DK176314B1 - Intraosseous needle - has threaded shaft with passageway extend through with solid pointed tip having cutting edges - Google Patents

Intraosseous needle - has threaded shaft with passageway extend through with solid pointed tip having cutting edges Download PDF

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Publication number
DK176314B1
DK176314B1 DK199200087A DK8792A DK176314B1 DK 176314 B1 DK176314 B1 DK 176314B1 DK 199200087 A DK199200087 A DK 199200087A DK 8792 A DK8792 A DK 8792A DK 176314 B1 DK176314 B1 DK 176314B1
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Denmark
Prior art keywords
needle
threaded
cutting edges
intraossal
side port
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DK199200087A
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Danish (da)
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DK8792A (en
DK8792D0 (en
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Richard J Melker
Peter F Gearen
Gary J Miller
Michael P Debruyne
Lisa Molitor
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Univ Florida
Cook Inc
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Priority claimed from DK073391A external-priority patent/DK166709B1/en
Application filed by Univ Florida, Cook Inc filed Critical Univ Florida
Publication of DK8792A publication Critical patent/DK8792A/en
Publication of DK8792D0 publication Critical patent/DK8792D0/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3472Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8811Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The intraosseous needle comprises a threaded shaft having first and second opposing ends and a passageway extending from the first end toward the second end, the second end having integrally formed thereon a boring member for initiating penetration of the shaft into bone. The boring member is a three-sided pyramid which defines three cutting edges that intersect in a pointed tip. The shaft defines an axis and includes a first side port proximal to the second end and axially aligned with one of the three cutting edges, the first side port being in communication with the passageway. The threads define a helical ridgeline which coincides at a point with one of the three cutting edges, and one of the cutting edges terminates at the point.

Description

, DK 176314 B1, DK 176314 B1

Den foreliggende opfindelse angår en intraossal nål omfattende et med gevind forsynet skaft med en første og anden modstående ende samt en indre væske-5 passage, der strækker sig imellem enderne og udmunder i umiddelbar nærhed af den anden ende via mindst en sideport, og ud fra hvilken anden ende der strækker sig boreorganer med i hovedsagen konisk tilspidsede skærekanter.The present invention relates to an intraossal needle comprising a threaded shaft having a first and second opposite ends as well as an inner fluid passage extending between the ends and opening in the immediate vicinity of the other end via at least one side port, and from which other end extends drill members with generally tapered cutting edges.

Ved forskellige medicinske ulykkestilfælde kan patientens liv afhænge af læ-10 gens eller medicinerens mulighed for at kunne tilføre en bestemt væske ind i patientens blodstrøm. Under nødsituationer såsom på slagmarken, ved trafikulykker eller i rum med akut behandling, er patienten ofte i chok, har lavt blodtryk, bløder kraftig og slår rundt omkring sig. Under sådanne omstændigheder kan det være umuligt at finde og få adgang til en velegnet blodåre, og resultatet 15 er en forsinkelse i tilføring af midlerne til patienten, hvilket muligvis kan være fatalt. Når det drejer sig om børn eller spædbørn, som er i fare, kan selv de største vener være så små, at de ikke kan lokaliseres. Og selv om man lokaliserer disse, kan et spædbarns største tilgængelige vener være så små, at en stabil infusionsadgang ikke kan være mulig.In various medical accident cases, the patient's life may depend on the ability of the physician or medication to inject a particular fluid into the patient's blood stream. During emergencies such as on the battlefield, in traffic accidents or in emergency treatment rooms, the patient is often in shock, low blood pressure, bleeding vigorously and beating around him. In such circumstances, it may be impossible to find and access a suitable vein, and the result is a delay in delivery of the agents to the patient, which may be fatal. In the case of children or infants at risk, even the largest veins may be so small that they cannot be located. And while locating these, an infant's largest accessible veins may be so small that stable infusion access may not be possible.

2020

Et alternativ til adgang til vener som for nylig er indført er intraossal tilføring. De lange benknoglers marvagtige kavitet er sammensat af et rigt svampet netværk af sinusformede kurver, som drænes ind i en central venekanal. Blodet forlader derved venekanalen ved næringsstoftransporterende vener eller udsendende 25 vener i cirkulationen. Væsker eller lægemidler som injiceres i knoglemarvsområdet spredes normalt kun få centimeter, trænger ind i blodstrømmen og når hjertet - på omkring kun 10 sekunder fra injiceringen ind i knoglemarvskaviteten.An alternative to access to veins recently introduced is intra-osseous administration. The marrow-like cavity of the long bones is composed of a richly spongy network of sinusoidal curves, which drain into a central venous duct. The blood thereby leaves the vein duct by nutrient transporting veins or emitting 25 veins into the circulation. Fluids or drugs that are injected into the bone marrow area usually spread only a few centimeters, penetrate the bloodstream and reach the heart - in about 10 seconds from the injection into the bone marrow cavity.

Ved de nuværende intraossale infusionsprocedurer anvendes der en hul nål, som har en smigskåret top og en trokar eller stilet. Med trokaren teleskopisk 30 positioneret inden i og sig strækkende delvis ud fra den smigskårede ende af nålen, kan nål og trokarsamlingen presses og føres frem vinkelret imod og gennem det ønskede knogleben, indtil cortex er blevet punkteret, og nålen med tro-karspidsen har ført sig ind i knoglemarvsrummet. Trokaren trækkes tilbage og 2 DK 176314 B1 efterlader den åbne ende af nålen i det rige knoglemarvsnetværk. Forskellige komplikationer har imidlertid gjort intraossal infusion en mindre ideel løsning.In the current intraosseous infusion procedures, a hollow needle is used which has a flatter cut top and a trocar or stylet. With the trocar telescopically positioned within and extending partially from the flattened end of the needle, the needle and trocar assembly can be pressed and advanced perpendicularly to and through the desired bone bone until the cortex has been punctured and the needle with the trocar tip has advanced. into the bone marrow compartment. The trocar is withdrawn and 2 DK 176314 B1 leaves the open end of the needle in the rich bone marrow network. However, various complications have made intraossal infusion a less ideal solution.

Selv om nålen og trokarsamlingen har en skarp, tilspidset spids, er knoglemarvskaviteten ikke i stand til at penetreres under normalt tryk. For høj kraft un-5 der forsøget på at punktere knoglebenet medfører somme tider i en bøjet nål, en brækket nål, splintring af benet, at nålen glider af på benet og punkterer hosliggende væv eller mere normalt at nålen på heldig måde tvinges igennem den modsatte side af knoglebenet. Hvis nålen er korrekt indsat i knoglemarvskaviteten, kan bevægelse af patienten nemt frigøre nålen eller medføre, at den be-10 væges, således at endeåbningen tilstoppes. Disse komplikationer opstår normalt i tilfælde, som omfatter intraossal infusion til spaedbørn og børn. På personer, som er ældre end seks år, er knoglebenene for hårde til, at man med succes kan udføre intraossal infusion uden at være klar over, at der foreligger en ekstrem høj mulighed for de ovenfor nævnte komplikationer. Fremgangsmåden 15 er derfor typisk blevet begrænset til børn, som er mindre end seks år, og kun efter at adskillige forsøg er blevet udført for at opnå veneinfusion.Although the needle and trocar joint have a sharp, pointed tip, the bone marrow cavity is unable to penetrate under normal pressure. Excessive force while attempting to puncture the bone will sometimes result in a bent needle, a broken needle, splintering of the bone, the needle slipping off the bone and puncturing adjacent tissues or, more usually, forcing the needle through the opposite side of the bone. If the needle is properly inserted into the bone marrow cavity, movement of the patient can easily release the needle or cause it to be weighed, causing the end opening to clog. These complications usually occur in cases involving intra-osseous infusion for infants and children. In people older than six years, the bone bones are too hard to successfully perform intra-osseous infusion without realizing that there is an extremely high possibility of the above mentioned complications. Therefore, procedure 15 has typically been restricted to children less than six years of age and only after several attempts have been made to obtain vein infusion.

Fra US patentskrift nr. 3.750.667 kendes en intraossal nål af denne art, hvor et boreorgan er anbragt for enden af et indre rør, der er anbragt, så det kan for-20 skydes frem og tilbage i et ydre rør med skaft. Boreorganet og det ydre rørs ende er forsynet med komplementære klør, som under indgreb sikrer, at væske-passageåbninger i det indre rør holdes aflukkede under indføringen af nålen.U.S. Patent No. 3,750,667 discloses an intraossal needle of this kind in which a drill member is disposed at the end of an inner tube disposed so that it can be moved back and forth in an outer tube with shaft. The drilling member and the end of the outer tube are provided with complementary claws which, when engaged, ensure that fluid passage openings in the inner tube are kept closed during insertion of the needle.

For at man kan være sikker på, at åbningerne holdes aflukkede og ikke tilstoppes med væv, når nålen drejes ind gennem knoglebenet, må nålen kun drejes 25 rundt i én retning om skaftets akse, og lægen må derfor gentagne gange gribe om skaftet, slippe dette igen, igen dreje en delomdrejning osv., hvilket er både arbejdsomt og besværligt.To be sure that the openings are kept closed and not clogged with tissue when the needle is rotated through the bone, the needle must only be rotated 25 in one direction about the shaft axis, and the doctor must therefore repeatedly grip the shaft, releasing this again, again turning a part revolution etc., which is both laborious and cumbersome.

Fra ansøgerens WO 90/04364 kendes flere intraossale nålsamlinger, som in-30 kluderer midler til at bore direkte ind i en patients knogle. Den fra disse intraossale nålsamlinger kendte nål angiver imidlertid ikke en intraossal nål, som har boreorganer, som danner tre skærekanter, som skærer hinanden i en spids.From applicant WO 90/04364, several intraossal needle assemblies are known which include means for drilling directly into a patient's bone. However, the needle known from these intraossal needle assemblies does not indicate an intraossal needle having drilling means which form three cutting edges which intersect at one point.

3 DK 176314 B13 DK 176314 B1

Den intraossale nål ifølge den foreliggende opfindelse er ejendommelig ved, at boreorganerne er stift forbundet med skaftets anden ende, og at den mindst ene sideport er tildannet i dalen mellem to hosliggende gevindomgange på skaftet, hvorhos boreorganerne omfatter tre skærekanter, som udgøres af en 5 pyramideformet spids' tre kanter.The intraossal needle according to the present invention is characterized in that the drilling members are rigidly connected to the other end of the shaft and that the at least one side port is formed in the valley between two adjacent threaded ends of the shaft, the drilling means comprising three cutting edges constituted by a pyramid shaped tip 'three edges.

Herved opnås, at der tilvejebringes en intraossal nål, som under boringen ind gennem knoglebenet med et fast og konstant greb med hånden kan drejes frem og tilbage i begge omdrejningsretninger, uden at det altså er nødvendig at slip-10 pe grebet for drejning i kun den ene retning. Samtidig undgås det, at væskepassagens åbninger tilstoppes.This provides an intraossal needle which, during drilling, can be rotated back and forth by hand with a fixed and constant grip in both directions without the need to release the grip for rotation in only the one direction. At the same time, the openings of the fluid passage are prevented from clogging.

Under boring ind gennem knoglebenet drejer lægen med et fast greb i nålens skaft frem og tilbage, indtil boreorganet er trængt ind gennem knoglen og ind i 15 knoglemarven. På grund af at væskepassagens åbninger er beliggende i dalen mellem hosliggende gevindomgange, vil disse ikke tilstoppes af væv. Efter af boreorganeme er trængt ind i knoglemarven, drejer lægen kun den ene vej rundt, normalt i retning med uret, således at skaftets gevind kan dreje sig ind i knoglen, så nålen sidder godt fast i denne, når der skal injiceres væske i knog-20 lemarven.While drilling in through the bone, the doctor rotates firmly in the needle shaft back and forth until the drill is penetrated through the bone and into the bone marrow. Because the openings of the fluid passage are located in the valley between adjacent thread passages, these will not be clogged by tissue. After the drill is penetrated into the bone marrow, the doctor turns only one way, usually clockwise, so that the thread of the shaft can rotate into the bone, so that the needle is firmly stuck in it when fluid is injected into the bone. 20 limb marrow.

Opfindelsen forklares nedenfor detaljeret under henvisning til specielt foretrukne udførelsesformer samt tegningen, hvor 25 figur 1 viser en intraossal nål til en intraossal samling ifølge en foretrukken udførelsesform af opfindelsen, figur 2 delvis i snit den i figur 1 viste nål drejet 90° omkring sin egen akse, 30 figur 3 fra siden og delvis i snit et skaft og en intraossal nål fra den intraossale nål ifølge opfindelsen, figur 4 forfra det i figur 3 viste greb, s 4 DK 176314 B1 figur 5 fra enden den i figur 1 viste intraossale nål, figur 6 skematisk fra siden den proximate tibia, som viser den foretrukne til-5 gangsside for brug af den foreliggende opfindelse, figur 7 en anden foretrukken udførelsesform af nålen ifølge opfindelsen, set fra siden, 1 o figur 8 samme set fra enden, og figur 9 samme set fra siden, men drejet 90° om sin længdeakse.The invention is explained in detail below with reference to particularly preferred embodiments and the drawing, in which Figure 1 shows an intraossal needle for an intraossal joint according to a preferred embodiment of the invention, Figure 2 partially in section the needle shown in Figure 1 rotates 90 ° about its own axis Fig. 3 is a side view, partly in section, of a shaft and an intraossal needle from the intraossal needle according to the invention, Fig. 4 from the end of the grip shown in Fig. 3, Fig. 5 from the end the intraossal needle shown in Fig. 1, Fig. 6 is a schematic side view of the proximate tibia showing the preferred access site for use of the present invention; Fig. 7 is a side view of the preferred embodiment of the needle of the invention; 9 the same from the side, but rotated 90 ° about its longitudinal axis.

Den følgende beskrivelse af opfindelsens principper foretages under henvisning 15 til tegningen, og der vil blive anvendt et specifikt ordbrug i denne forbindelse.The following description of the principles of the invention will be made with reference to the drawings, and a specific word use will be used in this connection.

Denne beskrivelse skal dog på ingen måde forstås som en begrænsning af selve opfindelsens idé, idet der kan foretages mange ændringer og modificeringer af den viste indretning, uden at man afviger fra selve opfindelsens idé.However, this description should in no way be construed as a limitation of the very idea of the invention, since many modifications and modifications of the device shown can be made without departing from the idea of the invention itself.

20 I både figur 1 og 2 er vist den samme intraossale nål 10 ifølge opfindelsen. Nålen 10 omfatter et nav 11, et med gevind forsynet skaft 12 og boreorganer. Ved den foretrukne udførelsesform er boreorganerne en med spånrille forsynet pencilspids 13, og der er seksten gevindomgange 15 pr. 25 mm på akslen 12, en art gevind, hvor den fremadvendende flade er vinkelret på skrueakslen, og den 25 bagud vendende flade danner en vinkel med akslen. Den fremadvendende vinkel eller stigningsvinklen Θ er angivet som vinklen dannet af et plan (angivet med det generelle henvisningstal 17), og som er tangent til stigningskruelinien og et plan (angivet med det generelle henvisningstal 18), som er vinkelret på det med gevind forsynede skafts 12 akse 21. De fremadvendende og bagud 30 vendende gevindflader er angivet med det generelle henvisningstal 18’ henholdsvis 19. Den bagud vendende gevindvinkel α er her angivet som den vinkel, der dannes af et plan (angivet med det generelle henvisningstal 20), og som strækker sig tangentielt til den bagud vendende gevindflade 19 og et plan 18 5 DK 176314 B1 vinkelret på akslen 12. Den bagud vendende gevindvinkel α er ved den foretrukne udførelsesform af samme størrelsesorden som skruelinievinklen Θ. Det vil sige, at planet 17 er parallelt med planet 20. Som vist ved udførelsesformen i figur 1 er den bagud vendende gevindvinkel α omtrent 8°, mens den fremad-5 vendende flade 18' danner en vinkel med normalplanet 18 på omkring 30°. Det vil sige, at de fremadvendende og bagud vendende flader 18' og 19 ikke er parallelle.In both Figures 1 and 2, the same intraossal needle 10 of the invention is shown. The needle 10 comprises a hub 11, a threaded shaft 12 and drilling means. In the preferred embodiment, the drilling means is a pencil tip 13 provided with chip groove and there are sixteen threaded turns 15 per head. 25 mm on shaft 12, a type of thread where the forward face is perpendicular to the screw shaft, and the 25 back face forms an angle with the shaft. The forward or angular angle Θ is indicated as the angle formed by a plane (indicated by the general reference numeral 17) and tangent to the slope and a plane (indicated by the general reference numeral 18) perpendicular to the threaded shaft. 12 axis 21. The forward and backward threaded faces are indicated by the general reference numerals 18 'and 19. The rearward facing angle α is here indicated as the angle formed by a plane (indicated by the general reference numeral 20) and as extends tangentially to the rearward threaded face 19 and a plane 18 5 perpendicular to the shaft 12. The rearwardly facing threaded angle α is in the preferred embodiment of the same order of magnitude as the helical angle Θ. That is, the plane 17 is parallel to the plane 20. As shown by the embodiment of Figure 1, the rearwardly facing thread angle α is about 8 °, while the forward face 18 'forms an angle with the normal plane 18 of about 30 °. That is, the forward and backward faces 18 'and 19 are not parallel.

Navet 11, som er anbragt ved den bagud vendende eller bageste ende af det 10 med gevind forsynede skaft 12, danner hunpartsenden for sammenføjning med en proportionel Luer-type fitting og omfatter en i hovedsagen cylindrisk part 22 og en ringformet flangepart 23. En i hovedsagen cylindrisk sektion 24 er anbragt imellem den cylindriske part 22 og det med gevind forsynede skaft 12. Diametrene af flangeparten 23 og den cylindriske sektion 24 er i hovedsagen 15 ens og er begge større end diameteren af den cylindriske part 22. Den cylindriske sektion 24 omfatter et par diametralt modstående og indbyrdes parallelle flade flader 25. Flangeparten 23 har ligeledes et par diametralt modstående og indbyrdes parallelle flade flader 26, som er coplanare med de korresponderende flade flader 25. En boring 29 med stor diameter er tildannet i navet 11 og 20 strækker sig fra enden 30 gennem den cylindriske part 22 og delvis gennem den cylindriske sektion 24. En boring 29 optager Luerfittingens hanpart. En ak-sial passage 31 med mindre diameter står i forbindelse med boringen 29 og strækker sig fra boringen 29 fremad gennem næsten hele den med gevind forsynede aksels længde. Et par sideporte eller åbninger 33 og 34 strækker sig 25 radialt udad fra den aksiale passage 31 nær spidsen 13. Åbningerne 33, 34 er anbragt 270° fra hinanden. Åbningen 33 er tildannet i dalen mellem det fremadvendende eller den første fulde gevindomgang 36 og den anden gevindomgang 37. Åbningen 34 åbner udad i dalen mellem den anden gevindomgang 37 og den tredje gevindomgang 38 og er fortrinsvis forsat 270° efter den første åb-30 ning.The hub 11, which is located at the rear or rear end of the threaded shaft 10, forms the female part end for joining with a proportional Luer type fitting and comprises a generally cylindrical portion 22 and an annular flange portion 23. cylindrical section 24 is arranged between the cylindrical portion 22 and the threaded shaft 12. The diameters of the flange portion 23 and the cylindrical section 24 are substantially the same and are both larger than the diameter of the cylindrical portion 22. The cylindrical section 24 comprises a pair of diametrically opposed and mutually parallel flat faces 25. The flange portion 23 also has a pair of diametrically opposed and mutually parallel flat faces 26 which are coplanar with the corresponding flat faces 25. A large diameter bore 29 formed in the hub 11 and 20 extends from the end 30 through the cylindrical portion 22 and partly through the cylindrical section 24. A bore 29 accommodates the Luerf fitting nature. A smaller diameter axial passage 31 communicates with the bore 29 and extends from the bore 29 forward through nearly the entire length of the threaded shaft. A pair of side gates or openings 33 and 34 extend radially outwardly from the axial passage 31 near the tip 13. The openings 33, 34 are spaced 270 ° apart. The opening 33 is formed in the valley between the forward or the first full thread 36 and the second thread 37. The opening 34 opens outward in the valley between the second thread 37 and the third thread 38 and is preferably positioned 270 ° after the first opening. .

Den med spånrille forsynede pencilspids 13 er i det væsentlige konisk med den koniske ydre flade 40 under dannelse af en vinkel Φ med aksen 21 på i hoved- 6 DK 176314 B1 sagen 20°. Et par diametralt modstående spånriller 41 og 42 er fræset ned i enden af spidsen 13 ved anvendelse af en kugleformet fræsetap. Denne fræsetap er rettet ind til at rotere om en akse, som er parallel med aksen 21 under fræs-ningen. Den forreste ende 43 af den første gevindomgang 36 afbrydes ved 5 fræsningen, således at den forreste gevindomgang 36 ender ved en af spånrillerne 42. Ved fræsningen dannes derved skarpe skærekanter 44 og 45 mellem spånrillen 41 og den koniske flade 40 og skarpe skærekanter 46 og 47 mellem spånrillen 42 og den koniske flade 40. Grænsen mellem den forreste gevindomgang 36 og spånrillen 42 danner ligeledes en skarp skærekant ved det gene-10 relle henvisningstal 43. Som vist i figur 1 bearbejdes spånrillen 42 længere bagud end spånrillen 41. Ved den foretrukne udførelsesform er den samlede aksiale længde af spånrillen 41 målt fra spidsen 48 3,5 mm, mens den samlede aksiale længde af spånrillen 42 målt fra spidsen 48 er 4,0 mm.The chip-shaped pencil tip 13 is substantially tapered with the tapered outer surface 40 to form an angle Φ with the axis 21 of the case 20 ° in the main case. A pair of diametrically opposed chip grooves 41 and 42 are milled down to the end of the tip 13 using a spherical milling pin. This milling pin is directed to rotate about an axis parallel to the axis 21 during milling. The front end 43 of the first thread 36 is interrupted by the milling so that the front thread 36 ends at one of the chip grooves 42. In the milling, sharp cutting edges 44 and 45 are formed between the chip groove 41 and the tapered surface 40 and sharp cutting edges 46 and 47. between the chip groove 42 and the tapered face 40. The boundary between the front threaded end 36 and the chip groove 42 also forms a sharp cutting edge at the general reference number 43. As shown in Figure 1, the chip groove 42 is machined further backward than the chip groove 41. In the preferred embodiment the total axial length of the chip groove 41 measured from the tip 48 is 3.5 mm, while the total axial length of the chip groove 42 measured from the tip 48 is 4.0 mm.

15 En komplet intraossal nålsamling omfatter sammen med den intraossale nål 10 et korresponderende gribeorgan eller gribeelement, såsom håndgrebet 50 (figur 3 og 4). Håndgrebet 50 omfatter en plastkugleknop 51 med en aksial boring 52.A complete intraossal needle assembly, together with the intraossal needle 10, comprises a corresponding gripping means or gripping member, such as the handle 50 (Figures 3 and 4). The handle 50 comprises a plastic ball knob 51 with an axial bore 52.

En indsats 53 er på passende måde såsom ved limning fikseret inden i boringen 52. Indsatsen 53 er indrettet til sammenkobling med nålen 10 og har en 20 central åbning 55, som er i hovedsagen cylindrisk med modstående piane flader 56. Åbningen 55 har en størrelse, som er indrettet til at modtage den komplementære form af navet 11 med dets cylindriske sektion 24 og modstående flade sider 25. Indsatsen 53 omfatter endvidere stumpen 57, der strækker sig fremad ind i åbningen 55. Når nålens 10 nav 11 er modtaget inden i åbningen 55, 25 trænger stumpen 57 ind i navets 11 boring 29. Stumpen 57 er tilspidset en smule i fremadgående retning, således at den største diameter er ved dens fod 58 og er den samme eller er en smule større end den indre diameter af boringen 29. Når stumpen 57 føres ind i hullet 29, kiler den større diameter af stumpens 57 fod 58 sig fast inden i boringen 29 og former en pæn pasning mellem nålen 30 10 og håndgrebet 50. Navet 11, boringen 29, åbningen 55 og stumpen 57 er dimensioneret med henblik på at tilvejebringe en indbyrdes tæt forbindelse, som er tilstrækkelig til at medføre, at navet 11 forbliver fast anbragt inden i håndgrebet 50, men kan fjernes under en moderat manuelt udøvet trækkraft.An insert 53 is suitably fixed, such as by gluing, within the bore 52. The insert 53 is arranged for engagement with the needle 10 and has a central aperture 55 which is generally cylindrical with opposed pane faces 56. The aperture 55 is sized. which is arranged to receive the complementary shape of the hub 11 with its cylindrical section 24 and opposite flat sides 25. The insert 53 further comprises the butt 57 extending forwardly into the opening 55. When the hub 11 of the needle 10 is received within the opening 55 25, the stub 57 penetrates into the bore 29. of the hub 11 The stub 57 is tapered slightly forward, such that the largest diameter is at its foot 58 and is the same or slightly larger than the inner diameter of the bore 29. When the stub 57 is inserted into the hole 29, the larger diameter of the stub 57 foot 58 wedges itself within the bore 29 and forms a neat fit between the needle 30 10 and the handle 50. The hub 11, the bore 29, The aperture 55 and the stub 57 are sized to provide a mutually tight connection sufficient to cause the hub 11 to remain firmly positioned within the handle 50 but can be removed under a moderately manually exerted traction.

s 7 DK 176314 B1s 7 DK 176314 B1

Der anvises alternative udførelsesformer, hvor gribeorganerne kan være et permanent fastgjort håndgreb eller andre udformninger, som er velegnet til at gribes af en person ved indsætning af nålen. Gribeorganet kan også være eller 5 omfatte en type af mekanisk eller elektromekanisk indretning, som udøver den nødvendige vridning og drejning.Alternative embodiments are disclosed in which the gripping means may be a permanently attached handle or other configurations suitable for grasping by a person by insertion of the needle. The gripping means may also be or comprise a type of mechanical or electromechanical device which carries out the necessary twisting and turning.

Den intraossale nålsamling anvendes som følger: 10 Den intraossale nålsamling 10 fastgøres sikkert til et håndgreb 50. Det foretrukne indgivningssted markeres, og der laves en indskæring i huden ind til knoglebenet. Det foretrukne indgivningssted 64 findes ved først at identificere skinne-benstuberøsiteten 62 på den ydre overflade af det proximale skinneben. En imaginær linie trækkes fra skinnebenstuberøsiteten til mediankanten af skinne-15 benet 61. Denne linie opdeles ensartet 63 og indgivningsstedet 64 er vinkelret og distalt i forhold til 63. Det foretrukne indgivningssted 64 forøges i afstand fra 63 med tiltagende alder. Ved en nyfødt eller et spædbarn kan denne afstand være så kort som 0,3 til 0,5 cm og forøges til omtrent 2,5 cm ved seksårsalderen. Indsætningen ved niveauet for skinnebenstuberøsiteten eller distalt undgår 20 indsætningen af nålen i vækststedet for skinnebenet. Det distale mediale skinneben er også et velegnet sted.The intra-osseous needle assembly is used as follows: 10 The intra-osseous needle assembly 10 is securely fastened to a handle 50. The preferred site of administration is marked and an incision is made in the skin to the bone. The preferred site of administration 64 is found by first identifying the shin bone tuberosity 62 on the outer surface of the proximal tibia. An imaginary line is drawn from the tibial tuberosity to the median edge of the tibia 61. This line is uniformly divided 63 and the site of administration 64 is perpendicular and distal to 63. The preferred site of 64 is increased at a distance of 63 with increasing age. In the case of a newborn or an infant, this distance may be as short as 0.3 to 0.5 cm and increased to approximately 2.5 cm at the age of six. The insertion at the level of the tibia or distally avoids the insertion of the needle into the growth site of the tibia. The distal medial tibia is also a suitable site.

Med håndgrebet 50 fast anbragt mod operatørens håndflade kan nålen valgfrit rettes mod det ønskede tilgangssted 63 og bringes til berøring med knoglebe-25 net. En frem- og tilbagegående drejningsbevægelse med et svagt tryk får de fire skærekanter 44-47 til at skære sig ind i knoglebenet og muliggøre at spånrillerne 41 og 42 kan trænge ind til den med gevind forsynede sektion af nålen. Under den frem- og tilbagegående drejning bærer spånrillerne 41 og 42 benfragmenter ud af hullet. Så snart den første gevindomgang 36 har nået hullet 30 60, kræves der ikke yderligere tryk. Operatøren skruer på simpel måde nålen i retning med uret ind i knoglemarven til den ønskede dybde. Patientens størrelse vil selvfølgelig afgøre, hvor langt nålen skal skrues ind. Mens nålen føres DK 176314 B1 8 frem ved drejningen, vil udformningen af gevindet 15 rette benmarven ud og væk fra åbningerne 33 og 34.With the handle 50 firmly affixed to the operator's palm, the needle can optionally be directed to the desired access point 63 and brought into contact with the bone. A reciprocating rotational movement with a slight pressure causes the four cutting edges 44-47 to cut into the bone and allow the chip grooves 41 and 42 to penetrate the threaded section of the needle. During the reciprocating rotation, the chip grooves 41 and 42 carry bone fragments out of the hole. Once the first threaded round 36 has reached the hole 30 60, no additional pressure is required. The operator simply screws the needle in a clockwise direction into the bone marrow to the desired depth. Of course, the patient's size will determine how far the needle should be screwed. As the needle is advanced by rotation, the design of the thread 15 will straighten the bone marrow out and away from the openings 33 and 34.

Når nålen 10 har nået til den ønskede position, kan håndgrebet 50 frigøres fra 5 nålen 10 ved en svag manuel påført trækkraft derimellem. Væske injiceret gennem nålen 10 kan derefter trænge ud gennem åbningerne 33 og 34 uden at være hindret af benmarv eller andet væv, som ellers ofte tilstopper konventionelle intraossale nåle. Den korrekte medicinindgivningsmekanisme såsom en kanyle eller I.V. rør kan derefter fastgøres via Luer-fittingen. Efter at patienten 10 har nået en stabil tilstand, hvor der kan søges adgang igennem vener, kan nålen 10 fjernes ved at frigøre I.V. røret eller kanylen fra nålen 10 og ved at igen fastgøre håndgrebet 50 dertil. Nålen kan derefter bakkes ud ved at dreje nålen 10 i retning mod uret.When the needle 10 has reached the desired position, the handle 50 can be released from the needle 10 by a weak manual applied force therebetween. Fluid injected through the needle 10 can then penetrate through the openings 33 and 34 without being obstructed by bone marrow or other tissue, which otherwise often clogs conventional intraossal needles. The correct drug delivery mechanism such as a cannula or I.V. pipes can then be attached via the Luer fitting. After the patient 10 has reached a steady state of access through veins, the needle 10 can be removed by releasing I.V. the tube or cannula from the needle 10 and by reattaching the handle 50 thereto. The needle can then be backed out by turning the needle 10 in a counterclockwise direction.

15 Den i figur 7, 8 og 9 viste intraossale nål 70 ifølge en anden foretrukken udførelsesform for opfindelsen omfatter et nav, som ikke er vist, men som er identisk med det tidligere beskrevne nav 11. Nålen 70 omfatter endvidere et med gevind forsynet skaft 72 og en ende med boreorganer 73. På samme måde som i den tidligere beskrevne udførelsesform omfatter skaftet 72 en aksial passage 74, 20 som står i forbindelse med sideboringer eller åbninger 75 og 76. I modsætning til den tidligere beskrevne udførelsesform kan gevindets fremadvendende vinkel og stigningsvinklen τ være omkring 45°. Enden med boreorganeme 73 hårform af en regulær tresidet pyramidespids, hvor de tre skærekanter 77, 78 og 79 mødes i spidsen 80. Skærekanterne 77, 78 og 79 er beliggende 120° adskilt om 25 nålens akse 81. Enden med boreorganerne 73 kan dannes ved spåntagende bearbejdning eller på enhver anden måde, således at skærekanterne efterlades relativt skarpe. Åbningerne 75 og 76 er anbragt på samme måde som ved den tidligere viste udførelsesform, altså således at åbningen 76 er anbragt imellem de første gevindomgange, og åbningen 75 er anbragt yderligere 270° forskudt i 30 gevindets omdrejningsretning fra den første åbning 76. En af skærekanterne afbryder fortrinsvis den forreste gevindomgang.The intraossal needle 70 shown in Figures 7, 8 and 9 according to another preferred embodiment of the invention comprises a hub which is not shown but which is identical to the previously described hub 11. The needle 70 further comprises a threaded shaft 72 and an end with drilling means 73. In the same manner as in the previously described embodiment, the shaft 72 comprises an axial passage 74, 20 which communicates with lateral bores or openings 75 and 76. In contrast to the previously described embodiment, the forward angle of the thread and the angle of pitch can be τ be about 45 °. The end of the drilling means 73 is a regular three-sided pyramid tip, with the three cutting edges 77, 78 and 79 meeting at the tip 80. The cutting edges 77, 78 and 79 are located 120 ° apart about the axis of the needle 81. The end of the drilling means 73 can be formed by cutting. machining or in any other way, leaving the cutting edges relatively sharp. The openings 75 and 76 are positioned in the same manner as in the previously shown embodiment, i.e., the opening 76 is disposed between the first threaded turns and the opening 75 is positioned a further 270 ° offset in the direction of rotation of the thread from the first opening 76. One of the cutting edges preferably interrupts the front thread.

Claims (5)

1. Intraossal nål (10, 70) omfattende et med gevind forsynet skaft (12, 72) med en første og en anden modstående ende samt en indre væskepassage 5 (31, 74), der strækker sig imellem enhederne og udmunder i umiddelbar nær hed af den anden ende via mindst en sideport (33, 76), og ud fra hvilken anden ende der strækker sig boreorganer (13, 73) med i hovedsagen konisk tilspidsede skærekanter, kendetegnet ved, at boreorganerne (13, 73) er stift forbundet med skaftets (12, 72) anden ende, og at den mindst ene sideport (33, 76) er til-10 dannet i dalen mellem to hosliggende gevindomgange på skaftet (12, 72), hvorhos boreorganeme (73) omfatter tre skærekanter (77, 78, 79), som udgøres af en pyramideformet spids’ (80) tre kanter.An intraossal needle (10, 70) comprising a threaded shaft (12, 72) having a first and a second opposite end and an inner fluid passage 5 (31, 74) extending between the units and opening in the immediate vicinity from the other end via at least one side port (33, 76) and from which other end extends drilling means (13, 73) with generally tapered cutting edges, characterized in that the drilling means (13, 73) are rigidly connected to the other end of the shaft (12, 72) and the at least one side port (33, 76) formed in the valley between two adjacent threaded turns of the shaft (12, 72), the drilling means (73) comprising three cutting edges (77, 78, 79), which is constituted by three edges of a pyramid shaped tip (80). 2. Intraossal nålsamling ifølge krav 1, kendetegnet ved, at skaftet har et antal 15 gevindomgange omfattende en forreste gevindomgang proximal med boreorganerne (13, 73), en anden gevindomgang modstående den første gevindomgang og en tredje gevindomgang modstående den anden gevindomgang, og at én af boreorganernes skærekanter (43, 78) afbryder den forreste gevindomgang.Intraossal needle assembly according to claim 1, characterized in that the shaft has a plurality of 15 threads including a front threaded proximal to the drilling means (13, 73), a second threaded opposite the first threaded and a third threaded opposite the second threaded, and one the cutting edges (43, 78) of the drill bits interrupt the anterior thread. 3. Intraossal nålsamling ifølge krav 2, kendetegnet ved, at en anden sideport (34, 75), der står i forbindelse med passagen (31, 74) og den første sideport (33, 76), er indrettet mellem den forreste gevindomgang og den anden gevindomgang, at den anden sideport (34, 75) er indrettet mellem den anden gevindomgang og den tredje gevindomgang, og at den første og anden sideport er be-25 liggende 270° fra hinanden.An intraossal needle assembly according to claim 2, characterized in that a second side port (34, 75) communicating with the passage (31, 74) and the first side port (33, 76) is arranged between the anterior thread passage and the second threading, that the second side port (34, 75) is arranged between the second threading and the third threading, and that the first and second side port are located 270 ° apart. 4. Intraossal nålsamling ifølge et eller flere af de foregående krav, kendetegnet ved, at hver af gevindomgangene har en spirallinievinkel (Θ) og en bagud vendende vinkel (a), og at den bagud vendende gevindvinkel (a) og spirallinie-30 vinklen (Θ) er i det væsentlige ens. 10 DK 176314 B1Intraossal needle assembly according to one or more of the preceding claims, characterized in that each of the threaded turns has a spiral line angle (Θ) and a rearward angle (a), and that the rearward threaded angle (a) and the spiral line angle ( Θ) is essentially the same. 10 DK 176314 B1 5, Intraossal nålsamling ifølge et eller flere af de foregående krav, kendetegnet ved, at nævnte mindst ene sideport (33, 76) er på linie med én af de tre skærekanter (77, 78, 79) for at nedsætte risikoen for tilstopning med væv. 55, Intraossal needle assembly according to one or more of the preceding claims, characterized in that said at least one side port (33, 76) is aligned with one of the three cutting edges (77, 78, 79) to reduce the risk of tissue clogging . 5
DK199200087A 1990-12-13 1992-01-23 Intraosseous needle - has threaded shaft with passageway extend through with solid pointed tip having cutting edges DK176314B1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US62702090A 1990-12-13 1990-12-13
US62702090 1990-12-13
DK73391 1991-04-22
DK073391A DK166709B1 (en) 1988-10-24 1991-04-22 Intraossal pin

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DK8792A DK8792A (en) 1992-01-23
DK8792D0 DK8792D0 (en) 1992-01-23
DK176314B1 true DK176314B1 (en) 2007-07-30

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