WO1993002735A1 - Dilatateur - Google Patents

Dilatateur Download PDF

Info

Publication number
WO1993002735A1
WO1993002735A1 PCT/CA1992/000345 CA9200345W WO9302735A1 WO 1993002735 A1 WO1993002735 A1 WO 1993002735A1 CA 9200345 W CA9200345 W CA 9200345W WO 9302735 A1 WO9302735 A1 WO 9302735A1
Authority
WO
WIPO (PCT)
Prior art keywords
cross
dilator
section
blood vessel
catheter
Prior art date
Application number
PCT/CA1992/000345
Other languages
English (en)
Inventor
Geoffrey S. Martin
Original Assignee
Med-Pro Design, Inc.
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 Med-Pro Design, Inc. filed Critical Med-Pro Design, Inc.
Publication of WO1993002735A1 publication Critical patent/WO1993002735A1/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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • 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

Definitions

  • This invention relates to subcutaneous insertion of catheters into blood vessels such as the femoral or subclavian veins, and more particularly to a dilator for following a guide wire to form a tunnel for receiving the catheter.
  • Dr. Seldinger introduced his technique in 1953, it has become common practice to use guide wires when inserting catheters into blood vessels.
  • a hollow needle is first used to create a small incision in a blood vessel, typically 4 French. This hollow needle allows blood flow to show that the needle has been positioned in the blood vessel.
  • a very flexible wire is pushed through the needle, into the blood vessel, and then moved for some distance down the blood vessel to act as a guide for subsequent engagement of a dilator and then a catheter. With the wire in place, the needle is withdrawn leaving behind tissue expanded to about 4 French and an opening in the blood vessel of about the same size.
  • the eventual catheter to be placed is typically 11 French so that dilation to 11 French (or close to this size) must take place.
  • As the dilator is pushed along the wire, blood will flow through the dilator so there is further blood loss as this takes place.
  • this is a subcutaneous procedure which means that the leading end of the dilator must first stretch the quite strong skin which requires a significant force and then dilate the underlying tissue, before stretching the blood vessel.
  • the forces required and the fact that the surgeon is dealing with very flexible and resilient material makes it difficult for the surgeon to sense the dilator following the wire, especially if larger forces are required due to the enlargement being done by a single dilator.
  • the procedure can be very traumatic for the patient if not done properly.
  • the tactile sensitivity can be improved by the use of a series of dilators of increasing diameter. Such a procedure is slow because each of the dilators must be engaged over the wire, removed, and a new dilator put in place. Because the dilators are forming a tunnel of increasing size, there will be a significant loss of blood. Also, each of the dilators must be handled very carefully because the leading ends enter the blood vessel and if the dilator is pushed too far, it could damage the side of the blood vessel opposite the entry opening.
  • a second approach to dilation which has been used is to insert the ultimate catheter directly over the wire. This is not a desirable procedure because the design requirements of a catheter used in this way for dilation are contrary to the design requirements of a catheter which make it suitable to be placed in a blood vessel for the time needed for treatment.
  • the tip of the catheter designed for dilation must be quite firm so that when it is pushed along the wire, the tip ' will dilate the tissue without collapsing the tip.
  • a catheter designed for prolonged use in a blood vessel should have a very flexible tip so that any movement which causes contact between the tip of the catheter and the blood vessel will result in the tip flexing to minimize the risk of deforming the blood vessel.
  • a further approach to dilation has been to provide a set of dilators which fit one over another.
  • a first and smaller dilator is entered over the wire and then this is followed by one or more dilators which are slipped over one another and lead forwardly to a predetermined location so that the resulting combination of dilators represents generally the size of the catheter to be placed. While this combination of dilators has some advantages, it must be remembered that the sizes are very small.
  • the dilator is expanding tissue generally from the size of the needle which is typically 4 French up to about 10 or 11 French.
  • the invention provides a dilator for defining a tunnel to receive a catheter having a selected cross-section, the tunnel extending through body tissue and entering a blood vessel, the dilator comprising: an elongate main body having a first cross-section generally equal to said selected cross-section; a tip portion of lesser cross-section than said main body and extending longtiiidinally from the main .body and terminating at a distal end of the dilator; the main body and the tip portion defining a continuous longitudinal opening for .engaging the dilator over a guide wire; the tip portion having a leading taper enlarging from the distal end about said opening and a trailing taper blending the tip section into the main body; the tip portion having a length selected to permit dilation of the blood vessel and part of said tissue to the cross-sectional shapes of the tip portion, trailing taper, and part of the main body so that the resulting tunnel has an entry corresponding generally to the size of the catheter for
  • the invention provides an improvement to catherization procedures.
  • the method comprising the steps: providing a hollow elongate needle and engaging the needle through the skin, underlying tissue, and into the blood vessel; providing a flexible guide wire and pushing the guide wire through the needle and into the blood vessel until the guide wire has progressed down the blood vessel sufficient to guide a catheter into position in the blood vessel; withdrawing the needle over the guide wire leaving the guide wire in place; providing a dilator having an elongate main body with a first cross-section extending about a longitudinal axis, a tip portion extending from the main body longitudinally and terminating at a distal end of the dilator, and the main body extending from the tip portion to a proximal end of the dilator, and the tip portion having a leading taper enlarging from the distal end towards a second cross-section smaller than the first cross-section, and a trailing taper extending smoothly
  • Fig.l is a somewhat schematic isometric view of a preferred embodiment of a dilator according to the invention shown partly entered into a subcutaneous tunnel and following a wire which has been engaged in a blood vessel.
  • a dilator 30 consists of an elongate main body 32 extending about a longitudinal axis from a proximal end fitting 34 to a tip portion 36 at the distal end of the dilator.
  • This tip portion has a leading taper 38 spaced from a trailing taper 40 which together combine to dilate the tunnel.
  • the tapers 38 and 40 are separated in this preferred eiribodiinent by a leading portion 42 which is of reduced cross section compared with the main body 32.
  • the main body is of 12 French and the portion 42 of 10 French and an opening 44 extends longitudinally through the dilator to contain the wire 28 as shown in broken outline.
  • the main body 32 and leading portion 42 are circular in cross-section with the diameter of leading portion being about 40 per cent that of the main bcidy, (e.g. 4 French compared with 10 French.
  • the opening in the dilator at the leading taper 38 fits snugly about the wire 28.
  • the dilator initially makes contact with the skin 24 and the leading taper dilates the skin and then commences dilation of the tissue 22. This continues until the trailing taper 40 meets the skin whereupon dilation of the skin to the full size of the body 32 takes place as the taper 38 continues to dilate the tissue.
  • the trailing taper 40 dilates tissue until the leading taper 38 has dilated the blood vessel and entered the blood vessel, thereby dilating the blood vessel to the size of the leading portion 42.
  • the length of the leading portion 42 is selected according to the amount of tissue to be dilated to the size of this portion.
  • a subcutaneous tunnel is formed capable of receiving a catheter guided by the wire 28 and which is itself used to dilate only a portion of the tissue and the blood vessel from about 10 French to 11 French.
  • This permits the use of a relatively soft tip catheter and yet permits the catheter to complete the dilation to the size and shape of the catheter. Consequently, if the catheter is not entirely round or the exact shape of the dilator, the stretching will enable the catheter to form an opening in the blood vessel which tends to be self sealing.
  • the catheter is not required to dilate the skin and all of the tunnel, but only the very last part of the tunnel where it engages the blood vessel. The tissue stretches around the catheter and this combined with the flexibility of the blood vessel helps to ensure sealing.
  • the catheter insertion is done using a single dilator which minimizes time, ensures a good seal, and at the same time makes engagement simple because the lead part is of a small cross section and this follows the existing tunnel and then leads the larger taper 40 along the desired path.
  • leading portion 42 can have any length consistent with meeting the requirements of having the portion 40 engage through the skin and into the tissue at the time the leading taper 38 engages the blood vessel.
  • portion 42 could itself be slightly tapered resulting in a gradual dilation from the leading end of the dilator through to the main body 32. Procedurally, the dilator helps to ensure a smooth entry of the catheter with minimal trauma.
  • the dilation can be considered to be in three stages: firstly dilation of the complete tunnel to the size of portion 42; secondly, and contemparaneously with the latter part of the dilation to the size of portion 42, dilation of skin and adjacent tissue to the size of body 32; and lastly, dilation of the blood vessel and adjacent tissue to the size of the catheter by the catheter.
  • the dilator can be made of any suitable material but is preferably of a plastics material such as that sold under the trade mark NYLON.
  • the selected material should have sufficient stiffness to permit insertion and be readily sterlized.
  • the dilator is used to enlarge a tunnel created initially by a hollow needle which passes through body tissue and into a blood vessel.
  • a single guide wire is fed through the needle before the needle is removed over the guide wire.
  • the needle is as small as possible to minimize trauma and blood loss.
  • the dilator is then fed over the needle until the leading taper 38 enters the blood vessel 20 at which point the blood vessel and an adjacent part of the tissue 22 has been dilated to match the size of the leading portion 42 and the remainder of the tissue 22 has been dilated to the size of the main body 32. Because the main body is of similar size to the catheter to be placed in the tunnel, an entry is formed and the catheter is required to dilate only the portion of the tissue near the blood vessel, as well as the blood vessel. This permits softer catheters to be inserted over a guide wire and minimizes trauma while enhancing the sealing effects of the blood vessel and tissue about the catheter.

Abstract

On décrit un dilatateur (30) pouvant s'utiliser avec un fil de guidage (28) pour créer un tunnel sous-cutané (26) dans un vaisseau sanguin (20) afin d'insérer par la suite un cathéter au-dessus du fil et dans le vaisseau sanguin. Le dilatateur se compose d'un corps principal allongé (32) pourvu d'une première section transversale s'étendant autour d'un axe longitudinal, et d'une partie de tête (36) s'étendant longitudinalement depuis le corps principal et finissant à une extrémité distale du dilatateur. La partie de tête comporte un cône de guidage (38) s'élargissant depuis l'extrémité distale vers une seconde section transversale plus petite que la première. Un cône arrière (40) s'étend avec régularité depuis le corps principal et converge de la première section transversale vers la seconde, et une ouverture (44) s'étend entre les extrémités proximales et distales du dilatateur pour recevoir le fil de guidage. On décrit également un procédé pour créer un tunnel sous-cutané.
PCT/CA1992/000345 1991-08-07 1992-08-07 Dilatateur WO1993002735A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CA 2048513 CA2048513A1 (fr) 1991-08-07 1991-08-07 Dilateur
CA2,048,513 1991-08-07

Publications (1)

Publication Number Publication Date
WO1993002735A1 true WO1993002735A1 (fr) 1993-02-18

Family

ID=4148138

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA1992/000345 WO1993002735A1 (fr) 1991-08-07 1992-08-07 Dilatateur

Country Status (3)

Country Link
AU (1) AU2418892A (fr)
CA (1) CA2048513A1 (fr)
WO (1) WO1993002735A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997026938A1 (fr) * 1996-01-22 1997-07-31 Endogad Research Pty. Limited Ensemble dilatateur et d'insertion
WO1998052474A1 (fr) * 1997-05-22 1998-11-26 Kensey Nash Corporation Systeme d'anastomose et technique d'utilisation
WO2006130451A1 (fr) * 2005-05-27 2006-12-07 Cook Incorporated Appareil introducteur peu encombrant
US7682337B2 (en) 2007-02-07 2010-03-23 Cook Incorporated Method and apparatus for gaining percutaneous access to a body
CN102671287A (zh) * 2012-05-07 2012-09-19 先健科技(深圳)有限公司 一种穿刺扩张器

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0092389A1 (fr) * 1982-04-19 1983-10-26 Cook Incorporated Appareil de cathétérisation permettant l'emploi d'une aiguille de petit calibre
EP0161636A2 (fr) * 1984-05-09 1985-11-21 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Instrument pour introduire un cathéter
US4840622A (en) * 1987-10-06 1989-06-20 Menlo Care, Inc. Kink resistant catheter
EP0383426A1 (fr) * 1989-01-31 1990-08-22 Cook Incorporated Assemblage composé d'un dilatateur embouti et d'une enveloppe et son procédé de fabrication

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0092389A1 (fr) * 1982-04-19 1983-10-26 Cook Incorporated Appareil de cathétérisation permettant l'emploi d'une aiguille de petit calibre
EP0161636A2 (fr) * 1984-05-09 1985-11-21 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Instrument pour introduire un cathéter
US4840622A (en) * 1987-10-06 1989-06-20 Menlo Care, Inc. Kink resistant catheter
EP0383426A1 (fr) * 1989-01-31 1990-08-22 Cook Incorporated Assemblage composé d'un dilatateur embouti et d'une enveloppe et son procédé de fabrication

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997026938A1 (fr) * 1996-01-22 1997-07-31 Endogad Research Pty. Limited Ensemble dilatateur et d'insertion
US6106540A (en) * 1996-01-22 2000-08-22 Baxter International Inc. Dilator and introducer assembly
WO1998052474A1 (fr) * 1997-05-22 1998-11-26 Kensey Nash Corporation Systeme d'anastomose et technique d'utilisation
US6030395A (en) * 1997-05-22 2000-02-29 Kensey Nash Corporation Anastomosis connection system
US6036705A (en) * 1997-05-22 2000-03-14 Kensey Nash Corporation Anastomosis connection system and method of use
US6056762A (en) * 1997-05-22 2000-05-02 Kensey Nash Corporation Anastomosis system and method of use
US6402767B1 (en) 1997-05-22 2002-06-11 Kensey Nash Corporation Anastomosis connection system and method of use
US9114234B2 (en) 2005-05-27 2015-08-25 Cook Medical Technologies Llc Low profile introducer apparatus
US8152767B2 (en) 2005-05-27 2012-04-10 Cook Medical Technologies Llc Low profile introducer apparatus
US8628496B2 (en) 2005-05-27 2014-01-14 Cook Medical Technologies Llc Low profile introducer apparatus
WO2006130451A1 (fr) * 2005-05-27 2006-12-07 Cook Incorporated Appareil introducteur peu encombrant
US9795768B2 (en) 2005-05-27 2017-10-24 Cook Medical Technologies Llc Low profile introducer apparatus
US10576252B2 (en) 2005-05-27 2020-03-03 Cook Medical Technologies Llc Low profile introducer apparatus
US11638807B2 (en) 2005-05-27 2023-05-02 Cook Medical Technologies Llc Low profile introducer apparatus
US7682337B2 (en) 2007-02-07 2010-03-23 Cook Incorporated Method and apparatus for gaining percutaneous access to a body
CN102671287A (zh) * 2012-05-07 2012-09-19 先健科技(深圳)有限公司 一种穿刺扩张器

Also Published As

Publication number Publication date
AU2418892A (en) 1993-03-02
CA2048513A1 (fr) 1993-02-08

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