Source: https://patents.google.com/patent/WO2015022040A1/en
Timestamp: 2019-04-24 13:35:47
Document Index: 743696431

Matched Legal Cases: ['arts 1', 'art 5', 'art 4', 'art 4', 'art 4', 'art 4', 'art 5', 'art 4', 'art 4', 'art 4', 'art 4', 'art 5']

WO2015022040A1 - Surgical set for placing an access tube in the intervertebral disc of a patient - Google Patents
Surgical set for placing an access tube in the intervertebral disc of a patient Download PDF
WO2015022040A1
WO2015022040A1 PCT/EP2014/001834 EP2014001834W WO2015022040A1 WO 2015022040 A1 WO2015022040 A1 WO 2015022040A1 EP 2014001834 W EP2014001834 W EP 2014001834W WO 2015022040 A1 WO2015022040 A1 WO 2015022040A1
PCT/EP2014/001834
2013-08-14 Priority to DE202013007340.3 priority Critical
2013-08-14 Priority to DE202013007340.3U priority patent/DE202013007340U1/en
2014-07-03 Application filed by Joimax Gmbh filed Critical Joimax Gmbh
2015-02-19 Publication of WO2015022040A1 publication Critical patent/WO2015022040A1/en
The invention relates to a surgical set for placing an access tube (4) in the intervertebral disc of a patient, comprising a stylet (1), a cannula (2), a guiding wire (3) and an access tube (4) to be placed. In order to create access to the surgical site in a way that is easy and less stressful for the patient, the invention also provides an obturator (5) for the access tube (4), the outside diameter of which corresponds to the inside diameter of the access tube (4) and which has a lumen of a diameter that corresponds to the diameter of the guiding wire (3).
Operationsset for laying an access tube into the
Intervertebral disc of a patient
The invention relates to a Bandscheibenzugangs- Operationsset for laying of an access tube into the intervertebral disc of a patient with a stylet, a cannula, a guide wire and a guide tube to be applied.
In minimally invasive, percutaneous (ie through the skin of a patient taking place), especially endoscopic operations in the area of ​​the spinal canal of a patient, such as removal of an intervertebral disc, sclerosing of tissue Edit Ranges of vertebral bodies etc. is first to put an access tube through which further instruments and tools for the observation of the operating field and to perform the corresponding operation activities are introduced.
Typically this is first through an incision in the skin of a unit of (hollow) needle and stylet located therein, which are pointed at their distal end faces of both, to the disc center leads einge-. Then the stylet is removed from the cannula and inserted through this, a guide wire with its distal end up on the opposite fiber ring edge and then the hollow needle, which at its proximal end for connection to the first located therein stylet a luer adapter education, over the guide wire is pulled out and removed. then takes place in the further dilation of the access path from the skin surface to the spinal canal by means of sleeve-like dilators by providing a dilator is first pushed with a very small diameter over the guidewire, through this then a dilator with a larger diameter and so a total of two to four dilators are inserted is , After insertion of the last dilator the dilator located in this and the guidewire are removed, and then an access tube for instruments and tools, preferably in the form of a Spülschaftes inserted through the dilator are consistent with the largest diameter.
The foregoing description shows that is performed by this method, a widening of the access channel in the radial direction over a cross-sectional addition, as it is required for the finally to be provided access tube or the flow sheath, since the latter, as said, passed through the underlying obturator so that it must have a larger diameter than the access tube or the flow sheath. In this way, more trauma and tissue damage caused when they are absolutely necessary to perform the procedure.
The invention has for its object to provide a Operationsset for providing access to the intervertebral disc, in particular for laying of an access pipe to the spinal canal, the laying of the access tube into simpler, less expensive, faster and time-saving manner and with less traumatic stress for the patient allows.
According to the invention the above object is achieved by an intervertebral disc access Operationsset of the type mentioned, which is characterized by an obturator for the access tube whose outer diameter corresponds to the inner diameter of the access tube and having a lumen, the diameter of which corresponds to the diameter of the guidewire.
By the invention it is possible, after removing the cannula via the inserted through this guide wire so that only the guidewire from the skin surface is to the intervertebral disc, common to insert the unit of access tube and located therein obturator to the operation area in the disc, while in a step to cause a widening of the access path in the tissue of the patient, must said take place for a given diameter of the access tube, an expansion to a smaller diameter to and is therefore less traumatic because there is no the access tube for insertion surrounding di- required lator (guide sleeve).
After insertion of the unit of access tube and obturator latter kanulier- system are removed together with the guide wire so that only can remain the access tube, which is preferably constructed as a flow sheath lie. By this flushing of the surgical area can then take place and it may further instruments and tools are introduced, as described above.
The elongate, in particular cylindrical and rod-shaped parts of the set are made of metal, preferably
(Stainless) steel, whereby nitrate is suitable. The guide wire is preferably constructed as a solid part, in particular as an integral rod, proximal structural elements of a component, such as adapter head and handle parts are preferably made of plastic, such as PE, PP.
While the other instrument parts have standard dimensions, in particular guide wire and the wall of the access tube, which is formed as thin as possible (0.15 mm to 30 mm), as required for the stability and in particular stiffness requirements, the obturator between its inner central axial lumen and its outer wall a greater wall thickness on when it is required for the static and stability reasons. In particular, the wall of the obturator is at least as strong as the diameter of the guidewire, so that therefore, the outer diameter of the obturator is three times the strength of the guidewire. This makes it possible in a
Step effected a substantial widening of the access channel through the tissue of the patient from his skin surface to the spinal canal upon insertion of the assembly of access tube and obturator located therein.
In a preferred embodiment it is provided that a distal end portion of the obturator is tapered toward its distal end side. Here, the access tube should in particular over more than three quarters of its length, be rigid. Most preferably the entire access tube is rigid. In another preferred embodiment it is provided that the distal end face of the obturator is designed to be blunt. The obturator has a lumen with an opening at its distal end side. That the end face is blunt, i.e. that the opening surrounding wall, in particular the frontal area of ​​the same ring is blunt and especially no. Cutting elements such as cutting or
Cutting edges has. The annular end face may be rounded, or flattened. This reduces the risk of injury is reduced to penetrating tissue. In addition, the expansion of the tissue to be penetrated is gentler.
In order to support a little incriminating widening of the access path in the tissue of the patient, see more Ausges ¬ taltungen the invention provides that the distal end portion of the obturator is tapered toward its distal end side, in particular, the taper of the obturator has a convex conical, and most preferably the taper in longitudinal section from the outside to the center axis of the obturator is effected parabolically with the origin of the parabola on the axis of the obturator.
Further embodiments of the invention provide that the tapered distal end of the obturator the distal end. of the access tube in the distal direction dominates.
In another preferred embodiment it is provided that a maximum introduced into the access tube obturator distal end side of the access tube is true axial compliance with the transition of the obturator from its cylindrical main portion with a constant diameter to its tapered area. The maximum depth of insertion of the obturator is limited in the access tube by proximal abutment parts of both elements, such as a head portion of the guide tube and a handle part at the obturator. By such is steady towards distal. tapering transition without edges the fabric is expanded very gently during insertion. In addition, it can be provided that the outer diameter of the stylet corresponds to the inner diameter of the hollow needle and / or axial stylet via a connection head and rotationally fixed to a connecting head of the hollow cannula is connectable. In particular, the connection can be configured as a luer adapter.
In addition, it can be provided that the access tube is a flow sheath, in particular wherein the access tube comprises at its proximal end a purge port. The purge port located on the side of the flow sheath serving as the access tube, preferably at an angle of 60 ° to 90 °.
The inventive Operationsset a procedure is possible such that a cannula with an inserted stylet through the skin of the patient is guided up to the spinal canal, and then the stylet is removed from the cannula and is inserted through the cannula, a guide wire, and thereafter, the cannula is removed, then continue a. Unit is pushed out to legendem access tube and located therein obturator having an axial lumen through the lumen of the obturator through the guide tube to the spinal canal expansion of the access path in the body of the patient and then the obturator and guide wire are removed from the access tube. It can be in particular the procedure is such that the widening of the guide path through the patient's tissue to the disc by means of a tapered end portion of the obturator is effected and / or that located after insertion of the access tube and removing obturator with guide wire distally of the distal end of the access tube operation area of ​​the patient proximally disposed at designed as a flow sheath access tube is rinsed Spülan- circuit. In further procedures that will be introduced after the removal of obturator and guide wire from the access tube through this additional instruments and / or tools to the distal to the distal end of the access tube located area of ​​operations, such as endoscopes, forceps, graspers, cutters and high frequency probes.
see Preferred embodiments provide that the lumen of the obturator has a diameter of 2 mm to 5 mm, that the wall thickness of the access tube is between 0.25 mm and 0.5 mm and / or that the outer diameter of the cannula is between 0.9 mm and 1.2 mm, wherein a cannula having an outer diameter of 0.9 mm to 1.0 mm as a 20G cannula (according to EN ISO 4626) (G = gauge) and a cannula having an outer diameter of 1.2 mm as 18G- cannula is referred to.
In a preferred embodiment it is provided that the Operationsset consists solely of the above-mentioned parts.
Further advantages and features of the invention will become apparent from the claims and from the following description in which an embodiment of the invention with reference to the drawing ¬ acquisition explained in detail is. In which: a hollow cannula having chem in this befindli stylet; an enlarged view of dista len end portion of the hollow needle and a stylet plugged; an enlarged view of dista len end portion of the hollow needle and a stylet plugged in alternative imple mentation; an illustration of the hollow cannula after removal of the stylet therethrough guided through the hollow cannula guide wire; in mere guide wire after removal of the hollow cannula; an over the guide wire to the spinal canal inserted unit of flow sheath as an access tube located in this obturator; a diagram illustrating the common removal of obturator and guidewire;
6 shows the remaining in operation position.
Flow sheath as an access tube; Fig. 7 is a schematic obturator alone
Side view; and
Fig. 8 in the obturator Längsschn
The surgical instruments or -set the invention consists of the following parts:
1 stylet, hollow cannula 2, guide wire 3, access tube 4 in the form of a Spülschaftes and obturator. 5
The stylet 1 is shown in Fig. 1 only shown in- its inserted into the hollow cannula 2 position, with only the distal tip of the stylet and its 1.1 1.2 connection head can be seen. FIG. La shows an enlarged view this situation.
The hollow needle 2 is formed as a cutting cannula and has a one-sided beveled tip at its distal end to 2.1. At its proximal end is also provided with a connection head 2.2, the connection heads are 1.2 and 2.2 formed as a luer adapter so that the hollow needle 2 and stilette 1 are connected to one another for introducing, in particular axially, but rotationally fixed.
Fig. Lb shows an alternative embodiment of stylet 1 and the hollow needle 2, wherein the distal tip of 1.1 of the stylet 1 of the hollow cannula is designed in alignment with the tip of 2.1, while the front end of stylet 1 and hollow cannula 2 extends over the entire cross-sectional area of ​​both parts just with a finite angle not equal to 90 ° to the axes of the parts 1, 2 and with the axis, in particular an angle of 30 ° to 65 °. The outer diameter of the stylet 1 corresponds to the internal diameter of the hollow needle 2. This means that both standard diameter are basically the same and the diameters are adapted in compliance with tolerances such that the stylet 1 without major difficulties and overcoming larger frictional forces can be introduced into and through the hollow cannula 2 and from this can be guided out again without unnecessary radial gaps between the outer periphery of the stylet 1 and the inner circumference of the hollow needle 2 are formed.
The strength of the guidewire is at a maximum such that they in relation to the lumen of the hollow needle 2 also corresponds to the above design rules. The guidewire can also be formed thin, so that it can be introduced with clearance through the hollow cannula. 2 In any case, the length of the guide wire 3 projects beyond substantially the length of the hollow needle 2 (and thus also the of the stiletto 1), at least one quarter, preferably one third of the length of the hollow needle 2. Both head parts of the guide wire 3 are obtuse and as conics designed.
The essential novel parts of the operation sets according to the invention or -bestecks ​​are the parts shown in FIG. 4, access tube 4 and obturator 5. With regard to the inner diameter of the access tube 4 and the Au 5 final diameter of the obturator on the one hand and with respect to the inner diameter of the lumen of the obturator 5 and the outer diameter of the guidewire used 3 on the other hand, the same design rules as they were described above with respect to the hollow needle 2 and stilette 1 are high. The longitudinal dimensions of the access tube, particularly the inlet • transition pipe 4, in particular the pure pipe shaft 4.1 are of the same order of magnitude as that of the hollow needle 2, preferably somewhat above. The distal end face 4.2 of the access tube 4 is also chamfered on one side, ie with a 4. At the proximal end, from one side of the wall of the tubular shaft 4.1 to the diagonally opposite side through the end face chamfer, approximately at an angle of 45 ° to the longitudinal extension axis' A of the access tube the access tube 4 a header to 4.3, which is described in more detail below.
The obturator 5 has a length such that upon full insertion into and through the guide tube 4 with its stop head part 5.1 part 4.6 on the adapter of the head part 4.3 of the access tube 4 with its distal end portion 5.2 of the He. protruding end face 4.2 of the access pipe. 4 The distal end portion 5.2 of the obturator 5 is tapered toward the distal end face 5.3. While in principle a conical tip formation is possible, the taper preferably and in the embodiment shown a convex configuration, whose radius of curvature on the front side 5.3 is smaller than at the proximal thereto lying transition to the cylindrical shaft portion of the obturator 5, so that the outer wall of the tapered distal end region 5.2 follows in section from the central axis a to the side wall of the obturator 5 is substantially a parabolic shape originating at the distal end face 5.3.
The obturator 5 has a handle portion at the proximal end 5.4 of a head portion 5.1. Together with the adapter part 4.6 of the head part 4.3 of the access tube 4 a stop is formed, wherein the maximum depth of penetration of the obturator limited in the access tube 4. 5 In this position, the distal end side protrudes 5.3 of the obturator beyond the distal end face 4.2 of the access tube addition, in such a way that a virtually constant edgeless transition from the tapered distal end face 5.3 of the obturator 5 to the distal end face 4.2 of the access tube 4 is given.
The handle part 5.4 has two pins which pass axially in the condition of maximum penetration of the obturator 5 · in the access ^ pipe 4 in the direction of extension of the obturator 5 behind undercut edges of the adapter part 4.6 of the access tube. These are radially offset to the axis of extension of the access tube 4 so that an axial relative movement of the access tube and obturator 4 5 is possible. In the state of maximum penetration a mounted on the adapter part 4.6 lever (not shown) enables axial rotation of access tube 4 and obturator 5. 5.4 This grip the pin of the grip part behind the undercut edges of the adapter part 4.6 and block in this state, an axial relative movement of the two parts , By opposite rotation of the lever, this locking is released again.
The head part 4.3 of the access tube 4 has a radially extending lateral flushing connection 4.4, via which the distal end face 4.2 of the access tube 4 opposite operation range in the region of the disc from the outside of the patient's body forth across the purge port 4.4 and the shaft 4.1 of the access tube 4 can be flushed, so that the access tube 4 is designed as a flow sheath in the illustrated embodiment. The purge port is further provided with a valve lever 4.5. This is conically shaped and fixed at the opposite end to the flushing connection 4.4. The valve lever 4.5 has a hole-shaped bore which is aligned in the open state with the interior of the rinsing connection 4.4. In the closed state the bore is oriented perpendicular to this direction, so that access is blocked to the access tube.
The surgical technique for introducing the access tube through the skin 4 of a patient up into the operating area of ​​the spinal canal is as follows:
First, in the usual way the unity of the hollow cannula is inserted stylet 2 and 1 inserted through an incision in the skin of the patient to the spinal canal.
1 the stylet removed from the hollow cannula 2 - is subsequently releasing the parts formed by the 1.2 and 2.2 luer adapter - means of rotation of the parts against each other.
Next, the guide wire 3 is pushed into the hollow needle and through this, to the distal end of the guidewire 3 enters the operation area.
the hollow cannula is then withdrawn 2 in the proximal direction over the guide wire 3 so that initially remains lying 3, only the guide wire, as shown in Fig. 3 in a further operating step.
Subsequently, over the guide wire 3, the unit of access tube 4 and inserted, is inserted with its distal end portion of this superior obturator into the operating area, said tapered distal end portion
5.2 of the obturator 5 or from the distal end face
5.3 widening the circumference of the shaft portion of the obturator 5.4 cylindrically shaped distal end portion on a 5.2 Zeitung the through-channel limited ,, which is held open in the further through the access pipe. 4
Obturator 5 through the handle part 5.5 - - in a last step are common and guide wire 3 is removed from the access tube. 4
Then rinsing the operation area can be done and then an endoscope to be pushed off by the access tube 4 to through this and look at its appearance the operating area of ​​the distal end of the access tube 4.2. 4 Further, Common operation measures can then be provided, such as the introduction of cutting, gripping or cutting tools through the access tube 4 or even the insertion of a high-frequency probe through the access tube 4 so as to obliterate tissues in the spinning alkane Alber calibration or perform denervation.
1. disc access Operationsset for placing an access tube (4) to an intervertebral disc of a patient with a stylet (1), a cannula (2), a guide wire (3) and a legends access tube (4), characterized by an obturator ( 5) for the transition to ¬ pipe (4) whose outer diameter (the inner diameter of the access tube 4) corresponding to and having a lumen, the diameter of which corresponds to the diameter of the guide wire (3).
2. Set according to claim 1, characterized in that the access tube (4) at least over the greatest part of its length is rigid from its proximal end.
3. Set according to claim 1 or 2, characterized in that
that a distal end portion (5.2) of the obturator (5) to its distal end (5.3) tapers.
4. Set according to claim 3, characterized in that the taper of the obturator (5) is convex arcuate forms excluded.
Set according to claim 3 or 4, characterized in that the taper in longitudinal section from the outside to the center axis (A) of the obturator (5) parabolically with the origin of the parabola on the axis (A) of the obturator (5).
Set according to any one of the preceding claims, characterized in that the distal end face of the obturator is designed to be blunt.
Set according to any one of the preceding claims, characterized in that the tapered distal end portion (5.2) of the obturator (5) projects beyond the distal end of the transition to the tube (4) in the distal direction.
Set according to any one of the preceding claims, characterized in that introduced at a maximum into the access tube (4) obturator (4.2) de access tube matches the distal end face axially with the transition of the obturator from its cylindrical main portion with a constant diam ser to its tapered area.
Set according to any one of the preceding claims, characterized in that the access tube (4) at its dista len end a unilateral chamfer and thus a tip as a distal end side (4.2) has.
Set according to any one of the preceding claims, characterized in that the access tube (4) is designed as a flow sheath. Set according to claim 10, characterized in that the access tube (4) has a Spülan circuit at its proximal end (4.4).
Set according to claim 11, characterized in that the "flushing connection (4.4) of the access tube (4) is provided laterally.
Set according to claim 12, characterized in that the rinsing connection is oriented at an angle of 90 ° to the axis (A) of the access tube (4).
Set according to any one of the preceding claims, characterized in that the outer diameter of the stylet (1) corresponds to the internal diameter of the hollow cannula (2)
Set according to any one of the preceding claims, characterized in that the stylet (1) via a connection head (1.2) axially and rotationally fixed to a connecting head of the hollow cannula is connectable.
Set according to any one of the preceding claims, characterized in that the 'lumen of the obturator (5) has a diameter of 2 mm to 5 mm.
Set according to any one of the preceding claims characterized ge that the wall thickness of the access tube (4) is between 0.25 mm and 0.5 mm.
Set according to any one of the preceding claims, characterized that is the outer diameter of the cannula (2) is between 0.9 mm and 1.2 mm. Set according to any one of the preceding claims, characterized in that it consists exclusively of the said parts of the preceding claims.
A method for laying of an access tube into the intervertebral disc of a patient, a cannula (2) with an inserted stylet (1) through the skin of the patient is guided up to the disc, then the stylet (1) is removed from the cannula (2) and by the cannula, a guide wire (3) is inserted and thereafter the cannula (2) is removed, characterized in that a unit consisting of at legendem access tube (4) and located therein obturator (5) (having an axial lumen through the lumen of the obturator 5) (through the access pipe 4) is pushed up to the disc center with widening of the access path in the body of the patient, and then (the obturator 5) and guide wire (3) are removed from the access tube (4).
A method according to claim 20, characterized in that the widening of the guide path through the patient's tissue to the disc by means of a tapered end portion (5.2) of the obturator (5).
A method according to claim 21, characterized in that the widening of the passageway through the patient's tissue by means of a from its end face,
(5.3) of the obturator (5) to its cylindrical portion
(5.4) convex toward expanding the end portion (5.2) is carried out.
23. The method according to any one of claims 20 to 22, characterized in that after insertion of the access tube (4) and removal of the obturator (5) with guide wire (3) of the operation area distal to the distal end of the access tube located of the patient formed proximally on the flow sheath The access tube (4) is arrange th flushing connection (4.4) is rinsed.
24. The method according to any one of claims 20 to 23, characterized in that after removal of the obturator (5) and guide wire (3) from the access tube (4) by this more instruments and / or tools to the distal of the distal end (4.1) the operational area access tube (4) located to be introduced, such as endoscopes, forceps, graspers, cutters and the Hochfrequenzson.
PCT/EP2014/001834 2013-08-14 2014-07-03 Surgical set for placing an access tube in the intervertebral disc of a patient WO2015022040A1 (en)
DE202013007340.3 2013-08-14
DE202013007340.3U DE202013007340U1 (en) 2013-08-14 2013-08-14 Operationsset for laying an access tube into the intervertebral disc of a patient
JP2016533830A JP2016529987A (en) 2013-08-14 2014-07-03 Surgery set for placing a guide tube into the disc of the patient
KR1020157018222A KR20160043925A (en) 2013-08-14 2014-07-03 Surgical set for placing an access tube in the intervertebral disc of a patient
US14/765,170 US20150359570A1 (en) 2013-08-14 2014-07-03 Surgical kit for placing an access tube in the intervertebral disk of a patient
EP14741522.8A EP2895091A1 (en) 2013-08-14 2014-07-03 Surgical set for placing an access tube in the intervertebral disc of a patient
CN201480004821.0A CN104918569A (en) 2013-08-14 2014-07-03 Surgical set for placing an access tube in the intervertebral disc of a patient
WO2015022040A1 true WO2015022040A1 (en) 2015-02-19
ID=51211723
PCT/EP2014/001834 WO2015022040A1 (en) 2013-08-14 2014-07-03 Surgical set for placing an access tube in the intervertebral disc of a patient
US (1) US20150359570A1 (en)
EP (1) EP2895091A1 (en)
JP (1) JP2016529987A (en)
KR (1) KR20160043925A (en)
CN (1) CN104918569A (en)
DE (1) DE202013007340U1 (en)
WO (1) WO2015022040A1 (en)
EP2361568A1 (en) * 2008-10-17 2011-08-31 St. Marianna University School of Medicine Bone cement injection needle
CN2233727Y (en) * 1995-06-30 1996-08-28 潘海光 Automatic intervertebral discs enucleator
CN202875456U (en) * 2012-11-02 2013-04-17 张宗恒 Medical apparatus used for percutaneous waist disc target section nucleus pulposus removal minimally invasive surgery
2013-08-14 DE DE202013007340.3U patent/DE202013007340U1/en active Active
2014-07-03 US US14/765,170 patent/US20150359570A1/en active Pending
2014-07-03 EP EP14741522.8A patent/EP2895091A1/en not_active Withdrawn
2014-07-03 JP JP2016533830A patent/JP2016529987A/en active Pending
2014-07-03 KR KR1020157018222A patent/KR20160043925A/en unknown
2014-07-03 CN CN201480004821.0A patent/CN104918569A/en active Search and Examination
2014-07-03 WO PCT/EP2014/001834 patent/WO2015022040A1/en active Application Filing
EP2895091A1 (en) 2015-07-22
DE202013007340U1 (en) 2014-08-18
JP2016529987A (en) 2016-09-29
KR20160043925A (en) 2016-04-22
US20150359570A1 (en) 2015-12-17
CN104918569A (en) 2015-09-16
US6223752B1 (en) 2001-05-01 Transmyocardial implant procedure
US20130231708A1 (en) 2013-09-05 Bone Screw
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