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EP4572690A1 - Système de ponction médicale - Google Patents

Système de ponction médicale

Info

Publication number
EP4572690A1
EP4572690A1 EP23757593.1A EP23757593A EP4572690A1 EP 4572690 A1 EP4572690 A1 EP 4572690A1 EP 23757593 A EP23757593 A EP 23757593A EP 4572690 A1 EP4572690 A1 EP 4572690A1
Authority
EP
European Patent Office
Prior art keywords
puncture
handle section
tubular body
unit
puncture needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23757593.1A
Other languages
German (de)
English (en)
Inventor
Jens EBNET
Sven Lahme
Werner Schwarz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ebnet Medical GmbH
Original Assignee
Ebnet Medical GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ebnet Medical GmbH filed Critical Ebnet Medical GmbH
Publication of EP4572690A1 publication Critical patent/EP4572690A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A61B2090/3614—Image-producing devices, e.g. surgical cameras using optical fibre

Definitions

  • the invention is based on the object of specifying an improved puncture system which avoids the previously explained disadvantages and accordingly improves the safety of the medical procedure.
  • the puncture system according to the invention is characterized in that it combines all the necessary components for carrying out a PCNL, in particular mini-PCNL, into one instrument. All components are connected to each other at the handle area and can be detached from each other. The user can only operate the connection and release steps in a certain sequence on the handle area. This ensures a safe sequence of the individual process steps and thus prevents the risk of accidental incorrect operation of the individual components.
  • the first, second and third handle sections are each shaped to be particularly easy to grip, i.e. H. ergonomically shaped so that they support easy and safe gripping by the user.
  • H. ergonomically shaped so that they support easy and safe gripping by the user.
  • This has the advantage that the user does not have to place the individual parts of the puncture system in places that are not actually intended for this purpose, such as: B. on Luer/Lock connections, but has defined handle sections available, which stand out visually from other parts of the puncture system due to their easy-to-grip design and are therefore easily perceived by the user as handle sections. This also promotes intuitive working with the puncture system according to the invention.
  • the first, second and/or third handle sections can have a hyperboloid shape, for example.
  • the curvature of the hyperboloid shape of the second handle section can be less than the curvature of the first and/or third handle sections.
  • the first, second and/or third handle section can also be designed as another rotationally symmetrical body.
  • grooves and/or knobs or another surface structure can also be present to increase the grip.
  • Individual or all handle sections can at least partially consist of or be coated with a material that increases the frictional resistance. This prevents the user's fingers from accidentally slipping.
  • the grip area can also be completely or partially z. B. made of an elastomer, e.g. B. rubber or silicone, or made of any other material that is softer than the other material of the puncture system.
  • Individual or all handle sections can also consist of at least one antimicrobial material or be coated with at least one.
  • Individual or all handle sections can also consist of or be coated with at least one material that has particularly hydrophobic properties. Properties in the sense of or similar to a lotus effect are also conceivable.
  • handle sections can at least partially be designed in a different color than the other components of the puncture system, for example in green, yellow or red.
  • the handle sections can be designed in different colors. This is intended to remind the user of the colors of a traffic light and can indicate the sequence of the operating steps.
  • the sequence of the operating steps can be identified by numbering or generally a label, for example numbering or other labeling of the handle sections.
  • Special patterns in the handle area are also possible, e.g. cross- or arrow-like patterns.
  • the color “yellow” is also conceivable, at least partially in areas that should not be touched, but which can still be touched in special situations.
  • the color “green” can then be used for areas that can be touched.
  • handle sections are initially covered by an adhesive structure, for example a film, which can be removed before, during or after the puncture process.
  • an adhesive structure for example a film
  • the puncture system is designed to be partially, predominantly or completely transparent so that fluid/urine/blood flows can be recognized directly.
  • the puncture needle can also be designed to be transparent, provided the material properties allow it.
  • the first handle section can be releasably coupled to the second handle section by positive locking via at least one positive coupling element and/or the second handle section can be releasably coupled to the third handle section by positive locking via at least one positive coupling element.
  • the first, second and third handle sections form a homogeneous handle section for gripping and manually handling the puncture system when they are coupled to one another via the positive coupling elements.
  • the homogeneous handle section formed in this way forms a type of handle of the puncture system.
  • the first, second and third handle sections can each form part of such a handle.
  • the homogeneous handle section can, for example, be designed to be homogeneous in the sense that the first handle section merges into the second handle section without a noticeable transition or with a gentle transition.
  • the second handle section can be used without a noticeable transition or with one smooth transition into the third grip section.
  • the first handle section can directly adjoin the second handle section.
  • the second handle section can directly adjoin the third handle section.
  • the second handle section which is positively coupled to the first handle section
  • the third handle section which is positively coupled to the second handle section
  • accidental detachment of one handle section from the other handle section is reliably avoided.
  • the user must perform a defined rotational movement of a handle section relative to the adjacent handle section.
  • the rotational movement required to release one handle section from the other handle section can, for. B. be a rotation in an angular range of 90 to 180 degrees.
  • a thread can be avoided to realize the positive coupling, which has the advantage that there is no need to turn one handle section several times from the other handle section, i.e. H. an angle of more than 360 degrees is required.
  • the second handle section can be released from the first handle section relative to the first handle section, for example, by a rotational movement about the longitudinal axis.
  • the positive coupling between the first and second handle sections can be designed in the manner of a bayonet connection.
  • the third handle section can be released from the second handle section relative to the second handle section by a rotational movement about the longitudinal axis.
  • the positive coupling between the second and third handle sections can be designed in the manner of a bayonet connection.
  • the puncture needle is longitudinally displaceable relative to the inner tubular body, the puncture needle unit being removable from the dilator unit in a direction facing away from the end of the puncture system near the patient.
  • the positive coupling between the second and third handle sections must first be removed.
  • the inner tubular body is longitudinally displaceable relative to the outer tubular body, the dilator unit being removable from the shaft unit in a direction facing away from the end of the puncture system near the patient. To remove the dilator unit, the positive coupling between the first and second handle sections must first be removed.
  • the puncture can be carried out in such a way that initially only the puncture needle is guided with its tip first to the desired position inside the patient's body. Then the positive coupling between the second and third handle sections is released. Now the still connected unit consisting of the dilator unit and the shaft unit can be pushed forward. It is guided over the puncture needle. The puncture needle therefore acts like a guide wire. The opening is widened by the dilator unit so that the shaft unit can also be advanced. Once the unit consisting of the dilator unit and the shaft unit is placed in the correct place, the puncture needle unit can be removed, i.e. H. the puncture needle unit is pulled out of the inner tubular body.
  • the positive coupling between the first and second handle sections can be released and the shaft unit can be advanced and placed in the correct location.
  • the dilator unit can then be removed by pulling it out of the outer tubular body. All that remains on the patient is the shaft unit with the relatively large outer tubular body. A lithotripter, for example, can be guided directly through this outer tubular body.
  • the inner tubular body has a dilatation section in an area close to the patient, which tapers on the outer circumference towards the end of the puncture system close to the patient.
  • the dilation section can be directly, for example connect to a hollow cylindrical part of the inner tubular body.
  • the dilation section can e.g. B. have a linear, progressive or degressive ramp-shaped outer contour.
  • the difference between the outer diameters of the inner tubular body and the outer tubular body is relatively small, e.g. B. less than 50% of the outer diameter of the inner tubular body.
  • the puncture needle protrudes from the inner tubular body at the end near the patient, at least when the first, second and third handle sections are coupled to one another via the positive coupling elements.
  • the medical puncture system in the basic state in which the puncture system can be delivered by the manufacturer, for example, can be used directly as an integrated tool for carrying out the entire puncture process.
  • the user does not need to make any special preparations for the puncture system.
  • the puncture system can be guided directly with the tip of the puncture needle first to the desired location inside the patient's body. This can be additionally checked and visualized, for example, through an ultrasound examination or radiological monitoring.
  • the length of the part of the puncture needle protruding from the third handle section can, for example, be at least 1.5 times as long be as large as the length of the part of the outer tubular body protruding from the first handle section.
  • the puncture system according to the invention allows a type of all-in-one puncture and accordingly an optimized workflow for nephrolitholapaxy. The surgeon does not have to switch between different instruments.
  • the puncture needle is at least 1.5 times or at least twice as long as the outer tubular body
  • the outer tubular body is adjustable in length and/or has at least one predetermined breaking point for selectively shortening the outer tubular body and/or is designed to be slotted in the longitudinal direction from the end remote from the patient.
  • This has the advantage that the length of the outer tubular body can be adapted to specific features of the operation and the patient directly while an operation is being carried out, that is to say it can be shortened to a desired length. This can optimize the irrigation flow and improve the flushing out of stone fragments and prevent the outer tubular body from protruding unnecessarily far from the patient, which would make it more difficult to carry out procedures.
  • the invention relates to an outer tubular body in the form of an Amplatz shaft for carrying out a percutaneous nephrolitholapaxy, the Amplatz shaft having a plurality of circumferential notches distributed over its longitudinal extent, through which predetermined breaking points for selectively shortening the Amplatz shaft at a respective one User selected location are formed.
  • the previously explained advantages can also be realized in this way.
  • the Amplatz shaft can have one or more of the aforementioned features of the outer tubular body.
  • the Amplatz shaft is designed without the previously explained predetermined breaking points.
  • the invention also relates to a method for adjusting the length of an Amplatz shaft for carrying out a percutaneous nephrolitholapaxy, in which the Amplatz shaft is shortened to a desired dimension before or during the performance of the percutaneous nephrolitholapaxy on the patient, for example by removing a piece of the Amplatz shaft using a Tool is separated and / or a piece of the Amplatz shaft is broken off using at least one predetermined breaking point.
  • FIG 2 shows an enlarged detail of the area near the patient of the medical puncture system according to Figure 1
  • FIG. 1 individual structural units of the medical puncture system
  • Figure 4 shows the handle section of the medical puncture system in a partially sectioned perspective view
  • FIG. 5 shows the handle section according to FIG. 4 in a side view
  • FIG. 6 shows a sectional view according to the section plane BB shown in FIG. 5,
  • FIG. 7 shows a sectional view according to the section plane AA shown in FIG. 5,
  • Figure 8 is a further partial sectional view analogous to Figure 4,
  • FIG. 9 shows a handle section according to FIG. 8 in a side view
  • FIG. 11 shows a sectional view according to the section plane CC shown in FIG. 9,
  • Figure 12 is a further partial sectional view analogous to Figure 4,
  • FIG. 13 shows the handle section according to FIG. 12 in a side view
  • Figure 14 is a sectional view according to the section plane EE shown in Figure 13
  • Figure 15 is an image display unit
  • Figure 20 shows a further embodiment of a shaft unit in side view
  • 21 shows the shaft unit according to FIG. 20 in a front view of the first handle section
  • Figure 22 shows the shaft unit according to Figure 20 in a modified form
  • Figure 23 shows the placement of the shaft unit according to Figure 22 on the patient
  • Figures 24-28 shows a shaft unit with predetermined breaking points
  • Fig. 29-33 a shortened tubular body with a final body.
  • the medical puncture system is essentially made up of three structural units, namely a shaft unit 14, a dilator unit 13 and a puncture needle unit 12.
  • the puncture needle unit 12 has a puncture needle 1 and a third handle section 6 connected to the puncture needle 1.
  • the dilator unit 13 has an inner tubular body 2 and a second handle section 5, which is connected to the inner tubular body 2.
  • the shaft unit 14 has an outer tubular body 3 and a first handle section 4 connected thereto.
  • the puncture needle 1 can be in the area A close to the patient, i.e. H. at the end, be pointed, d. H. have a puncture needle tip.
  • the puncture needle 1 can be designed as a hollow needle.
  • optics 7 can be arranged within the puncture needle.
  • the optics 7 can be guided outwards via an electrical cable 8 or light guide through the puncture needle 1 and through the third handle section 6 and connected to an image display unit.
  • the puncture needle unit 12 e.g. B. behind the third handle section 6, have a kink protection 11, which prevents the electrical cable 8 or the light guide from kinking.
  • the puncture needle 1 can have one or more side openings 9, which are arranged behind the optics 7 as seen from the end of the puncture needle 1 near the patient. Body fluids can enter the interior of the puncture needle 1 through the side openings 9.
  • the puncture needle unit 12 can, for example, have an opening 10 in the area of the third handle section 6, e.g. B. with a Luer connection in order to direct and collect and/or analyze the liquids received via the side openings 9 to the outside.
  • the outer tubular body 2 has a dilation section 25 at the end near the patient.
  • the delivery state which is shown in FIG. 1, is seen from the end A near the patient the second handle section behind the first handle section and the third handle section behind the second handle section 5.
  • the inner tubular body 2 protrudes from the outer tubular body 3 at the end near the patient, at least by the length of the dilation section 25.
  • the puncture needle 1 protrudes at the end near the patient significantly longer from the inner tubular body 2, for example by at least 1.5 times the length of the inner tubular body.
  • Fig. 9 shows the representation when the dilator unit 13 is rotated by 90°.
  • the sectional view C Fig.11 shows the open position.
  • the dilator unit 13 is released in this position by the dilator groove 19 and can now be detached from the puncture needle unit 12.
  • the dilator unit 13 is then advanced axially together with the shaft unit 14 over the puncture needle 1 to over the optics 7.
  • the puncture needle unit 12 is removed.
  • the dilator unit 13 is then rotated further until a noticeable stop is reached.
  • the sectional view E-E in Fig. 14 shows the open position.
  • the shaft unit 14 is released in this position by the dilator groove 19 and can be detached from the dilator unit.
  • the shaft unit 14 is then advanced axially via the dilator unit 13 into the hollow system 21 of the kidney 22. If the shaft unit 14 is in the correct position, the dilator unit 13 is then removed.
  • Figure 15 shows an example of an image display unit 20, which can be connected to the electrical cable 8 or the light guide.
  • the image display unit 20 can z. B. have an image display device (monitor), an interface and a dimmer.
  • the puncture system can be connected, for example, to the image display unit 20 via a cable 8 close to the user.
  • the cable 8 can be led out centrally from the third handle section 6 so that the puncture system can be rotated without any problems and can be operated with both hands.
  • a guide wire is no longer required since the position of the puncture needle with tip can be checked optically.
  • the X-ray exposure for patients and staff is also reduced and may even be eliminated altogether.
  • the outer tubular body 3 can be formed with notches 24 at the end remote from the patient.
  • the notches 24 run axially outside the outer tubular body 3 with a defined notch length.
  • the notches allow for a predetermined breaking point so that if necessary the shaft can be split open to allow for improved flow length.
  • the representations Fig. 22 and Fig. 23 show the outer tubular body with a split end remote from the patient.
  • Another possible embodiment is a length-adjustable outer tubular body with assembled tubular parts.
  • the individual tube parts In the area of the outer tubular body that is remote from the patient, the individual tube parts have screw connections.
  • the shaft length can be shortened by loosening the screw connection of the individual pipe parts.
  • FIG. 24 to 28 Another embodiment is an outer tubular body 3 with several predetermined breaking points 26 surrounding the circumference, as shown in Figures 24 to 28.
  • a specific longitudinal section of the outer tubular body 3 can, for example, be provided with several such predetermined breaking points 26, which are arranged at equal or unequal distances from one another, for example at intervals of 1 cm.
  • the predetermined breaking points 26 can be designed, for example, as circumferential depressions (grooves) formed on the outside, with different profile cross sections of the depressions being conceivable.
  • Figure 26 shows a predetermined breaking point 26 with a rectangular cross section
  • Figure 27 shows a predetermined breaking point 26 with a triangular cross section
  • Figure 28 shows a predetermined breaking point 26 with a semicircular cross section.
  • the Shaft length of the outer tubular body 3 can be shortened by breaking it off at the desired breaking point 26 when the outer tubular body 3 is placed on the patient.
  • Figures 29 and 30 show the outer tubular body 3 according to Figures 24 to 28 in a shortened form at a predetermined breaking point 26.
  • a closing body 27 is placed there.
  • the shortened outer tubular body 3 can continue to be used without such a closing body.
  • the exposed predetermined breaking point can be covered.
  • better manual operation can be carried out on the remaining part of the outer tubular body 3.
  • the end body 27 can have a funnel shape, at least in an inner hollow area.
  • the closure body 27 can have a fastening element 28.
  • the fastening element 28 can in particular be designed to engage in a notch-shaped predetermined breaking point 26 in order in this way to form a positive coupling of the closing body 27 with the outer tubular body 3.
  • the fastening element 28 can be designed as a displaceably arranged fastening clip, which then engages in a notch-shaped predetermined breaking point 26 when moved.
  • the inner tubular body and/or the outer tubular body can consist of at least one hydrophilic material and/or be coated with at least one hydrophilic material.
  • the outer tubular body can also be made of plastic or at least one metallic material or be formed of a corresponding alloy or be coated with at least one such material over a partial length, the majority or the entire length. Furthermore, the outer tubular body can be designed in two parts made of plastic and metal.
  • the inner tubular body and/or the outer tubular body can have a conical or curved tip.
  • Inner tubular body e.g. dilator
  • First handle section (e.g. Amplatz handle)
  • Second handle section (e.g. dilator handle)
  • Third handle section e.g. puncture needle handle
  • image display unit interface, dimmer, monitor

Landscapes

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

Abstract

L'invention concerne un système de ponction médicale pour réaliser une ponction sur un patient, le système comprenant les caractéristiques de la revendication 1. Le système de ponction médicale peut en principe être utilisé pour des ponctions de n'importe quel type. Le système de ponction médicale est particulièrement adapté à la réalisation d'une néphrolitholapaxie percutanée minimalement invasive (mini-PCNL).
EP23757593.1A 2022-08-16 2023-08-15 Système de ponction médicale Pending EP4572690A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102022120628.9A DE102022120628A1 (de) 2022-08-16 2022-08-16 Medizinisches Punktionssystem
PCT/EP2023/072452 WO2024038043A1 (fr) 2022-08-16 2023-08-15 Système de ponction médicale

Publications (1)

Publication Number Publication Date
EP4572690A1 true EP4572690A1 (fr) 2025-06-25

Family

ID=87748171

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23757593.1A Pending EP4572690A1 (fr) 2022-08-16 2023-08-15 Système de ponction médicale

Country Status (4)

Country Link
EP (1) EP4572690A1 (fr)
CN (1) CN119730801A (fr)
DE (1) DE102022120628A1 (fr)
WO (1) WO2024038043A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120154398A (zh) * 2025-04-14 2025-06-17 江门市硕通医疗器械科技有限公司 一种经皮肾穿刺装置

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5242410A (en) * 1991-04-15 1993-09-07 University Of Florida Wireless high flow intravascular sheath introducer and method
EP2248549A3 (fr) * 2001-12-26 2010-12-08 Yale University Dispositif d'accès vasculaire
US9326756B2 (en) * 2006-05-17 2016-05-03 St. Jude Medical, Atrial Fibrillation Division, Inc. Transseptal catheterization assembly and methods
US8152767B2 (en) * 2005-05-27 2012-04-10 Cook Medical Technologies Llc Low profile introducer apparatus
DE102009060921A1 (de) 2009-12-31 2011-08-18 Bader, Markus, Dr., 81825 Punktionsnadelsystem
US9358039B2 (en) * 2012-05-08 2016-06-07 Greatbatch Ltd. Transseptal needle apparatus
EP2994187B1 (fr) * 2013-05-08 2019-12-04 Clph, Llc Dispositif d'accès pour des procédures transeptales
CN109512473A (zh) * 2017-09-20 2019-03-26 史军 带可视穿刺装置的医疗设备

Also Published As

Publication number Publication date
DE102022120628A1 (de) 2024-02-22
CN119730801A (zh) 2025-03-28
WO2024038043A1 (fr) 2024-02-22

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