Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14525—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using microdialysis
  • A61B5/14528—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using microdialysis invasively
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150022—Source of blood for capillary blood or interstitial fluid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
  • A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
  • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
  • A61B5/150435—Specific design of proximal end

Definitions

• the present invention relates to a needle for medical applications for piercing a tissue, in particular a needle for inserting a dialysis membrane into a human or animal tissue, according to the preamble of claim 1.
• a medical device or an examination device into a tissue, such as human, animal or other biological tissue.
• a tissue such as human, animal or other biological tissue.
• the surface of the tissue must be penetrated, the opening in the tissue and the force used for penetration should be as small as possible in order to keep pain or tissue changes that arise as low as possible.
• the requirements of medical application or examination must be able to be met, which often requires large penetration openings and depths.
• Round hollow needles are used, for example, to introduce or export a product, such as a medical, pharmaceutical or cosmetic fluid, or to enable an examination fluid to be exchanged with the tissue, as is required, for example, in dialysis.
• These hollow needles are chamfered at their distal end in such a way that an oval ring surface is formed with a cutting edge forming the tip of the needle.
• a needle is disclosed, for example, by a hypodermic needle from "Therumo Medical Corporation".
• This needle is additionally chamfered in a hyperbolic region of the oval surface of the needle tip, so that two phases arise which form an angular tip in the hyperbolic reversal point.
• Microdialysis probes use special needles to guide a perfusion solution through the tissue that interacts with the surrounding environment of the tissue via a dialysis membrane. Since both a supply and a discharge are necessary for the perfusion solution, the needles cannot be made very thin for this purpose, but generally have a thickness through which the insertion of the needle is uncomfortable for a user.
• a pressure force to be used for this which is referred to below as the initial penetration force, is reduced by a fine point tip in comparison to a cutting edge.
• the needle region adjoining the distal end region which forms the tip penetrates the tissue. Since this needle area has a thicker cross-section, i.e. is thicker than the distal end region of the needle tip, a higher force is to be used for this, which is referred to below as the full penetration force than is necessary for the initial penetration force of the tip.
• This full penetration force is reduced by a cutting edge in contrast to a point tip on the needle tip.
• needles of microdialysis probes can often not be designed to be particularly pointed or sharp because in many cases the dialysis membrane is located in or around the needle tip area and could be damaged by sharp edges or tips.
• the needle according to the present invention is intended for insertion into a tissue and has an elongated needle region and a distal end region which adjoins the needle region and which forms a needle tip.
• the needle according to the present invention is intended to be used to insert a dialysis membrane into a body tissue.
• the distal end region of the needle is made of solid material, i.e. the distal end region preferably has no passages, openings, recesses, depressions or the like, but is preferably made of homogeneous material. However, it is conceivable to provide thin passages or depressions in the distal end region, as long as these are negligible in relation to the volume mass of the end region. Metal or a plastic, such as silicone, can be used as the material, for example.
• the entire needle is preferably made from a single material. However, it is conceivable to manufacture the needle tip from a separate material or to cover the distal end region with a suitable material.
• the distal end region has at least two surfaces which on the one hand intersect a longitudinal axis of the needle and on the other hand, as a result of which there is at least one cutting line, one intersection point or both between these two surfaces on a surface of the distal end portion.
• the cut line or the intersection point form the tip of the needle and come into contact with the tissue surface first when penetrating a tissue.
• At least one of the cutting lines preferably forms a cutting edge at the distal end region. For this it is necessary that the two surfaces which form the cutting line intersect at an acute angle, preferably at an angle of less than 20 °.
• the at least two surfaces of the distal end region are particularly preferably designed and arranged relative to one another in such a way that the cutting lines of the surfaces, ie the cutting edges of the distal end region of the needle, converge on a common intersection point which forms the foremost point of the needle and thus the needle tip.
• the at least one cutting line and / or the intersection point lie within the circumference of a cross section of the needle region. It is also advantageous if a cutting line, or a cutting edge, and / or the point of intersection lies on a plane of symmetry, preferably on a center line of symmetry, ie on the longitudinal axis of the needle, of the cross section of the needle region. In other words, the cutting edges and the intersection, which forms the piercing tip of the needle, should be arranged as centrally as possible in the cross section of the needle.
• the cross section of the needle in the needle area in front of the distal end area can be round, oval or polygonal.
• the needle is preferably designed for use as a microdialysis needle with a polygonal cross section in its needle region, particularly preferably it has a rectangular cross section.
• the outer circumference of the needle region is in turn formed by a plurality of adjoining circumferential surfaces, preferably four circumferential surfaces, which extend along the longitudinal axis of the needle and merge into the surfaces of this end region at the distal end region, forming an obtuse angle with them.
• a point tip can be formed on the needle tip, which lowers the initial penetration force for penetrating the surface of a tissue, or a cutting edge can be generated in the region of the tip of the needle, which has the full penetration force for the complete insertion of the needle degraded into a tissue.
• the initial penetration force by the point tip according to the invention and the full penetration force by the cutting edge according to the invention can preferably be reduced at the same time. Overall, therefore, a considerably lower pressure force has to be applied to insert the needle into the tissue, which means, for example, that a patient experiences less pain or the tissue is less affected and changed.
• the surfaces of the distal end region of a needle according to the invention can be planar or curved, or curved. They can also be partly planar and partly curved. Accordingly, the intersection lines of such surfaces are straight or curved. Furthermore, at least two surfaces are arranged mirror-symmetrically to a plane of symmetry which runs along the longitudinal axis of the needle. It is also conceivable that the distal end region of the needle is arranged mirror-symmetrically to two mutually perpendicular planes of symmetry that intersect in the longitudinal axis of the needle.
• two surfaces of the distal end region are each designed as conical or conical partial surfaces that converge.
• the geometric cone tip points belonging to the cone surfaces are offset from one another in such a way that the cone surfaces intersect at an acute angle.
• a point tip is formed on the longitudinal axis of the needle and two cutting edges run in an arc on two opposite sides of the point tip towards the tip.
• the surfaces of the distal end region can be arranged in a pyramid-like manner, preferably in the form of a four-sided pyramid.
• the distal end region forms four planar surfaces, the intersect at a single point of intersection that lies on the longitudinal axis of the needle so that this point of intersection forms a point tip.
• a surface advantageously forms an acute angle with its surface adjacent on one side and an obtuse angle with its surface adjacent on the other side. This creates a cutting edge along the intersection of the acute angle at the distal end region of the injection tip.
• four surfaces of the end region do not meet at a single intersection point, so that instead of a point tip, a cutting edge is formed as the foremost point of the needle.
• Two first opposite surfaces which run parallel in one dimension, form an angle whose apex lies on the longitudinal axis of the needle.
• the two other opposing surfaces which are also parallel in one dimension, are arranged between the first surfaces and form an angle whose apex on the longitudinal axis is closer to the distal end region on the longitudinal axis than the apex of the first two surfaces.
• Such an end region forms a kind of half pyramid.
• a needle region with a rectangular cross section that is to say with a width of the cross section that is longer than its height
• the distal end region has surfaces arranged in a facet-like manner with respect to one another.
• two opposite side surfaces of the distal end region are arranged obliquely to one another in such a way that they meet at an acute angle on a plane of symmetry of the rectangular cross section.
• the acute angle can be 20 °, for example.
• the side surfaces can form, for example, the extension of the lateral peripheral surfaces of the needle region, which correspond to the height of the cross section.
• the two other lateral circumferential surfaces of the needle region which run perpendicular to the previous peripheral surfaces, are chamfered in a front region of the distal end region in such a way that they .
• Form surfaces of the distal end region that are oblique to the. two planes of symmetry that are perpendicular to the surfaces of the needle area, so that they form a cutting edge that contains the intersection of the two planes of symmetry. It follows that the intersection lines of these facet surfaces form a more acute angle on one side with the two other opposing lateral surfaces than on the other opposite side of the distal end region. It also follows from this that a point tip slightly offset from the longitudinal axis of the needle is formed on the cutting edge between these two facet-like surfaces and one of the side surfaces of the distal end region.
• This embodiment with the facets arranged in a faceted manner provides a robust tip that withstands bending when piercing the surface of a fabric and has a shape that can be easily machined and processed. Furthermore, measurements have shown that both the initial penetration force and the full penetration force can simultaneously be reduced compared to the prior art.
• a needle with, for example, a square needle cross-section and the needle tip designed according to the invention depressions can run along the outer surface of the needle area or a slit can be formed through this needle area, so that a dialysis membrane can be provided in the depressions or in the slot.
• a microdialysis probe is such. B. described in the patent application entitled “microdialysis probe and method for its production", which goes back to the applicant and has the same filing date as the present application.
• the microdialysis probe needle described there is further improved by a needle tip according to the invention, since the insertion of the needle into a tissue is less painful for a user.
• the surfaces of the distal end region are preferably formed by wet or dry grinding, or by honing or lapping.
• the edges along the lines of intersection between the surfaces of the distal end region are advantageously deburred, the arrangement of the surfaces of the distal end region according to the invention, as z. B. is described in the previous embodiment, a simple and rapid processing of this area ensures.
• FIG. 1A perspective view of a preferred embodiment of a needle according to the invention with a facet-like distal end region
• FIG. 1D cross section through a needle region of the embodiment of the invention from FIG. 1A,
• FIG. 2 shows a perspective view of a second embodiment of a needle according to the present invention with a distal end region with conical surfaces
• FIG. 3A shows a perspective view of a third embodiment according to the present invention with a pyramid-like distal end region
• FIG. 1A shows a needle for medical applications with a distal end region 1, the surfaces of which are faceted to one another.
• the distal end region 1 has an upper side 2 and an underside 3 (not shown in FIG. 1A) which is not visible in FIG. 1A and which lie opposite one another and run parallel to one another.
• the distal end region points perpendicular to the upper side 2 and the lower side 3 1 two side surfaces 4 and 5 (not visible), which lie opposite one another and form an angle A with the longitudinal axis of the needle, which is shown in FIG.
• the two side surfaces 4 and 5 therefore run parallel in one dimension.
• the needle region 6 has a rectangular cross section, the surfaces of the broad side of this needle region 6 corresponding to the surfaces of the top and bottom surfaces 2 and 3 of the distal end region 1 and narrow surfaces of the needle region running perpendicular to the broad surfaces 6 merge into the side surfaces 4 and 5 of the distal end region 1 by a bevel by the angle A.
• the needle region 6 could also have a suitable other cross-section, such as an oval cross-section, the top and bottom surfaces 2, 3 and the side surfaces 4, 5 of the distal end region 1 being able to be produced by appropriate grinding of such a needle. Under certain circumstances, the top and bottom would not run parallel to one another, but would form an angle to one another.
• two facet surfaces 7 and 8 are arranged on the distal end region 1, which form a tip 9 and a cutting edge 12 of the needle.
• the facet faces 7 and 8 are oriented in such a way that, starting from the orientation of the upper side 2 or the lower side 3, they fall in the direction of the needle tip 9 and at the same time fall in the direction of the same side face 4.
• the facet surfaces are therefore not aligned parallel to each other in any dimension.
• the facet surface 7 forms an intersection line 10 with the upper side 2 and accordingly the facet surface 8 forms an intersection line 11 with the underside 3, which however is not visible in FIG. 1A.
• the cutting lines 10 and 11 and the cutting edge 12 are oriented obliquely to the longitudinal direction of the needle due to the orientation of the facet surfaces 7 and 8.
• the facet surfaces 7 and 8 are also aligned obliquely to the planes of symmetry, which are perpendicular to one another and intersect the surfaces of the needle region perpendicularly through the longitudinal axis of the needle.
• FIG. IB is a view of the top 2 and in Figure IC is a side view of the side 4 of the needle shown in Figure 1A on •.
• the side surfaces 4 and 5 are opposite the side surfaces of the Needle area 6 is chamfered by an angle A of 10 ° to the longitudinal axis of the needle, so that there is an angle of 20 ° between the side surfaces 4 and 5.
• the angle A can also have a different size, but should preferably be between 5 ° and 30 °.
• the cutting edge 12 preferably forms an angle between 30 ° and 55 ° with the longitudinal axis of the needle.
• the bevel cut line between the side surfaces of the needle region 6 and the side surfaces 4 and 5 of the distal end region 1 are arranged symmetrically to the longitudinal axis of the needle.
• FIG. 1C shows the top 2, which runs parallel to one another, and the bottom 3, as well as the facet surfaces 7 and 8, which are also opposite one another.
• the facet surface 7 is chamfered in relation to the top 2 in the direction of the longitudinal axis of the needle.
• the facet surface 7 is also beveled in the direction of the side surface 4 ' .
• the facet surface 8 is beveled relative to the underside 3 in the direction of the longitudinal axis and at the same time in the direction of the side surface 4. It follows from this that the intersection lines of the facet surfaces 7 and 8 form different angles with the side surfaces 4 and 5.
• intersection line 13 between the facet surface 7 and the side surface 4 and the intersection line 14 between the facet surface 8 and the side surface 4 together form an angle B of approximately 16.5 °.
• the angle B can also be in a range around this value, preferably between 10 ° and 22 °.
• the intersection line 15 between the facet surface 7 and the side surface 5, which lies opposite the side surface 4, and the intersection line 16 between the facet surface 8 and the side surface 5 forms an angle C of 23.5 °, which is also in an area around this Value can be, preferably between 15 ° and 35 °.
• the facet surfaces 7 and 8 are arranged symmetrically with respect to a plane of symmetry which runs along the longitudinal axis of the needle and in the direction of the upper or lower side 2, 3.
• the bevels of the facet surfaces 7 and 8 with respect to the upper or lower side 2 or 3 are chosen so large that the facet surfaces intersect in the cutting edge 12 and form a tip 9.
• the cutting edge 12 and the tip 9 lie on the plane of symmetry in the direction of the top or bottom 2, 3 and the intersection of the mutually perpendicular planes of symmetry of the needle region 6, ie the longitudinal axis of the needle also lies on the cutting edge 12, but not in the tip. 9.
• the tip 9 is therefore not arranged in a center of symmetry of the needle.
• the angle A between the side surfaces 4 and 5, the angles B and C between the facet surfaces 7 and 8 and the distance between the top 2 and the bottom 3 are thus coordinated with one another in such a way that the facet surfaces 8 and 9 intersect in the distal end region 1 and not the side surfaces 4 and 5.
• FIG. 1B shows that the cutting line 10 and the cutting edge 12 run obliquely to the longitudinal direction of the needle and thus also obliquely to a direction perpendicular to the longitudinal direction of the needle.
• FIG. 1D shows a sectional view through the needle region 6 of the needle.
• the intersection lines 13, 14, 15 and 16 between the facet surfaces 7 and 8 and the side surfaces 4 and 5 are shown as dashed lines.
• the cutting edge 12 is drawn with broken lines'. It can be seen that the cutting edge 12 lies on the plane of symmetry running parallel to the upper side 2, but the tip 9 lies outside a second plane of symmetry running perpendicular to this plane of symmetry. It can also be seen that the path differs from the lateral start of the side surface 4 to the beginning of the facet surfaces, that is to the intersection line 12 in FIG. 1A, and the path between the beginning of the side surface 5 and the beginning of the facet surfaces.
• FIGS. 1A to 1D has a point tip 9, by means of which the initial penetration force is reduced.
• this embodiment has a cutting edge 12 by means of which the full penetration force when the microdialysis needle is inserted is also reduced.
• the surfaces of the distal end region 1 were removed by using a surface grinder with a diamond grinding unit with a grinding degree of D500 by wet or Dry grinding generated.
• the cutting lines or cutting edges were deburred after grinding, which further reduced the required penetration force.
• the needle is used for use as a microdialysis needle of a microdialysis probe.
• the needle region 6 has a slot-like recess 17, which extends partially into the distal end region 1.
• a dialysis membrane in the form of a hollow fiber 18 is arranged within the slot 17.
• the hollow fiber 18 is adapted in the slot 17 such that it forms a feed line and a discharge line for a perfusion solution.
• two hollow fiber sections are arranged next to one another, which undergo a reversal in the rounded end region of the slot 17 in the distal end region 1.
• FIG. 1D shows how the cross sections of the two sections of the hollow fiber membrane 18 are arranged parallel and side by side within the slot 17.
• FIG. 2 shows a further embodiment of the present invention, in which a distal end 1 of a needle with a needle region 6 corresponding to FIG. 1 is shown.
• the distal end region 1 has two conical surfaces 20 which converge towards one another and are arranged on opposite sides.
• the two conical surfaces 20 run obliquely in the direction of the longitudinal axis of the needle and intersect at a center point of the cross-section of the needle region 6.
• Two opposing cutting edges 21 and 22 are formed, which taper towards one another and form the needle tip 23.
• the needle tip 23 lies on the center of the cross section of the needle and the cutting edges 21 and 22 lie on a plane of symmetry which is on the The longitudinal axis of the needle lies and runs parallel to the narrow side of the rectangular cross section of the needle region 6. Due to the conical shape of a surface 20, it is more domed ⁇ in a region near the needle tip 23 than in a region near the needle region 6. A smooth transition from the conical surfaces 20 to the side surfaces of the needle region 6 can thereby be produced.
• FIG. 3A shows a further embodiment of the invention, in which the distal end region 1 has a pyramid-like shape.
• the needle region 6 of the needle is rectangular as in FIGS. 1A to 1D.
• the distal end region 1 of the needle has four diamond-like pyramid surfaces 30, which form a pyramid tip as the needle tip 31 in the center of the cross section of the needle region 6.
• the pyramid surfaces 30 are arranged symmetrically to the planes of symmetry of the rectangular cross section of the needle region 6.
• a broad side of the cross section merges into two pyramid surfaces, which form an obtuse angle with one another.
• the narrow side of the cross section merges into two pyramid surfaces which form an acute angle with one another so that their cutting line forms a cutting edge 32.
• a pyramid surface forms an obtuse angle with another pyramid surface adjacent on one side and an acute angle with its pyramid surface adjacent on the other side.
• the cutting lines run on the axes of symmetry of the cross section of the needle region 6.
• FIG. 3B shows another embodiment of a pyramid-like distal end region 1, which forms a type of semi-pyramid.
• the needle region 6 has a rectangular shape as in FIGS. 1A to 1D.
• the narrow sides of this rectangle are chamfered in the distal end region 1 in the direction of the longitudinal axis of the needle, so that they form side surfaces 33 which are symmetrical to a plane of symmetry of the needle region.
• Surfaces of the needle region 6 are beveled in such a way that they are oriented obliquely to both planes of symmetry of the needle region 6 and at the same time run parallel to one another in one dimension. This creates two opposing surfaces 35 which form a cutting edge 34.
• the cutting edge runs obliquely to the lines of symmetry of the cross section of the needle region 1, but perpendicular to the longitudinal axis of the needle.
• a fabric with a needle according to the invention could be used for the initial penetration force to penetrate the surface, a value of 0.75 and N 'for the Volleindringkraft for inserting the needle into the tissue, a value of 0.9 N be measured.
• the needle tip and the cutting edge of the needle are strong enough in such a distal end region that they are not subject to bending or any other change when the needle penetrates a tissue.
• the penetration forces in a prior art needle such as the "Therumo Medical Corporation” needle, which has a smaller cross-sectional area in the needle region than the needles according to the embodiments of the present invention, have values from 0.5 N to 0, 7 N for the initial penetration force and 0.7 N to 0.9 N for the full penetration force
• a sewing needle for example with a diameter of 0.6 mm, requires a full penetration force of 2.5 N and a strongly differing initial penetration force.
• a needle according to the present invention therefore has a lower or just as high required penetration force with an approximately equal cross-section in comparison with a sewing needle and an even larger cross-section in comparison with the needle from "Therumo Medical Corporation".

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• 2002
  • 2002-10-09 DE DE10247022.7A patent/DE10247022B4/de not_active Expired - Lifetime
• 2003
  • 2003-10-01 CA CA002499810A patent/CA2499810A1/en not_active Abandoned
  • 2003-10-01 AU AU2003273936A patent/AU2003273936A1/en not_active Abandoned
  • 2003-10-01 JP JP2004544055A patent/JP2006502771A/ja active Pending
  • 2003-10-01 EP EP03757901A patent/EP1549369A1/de not_active Withdrawn
  • 2003-10-01 WO PCT/EP2003/010891 patent/WO2004035119A1/de not_active Application Discontinuation
• 2005
  • 2005-11-23 US US11/287,581 patent/US7824382B2/en active Active

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