in
(19) Within the encasing element 120 runs a metal core 130, which preferably has a diameter of 1 mm. The metal core 130 is provided to increase the stability of the expansion device 110 and facilitates the insertion of the expansion device 110 into a tubular bone. Preferably, the metal core 130 is also constructed such that it has a good X-ray contrast. By this means the position of the expansion device 110 within the tubular bone can be readily checked.
(20) The total length of the expansion device 110 shown in
(21) Within the encasing element 120, as already mentioned above, three chambers 121, 122, 123 are provided, which each independently and individually can be filled with a particular medium, such as, for example, a liquid, a gel or a gas.
(22) In this first embodiment, the chambers 121, 122 and 123 are formed by identical balloons, which are arranged uniformly and directly in succession in the longitudinal direction shown in
(23) When the chambers/balloons 121, 122 and 123 are filled with the medium, the balloons 121, 122, 123 expand radially in the Y-Z plane shown in
(24) The encasing element 120 encloses the chambers 121, 122, 123 or balloons completely and in a sealed manner. As a result, the chambers 121, 122, 123 come into direct contact with no body elements, such as bones, bone marrow or body fluids. This has the advantage that the chambers 121, 122, 123 can have dimensions and be constructed from materials merely with respect to the maximum pressures or forces to be expected.
(25) In this first preferred embodiment, the chambers/balloons 121, 122, 123 are constructed, for example, such that they can withstand a pressure of 25 bar.
(26) At the proximal end 124 of the expansion device 110 three pressure tubes 142, 143, 144 (
(27) Via the particular pressure tubes 142, 143, 144, the medium can be guided into the corresponding chamber, as a result of which the expansion device 110 can be expanded radially (Y-Z plane) in sections in the longitudinal direction (X direction) shown in
(28) In this first preferred embodiment, the chambers/balloons 121, 122, 123 are in each case connected indirectly or directly (fixed) to the metal core 130, so that the chambers/balloons 121, 122, 123 mainly expand in the radial direction (Y-Z plane) when the medium is introduced.
(29) The line 140 leads from the proximal end 124 of the expansion device 110 to a connector element 141 (connection/disconnection element) which, when the medical apparatus 100 is used as intended, is arranged within the body tissue.
(30) From the connector element 141 the line 140 runs further to the pump 150, which, when the medical apparatus is used as intended, is outside the patient's body.
(31) This part of the line 140, i.e. from the connector element 141 to the pump 150, is preferably coated with an antibiotic coating and/or a silver coating to avoid bacterial colonization of the line 140.
(32) The medium which is pumped by the pump 150 into the chambers/balloons 121, 122, 123 is contained in a reservoir 160. The reservoir 160 can be a part of the pump 150 or, as shown in
(33) Alternatively, the medical apparatus 100 shown in
(34) For implantation into the body, the reservoir 160 is preferably formed from a flexible, resilient material and can expand to accommodate various amounts of the medium.
(35) The volume of the reservoir 160 can vary according to what amount of the medium is to be accommodated therein. It is not absolutely necessary for the reservoir 160 to be implanted already in the filled state.
(36) For filling the reservoir 160, a vascular access port system (not shown) can be provided thereon, which can be arranged in the patient's tissue such that it can be punctured with a needle and the medium can be passed into the reservoir 160. This embodiment of the reservoir 160 is also advantageous in that it can be readily refilled.
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(38) The chamber which can be seen in
(39) On the encasing element 120 preferably at least one protrusion 126—in this preferred embodiment four protrusions—is formed, which is provided so that the expansion device 110 retains its position in the inserted state. When the expansion device 110 according to the invention has been inserted into the medullary space via an intramedullary access and the expansion device 110 is expanded, the protrusions 126 ensure secure positioning of the expansion device 110 within the medullary space.
(40) In a preferred construction, not shown, of the protrusion(s) 126, the pressure tubes 142, 143, 144 can be accommodated therein and run in the protrusion(s) to the corresponding chambers/balloons 121, 122, 123. This construction of the protrusion(s) 126 or this installation of the pressure tubes 142, 143, 144 has the advantage, for example, that the chambers 121, 122, 123 can be better fixed to the metal core 130, since none of the pressure tubes 142, 143, 144 has to be passed through at the connection between the chamber/balloon 121, 122, 123 and metal core 130.
(41) The pump 150 shown in
(42) The pump 150 is preferably controlled by a controller (not shown). The controller can be co-accommodated in the pump 150 or also be a unit separate from the pump 150.
(43) The controller can control the pump 150 such that this pumps the medium stepwise into the chambers and therefore the expansion device expands stepwise. By this means the pump can guide the medium in uniform steps, i.e. always the same amount of liquid, or in non-uniform steps, i.e. different amounts of liquid, into the chambers/balloons 121, 122, 123. For example, the controller can be programmed such that it automatically pumps a defined amount of the medium from the reservoir 160 into the expansion device 110 at certain time intervals.
(44) Alternatively, the controller can also control the pump 150 such that the pump expands the expansion device 100 or the chambers/balloons 121, 122, 123 continuously from a starting state.
(45) Furthermore alternatively, the controller determines, for example, with the aid of the amount of liquid already guided into the chambers 121, 122, 123, the current volume of the expansion device 110 or of the chambers/balloons 121, 122, 123 and the amount of liquid necessary for a desired expansion of the expansion device 110 which is to be introduced into the chambers/balloons 121, 122, 123. The controller subsequently controls the pump 150 such that it pumps the amount of liquid to be introduced into the chambers/balloons 121, 122, 123.
(46) Generally, the controller is preferably programmed such that it feeds the expansion device 110 with an amount of liquid such that this expands stepwise or continuously in accordance with the principle of callus distraction.
(47) If the pump 150, the reservoir 160 and the expansion device are to be implanted together into the patient's body, the controller is preferably configured such that either it is co-accommodated in the pump 150 or it can control the pump 150 in a wireless manner.
(48) For example, for wireless control the controller comprises a cuff which is arranged on a particular body part of the patient and via which the controller can transmit control signals to the implanted pump 150, for example by application of a magnetic, electrical or electromagnetic field.
(49) The controller can also be configured as a feedback controller, wherein a parameter recorded by measurement, such as the pressure prevailing in the chambers or the volume thereof, is fed back to the controller for the feedback control.
(50) As a result of the expansion device 110 having a plurality of chambers/balloons 121, 122, 123, different forces can be exerted on the tubular bones and the expansion device/tubular bone can be expanded in a particular manner.
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(53) The remaining elements of the medical apparatus 100 shown in
Second Embodiment
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(56) Preferably, the tube 220 is constructed such that it does not have a constant internal diameter, and for this reason the wall thickness of the tube 220 changes. This is advantageous to the extent that during the expansion the tube 220 does not expand uniformly in all directions, and for this reason the expansion device 210 cannot be readily rotated within the bone marrow and remains fixed.
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(58) In all the embodiments and variants of the medical apparatus shown with reference to
Third Embodiment
(59) A third preferred embodiment of the medical apparatus for bone expansion is described in the following.
(60) The medical apparatus 300 comprises an expansion device 310 for bone expansion.
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(62) The X direction shown in
(63) As shown in
(64) The spring elements 321, 322, 323 each have a first leaf spring 3212, 3222, 3232 and a second leaf spring 3214, 3224, 3234, which each are fixed on the one hand to a first sleeve 3211, 3221, 3231 and on the other hand to a second sleeve 3213, 3223, 3233.
(65) The spring elements 321, 322, 323 cooperate with a threaded spindle 330 such that the spring elements 321, 322, 323 or their leaf springs can be expanded. For this, the first and second sleeves are arranged on the threaded spindle 330 or the threaded spindle 330 is passed through the first and second sleeves.
(66) The first sleeves 3211, 3221, 3231 and the threaded spindle 330 engage via a thread such that by rotation of the threaded spindle 330 the first sleeves 3211, 3221, 3231 can be displaced translatorially in the X direction on the threaded spindle 330. The state of the expansion device 310 in which the first sleeves 3211, 3221, 3231 are displaced is shown in
(67) The second sleeves 3213, 3223, 3233 are mounted rotatably on the threaded spindle 330; however, they are not displaced by rotation of the threaded spindle 330 but remain fixed with respect to the longitudinal direction of the expansion device 310 (X direction) on rotation of the threaded spindle 330.
(68) By this construction of the spring elements 321, 322, 323, on rotation of the threaded spindle 330 the first sleeves 3211, 3221, 3231 are displaced translatorially in the longitudinal direction shown in
(69) The expansion device 310 and the spring elements 321, 322, 323, respectively, consequently expand on rotation of the threaded spindle 330, a force being exerted via each spring element 321, 322, 323 on to the tubular bone for callus distraction when the expansion device 310 is arranged within a tubular bone to be expanded.
(70) Depending on the dimensions of the spring elements 321, 322, 323, such as, for example, the choice of the spring constants and the lengths of the leaf springs, and the degree of displacement of the first sleeves 3211, 3221, 3231, a particular force can be exerted via each of the spring elements 321, 322, 323 on the tubular bone for callus distraction.
(71) The threaded spindle 330 is preferably constructed such that it can be bent to a certain degree. By this means the arrangement of the expansion device 330 within a tubular bone through an intramedullary access is facilitated.
(72) At the proximal end 324 of the expansion device 310 according to the invention a coupling means 326 shown in
(73) In this third preferred embodiment, the actuator is realized by an electric motor which is operated by a controller (not shown) such that it rotates the threaded spindle 330 for extension of the expansion device 310.
(74) As also in the first and second preferred embodiment, the actuator, i.e. the electric motor 350, can be configured such that this can be implanted into the patient's body together with the expansion device 310.
(75) The controller can control the electric motor such that this rotates the threaded spindle 330 stepwise and therefore expands the spring elements 321, 322, 323 stepwise. By this means the electric motor 350 can rotate the threaded spindle 330 in uniform steps or in non-uniform steps.
(76) For example, the controller can be programmed such that it automatically rotates the threaded spindle 330 by a defined amount at certain time intervals.
(77) Alternatively, the controller can also control the electric motor 350 such that the expansion device 310 or the spring elements 321, 322, 323 are expanded continuously from a starting state.
(78) As also in the above preferred embodiments, the controller controls/regulates the actuator or the electric motor such that it expands the expansion device 310 in accordance with the principle of callus distraction.
(79) Preferably, for feedback control of the expansion of the expansion device 310, the force necessary for rotation of the threaded spindle 330, from which the forces exerted on the tubular bones by the spring elements 321, 322, 323 can be concluded, is determined and used for the feedback control (and returned to the controller, respectively).
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(81) As can be seen from this, the forces F can be exerted via the leaf springs 3212, 3214, which expand in the Y direction shown, on a tubular bone in which the expansion device 310 is arranged.
(82) For production of the expansion means and the spring elements 321, 322, 323, respectively, hollow profiles (tubes or polygons) into which the threaded spindle 330 can be inserted are preferably used. The hollow profiles are (partially) slit on two opposite sections running in the longitudinal direction (X direction) such that the end sections of the hollow profiles lying in the longitudinal direction form the first and second sleeve. The sections lying between the sleeves and running in the longitudinal direction form the leaf springs.
(83) To prevent overloading of the spring elements 321, 322, 323, stops can preferably be provided on the first and/or second sleeves, which stops come to rest when the first sleeves 3211, 3221, 3231 are displaced beyond a certain extent. The stops are preferably arranged between the leaf springs in the Y-Z plane shown in
(84) Preferred modifications of the third preferred embodiment of the medical apparatus 300 and of the expansion device 310 are also explained in the following.
(85) In general, as shown by way of example in
(86) As can be seen from
(87) The spring elements 321, 322, 323 have been described above as identical. However, the invention is not limited to this. The spring elements 321, 322, 323 can also be different. For example, the spring constants of the leaf springs assigned to one spring element or different spring elements can be different.
(88) Furthermore, the spring elements 321, 322, 323 can be configured such that the corresponding second sleeves 3213, 3223, 3233 also engage with the threaded spindle 330 via a thread. In this case it is necessary for the threaded spindle 330 to have in the portion assigned to one of the spring elements a thread running opposite such that, depending on the direction of rotation of the threaded spindle 330, the particular first and second sheaths either approach one another or are displaced in the opposite direction.
(89) As can be seen from the above description of the third preferred embodiment, the spring elements 321, 322, 323 to be expanded have uniform or different dimensions depending on the nature of the tubular bone to be expanded, so that the tubular bone in which the expansion device 310 is arranged can be expanded in a particular manner—preferably in accordance with the principle of callus distraction.
Fourth Embodiment
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(91) The elements of the fourth preferred embodiment of the medical apparatus 400 which are identical to those of the third preferred embodiment have the same reference numerals and are not explained again.
(92) The medical apparatus 400 differs from that explained with reference to
(93) The expansion device 410 likewise comprises three expansion means 421, 422, 423, wherein instead of the leaf springs, the corresponding sheaths 3211, 3213, 3221, 3223, 3231, 3233 are connected to one another via struts. The expansion means, i.e. the scissor elements 421, 422, 423, are identical in construction, and for this reason these are described only with reference to the first scissor element 421.
(94) The struts 4211, 4212, 4213, 4214 of the first scissor element 421 on the one hand are fixed in a rotatably mounted manner on the sleeves 3211, 3213 and on the other hand are connected to one another in a rotatably mounted manner at a common connection point 4215, 4216.
(95) When the threaded spindle 330 is rotated, this leads to a displacement of the sheath 3211, as a result of which the rotatably mounted struts 4211, 4212, 4213, 4214 are deflected outwards (in
(96) The struts 4211, 4212, 4213, 4214 carry on their common connection points 4215, 4216 in each case a force distribution element 424, 425, via which the scissor element 421 can exert the force for bone expansion or for callus distraction on the bone on rotation of the threaded spindle 330, the force distribution elements 424, 425 being configured such that they distribute the exerted force over the surface.
(97) In this embodiment the force distribution elements 424, 425 are constructed as force distribution struts which in each case run in the longitudinal direction (X direction) and are supported/held by the scissor elements 421, 422, 423 in succession in the longitudinal direction. The force distribution struts 424, 425 are here in each case fixed to the connection points of the struts of the first to third scissor element, so that the force distribution struts 424, 425 are raised uniformly on rotation of the threaded spindle 330 and extension of the scissor elements 421, 422, 423.
(98) In
(99) Nevertheless, the scissor elements 421, 422, 423 can also have additional struts, which are displaced by 90° as also are the leaf springs shown in
(100) The additional struts can likewise carry a force distribution element or a force distribution strut on their connection points.
(101) If the force distribution elements are constructed as the force distribution struts 424, 425 shown, the force distribution struts 424, 425 preferably have a cross-section in the form of an arc of a circle (Y-Z plane) such that the force distribution struts 424, 425 form a casing of closed cross-section in the completely contracted state of the expansion device 410.
(102) As can be seen from the descriptions of the expansion devices according to the invention and the medical apparatuss according to the invention, devices for a faster bone expansion/callus distraction can be provided.