Trocar Sleeve, Trocar System And Method Of Manufacturing A Trocar Sleeve
20170209134 ยท 2017-07-27
Inventors
Cpc classification
A61B17/3468
HUMAN NECESSITIES
A61B17/3462
HUMAN NECESSITIES
A61B17/3415
HUMAN NECESSITIES
A61B2017/3433
HUMAN NECESSITIES
A61B17/3417
HUMAN NECESSITIES
A61B2017/0225
HUMAN NECESSITIES
International classification
Abstract
A trocar sleeve comprises a flexible hollow shaft comprising a distal end and a proximal end, and a handling head that is formed at the proximal end of the hollow shaft. The trocar sleeve is manufactured from an elastomer material. The hollow shaft comprises an inner contour that is adapted to an outer contour of a trocar mandrel in such a way that the trocar sleeve and the trocar mandrel are arranged to be coupled to one another while generating a defined preload to stabilize the trocar sleeve. A trocar system comprises a trocar sleeve and a trocar mandrel that is arranged to be inserted in the trocar sleeve, while generating a defined preloading in the trocar sleeve. A method of manufacturing a trocar sleeve involves integrally forming a hollow shaft and a handling head in a common mold by molding.
Claims
1. A trocar sleeve comprising a flexible hollow shaft and a handling head, wherein the hollow shaft comprises a distal end and a proximal end, wherein the handling head is formed at the proximal end of the hollow shaft, wherein the trocar sleeve is manufactured from an elastomer material, wherein the hollow shaft comprises an inner contour arranged to insert therein a trocar mandrel having an outer contour, and wherein the inner contour of the hollow shaft is adapted to the outer contour of the trocar mandrel such that the trocar sleeve and the trocar mandrel generate, upon insertion of the trocar mandrel in the trocar sleeve, a defined preloading in the hollow shaft that stabilizes the trocar sleeve.
2. The trocar sleeve as claimed in claim 1, wherein the hollow shaft is, in a defined axial relative position between the trocar sleeve and the trocar mandrel, at least sectionally widened by the trocar mandrel.
3. The trocar sleeve as claimed in claim 1, wherein the elastomer material the trocar sleeve is made from has a Shore hardness, determined in accordance with ISO 7619-1, of no more than 90 Shore A,
4. The trocar sleeve as claimed in claim 3, wherein the Shore hardness is about 70 Shore A.
5. The trocar sleeve as claimed in claim 1, wherein the hollow shaft and the handling head are formed in one piece.
6. The trocar sleeve as claimed in claim 1, wherein the trocar sleeve is integrally shaped and manufactured by molding.
7. The trocar sleeve as claimed in claim 1, wherein the elastomer material is selected from the group consisting of: silicone, silicone rubber, thermoplastic elastomers, rubber, and compounds containing the same.
8. The trocar sleeve as claimed in claim 1, wherein the hollow shaft is, at least sectionally, tubular or cylindrically shaped,
9. The trocar sleeve as claimed in claim 1, wherein the hollow shaft comprises, at least sectionally, a smooth, elevation-free outer surface,
10. The trocar sleeve as claimed in claim 1, wherein the hollow shaft is, at least partially, provided with a friction-reducing coating.
11. The trocar sleeve as claimed in claim 1, wherein the hollow shaft comprises, at least sectionally, a wall thickness increasing from the distal end to the proximal end.
12. The trocar sleeve as claimed in claim 1, wherein the inner contour of the hollow shaft is, at least sectionally, tapered or spherically shaped, and wherein the inner contour has an inner diameter that is increasing from the distal end to the proximal end.
13. The trocar sleeve as claimed in claim 12, wherein the inner contour of the hollow shaft is adapted to an at least sectionally tapered or spherical shape of the outer contour of the trocar mandrel to prestress the trocar sleeve when the trocar mandrel is advanced in the hollow shaft towards the distal end.
14. The trocar sleeve as claimed in claim 1, further comprising a thread section that is formed at the hollow shaft, wherein the hollow shaft, the thread section and the handling head are formed in one piece.
15. The trocar sleeve as claimed in claim 1, wherein the inner contour of the hollow shaft is, at least sectionally, non-rotationally symmetric, and provided with a non-circular cross-section.
16. The trocar sleeve as claimed in claim 1, wherein one of a sealing contour and a sealing receiving contour is formed at the proximal end of the hollow shaft in the vicinity of the handling head.
17. A trocar system comprising a trocar sleeve as claimed in claim 1 and a trocar mandrel that is arranged to be inserted in the trocar sleeve, while generating a defined preloading at the hollow shaft of the trocar sleeve.
18. The trocar system as claimed in claim 17, wherein, in a detached state of the trocar sleeve and the trocar mandrel, a defined interference between the inner contour of the hollow shaft and the outer contour of the trocar mandrel in present, and wherein the hollow shaft is at least sectionally widened when the trocar mandrel is inserted in the trocar sleeve.
19. A method of manufacturing a trocar sleeve, comprising the following steps: providing a mold that is configured for integrally forming a trocar sleeve having a hollow shaft and a handling head, providing an elastomer material, molding the trocar sleeve, comprising filling the mold with the elastomer material, including integrally forming the hollow shaft and the handling head, wherein at the hollow shaft of the trocar sleeve an inner contour is formed that is adapted to an outer contour of a trocar mandrel such that the trocar sleeve and the trocar mandrel generate in an assembled state, upon insertion of the trocar mandrel in the trocar sleeve, a defined preloading that stabilizes the trocar sleeve.
20. A method for providing a trocar system, comprising: manufacturing a trocar sleeve in accordance with the method as claimed in claim 19, providing a trocar mandrel that is adapted to the trocar sleeve, wherein the trocar mandrel comprises an outer contour that is adapted to the inner contour of the hollow shaft, and inserting the trocar mandrel in the trocar sleeve, comprising at least sectionally widening the trocar sleeve, including generating a preloading in the hollow shaft of the trocar sleeve to stabilize the trocar sleeve upon the insertion of the trocar mandrel.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0067] Further features and advantages of the disclosure are disclosed by the following description of a plurality of exemplary embodiments, with reference to the drawings, wherein:
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0083] With reference to
[0084] The trocar mandrel 12 comprises a shaft 16 at the distal end thereof a tip 18 is formed. At the proximal end of the shaft 16 of the trocar mandrel 12, a handling section 20 is formed.
[0085] The trocar sleeve 14 comprises a hollow shaft 24 that may also be referred to as tube. The trocar sleeve 14 further comprises a handling head 26 that is arranged at a proximal end of the trocar sleeve 14 or at least adjacent thereto. By way of example, the handling head 26 comprises a port 28 that is provided with a valve through which irrigation fluids, gases and such like may be supplied and led away.
[0086] The trocar system 10 elucidated in
[0087] With reference to
[0088] The exemplary embodiments elucidated hereinafter relate to several aspects of the design and manufacture of trocar systems. It goes without saying that single features which are provided at one of the embodiments may also be transferred to other embodiments, and in fact isolated from other features of the respective exemplary embodiments.
[0089] With reference to
[0090] The trocar sleeve 40 comprises a hollow shaft 42 and a handling head 44. The hollow shaft 42 and the handling head 44 are integrally shaped and manufactured in one piece. The handling head 44 and the hollow shaft 42 together define a longitudinal extension of the trocar sleeve 40, refer also to a longitudinal axis that is designated in
[0091] The hollow shaft 42 further comprises a distal end 48 and a proximal end 50. The distal end 48 is the end that is facing the interior of the patient when the trocar sleeve 40 is placed at a tissue section, for instance at an abdominal wall of the patient. The proximal end 50 is in this state facing the user or operating surgeon and accordingly facing away from the interior of the patient. At the proximal end 50 of the hollow shaft 42, the handling head 44 is formed.
[0092] In exemplary embodiments, the hollow shaft 42 comprises, at least sectionally, a smooth surface 52 that is not arranged as a corrugated surface and/or a curly surface. Nevertheless, at least in accordance with some embodiments, at the hollow shaft 42 a thread section 54 is formed that comprises, for instance, at least one thread turn 56 which may also be referred to as helix. Preferably, also the thread section 54 is shaped as an integral component of the trocar sleeve 40. In this connection, reference is made to the broken cross-sectional view according to
[0093] The pitch and the height of the turn of the thread 56 may be variable and may consider specific operating conditions. This may involve a huge pitch at a distal run-out of the turn of the thread 56. At a proximal run-out of the turn of the thread 56, however, a significantly reduced pitch may be provided. Similarly, the thread turn 56 may comprise, at its distal end, a very small height gradually developing to a maximum height, wherein a greater reduction of the height (per circumferential section) is present towards the proximal end of the thread turn 56. This arrangement may have the effect that the trocar sleeve 40, on the one hand, may be easily inserted in tissue as the distal end of the thread turn 56 is, so to say, shaped as an insertion aid. The pitch of the thread turn 56 is reduced towards the proximal end of the thread turn 56, and, further, a considerable height is still present. In this way, the hollow shaft 42 that is provided with the thread section 54 is well secured against a displacement towards the proximal end. It goes without saying that the arrangement of the thread section 54 elucidated herein is merely exemplary.
[0094] In some embodiments, it is conceivable to manufacture the trocar sleeve 40 integrally and by casting from a flexible material, such as an elastomer material, for instance. This enables a great freedom of design and, in some embodiments, the formation of additional components. In some embodiments, with the selected materials, there is no great likelihood of a formation of cavities/shrinking and such like. Hence, not in each case great care has to be applied to provide a more or less constant wall thickness. This applies in particular also to the thread section 54. Accordingly, both the surface at the outer side of the hollow shaft 42 and an inner contour 72 (refer to
[0095] Taken in combination, it can be seen from
[0096] The handling head 44 is radially enlarged with respect to the hollow shaft 42 and also provides an increased receiving opening. Further, the handling head 44 is provided with basically axially extending ribs 58 and with basically circumferentially extending ribs 60. The axial ribs 58 and the circumferential ribs 60 form a cross structure. The ribs 58, 60 define and/or surround recesses or depressions 62 that contribute to the prevention of material accumulations and/or to weight reduction, and to the optimization of the weight distribution. The hollow shaft 42 comprises a cylindrical wall 70 that surrounds the longitudinal axis 68. At the inner side of the wall 70, the inner contour 72 is formed.
[0097] The embodiment of the trocar sleeve 40 elucidated with reference to
[0098] With reference to the longitudinal cross-section shown in
[0099] Embodiments may be envisaged wherein the inner contour 72 of the hollow shaft 42 comprises along its longitudinal extension a basically constant cross-section (D.sub.di=D.sub.pi). However, also embodiments may be envisaged, wherein D.sub.di<D.sub.pi applies. In accordance with this embodiment, the inner contour 72 is for instance conical or spherically shaped and provided with a tapering towards the distal end 48.
[0100] In accordance with alternative or additional arrangements, the thickness of the wall 70 along the longitudinal extension of the hollow shaft 72 is basically constant (t.sub.d=t.sub.p). However, there are also arrangements conceivable, refer for instance to the embodiment shown in
[0101] It is essential that the inner contour 72 is adapted to the outer contour of a trocar mandrel such that a widening of the hollow shaft 72 is generated in the desired manner when the trocar mandrel is inserted in the trocar sleeve 40. Therefore, in some embodiments, at least one of the hollow shaft 42 and the trocar mandrel is at least sectionally tapered, conically or spherically shaped.
[0102] In this connection, additional reference is made to the
[0103] As already elucidated in connection with
[0104] In
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[0106] In
[0107] In accordance with substantial aspects of the present disclosure, the trocar mandrel 80 widens the hollow shaft 42 of the trocar sleeve 40 while the trocar mandrel 80 is inserted in the trocar sleeve 40 and/or when the trocar mandrel 80 is entirely inserted therein. Radial expansion of the hollow shaft 42 is elucidated in
[0108] In
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[0110] With reference to
[0111] It can be seen from the cross-sectional view in
[0112] As a modification with respect to the exemplary embodiments elucidated herein before, the handling head 44 in
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[0114] In this connection, additional reference is made to
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[0116] The trocar sleeve 340 and the trocar mandrel 180 in accordance with the arrangement of
[0117] When, for instance due to external forces, either the trocar sleeve 340 or the trocar mandrel 180 are respectively rotated with respect to the other component, in the region of the position securing elements 116, 118, for instance, an increase of the preloading at the hollow shaft 42 is caused when the position securing elements 116, 118 tend to disengage. This results in a considerable local widening and hence in a further increase of the inherent stability of the hollow shaft 42 of the trocar sleeve 340. In other words, the increase of the stability of the hollow shaft 42 is the greater the greater the as such deforming moment is.
[0118] It goes without saying that the rotation prevention feature 114 may involve also other embodiments of position securing elements 116, 118. For instance, profiles of the inner contour 72 and the outer contour 88 may be oval shaped or in another way shaped non-circular.
[0119] With additional reference to
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[0121] The trocar sleeve 440 primarily differs from the arrangements in accordance with
[0122] In regard of the elevations 124 that are provided with respective entrainment flanks 126, it is to be noted that also the trocar sleeve 40 in
[0123] With reference to
[0124] A further step S14 that relates to the manufacture of the trocar sleeve by casting or molding follows on the steps S10 and S12. The step S14 involves filling the mold with an appropriate starting material. The casting or molding further involves integrally forming the hollow shaft and the handling head. At the hollow shaft, an inner contour is selected that is adapted to an outer contour of a trocar mandrel in such a way that the trocar sleeve and the trocar mandrel are arranged to be coupled with one another while generating a defined preloading to guide the trocar sleeve in a defined manner.
[0125] With reference to
[0126] Eventually a step S54 follows that relates to an insertion of the trocar mandrel in the trocar sleeve, wherein the trocar sleeve is at least sectionally widened. This involves the generation of a defined preloading in the hollow shaft of the trocar sleeve. This may be used for mechanically stabilizing the trocar sleeve in combination with the trocar mandrel.