EP2496153A1 - Ensemble d'accès d'introducteur - Google Patents

Ensemble d'accès d'introducteur

Info

Publication number
EP2496153A1
EP2496153A1 EP10777118A EP10777118A EP2496153A1 EP 2496153 A1 EP2496153 A1 EP 2496153A1 EP 10777118 A EP10777118 A EP 10777118A EP 10777118 A EP10777118 A EP 10777118A EP 2496153 A1 EP2496153 A1 EP 2496153A1
Authority
EP
European Patent Office
Prior art keywords
tubular
introducer
tubular channel
assembly according
access assembly
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.)
Withdrawn
Application number
EP10777118A
Other languages
German (de)
English (en)
Inventor
Fredrik Mahlin
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.)
St Jude Medical Coordination Center BVBA
Original Assignee
St Jude Medical Systems AB
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
Priority claimed from SE0950822A external-priority patent/SE534071C2/sv
Priority claimed from US12/611,277 external-priority patent/US8469944B2/en
Application filed by St Jude Medical Systems AB filed Critical St Jude Medical Systems AB
Publication of EP2496153A1 publication Critical patent/EP2496153A1/fr
Withdrawn legal-status Critical Current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, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • 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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/3445—Cannulas used as instrument channel for multiple instruments
    • A61B2017/3449—Cannulas used as instrument channel for multiple instruments whereby the instrument channels merge into one single channel

Definitions

  • the present invention relates to an introducer access assembly according to the preamble of the independent claim.
  • a medical introducer is generally used to gain access to internal organs in order to introduce another medical device into the body.
  • the other medical device may typically be a pressure sensor catheter inserted into arteries, inter alia to measure blood pressure within arteries, e.g. in coronary vessels, in order to detect and localize constrictions.
  • a pressure sensor catheter inserted into arteries, inter alia to measure blood pressure within arteries, e.g. in coronary vessels, in order to detect and localize constrictions.
  • the medical device is withdrawn, the introducer is maintained in place, and it is sometimes required to close and properly seal the artery.
  • a closing device may be inserted into the vessel in order to close the incision through the vessel wall. Introducers from different manufacturers might vary considerably in shape, length, structure etc.
  • proximal end of the introducer may have very different structures.
  • the object of the present invention is to achieve an introducer assembly enabling a more user- friendly procedure that is safe to use for the patient.
  • the present invention relates to an elongated introducer access assembly comprising a distal end and a proximal end, and provided with a first tubular channel having a longitudinal axis and running from a first proximal end opening to a distal end opening of said assembly and being adapted to receive a tubular medical device.
  • the assembly is provided with a second tubular channel having a second proximal end opening running from the proximal end of the assembly, said second tubular channel being arranged in an angled direction in relation to the longitudinal axis of the first tubular channel,
  • the assembly further comprises a cutting unit adapted to provide an opening cut through a part of a first tubular medical device arranged in said first tubular channel such that a second tubular device may be inserted into said second tubular channel and into the first tubular medical device via said opening cut.
  • an opening cut is achieved in the introducer wall in a controlled and safe way such that a tubular medical device may be guided and inserted into a vessel in a safe and controlled manner.
  • the tubular medical device may be e.g. another introducer specifically designed to receive e.g. a closing device as described above.
  • the access assembly may function as a handle when the second tubular medical device is inserted into the introducer during the following procedure, e.g. the closing of a vessel.
  • the introducer access assembly is attached to, or adapted to be attached to, a closure device introducing system such that the assembly easily may be positioned and fixated around an introducer in order to provide an opening cut in the introducer where a closing device may be inserted into the introducer and into a vessel in order to close an incision through the vessel wall.
  • Figures la and lb show different views of the introducer access assembly according to one embodiment of the present invention.
  • Figure 2 illustrates the use of the introducer access assembly according to one
  • Figures 3-6 show the introducer access assembly according to another embodiment of the present invention in different states.
  • Figure la shows, to the right, a perspective view of the assembly, and to the left a view from the distal side.
  • Figure lb shows, from left to right, a side view where the distal end of the assembly is down in the figure, a top view showing the two halves of the assembly in a disassembled state, and a side view along A-A showing the inner side of one of the halves.
  • an elongated introducer access assembly 2 comprising a distal end 4 and a proximal end 6, and provided with a first tubular channel 8, having a longitudinal axis 10, and running from a first proximal end opening 12 to a distal end opening 14 of the assembly and being adapted to receive a first tubular medical device (not shown).
  • the assembly is provided with a second tubular channel 16 having a second proximal end opening 18 running from the proximal end of the assembly.
  • the second tubular channel is arranged in an angled direction in relation to the longitudinal axis of the first tubular channel.
  • the second tubular channel enters the first tubular channel at a junction 20 proximally to the distal end of the assembly.
  • An intersectional angle is formed between the first tubular channel and the second tubular channel. The angle is indicated as a in the figure.
  • the inner diameters of the tubular channels are naturally related to the outer diameters of the tubular devices to be arranged in the channels, preferably such that a steady fit is achieved for the device arranged in the first channel and that the second tubular medical device may easily be inserted into the second channel but at the same time be securely guided into the channel and into the first tubular device in the first channel via the opening cut.
  • the assembly further comprises a cutting unit 22 adapted to provide an opening cut through a part of a first tubular medical device arranged in said first tubular channel such that a second tubular device may be inserted into the second tubular channel and into the first tubular medical device via the opening cut.
  • the cutting unit has a flat structure to be inserted into the assembly via a mating slit in the assembly.
  • the cutting unit is arranged in the slit in one of the halves of the assembly and when the halves are assembled around an introducer the cutting unit is pushed into the assembly resulting in that an opening cut is made in the introducer and the edge part of the cutting unit then continues into the opposing half where it is accommodated.
  • the size of the cutting unit must be such that when fully inserted into the assembly no part exists at the other side of the assembly.
  • the cutting edge has preferably a razor blade structure and is made from metal, e.g.
  • stainless steel It may also be possible to achieve a cutting edge in other materials, e.g. certain plastic materials.
  • the cutting unit is arranged at a location distally to the junction and comprises a recess 24 adapted to accommodate a first tubular medical device arranged in the first tubular channel when the cutting unit is fully pushed into the assembly.
  • the recess has a semicircular shape.
  • the cutting unit is arranged such that the opening cut is essentially perpendicular to the longitudinal axis of the first tubular channel and the cutting edge 26 (partly seen in figure la) is arranged such that it cuts through at least 1/2 and up to approximately 3/4 of the diameter of a first tubular medical device arranged in the first tubular channel.
  • the exact size of the opening cut is naturally dependent upon the diameter of the second tubular device to be inserted into the introducer via the second tubular channel and opening cut.
  • the cutting unit further comprises a pushing means 28 arranged at the outside of the assembly for moving the cutting unit into the housing in order to provide said opening cut.
  • the intersectional angle a i.e. the angle between the first and second tubular channels, is less than 45°, preferably in the interval of 20° and 40°.
  • the angle must not be too small in that then it would be difficult for the second tubular medical device to enter the opening cut.
  • the angle is too large, it would also be difficult for the second tubular medical device to enter the opening, and the insertion may also be hindered if the bend at the junction is too sharp.
  • the first tubular channel is straight and the second tubular channel is also straight but forms an angled channel together with the distal part of the first tubular channel distally to the junction.
  • the assembly comprises at least one fixation member 30 arranged at the inner surface of the first tubular channel adapted to fixate the first tubular medical device arranged in the first tubular channel in the longitudinal direction.
  • the fixation member is arranged proximally to the junction.
  • the fixation member may be in the form of a protrusion, a short pin, or a track or consists of an inert or rough material at the inner surface of the first tubular channel.
  • the assembly comprises two halves adapted to be assembled and positioned such that a tubular medical device may be arranged in the first channel, and also adapted to be separated from each other.
  • the two halves are two non-connected parts when the assembly is in its non- assembled state.
  • the two halves are connected to each other by at least one hinge (not shown).
  • the hinge or hinges may be arranged at one of the longer sides of the assembly such that the assembly may be folded around the introducer to be arranged in the first channel.
  • the assembly is further provided with mating means 32 for fastening and orientating the two halves in relation to each other during assembling.
  • the mating means may comprise a number of extending pins at one half of the assembly and mating depressions/holes at the other half to receive the pins such that a frictional connection is achieved.
  • the assembly is a separate device that is attached to an introducer when desired.
  • the assembly instead is integrated with a tubular medical device arranged in the second channel.
  • one of said halves is attached to, or adapted to be attached to, a closure device introducing system which is adapted to automatically, or semi-automatically, introduce a closure device into a vessel in order to close an incision through the vessel wall.
  • the first tubular medical device to be arranged in the first tubular channel is an introducer used e.g. when inserting measurement catheters into the body, e.g. via artery vessels.
  • the second tubular device to be inserted into the second tubular channel and into the tubular medical device via the opening cut is a so-called closure device used to seal and close a vessel inside the body.
  • Figures 3-6 illustrate one embodiment of the introducer access assembly according to the present invention.
  • the introducer access assembly is an attachable part, or an integrated part, of a closure device introducing system 50.
  • a closure device introducing system is adapted to automatically, or semi-automatically, introduce a closure device into a vessel in order to close an incision through the vessel wall.
  • Figures 3-6 illustrate different procedural steps performed when using the introducer access assembly according to this embodiment of the invention.
  • the assembly 2' comprises two main parts, a support unit 42 and a locking unit 40 movably attached to each other by a joint 44 enabling the parts to move (indicated by an arrow) in relation to each other from an open state which is illustrated in figure 3 to a closed state which is illustrated in figure 4 (and also in figures 5 and 6).
  • the joint 44 is preferably arranged at one side of the supporting unit and locking unit such that, when the assembly is in its open state, the introducer easily may be arranged at the support unit.
  • the support unit is preferably provided with a small depression (not shown) running along the entire unit.
  • the locking unit is provided with a recess 46 running along a lower side of the entire locking unit and that in combination with the support unit 42 form the first tubular channel.
  • the second tubular channel 16' is a channel running within the locking unit 40 from the part of the locking unit attached to, or adapted to be attached to, the closure device introducing system 50 and opens into the recess close to the joint 44.
  • the assembly 2' according to this embodiment is also provided with a cutting unit 22'. The cutting unit and its function are described in detail in connection with the other embodiments and will not be repeated again.
  • the support unit 42 is positioned such that an introducer 34, e.g. inserted into a vessel of a patient, rests in the small depression of the support unit.
  • the locking unit is then moved to lie in contact with the support unit ensuring that the introducer is positioned in the recess that, in combination with the depression of the support unit, forms the first tubular channel.
  • Figure 4 shows the entire closure device introducing system 50 provided with an introduces access assembly 2 being in the ready-to-use closed state.
  • Figure 5 shows in greater detail the introducer access assembly in this state.
  • the support unit and the locking unit are preferably provided with some locking means, e.g. knobs and mating indentations that provide for a frictional lock.
  • the cutting unit is then pushed into the assembly (see figure 6) providing an opening cut through a part of the introducer (also referred to as the first tubular medical device) and a closure device (also referred to as the second tubular medical device) may now be inserted into the introducer by the closure device introducing system.
  • the assembly essentially is made from plastic, but other materials may also be possible, e.g. metal, combinations of metal and plastic.
  • the assembly is a disposable device, and must be possible to sterilize prior use.
  • Figure 2 illustrates the use of the assembly according to another embodiment of the present invention. To the right in the figure the two halves of the assembly are shown when the halves are disconnected from each other after an opening cut is achieved in an introducer 34 and tubular medical device 36 being inserted into the opening cut 38.
  • the introducer is shown having a tubular medical device inserted into the opening cut.
  • a tubular arrangement 39 connected to the proximal end of the introducer 34.

Abstract

La présente invention concerne un ensemble d'accès d'introducteur (2) doté d'un premier canal tubulaire (8) ayant un axe longitudinal (10) et s'étendant d'une première ouverture d'extrémité proximale (12) à une ouverture d'extrémité distale (14) de l'ensemble et étant adapté pour recevoir un premier dispositif médical tubulaire. L'ensemble est doté d'un second canal tubulaire (16) ayant une seconde ouverture d'extrémité proximale (18) et étant disposé dans une direction formant un angle par rapport à l'axe longitudinal du premier canal tubulaire, le second canal tubulaire entre dans le premier canal tubulaire au niveau d'une jonction (20) et d'un angle d'intersection (alpha) entre les premier et second canaux tubulaires. L'ensemble comprend une unité tranchante (22) adaptée pour fournir une coupure d'ouverture dans une partie d'un premier dispositif médical tubulaire disposé dans ledit premier canal tubulaire de manière à ce qu'un second dispositif tubulaire puisse être inséré dans ledit second canal tubulaire et dans le premier dispositif médical tubulaire via ladite coupure d'ouverture.
EP10777118A 2009-11-03 2010-10-27 Ensemble d'accès d'introducteur Withdrawn EP2496153A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE0950822A SE534071C2 (sv) 2009-11-03 2009-11-03 Införingsanordningsmedel
US12/611,277 US8469944B2 (en) 2009-11-03 2009-11-03 Introducer access assembly
PCT/SE2010/051166 WO2011056125A1 (fr) 2009-11-03 2010-10-27 Ensemble d'accès d'introducteur

Publications (1)

Publication Number Publication Date
EP2496153A1 true EP2496153A1 (fr) 2012-09-12

Family

ID=43466488

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10777118A Withdrawn EP2496153A1 (fr) 2009-11-03 2010-10-27 Ensemble d'accès d'introducteur

Country Status (2)

Country Link
EP (1) EP2496153A1 (fr)
WO (1) WO2011056125A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4988356A (en) * 1987-02-27 1991-01-29 C. R. Bard, Inc. Catheter and guidewire exchange system
US4931049A (en) * 1988-07-05 1990-06-05 Camino Laboratorties, Inc. Catheter coupling system
US5687727A (en) * 1995-05-01 1997-11-18 Danforth Biomedical Incorporated Catheter adaptor with slitting blade and improved manual control and method of use
EP1440656A3 (fr) * 2003-01-14 2004-10-06 Radi Medical Systems Ab Dispositif pour l'indication visuelle d'une pression sanguine
US8162905B2 (en) * 2004-12-17 2012-04-24 W. L. Gore & Associates, Inc. Delivery system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2011056125A1 *

Also Published As

Publication number Publication date
WO2011056125A1 (fr) 2011-05-12

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