Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3286—Needle tip design, e.g. for improved penetration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
  • Y10T156/10—Methods of surface bonding and/or assembly therefor
  • Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
  • Y10T156/1026—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina with slitting or removal of material at reshaping area prior to reshaping

Definitions

• the present invention relates to a novel cannula grinding for a punch-less cannula, and in particular to a punch-less cannula with a polished section, and to a method for producing a puncture-poor cannula.
• cannula cuts which can reduce the punching tendency. Usually, these cuts work up to a certain diameter of the cannula. The larger and thinner the cannula, the more difficult it becomes to constructively prevent the punching of particles.
• US Pat. Nos. 2,746,454, EP 0 301 246 A1, DE 42 26 476 C1, EP 0 443 630 A1 and WO 94/03223 describe cannulas with a rigid cannula tube which is ground obliquely at the point and two on the front half of the section carries another against each other angularly arranged facet cuts.
• the tip of the cannula in the case of EP 0 301 246, is bent across the central axis of the cannula to the region between two imaginary parallel lines which extend the inner surface and the outer surface of the cannula tube forward.
• the rear edge of the ground section is rounded inwards.
• the tip of the cannula according to DE 42 26 476 C1 is bent between the imaginary extensions of the two opposite inner walls of the cannula tube. In addition, the entire ground section is blunted to the beginning of the facet cuts.
• These known cannulas have been proposed, in part, from the viewpoint that such a bent cannula tip when puncturing a blood vessel less easily punctures the opposite vessel wall.
• Other cannulas for the same purpose are described in EP 0 755 690 A2 and DE 41 01 231 A1. However, most of these known cannulas are also used for puncturing implantable port catheters because of a reduced punching effect.
• the oldest low-stent cannula which is generally referred to, is the Huber cannula (see US 2,746,454) in which the cannula tube is bent above the cut. This is done under the notion that the cut with its rear sharp ground eye is placed in the "shadow" of the cannula tip, but this idea is wrong, because the direction of the cannula is not determined by the user, but by the geometry of the cut von Müller and Zierski (see Klinische Klischr., Vol. 66 (1988), pp. 963-969) were able to demonstrate this convincingly.
• WO 92/05816 AI also discloses an allegedly low-punching cannula and in particular relies on a melt-rounded rear ground cutting edge.
• WO 92/05816 A1 also shows a curved cannula tip with relief grinding, it becomes clear from a comparison of the views in FIGS. 2A and 2B that the cannula was first bent and subsequently ground, which is complicated from a manufacturing point of view and leads to disadvantageous results can lead, because with an unbent cannula the desired grinding angle can be better controlled.
• Implantable port systems and pumps have another problem.
• the cannula tip regularly strikes a more or less hard surface.
• These floors or baffles, which are impacted by the cannulas, are either of hard and durable plastics, metal or ceramic.
• Most of the available cuts have very sharp edges that often bend to hooks when hitting a hard abutment. These hooks may damage the silicone membranes as the cannula is withdrawn, and may also be painful to the patient as they may become caught in the patient's skin.
• the invention relates to a cannula with a cannula longitudinal axis and a cannula tip with a polished section, which has a first ground surface defining a first ground surface and two partial cuts.
• the two partial cuts each define second and third grinding surfaces which intersect in a cutting line (forming a path of defined length), the cutting line being essentially perpendicular to the cannula longitudinal axis.
• substantially perpendicular is meant in connection with the Present invention, the angular range between 45 ° and 135 ° to be understood.
• the cutting line is then according to the invention then substantially perpendicular to the cannula longitudinal axis when the vertical component of the cutting line (relative to the plane through which the cannula axis extends) is greater than the horizontal component of the cutting line.
• the cutting line is then substantially perpendicular to the cannula longitudinal axis when the projection of the cutting line on the cannula longitudinal axis is smaller than or equal to the projection of the cutting lines on the plane perpendicular to the cannula longitudinal axis.
• the cutting edge of the cannula according to the invention before bending is substantially perpendicular to the cannula longitudinal axis.
• the grinding of the cannula does not end in a triangular tip, as in known cannulas, but in a sharp cutting edge which, when standing substantially perpendicular to the cannula wall, has approximately the length of the cannula wall thickness.
• the facet angle ⁇ as described, for example, in FIG. B. in the DIN 13097-4: 2009-08 (D) and defined in EN ISO 7864, is about 0 °.
• the cut according to the invention thus effectively represents the limiting case of a facet cut with ⁇ - * 0 °.
• the cutting edge of the cannula according to the invention is approximately perpendicular to the plane of the primary or primary cut, whereas all previously known cannulas have their cutting edges approximately in the plane of the primary section of the cannula. In the latter, there is usually a tearing of the membrane or the tissue which has been cut through the cannula in the direction of the primary gate and thus inevitably upon penetration of the ground into contact with the edge of the pre-cut or cracked opening, so that this edge can plan off particles there (as detailed below). In contrast, it comes with the cannula according to the invention to a substantially vertical pre-cutting of the membrane and when penetrating the cut logically to a substantially vertical tearing. This creates an approximately triangular gusset over the cannula cut where the rear edge of the cut penetrates into the material. That is, the back edge of the cut does not hit an edge that can chop it off (see above).
• the second advantage of the grinding according to the invention is that the stop lines of the sharpening tip do not leak to a sharp triangle with very thin wall thicknesses (such as this is the case in the prior art), but to a cutting edge which extends over the entire cannula wall thickness and is therefore relatively stable.
• a sharp triangle with very thin wall thicknesses (such as this is the case in the prior art)
• a cutting edge which extends over the entire cannula wall thickness and is therefore relatively stable.
• the intersecting line in which the second and third cut surfaces intersect and the cannula longitudinal axis subtends an angle between 70 ° and 110 °, preferably between 75 ° and 105 °, more preferably between 80 ° and 100 °, and most preferably between 85 ° and 95 °.
• the advantages discussed above are most pronounced when the angle included between the cutting line and the cannula's longitudinal axis is between about 70 ° and about 110 °. In some cases, too large puncture forces may occur at angles of about 90 °. Therefore, it is also preferred that the angle included between the cutting line and the cannula longitudinal axis is between about 45 ° and about 80 °, or between about 100 ° and about 135 °.
• the second and third grinding surfaces which are defined by the two part-cuts, form an angle between 20 ° and 90 °, preferably between 25 ° and 75 ° and particularly preferably between 30 ° and 60 °.
• the first ground surface and the cannula longitudinal axis preferably include an angle between 8 ° and 20 °, more preferably between 10 ° and 15 °.
• the cannula tip is bent inwards in the direction of the cannula longitudinal axis or central axis.
• This has the additional advantage that the tip-distant part of the cut is to a certain extent in the shadow of the cannula tip and thus no longer or to a lesser degree cuts into the tissue or into the membrane.
• the above-described angles between the cutting line and the longitudinal axis of the cannula, between the second and third cutting surfaces and between the first cutting surface and the cannula longitudinal axis are to be understood such that the angles are in the state of the unbent cannula.
• the angles can then naturally deviate from those angles which were achieved when producing the cut.
• the ground joint and the two part cuts do not define any after bending the cannula tip Smurf areas more, but curved cut surfaces. Nevertheless, the end product with curved cannula tip can detect which angles prevailed before bending the cannula.
• the cannula tip has a distal end.
• the cannula tip is bent so far inwards, ie in the direction of the cannula longitudinal axis, that the distal end of the cannula tip lies within the imaginary extension of the outer diameter of the unbent cannula.
• the arcuate cannula defines a cylinder that extends beyond the distal end of the cannula and has an inner diameter and an outer diameter.
• the distal end of the cannula tip should after bending lie within the outer diameter of this cylinder.
• the distal end of the cannula tip lies within the imaginary extension of the inner diameter of the unbent cannula, ie within the inner diameter of this cylinder.
• the cannula tip is bent inwardly beyond the cannula longitudinal axis such that the distal end of the cannula tip lies between the cannula longitudinal or central axis of the cannula and the imaginary extension of the opposite cannula inner wall, ie between the central axis and inner diameter of the cannula. extended) cylinder. It is further preferred that the cannula tip has been bent inwardly after the cannula has been polished. One, several or all of the ground surfaces are thereby preferred to curved ground surfaces, since the surface (s) produced during the preparation of the grounding is curved during inward bending.
• the end product thus preferably has one or more curved cut surfaces.
• the angles discussed above can be generated in a defined manner and the manufacturing process is simplified.
• the cutting edge is no longer perpendicular to the cannula's longitudinal axis.
• the shape of the cutting edge essentially remains in bending of the cannula tip, so that furthermore a vertical pre-cutting of the membrane by the cannula cutting edge and a subsequent perpendicular tearing occurs, so that punching or shaving off of the membrane (or of the tissue) is effectively prevented. This is true in any case if the cannula tip is not excessively bent so that the distal end of the cannula tip is as above within the imaginary extension of the outer diameter of the unbent cannula.
• the second advantage of the grinding according to the invention is also obtained regardless of how far the cannula tip is bent inwards, since the cutting edge extends over the entire cannula wall thickness even in the bent state and is accordingly stable and hooking of the cannula tip is prevented when hitting a port plate , It is further preferred that one or more sections of the bevel are truncated. In particular, it is preferred that one or more off-center portions, i. Sections which are spaced at least one mm from the tip of the cannula ground, are truncated or rounded.
• the present invention further provides a method for manufacturing a cannula with a bevel, in particular a cannula as described above.
• a cannula is provided with a cannula longitudinal axis, a ground cut defining a first cut surface is applied, and two partial cuts each defining second and third cut surfaces are provided.
• the second and third cut surface intersect in a respective sectional lines, which is substantially perpendicular to the cannula longitudinal axis.
• the three ground surfaces are mounted so as to satisfy the angular conditions discussed above.
• the method preferably further comprises a further step of bending the cannula tip onto the cannula's longitudinal axis, said bending occurring after the attachment of the three cuts.
• the bending takes place in such a way that the conditions discussed above with respect to the cannula according to the invention are met.
• Figures la and lb a side view and a plan view of a preferred embodiment of the cannula according to the invention
• Figure lc is a section through Figure lb along the line FF;
• Figure 2 is a side view of another preferredWhensforrn a erfmdungshielen cannula
• Figures 3a and 3b are side views of the embodiments of Figures 2 and 1;
• FIGS. 4a and 4b show a side view and a top view of the embodiment according to FIG.
• FIG. 5 schematically shows the cutting pattern produced by a cannula known from the prior art
• FIG. 6 shows the cutting pattern produced by a cannula according to the invention
• Figures 7a to 7d photographs of different cannula tips after a puncture attempt with a force of 20 N.
• FIGS. 1a and 4a each show a side view of a preferred embodiment of the cannula according to the invention.
• Figures lb and 4b show the corresponding plan view and Figure lc shows a section of Figure lb along the line F-F.
• the cannula 1 according to the invention has a cannula longitudinal axis or central axis M and a cannula tip 5.
• the cannula tip 5 has a bevel, which consists of a primary or primary grinding 6 and two partial cuts 7 and 8.
• the ground section 6 defines a first ground surface (see Figures la and 4a) and the two part ground sections 7 and 8 define a second and third ground surface (see Figures lb and 4b).
• the second and third cut surfaces intersect in a section line S, which is substantially perpendicular to the cannula longitudinal axis M.
• the angle a which the cutting line S and the cannula longitudinal axis M include, is between 45 ° and 135 °.
• the angle ⁇ is between 70 ° and 110 °, more preferably between 75 ° and 105 °, even more preferably between 80 ° and 100 ° and more preferably between 85 ° and 95 °.
• the fact that the angle is substantially perpendicular does not cause the grinding of the cannula to end in a triangular point, as in the case of known cannulas, but in a sharp cutting edge 9 which is substantially perpendicular to the cannula wall 2 and has approximately the length of the cannula wall thickness.
• the cutting edge 9 of the cannula according to the invention is approximately perpendicular to the surface 6 of the ground or primary cut.
• the angle between the cutting edge and the surface of the primary grinding between 70 ° and 82 °, more preferably between 75 ° and 80 °.
• the second ground surface 7 and the third ground surface 8 enclose an angle ⁇ (see Fig. 4b) which is preferably between 20 ° and 90 °, more preferably between 25 ° and 75 ° and most preferably between 30 ° and 60 ° is.
• the first ground surface 6 and the cannula longitudinal axis M preferably include an angle ⁇ (see Fig. 4a) between 8 ° and 20 °, more preferably between 10 ° and 15 °.
• ⁇ see Fig. 4a
• one or more sections of the bevel are truncated.
• one or more tip-distant portions are truncated or rounded.
• the portion of the tip beyond or distal to the line F-F in FIG. 1b may be sharpened, whereas the portion on either side of or proximal to the line F-F (or part thereof) may be truncated or rounded.
• Figures 2 and 3a show a particularly preferred embodiment of the cannula according to the invention in side view.
• the cannula tip 5 of the cannula 1 according to the invention is bent inwards in the direction of the cannula longitudinal axis M.
• the cannula tip 5 is bent inwards so far that its distal end or the cutting edge 9 comes to rest on the cannula longitudinal or center axis M.
• the distal end or the cutting edge 9 is within the imaginary extension of the outer diameter D a of the unbent cannula (see Fig. 3a).
• the distal end or the cutting edge 9 lies within the imaginary extension of the inner diameter Dj of the unbent cannula (compare to the definition of Di Fig. 3b).
• the distal end of the cannula tip 5 or its cutting edge 9 lies between the central axis M of the cannula and the imaginary extension of the opposite inner wall 2.
• the cannula tip 5 is preferably bent somewhat further than in FIGS. 2 and 3a shown.
• the angle between the cutting line S and the central axis M after bending the cannula tip 5 no longer corresponds to the 90 ° shown in Fig. 4a.
• the angles of the present invention are to be understood as describing the angles before bending, since these angles define the actual shape of the cut and are critical to the cutting characteristics.
• the cannula tip according to the invention has a significantly improved incision pattern compared to conventional cannula tips, with the result that the punching or shaving off of tissue or membrane material is extremely effectively prevented.
• the gray area 10 in FIGS. 5 and 6 is intended in each case to indicate a silicone membrane, into which, for example, a port cannula is inserted.
• the following explanations apply analogously to piercing in tissue.
• the puncture of a cannula through a synthetic membrane is always such that the synthetic membrane (usually made of silicone rubber) is first cut by the cutting edge of the cannula, then widened as the cannula sharpening progresses, usually causing it to tear further in the direction of the cannula primary incision comes.
• All previously known cannulas have a cutting edge which lies approximately in the plane of the primary section of the cannula.
• a membrane flap 12 forms the further penetration of the cannula tip into the membrane on the rear edge of the cutting edge or the ground 14 hits, the or can then plan the membrane 12 from the tab membrane particles.
• cannula cuts known from the prior art cause the above-discussed punching or shaving off of membrane or tissue material.
• a further advantage of the cannula according to the invention consists, as already explained above, in that the hooking lines of the tip do not run off into a pointed triangle with very thin wall thicknesses (as is the case in the prior art), but to a cutting edge which overhangs the entire cannula wall thickness is sufficient and accordingly extremely stable. This does not result in the cannula according to the invention curling hooking on the cannula tip when the cannula tip impacts the bottom plate of a port.
• FIGS. 7a-7c show photographs of the cannula tips of the two known cannulas and of the cannula according to the invention after the insertion test.
• the two port cannulas known from the prior art see Figures 7a and 7b) show a clearly pronounced curling hook formation on the cannula tip.
• the novel cannula grinding invention has significant advantages over known needles with a facet or relief, since on the one hand, the vertical edge of the cannula tip according to the invention effectively prevents punching or shaving membrane or tissue material and on the other hand with the stable cutting edge large wall thickness remains substantially dimensionally stable even under the influence of large forces and does not tend to hooking.
• the cannula according to the invention is also outstandingly suitable for other fields of use, in particular because of its superior punching freedom, which is always desirable when sensitive material is punctured or when the cannula tip is punctured Where bacterial infections are critical.
• the cannula according to the invention is outstandingly suitable inter alia for intraarticular puncture and as a spinal cannula.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Surgery (AREA)
• Vascular Medicine (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Pathology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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• 2011
  • 2011-08-31 DE DE102011112021A patent/DE102011112021B4/de not_active Expired - Fee Related
• 2012
  • 2012-08-31 JP JP2014527670A patent/JP2014527446A/ja active Pending
  • 2012-08-31 CN CN201280053939.3A patent/CN103917264A/zh active Pending
  • 2012-08-31 BR BR112014004746A patent/BR112014004746A2/pt not_active IP Right Cessation
  • 2012-08-31 WO PCT/EP2012/066945 patent/WO2013030327A1/de active Application Filing
  • 2012-08-31 RU RU2014111825/14A patent/RU2014111825A/ru not_active Application Discontinuation
  • 2012-08-31 EP EP12766603.0A patent/EP2750742A1/de not_active Withdrawn
  • 2012-08-31 US US14/241,601 patent/US20140236104A1/en not_active Abandoned
  • 2012-08-31 CA CA2846474A patent/CA2846474A1/en not_active Abandoned

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