The invention relates to a system including a sonotrode and a guide shaft and to a sonotrode suitable for the system, wherein sonotrode and guide shaft are adapted to each other for enabling operation of the sonotrode when at least part of the sonotrode length is positioned to extend through the guide shaft. The system is suitable for use in a device in which ultrasonic vibration is produced, e.g., by a transducer unit, and is transmitted through the sonotrode to a distal end thereof to be applied to an object or to a medium for achieving a desired effect. The system according to the invention is in particular suitable for applications in which the sonotrode distal end is to vibrate longitudinally, in which the sonotrode is slender and long, and in which a large portion of the sonotrode length is to extend in the guide shaft. This is the case, e.g., in the medical field of minimally invasive surgery, for which the transducer unit, e.g., being contained in an ultrasonic hand piece, is positioned outside of a patient, and the sonotrode is coupled to the transducer unit and has to reach through tissue to a target site within the patient, wherein the tissue through which the sonotrode is to reach is to be kept unaffected by the vibration with the aid of the guide shaft and the tissue opening through which the sonotrode is to reach is to be as small as possible.
WO2011/054123 discloses a system suitable for anchoring a permeable sleeve (in particular a cannulated bone screw) in hard tissue with the aid of a thermoplastic element. For achieving this anchorage, the thermoplastic element is positioned in the permeable sleeve, the permeable sleeve is coupled to an ultrasonic hand piece and is in situ liquefied and at least partly pressed through the permeable sleeve by the sonotrode of the hand piece being pressed against a proximal face of the thermoplastic element. The ultrasonic hand piece includes a housing in which a transducer unit and, coupled thereto, the sonotrode, and a driver spring are arranged, such that the combination of transducer unit and sonotrode is axially moveable within the housing in a limited manner and is acoustically decoupled from the housing, such that a distal end of the sonotrode is able to protrude from a distal housing end, and such that the driver spring, acting between a proximal housing portion and the transducer unit, biases the combination of transducer unit and sonotrode away from the proximal end of the housing. In an assembled configuration of the system, in which the permeable sleeve with the thermoplastic element positioned therein is coupled to the distal end of the housing, the system parts form a closed load frame in which the thermoplastic element is compressed between the distal face of the sonotrode and the permeable sleeve, and in which the sonotrode is completely encased by the housing and the permeable sleeve, being supported by two sliding bushes arranged on the inner surface of a distal housing part.
The publication EP1790303 (Olympus) discloses an ultrasonic treatment apparatus including a sonotrode arranged in a guide tube, a distal sonotrode end protruding from the guide tube and being shaped for treating tissue. At a node position of the sonotrode a support member made of silicone rubber is mounted in the guide tube. In a similar manner, publications DE 3707403, US2016/00374708 and EP3401025 disclose sonotrode arrangements in which the sonotrode carries elastic and/or abrasion-resistant rings in node positions. Publication U.S. Pat. No. 5,346,502 discloses a sonotrode extending in a polymeric sheath, which in node positions is in contact with the sonotrode (no radial clearance).
The full disclosure of all the publications cited above is incorporated herein by reference.
It is the object of the present invention to improve the system of sonotrode and guide shaft as known from the state of the art to make it better suitable for operation in cases in which the vibrating sonotrode is to be axially moved in the guide shaft, in which the sonotrode is slender and long, i.e., has a comparatively small bending strength, in which the sonotrode extends over a large portion of its length, in particular over its full length, in the guide shaft, in which the guide shaft is as slender as possible and possibly includes more than one piece and therefore radial clearance between sonotrode and guide shaft is small and coaxiality possibly not fully guaranteed. In this named system of sonotrode and guide shaft, transmission of vibrational energy though the sonotrode is to be as efficient as possible and friction between sonotrode and guide shaft as low as possible. Such friction and corresponding friction wear not only constitute an undesirable loss of energy and generation of heat in undesirable locations, and shortens the life span of the system but it is furthermore to be prevented because, in particular in medical applications, wear debris, in particular metal debris, may prove harmful for neighboring tissue. Furthermore, the measures according to the invention with which the named object is achieved are to be technically simple, in particular possible for the through opening of the guide shaft having a constant cross section.
The sonotrode of the system according to the invention, the same as known sonotrodes, is preferably designed to be adapted to a vibration frequency, e.g., in the range of 20 to 40 kHz and for vibrating substantially longitudinally in a stationary wave with anti-node positions (positions with maximum amplitude) at both ends. This means that the sonotrode has a length that corresponds to an integer multiple of half the wave length (λ/2) of the stationary wave, and that there is at least one node position (position of minimum amplitude) between the two sonotrode ends.
The above stated objects are achieved in the system according to the invention by providing, in an axial position of the system in which the most distal node position of the sonotrode is situated, a region in which radial clearance between sonotrode and guide shaft is at a minimum. This is realized by the sonotrode including, in the most distal node position an increased cross section, and by the through opening of the guide shaft portion extending form the distal end portion to beyond the most distal node position of the sonotrode including a constant cross section. Adjoining the sonotrode portion of increased cross section (most distal node position) in distal and in proximal direction are sonotrode portions of lesser cross section (larger radial clearance), wherein transition between the differing cross sections may include a step or may be a gradual transition, and wherein the cross section of the sonotrode portion on the distal side of the portion of increased cross section may be smaller than the cross section of the sonotrode on the proximal side of the portion with increased cross section. This means that radial clearance between sonotrode and guide shaft is greatest for the sonotrode portion extending through the most distal portion of the guide shaft, is reduced in the most distal node position of the sonotrode and is again greater for a proximally adjoining sonotrode portion but possibly not as great as for the most distal portion.
The sonotrode is preferably made of a metal, e.g., titanium, and the guide shaft is also made of a metal (e.g., stainless steel) or of a hard polymer material. The sonotrode portion in the most distal node position is preferably made of the same sonotrode material and is an integral part of the sonotrode. For further reducing friction between the sonotrode and the guide shaft, the most distal portion of the sonotrode at least including the most distal node position, or indeed the whole sonotrode, may be coated with a suitable friction reducing coating, which for a titanium sonotrode preferably consists of titanium nitride.
Furthermore, the distal sonotrode end, which constitutes an anti-node position, carries a ring that increases the sonotrode cross section and is made of a material being softer than the material of the guide shaft and softer than the sonotrode material. The distal ring is, e.g., made of a polymer, preferably of PEEK.
In most cases the cross sections of the sonotrode and the guide shaft through opening (bore) will be circular, but of course other cross section shapes are possible also, wherein, in any case, the mounting of the sonotrode within the guide shaft is to be as coaxial as possible such that equal radial clearance on all sides of the sonotrode is ensured as well as possible.
For systems including a sonotrode with an axial length corresponding to twice or three times or even more times the half wave length of the vibration to be transmitted by the sonotrode, it may be advantageous to not only equip the most distal node position in the above described manner but also one or possibly two node positions of further proximally situated sonotrode portions. The latter measure is advantageous in particular for very slender sonotrodes whose cross section does not or does only slightly increase from the distal towards the proximal sonotrode end.
Exemplary embodiments of the invention are described in further detail in connection with the appended Figs., wherein:
In all appended Figs., same reference numerals designate same elements or similar elements serving same functions.
As illustrated by the wave diagram, the sonotrode according to
According to the invention, radial clearance RC between the sonotrode 1 and the guide shaft 2 is to be minimal in the most distal node position N1 of the sonotrode 1. This is achieved in particular for being applicable for an axially displaceable sonotrode, by the through opening 3 of the guide shaft 2 having, at least in a distal portion extending form a distal end portion to beyond the most distal node position N1 of the sonotrode 1, a constant cross section, and by the sonotrode 1 including a portion 1.3 of an increased cross section in the most distal node position N1 (see cross section in position I) as compared to the cross sections in positions II and III adjoining the distal node position N1 distally and proximally. Therein, as mentioned further above, the radial clearance between sonotrode 1 and guide shaft 2 may be smaller on the proximal side of the most distal node position N1 (cross section position III) than on the distal side of the most distal node position (cross section position II) by the sonotrode having correspondingly differing cross sections (see example as illustrated in
Exemplary values for the radial clearance RC between sonotrode 1 and guide shaft 2 are for the most distal node position N1 a few hundredth of a mm (RC1: between 0.01 and 0.1 mm, preferably not more than 0.05 mm) and for positions II and III adjoining the most distal node position N1 about five to ten times more (RC2 and RC3: between 0.1 and 0.8 mm). The sonotrode portion of the most distal node position having an increased cross section has preferably an axial length which is no greater than 2 to 4% of half of the vibration wave length λ/2.
An exemplary embodiment of the system as illustrated in
The distal end 1.1 of the sonotrode as shown in
As seen from the cross section in position IV, the radial clearance RC4 between the ring 10 and an opening 11 of, e.g., a cannulated screw, in which the distal sonotrode end with the ring 10 is to operate, is advantageously in the same range as the radial clearance RC1 between the sonotrode and the guide shaft in the most distal node position N1 of the sonotrode.
For specific applications it may be sufficient to mount the ring 10 without providing a groove on the sonotrode end. In such a case, the ring is press-fitted onto the sonotrode end and/or is fixed with the aid of a suitable adhesive.
When the device as partly shown in
In particular, for being able to handle known poly-axial pedicle screws and for being applicable in minimally invasive surgery, the sonotrode and the guide shaft being parts of the device as illustrated in
Obviously, instead of a screw, any suitably perforated or fenestrated sleeve can be handled with the device according to
Further details regarding the device as in part illustrated in
Further shown is a treatment element in form of a cutting blade 40 with a proximal coupling portion 41, an intermediate transition portion 42 and a distal blade portion 43. The coupling portion 41, which is equipped for coupling to the distal end of the sonotrode 1, the coupling being equipped for as loss free transmission of the vibration energy and, e.g., by including a threaded bolt (not shown) carried by the coupling portion 41 and cooperating with a corresponding threaded blind bore in the distal face of the distal sonotrode end. The coupling portion 41 has e.g. about the same cross section as the distal end of the sonotrode 1. The blade portion 43 is blade-shaped with a narrow rectangular cross section and it possibly has sharp or serrated lateral and or distal cutting edges. For being able to be used also as a grinding tool, the lateral surfaces of the blade portion 43 may be rough or equipped with a grinding surface structure. The transition portion 42 is laterally tapering from a cross section adapted to the coupling portion 41 to the cross section of the blade portion 43. Preferably the cutting blade is integrally formed as one piece.
The guide shaft 2 reaches distally to cover the distal end of the sonotrode 1 and possibly also the coupling portion 41 of the cutting blade 40. As discussed further above, the sonotrode 1 is equipped with a portion 1.3 of a larger cross section in the node position N and with a ring 10 mounted to its distal end portion (anti-node position A).
As discussed in connection with the application of the inventive system according to
Further details regarding cutting blades with or without grinding surfaces and being suitable for use in connection with a system of sonotrode and guide shaft according to the invention are found in the co-pending application titled “Device and method for perforation a dense bone layer” by the same applicant.
Number | Date | Country | Kind |
---|---|---|---|
00150/18 | Feb 2018 | CH | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2019/052868 | 2/6/2019 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2019/154833 | 8/15/2019 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5346502 | Estabrook et al. | Sep 1994 | A |
5358505 | Wuchinich | Oct 1994 | A |
5664570 | Bishop | Sep 1997 | A |
9198703 | Giersch | Dec 2015 | B2 |
9301790 | Dorawa | Apr 2016 | B2 |
9510886 | Giersch | Dec 2016 | B2 |
20050096679 | Stulen | May 2005 | A1 |
20070106158 | Madan | May 2007 | A1 |
20090036912 | Wiener | Feb 2009 | A1 |
20090318944 | Kimura | Dec 2009 | A1 |
20120143261 | Giersch | Jun 2012 | A1 |
20150257780 | Houser | Sep 2015 | A1 |
20160332362 | Vogler et al. | Nov 2016 | A1 |
20160374708 | Wiener et al. | Dec 2016 | A1 |
20170143399 | Sakai | May 2017 | A1 |
20170197231 | Knorr | Jul 2017 | A1 |
20170239497 | Yoshimine | Aug 2017 | A1 |
20180055530 | Messerly | Mar 2018 | A1 |
20180146975 | Zhang | May 2018 | A1 |
20190201047 | Yates | Jul 2019 | A1 |
20190247080 | Yokoyama | Aug 2019 | A1 |
20190314051 | Li | Oct 2019 | A1 |
20200253631 | Apperson | Aug 2020 | A1 |
20200305923 | Maeda | Oct 2020 | A1 |
Number | Date | Country |
---|---|---|
107249489 | Oct 2017 | CN |
107466225 | Dec 2017 | CN |
3707403 | Sep 1987 | DE |
1 790 303 | May 2007 | EP |
2508203 | Aug 1996 | JP |
2001-8943 | Jan 2001 | JP |
2012-223582 | Nov 2012 | JP |
9814126 | Apr 1998 | WO |
2009109057 | Sep 2009 | WO |
2011054123 | May 2011 | WO |
2017119099 | Jul 2017 | WO |
Entry |
---|
English translation of Chinese Office Action dated Oct. 18, 2023, Application No. 2019800118112; 7 pages. |
Chinese Search Report dated Oct. 16, 2023, Application No. 2019800118112; 3 pages. |
Number | Date | Country | |
---|---|---|---|
20210045767 A1 | Feb 2021 | US |