WO2011026935A1 - Système d'introduction d'un dispositif dans un vaisseau sanguin, procédé et équipement à sas d'introduction - Google Patents

Système d'introduction d'un dispositif dans un vaisseau sanguin, procédé et équipement à sas d'introduction Download PDF

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Publication number
WO2011026935A1
WO2011026935A1 PCT/EP2010/062947 EP2010062947W WO2011026935A1 WO 2011026935 A1 WO2011026935 A1 WO 2011026935A1 EP 2010062947 W EP2010062947 W EP 2010062947W WO 2011026935 A1 WO2011026935 A1 WO 2011026935A1
Authority
WO
WIPO (PCT)
Prior art keywords
introducer sheath
introducer
valve
lock
sheath
Prior art date
Application number
PCT/EP2010/062947
Other languages
German (de)
English (en)
Inventor
Ute Urban
Joachim Georg Pfeffer
Thomas Schmitz-Rode
Original Assignee
Rwth Aachen
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 Rwth Aachen filed Critical Rwth Aachen
Publication of WO2011026935A1 publication Critical patent/WO2011026935A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/0065—Type of implements the implement being an adhesive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00853—Material properties low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00889—Material properties antimicrobial, disinfectant

Definitions

  • the invention relates to an insertion system for introducing a device into a blood vessel, a method for introducing a device into a blood vessel and an introducer device for introducing a device into a blood vessel.
  • WO2006 / 117154 Al discloses a method for introducing a catheter into a blood vessel. First, the vessel is punctured with a needle and created in this way an opening in the wall of the vessel. Subsequently, a lock located on the needle is introduced through the opening into the vessel. The lock allows insertion of the catheter after removal of the needle.
  • WO2006 / 117154 Al discloses a method of sealing the gap between the catheter inserted into the vessel and the wall. Such a seal can suppress bleeding and the ingress of germs.
  • a haemostatic agent for example collagen
  • a closing lock arranged on the collagen supports the guidance of the collagen.
  • the object of the invention is to provide an insertion system which allows the easy introduction of a device into a blood vessel and which ensures a reliable sealing of the blood vessel.
  • a further object of the invention is to provide a method for introducing a device using the introducer system and to provide an introducer sheath device which can be used as part of an introducer system and which can be produced inexpensively.
  • the delivery system comprises an introducer sheath, a slide, a lock and a closure means, wherein the slide and the closure means are slidably mounted on the introducer sheath, and the sheath lock is slidably mounted on the closure means, the introducer sheath having at least one predetermined tear location for tearing the introducer lock.
  • the introducer sheath of the delivery system allows a simple and reliable introduction of a device into the vessel.
  • the device is inserted through the introducer sheath into the vessel. Furthermore, once a device has been inserted, it can be removed again and, for example, another device introduced.
  • the at least one predetermined tear position of the introducer sheath allows for peel-away and removal of the introducer sheath without having to be withdrawn via the device This is advantageous, for example, for devices having a plug, a telemetry unit or other device with larger implants
  • the closure means can be securely arranged in the region of the opening of the vessel via the slide and the lock, and a seal of the opening can be ensured. the.
  • the insertion system already provides the closure means, it is therefore no longer necessary, for example, to arrange the closure means directly on the device to be inserted.
  • the materials used for the delivery system are preferably biocompatible.
  • the term "tearing” also includes tearing, tearing, tearing and / or peeling off
  • the closure lock and / or the slide likewise have at least one predetermined tear point for tearing open the lock lock or the lock In this way, the slide and the lock can be easily removed, except for the closure means, preferably the entire insertion system is removable after positioning the closure means in this way.
  • the introduction system additionally comprises a valve, wherein the valve is attached to the introducer sheath and is designed to reduce backflow through the introducer sheath.
  • the valve is attached to the introducer sheath and is designed to reduce backflow through the introducer sheath.
  • Valves with this purpose are also referred to as "hemostasis valves”.
  • the valve has at least one predetermined crack point for tearing open the valve.
  • the valve is easily removable in this way.
  • the delivery system according to the invention can be advantageously at least partially made of a biocompatible plastic with good sliding properties, such as PTFE (polytetrafluoroethylene).
  • PTFE polytetrafluoroethylene
  • the area of the locks is made of such a plastic.
  • the introduction System at least partially made of a plastic, which is at least in the region of the tissue or blood in contact surfaces of the delivery system with a biocompatible plastic, such as PTFE, coated. This makes it possible to use manufacturing advantages of a possibly non-biocompatible plastic and at the same time ensure good sliding properties and a sufficient compatibility when using the delivery system in the body.
  • the occlusive agent is with a pharmacologically active substance, e.g. a drug or nanoparticles.
  • a pharmacologically active substance e.g. a drug or nanoparticles.
  • the closure agent is antibacterial, e.g. by incorporation of silver ions. This is particularly advantageous in venous application of the system according to the invention.
  • the method according to the invention for introducing a device into a vessel using an introduction system comprises the steps of: a) inserting the introducer sheath into an opening in a wall of the vessel; b) introducing a device through the introducer sheath into the vessel.
  • the introducer sheath device comprises a tubular introducer sheath and a valve, wherein the valve is designed to reduce backflow through the introducer sheath, wherein the valve is at least partially made of a cast material and is materially bonded by pouring a portion of the introducer sheath with the introducer sheath.
  • the valve is at least partially made of a cast material and is materially bonded by pouring a portion of the introducer sheath with the introducer sheath.
  • the casting material is a silicone. Silicone is inexpensive, easy to process and allows fast production.
  • the use of a silicone that is biocompatible is preferred.
  • the entire valve is made of silicone.
  • the delivery system according to the invention, the method according to the invention and the introducer sheath according to the invention can be used in particular in the implantation of long-term arterial implants such as pressure probes or oxygen probes, central venous catheters, pacemaker probes or port implants.
  • long-term arterial implants such as pressure probes or oxygen probes, central venous catheters, pacemaker probes or port implants.
  • Fig. 1 is a perspective view of an embodiment of an inventive
  • FIG. 2 is a plan view of the delivery system shown in FIG. 1; FIG.
  • Fig. 3 is a perspective view of an introducer device, the part of in
  • FIG. 4 shows a plan view of the introducer device shown in FIG. 3
  • FIG. 5 shows the process state of an embodiment of a method for introducing a device into a vessel after puncturing the vessel
  • FIG. 1 shows a perspective view of an embodiment of an insertion system 1 according to the invention.
  • FIG. 2 shows a plan view of the insertion system 1.
  • the introduction system 1 comprises an introducer sheath 2, a slide 3, a closure sheath 4, a valve 9 and a closure means 5.
  • the introducer sheath 2, the slide 3, the sheath lock 4 and the closure means 5 are formed as tubular hollow bodies and arranged coaxially.
  • the slide 3 and the closure means 5 are attached to the lateral surface of the introducer sheath 2, the closure lock 4 is fitted on the lateral surface of the closure means 5 and on the lateral surface of the slide 3.
  • the inner diameter of the slider 3 and the closure means 5 are adapted to the outer diameter, so that a manual displacement of the slider 3 and the closure means 5 against friction is possible, but the gap between slide 3, closure means 5 and inlet lock 2 is kept low.
  • the inner diameter of the closure lock 4 is adapted to the outer diameter of the closure means 5 and the slide 3, so that a manual displacement of the lock 4 against friction is possible, but the gap between the lock 4 and slide 3 and closing means 5 is kept low.
  • the introducer sheath 2 splits at the end remote from the closing means 5 into two gap sections 12a, 12b.
  • the two points at which the introducer sheath splits form two Sollrissstellen 6a, 6b.
  • the Sollrissstellen allow a defined manual tearing of the introducer sheath 2 by opposing pulling on the gap sections 12a, 12b.
  • the slider 3 and the lock slit 4 split analogously to the introducer sheath 2 at its end facing away from the closure means 5 also in each case two gap sections to form two Sollrissstellen 7 and 8, the Sollrissstellen 7 and 8 a defined manual tearing of the slide. 3 and the lock lock 4 allow.
  • the introducer sheath 2, the slide 3 and / or the closure lock 4 may have a material weakening in the form of, for example, grooves or perforations.
  • the two predetermined crack locations 6a, 6b, 7, 8 lie opposite each other, so that the introducer sheath 2, the slide 3 and the lock sheath 4 each can be torn in half, allowing easy removal of the torn-open elements.
  • a plurality of predetermined crack locations could also be provided and / or the predetermined crack locations could be arranged asymmetrically.
  • the introducer sheath 2, the slide 3 and the lock sheath 4 are preferably made of polytetrafluoroethylene (PTFE). This allows an axial displacement of the slide 3 between the introducer sheath 2 and the lock sluice 4 and an axial displacement of the lock sluice 4 on the slide 3 while ensuring a small gap distance between the respective elements. Furthermore, PTFE exhibits a favorable tear-off behavior due to the linear structure of the macromolecules, in the above case tearing into two identical halves. In addition, PTFE is biocompatible.
  • the closure means 5 is a hemostatic material, preferably collagen or gelatin.
  • the introducer sheath 2 preferably has an inner diameter of ⁇ 1.3 mm and a wall thickness in the range of 0.13 mm to 0.3 mm, the slide 3 has a wall thickness in the range of 0.25 mm to 0.45 mm and / or the closure lock 4 a wall thickness in the range of 0.05mm to 0.2mm. Smaller values in the wall thickness allow easier tearing, but deteriorate the strength of the respective element. The values indicated are advantageous for an introducer system 1 that is miniaturized and requires only a small amount of intervention in a vessel. A strong leakage when removing the introducer sheath 2 from the vessel can be avoided in this way.
  • the inner diameter of the introducer sheath 2 is sufficient to introduce devices, such as measuring devices, into the vessel.
  • sufficient strength is ensured for the slide 3 in order to be able to position the closure means 5.
  • the insertion system 1 is not limited to the specified ranges.
  • the import lock 2 has an inner diameter of 1.19 mm and a wall thickness of 0.15 mm
  • the slide 3 has an inner diameter of 1.68 mm and a wall thickness of 0.3 mm
  • the lock 4 an inner diameter of 2.4 mm and a Wall thickness of 0.1mm.
  • the import lock 2 and the valve 9 form an introducer device, which is shown in more detail in Figures 3 and 4.
  • Figure 3 shows a side view
  • Figure 4 is a plan view of the introducer device.
  • the valve 9 comprises a main body 20 and a membrane 14. Both base body 20 and membrane 14 are made by a casting material, preferably made of silicone. During casting of the main body 20, a portion of the introducer sheath 2 is shed with, so that the base body 20 and thus the valve 9 is materially connected to the introducer sheath 2.
  • the main body 20 comprises two tab-shaped tear portions 13 a, 13 b, which are arranged mirror-symmetrically and radially aligned.
  • the gap sections 12a, 12b of the introducer sheath 2 are likewise aligned radially.
  • a gap section 12a, 12b terminates in a tear-open section 13a, 13b and is embedded therein, so that a firm connection between gap section 12a, 12b and the respective tear-open section 13a, 13b is ensured.
  • the main body 20 comprises two predetermined crack locations 10a, 10b, which allow tearing open of the valve 9.
  • the Sollriss slaughter 10 a, 1 Ob are formed as axially aligned, wedge-shaped slits, which face each other with mirror symmetry.
  • the Sollrissstellen are axially not continuous.
  • a web 23a, 23b which connects the tear-open sections 13a, 13b with one another and stabilizes the basic body 20 in its shape.
  • the predetermined crack locations 10a, 10b preferably extend to or nearly to to the introducer sheath 2, to allow easy tearing of the base body 20.
  • the introducer sheath 2 is completely surrounded by the casting material of the main body 20 in a region 21 in order to stabilize the position of the predetermined crack locations 6a, 6b.
  • valve 9 takes place by opposing pulling on the tear sections 13 a, 13 b. Because the gap sections 6a, 6b of the introducer sheath 2 are embedded in the tear-open sections 13a, 13b, the introducer sheath 2 is also torn open by pulling on the tear-open sections 13a, 13b. Valve 9 and introducer sheath 2 can be torn in this way in one operation and then removed. In order to facilitate the tearing of the valve 9, the upper web 23 a may be slit.
  • the membrane 14 is placed on the base body 20 and encapsulated in its edge region with silicone with the base body 20, so that the membrane 14 is firmly and tightly connected to the base body 20.
  • the membrane 14 is disc-shaped in this embodiment. In the center, it has a preferably disc-shaped recess 22, which faces the introducer sheath 2.
  • the recess 22 has a larger flow cross-section than the introducer sheath 2. This causes flow losses occur and the resulting pressure on the membrane 14 is reduced. This is advantageous for the functionality of the membrane 14.
  • the membrane 14 comprises a slot 15, which is provided in the region of the recess 22.
  • the membrane 14 prevents or reduces at least one return flow through the introducer sheath 2, in particular a return flow of liquids such as blood.
  • the slot 15 makes it possible to introduce devices through the membrane 14 into the introducer sheath 2.
  • FIGS. 5 to 9 show various process states of a method for introducing a device 19 into a vessel.
  • an insertion system 1 is used for insertion of the device 19, an insertion system 1 is used.
  • the vessel is in this embodiment, under a skin 24 lying blood vessel 17, for example, an artery. Of course, other types of vessels are
  • the blood vessel 17 is punctured by means of a needle 25 and in this way an opening 16 in the wall 18 of the blood vessel 17 is generated.
  • the state of the method after insertion of the lock 26 is shown in FIG. 1.
  • the needle is removed and a guide wire 27 is inserted through the sheath 26 into the blood vessel 17.
  • the method state after insertion of the guide wire 27 is shown in FIG. 6.
  • the sluice 26 is removed, for example by tearing or pulling the sluice 26 away from the guide wire 27.
  • the delivery system 1 is fed to the blood vessel 17 via the guide wire 27.
  • the guide wire 27 is guided through the introducer sheath 2 and through the valve 9.
  • the delivery system is advanced until the introducer sheath 2 is inserted through the opening 6 into the blood vessel 17.
  • the valve 9 prevents or reduces, at least when the introducer sheath 2 enters the blood vessel 17, the return flow of blood through the introducer sheath 2.
  • This process state is shown in FIG.
  • the guide wire 27 is removed and inserted through the valve 9 and the introducer sheath 2, a device 19 in the blood vessel 17, see Figure 8.
  • the device 19 has in this embodiment, a catheter 1 1, at the top of a probe 28, for example a pressure or temperature probe is arranged.
  • the closure means 5 is positioned in the region of the opening 16 in order to seal a gap between the wall 18 of the vessel 17 and the catheter 1 of the device 19. Positioning is accomplished by advancing the slider 3 and the lock-up lock 4. The introducer lock with the introducer sheath 2 is retracted to clear the area around the opening 16. The advancement of the slide 3, the lock 4 and the retraction of the introducer sheath device preferably takes place at least partially alternately in order to bring the closure means 5 into the region of the opening 16. After positioning of the closure means 5 in the region of the opening 16, the closure lock 4 is removed by tearing open. With the slider 3, the position of the closure means can be corrected. After reaching a hemostasis, the slider 3 is removed by tearing.
  • FIG. 9 The method state after performing this step is shown in FIG. 9.
  • the closure means 5 swells and seals the gap between the catheter 11 and the wall 18 of the blood vessel 17.
  • the introducer sheath 2, the slide 3, the lock 4 and the valve 9 are each removed by tearing.
  • FIG. 10 shows the state of the method after removal of these elements.
  • the introducer sheath 2 would replace the lock 26 in this case. The number of process steps could be reduced.
  • the present invention provides a compact delivery system 1 for in particular intravascular indwelling catheters, or fully implantable measuring systems with a large proximal end, such as a plug or a telemetry unit, which includes an introduction into the vessel 17, a simple removal of the introducer sheath 2 and a seal the puncture site after removal of the introducer sheath 2 allows.

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

Abstract

L'invention a pour objet un système, un procédé et un équipement d'introduction d'un dispositif dans un vaisseau sanguin. Le système d'introduction comprend un sas d'introduction (2), un poussoir (3), un sas de fermeture (4) et un organe de fermeture (5), le poussoir (3) et l'organe de fermeture (5) étant disposés de manière à coulisser sur le sas d'introduction (2), et le sas de fermeture (4) étant disposé de manière à coulisser sur l'organe de fermeture (5), le sas d'introduction (2) comportant au moins une zone de déchirure (6a, 6b) prévue pour le déchirement du sas d'introduction (2).
PCT/EP2010/062947 2009-09-07 2010-09-03 Système d'introduction d'un dispositif dans un vaisseau sanguin, procédé et équipement à sas d'introduction WO2011026935A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009040220.9 2009-09-07
DE102009040220A DE102009040220A1 (de) 2009-09-07 2009-09-07 Einführsystem zum Einführen einer Vorrichtung in ein Blutgefäß, Verfahren und Einführschleuseneinrichtung

Publications (1)

Publication Number Publication Date
WO2011026935A1 true WO2011026935A1 (fr) 2011-03-10

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PCT/EP2010/062947 WO2011026935A1 (fr) 2009-09-07 2010-09-03 Système d'introduction d'un dispositif dans un vaisseau sanguin, procédé et équipement à sas d'introduction

Country Status (2)

Country Link
DE (1) DE102009040220A1 (fr)
WO (1) WO2011026935A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019108618A1 (fr) * 2017-11-28 2019-06-06 Pneumonix Medical, Inc. APPAREIL ET PROCÉDÉ DE DIAGNOSTIC D'UN CAPTEUR DE NOX<i />
USD935611S1 (en) 2018-12-10 2021-11-09 Pneumonix Medical, Inc. Tissue tract sealant device

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049363A1 (fr) * 1999-12-30 2001-07-12 Cook Vascular Incorporated Valve medicale separable
US20060149293A1 (en) * 2004-11-29 2006-07-06 Eric King Reduced-friction catheter introducer and method of manufacturing and using the same
WO2006117154A1 (fr) 2005-05-03 2006-11-09 Rheinisch-Westfälische Technische Hochschule Aachen Dispositif permettant l'acquisition de grandeurs de mesure physiologiques a l'interieur d'un corps
WO2007044510A1 (fr) * 2005-10-05 2007-04-19 Loma Linda University Medical Center Appareil de fermeture de plaie vasculaire et méthode

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049363A1 (fr) * 1999-12-30 2001-07-12 Cook Vascular Incorporated Valve medicale separable
US20060149293A1 (en) * 2004-11-29 2006-07-06 Eric King Reduced-friction catheter introducer and method of manufacturing and using the same
WO2006117154A1 (fr) 2005-05-03 2006-11-09 Rheinisch-Westfälische Technische Hochschule Aachen Dispositif permettant l'acquisition de grandeurs de mesure physiologiques a l'interieur d'un corps
WO2007044510A1 (fr) * 2005-10-05 2007-04-19 Loma Linda University Medical Center Appareil de fermeture de plaie vasculaire et méthode

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019108618A1 (fr) * 2017-11-28 2019-06-06 Pneumonix Medical, Inc. APPAREIL ET PROCÉDÉ DE DIAGNOSTIC D'UN CAPTEUR DE NOX<i />
US11638578B2 (en) 2017-11-28 2023-05-02 Pneumonix Medical, Inc. Apparatus and method to seal a tissue tract
USD935611S1 (en) 2018-12-10 2021-11-09 Pneumonix Medical, Inc. Tissue tract sealant device

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