WO1998039039A1 - Canule aortique - Google Patents

Canule aortique Download PDF

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Publication number
WO1998039039A1
WO1998039039A1 PCT/US1998/004224 US9804224W WO9839039A1 WO 1998039039 A1 WO1998039039 A1 WO 1998039039A1 US 9804224 W US9804224 W US 9804224W WO 9839039 A1 WO9839039 A1 WO 9839039A1
Authority
WO
WIPO (PCT)
Prior art keywords
dilator
sleeve
cannula
cutter
aorta
Prior art date
Application number
PCT/US1998/004224
Other languages
English (en)
Inventor
John W. Fehrenbacher
Original Assignee
Fehrenbacher John W
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 Fehrenbacher John W filed Critical Fehrenbacher John W
Priority to AU66839/98A priority Critical patent/AU6683998A/en
Publication of WO1998039039A1 publication Critical patent/WO1998039039A1/fr

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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • 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
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue
    • 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
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters

Definitions

  • the present invention relates to an aortic cannula assembly and particularly to a cannula assembly that will penetrate, dilate and cannulate the aorta with a single maneuver by the surgeon.
  • the cannula of the present invention will provide a much simpler technique for aortic cannulation for routine as well as for more technically challenging surgeries including minimally invasive heart surgery procedures in which the aorta is more difficult to access.
  • aortic cannula for connecting the aorta to the heart-lung machine and returning blood to the body during surgery.
  • blood is taken from the heart-lung machine and inserted into the aorta through such a cannula as a blood supply to the body during surgery.
  • a cannula is also usable in left heart bypass procedures to make two connections to the aorta, a first connection for removing blood from the aorta and a second connection for introducing blood to the aorta beyond the bypassed section.
  • the cannula assembly comprises a needle or cutter for starting the initial small opening in the aorta, typically in the aorta arch area, a dilator for enlarging the opening, and a sleeve (cannula) over the dilator to be left in the aorta extending through the opening when the dilator and needle are retracted.
  • the needle, dilator and cannula are concentric and assembled together to provide a convenient instrument.
  • the needle, of relatively small diameter, is in the very center of the assembly to extend from its distal end to make the cut or initial penetration into the wall of the aorta.
  • the needle is slidable in a concentric bore in the dilator to be partially or fully retracted.
  • the dilator at the distal end from which the needle protrudes, is conical in shape to dilate the opening made by the needle as the cannula assembly is inserted into the opening.
  • the needle may be retracted after forming the opening for the dilator.
  • the outer sleeve of the cannula is carried on the dilator to be introduced into the aorta as the dilator is introduced.
  • the dilator with the needle is retracted to leave the sleeve as a conduit communicating with the interior of the aorta.
  • the initial opening is made in an area defined by concentric purse string sutures which are cinched down around the cannula to provide a seal.
  • the cannula assembly comprises a needle or cutter carried at the distal end of the assembly for starting the initial opening in the aorta and dilating that opening to the extent that the sleeve (cannula) can move through the opening into the aorta.
  • the needle or cutter is carried at the distal end of a plunger or shaft which is concentrically received in the cannula, and the distal end of the cannula and the cutter are beveled and formed to serve as a dilator of the initial opening to facilitate the entry of the distal end of the cannula into the aorta.
  • the plunger and the needle or cutter are retracted in the cannula as soon as the penetration through the aorta wall is accomplished to avoid any damage to the opposite wall of the aorta.
  • the cannula assembly of the present invention is particularly suited for use in minimally invasive surgery approaches in which a rather small incision is made to gain access to the aorta while working through the small incision.
  • the assembly may be used by the surgeon in a single insertion maneuver to penetrate, dilate and then cannulate the aorta. This is in contrast to the present aorta cannulation procedure involving first using a knife to cut a very small opening in the aorta. The surgeon places a finger over the opening made by the knife to stop blood flow. A dilator is then moved in to replace the finger to dilate the small opening to a size large enough to receive the cannula.
  • the surgeon's finger is then again used to close the opening.
  • the distal end of the cannula may be slid into position as the finger is removed to insert the cannula.
  • This present procedure is cumbersome, time consuming, and blood is lost as the surgeon transfers from the initial cutting instrument to the dilator and then to the cannula.
  • the blood loss occurs in the time it takes to remove the present instruments and to cover the opening with the finger.
  • the cannula or outer sleeve that serves as the cannula enters the opening through the wall of the aorta with the dilator. While the cannula assembly of the present invention is ideally suited for minimally invasive surgery, it is also very applicable to open chest surgery where a larger incision is made to gain access to the aorta. Even in open chest surgery, the aorta is often positioned considerably below the surface of the chest making it difficult for the surgeon to use his or her finger and existing instruments in the procedure just described.
  • the cannula assembly of the present invention which includes a separate dilator
  • the cannula assembly is used in a single insertion maneuver to start the opening with the needle, to dilate that opening as the assembly is further moved into the aorta wall and then to insert the cannula as the assembly is further inserted into the aorta.
  • the dilator and needle are then retracted to leave the cannula.
  • the needle may preferably be retracted into the dilator as soon as the first small opening is made and the dilator introduced, thereby preventing any damage to the opposite wall of the aorta by the needle.
  • the cannula assembly of the present invention which includes a needle or cutter integral with or affixed to the dilator plunger or shaft, once the surgeon has placed the purse string suture arrangement to define the area in which the aorta opening is made, the cannula assembly is used in a single insertion maneuver to start the opening with the needle or cutter and also to dilate that opening as the assembly is further moved into the aorta wall and then to insert the cannula as the assembly is further inserted into the aorta.
  • the needle or cutter and the concentric plunger to which it is affixed are then retracted into the cannula as soon as an opening is made through the aorta wall to receive the cannula.
  • a cannula is provided.
  • the cannula comprises a sleeve with proximal and distal ends, a cutter configured for movement through the distal end of the sleeve to form an initial opening in a vessel, such as an artery, and a dilator positioned within the sleeve.
  • the dilator has a conically-shaped portion for enlarging the initial opening so that the sleeve may extend through the enlarged opening.
  • an aortic cannula is provided.
  • the aortic cannula comprises a sleeve, a dilator configured for slidable movement through the sleeve, and a needle.
  • the dilator has a tapered outer surface converging toward its distal end, and an axial bore.
  • the needle is configured for slidable movement in the bore.
  • the needle has a distal tip sharpened to start an initial opening in the aorta so that the dilator and then the sleeve may extend through the opening.
  • an aortic cannula assembly for use in a single insertion maneuver to start an opening in the wall of an aorta, dilate that opening as the assembly is moved into the aorta wall and to cannulate the aorta as the assembly is moved further.
  • the cannula assembly comprises a sleeve, a dilator, and a cutter.
  • the sleeve has proximal and distal ends and the dilator is slidable within the sleeve and has a tapered end protruding from the distal end of the sleeve.
  • the cutter is carried by the dilator to lead the dilator into the aorta wall.
  • a method of cannulating an aorta comprises the steps of providing a cannulating assembly including a sleeve, a dilator positioned within the sleeve, the dilator including a tapered outer surface converging toward its distal end, and a cutter carried by the dilator at its distal end, the cutter and dilator protruding from the distal end of the sleeve and moving the assembly in a single movement toward the aorta until the cutter pierces an initial opening in the aorta wall and with further movement the tapered outer surface of the dilator enlarges the opening formed by the cutter to a size suitable for receiving the sleeve.
  • the method further includes the steps of inserting the sleeve within the enlarged opening formed in the vessel and retracting the cutter and dilator from the vessel.
  • Fig. 1 is a view of the heart and an aorta showing the beginning of a procedure for use of a cannula assembly of the present invention and showing the heart partially cut away to show a further procedure for drawing blood from the heart to feed to a heart-lung machine;
  • Fig. 2 is an enlarged segmented view of the heart and the aorta of Fig. 1 showing an aortic arch with a purse string suture arrangement;
  • Fig. 3 is a fragmentary, partially sectioned view of the cannula assembly of the present invention showing an initial penetration of a needle through a wall of the aorta;
  • Fig. 4 is a fragmentary, partially sectioned view similar to Fig. 3 showing a dilator entering the wall of the aorta and the needle partially retracted;
  • Fig. 5 is a view similar to Fig. 3 showing a cannula inserted into the aorta with the dilator and the needle both being retracted;
  • Fig. 6 A is a view of an illustrative embodiment of the present invention.
  • Fig. 6B is a view similar to Fig. 6 A showing the distal end of the cannula being slanted or cut at an angle;
  • Fig. 7 is a sectional view of another embodiment of the present invention in which a needle or cutter is affixed to a movable plunger within a cannula;
  • Fig. 8 A is another sectional view showing the plunger and needle retracted from a distal end of the cannula for safety purposes;
  • Fig. 8B is a view of the distal end of the cannula of Fig. 8 A that is formed to include a slanted tip;
  • Fig. 9 is a fragmentary view showing an illustrative cutting blade arrangement.
  • Fig. 10 is a fragmentary view showing the sharpened end of a needle used as a cutter.
  • a purse string suture arrangement 10 is started to provide a circular area in an arch 11 of an aorta 13 where the catheterization will take place.
  • Fig. 1 also shows and a further procedure for drawing blood from heart 17 to feed to a heart-lung machine 19.
  • Fig. 2 shows the conventional double concentric purse string suture arrangement 10 in arch 11 of aorta 13.
  • This purse string suture arrangement 10 is conventional in heart surgery, and the sutures are drawn through tubes 12, 14 in a conventional fashion.
  • assembly 16 of the present invention comprises needle 18, dilator 20 and cannula 22 with an adjustable collar 24 as illustrated.
  • Needle 18 has a sharpened distal point 26 that protrudes from a conical end 28 of dilator 20 as illustrated.
  • the amount that distal point 26 of needle 18 protrudes from distal end 28 of dilator 20 may be adjusted, for instance, to be slightly greater than the thickness of a wall 15 of aorta 13. It is important, of course, not to penetrate through to the opposite wall of aorta 13.
  • the surgeon may adjust the extension of distal point 26 of needle 18 from distal end 28 of dilator 20 and in other embodiments, the extension may be fixed in the factory. In any event, it is distal point 26 of needle 18 which makes an initial small opening in wall 15 of aorta 13. This is best seen in Fig. 3.
  • dilator 20 is shown entering wall 15 of aorta 13. Needle 18 is shown retracted a short distance into dilator 20 for obvious safety reasons.
  • Cannula 22 is carried on dilator 20 to follow distal end 28 of dilator 20 into and through wall 15 of aorta 13.
  • Fig. 5 shows cannula 22 fully through wall 15 into aorta 13 with dilator 20 and needle 18 being removed from cannula 22 to provide communication via a passageway 25 to aorta 13 through cannula 22.
  • adjustable collar 24 limits the insertion of a distal end 23 of cannula 22 into aorta 13. It is a conventional practice to push tubes 12, 14 carefully down against the sutures to snug wall 15 of aorta 13 about cannula 22 to make the seal.
  • Figs. 3, 4 and 5 The introduction of cannula 22 into aorta 13 takes place as shown in Figs. 3, 4 and 5 by a single thrusting maneuver downwardly and inwardly with needle 18 first entering wall 15 of aorta 13, then distal end 28 of dilator 20 entering wall 15 and then cannula 22 entering wall 15.
  • angle A' of penetration during insertion of cannula 22 into aorta 13 is shown in Fig. 5 as being approximately ninety degrees (90°).
  • angle A' can be in the range of ninety degrees (90o) to forty five degrees (45°), and most commonly about sixty (60°).
  • Fig. 6A is a sectional plan view of the illustrative embodiment of assembly 16.
  • cannula 22 may be made from plastic and that dilator 20 may be made from plastic. Other materials, of course, may reasonably be used in such applications. Cannula 22 may be various sizes and cannula are often provided in 20, 22 or 24 French diameter for aortic cannulation. The distance from distal point 26 of needle 18 to distal end 23 of cannula 22 may be, for instance, 1.0 cm up to 1.5 cm or less, depending upon the testing of prototypes. Conical end 28 of dilator 20 may have a suitable conical dimension to facilitate the dilation. In Fig. 6B, distal end 23 of cannula 22 is formed to include a slanted tip 50, which may be preferable to some surgeons.
  • cannula assembly 16 of Figs. 1-6B comprises a needle 18, a dilator 20 and a cannula 22 arranged together to facilitate the entry of cannula 22 through wall 15 of aorta 13.
  • needle 18, dilator 20, and cannula 22 are separate parts arranged for relative axial reciprocation, needle 18 within dilator 20, and dilator 20 within cannula 22.
  • Collar 24 is axially adjustable on cannula 22 to control the depth of penetration of cannula 22.
  • cannula 122 is shown with its adjustable stop or collar 124 and with its distal end 126 beveled as illustrated.
  • Proximal end 128 of cannula 122 is shown with a peripherally and outwardly extending rib 130.
  • a plunger or shaft 140 is concentrically arranged to reciprocate in cannula 122.
  • Plunger 140 has a gripping head 142 at its proximal end.
  • a rubber-like protective boot 144 is shown over proximal end 128 of cannula 122 and head 142.
  • Boot 144 is provided with a peripherally and inwardly extending bead 146 which is pulled over bead 130 to remove plunger 140 from cannula 122.
  • plunger 140 may be pulled from proximal end 128 of cannula 122 a distance to withdraw distal end 160 of plunger 140 and needle or cutter 162 into cannula 122 as shown in Fig. 8.
  • plunger 140 can be retracted from proximal end 128 of cannula 122.
  • distal end 126 of cannula 122 is formed to include a slanted tip 150, which may be preferable to some surgeons. Slanted tip 150 is cut at a pre-determined angle 152. It is understood that angle 152 may vary in accordance with the present invention.
  • Distal end portion 160 of plunger 140 is formed to facilitate the rigid attachment of sharpened needle 162 which has a cutting edge 164.
  • sharpened needle 162 is provided with a reduced portion 168 that is received in an opening 170 formed concentrically in distal end portion 160 of plunger 140.
  • needle 162 may be mechanically crimped, attached or affixed to distal end portion 160 of plunger 140 using a variety of fastening approaches. The concept is to have needle 162 serving as the initial cutter rigidly attached to plunger 140 to be movable with plunger 140. Needle 162 may be equivalent in size to a ten gauge needle or an eight gauge needle or less.
  • distal end portion 160 of plunger 140 may be beveled so that it cooperates with the bevel on distal end 126 of cannula 122 to dilate the initial opening.
  • distal end portion 160 of plunger 140 carries a knife blade assembly 180 which may be preferable to some surgeons.
  • Assembly 180 comprises an attachment member 182 which may have an extension such as indicated at 184 to be received in a concentric bore 170 in distal end portion 160 of plunger 140.
  • the center portion of lead blade 190 is open and second blade 192 is arranged, as illustrated, at right angles to follow lead blade 190. It will be appreciated that this blade structure shown in Fig. 9 is very similar to blades used on the tips of hunting arrows, although much smaller than such arrow tips.
  • Lead blade 190 will make an incision initially and then second blade 192 will make a cross incision to provide an initial opening in aorta 13. This opening will be enlarged by beveled end 160 of plunger 140 and/or the beveled end of distal end 126 of cannula 122.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Pathology (AREA)
  • Heart & Thoracic 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

L'invention concerne une canule (16) aortique permettant, en une seule manoeuvre d'insertion, de pratiquer une ouverture dans une paroi (15) de l'aorte (13). Ladite canule (16) comprend une gaine (22), un élément tranchant (26) conçu pour être mobile au niveau de l'extrémité distale (23) de la gaine (22) de façon à former l'ouverture initiale dans l'aorte (13), et un dilatateur (20) disposé à l'intérieur de la gaine (22). Le dilatateur (20) comporte une partie conique (28) permettant d'élargir l'ouverture initiale pour que la gaine (22) puisse passer à travers l'ouverture élargie.
PCT/US1998/004224 1997-03-05 1998-03-05 Canule aortique WO1998039039A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU66839/98A AU6683998A (en) 1997-03-05 1998-03-05 Aortic cannula

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3986697P 1997-03-05 1997-03-05
US60/039,866 1997-03-05

Publications (1)

Publication Number Publication Date
WO1998039039A1 true WO1998039039A1 (fr) 1998-09-11

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ID=21907745

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/004224 WO1998039039A1 (fr) 1997-03-05 1998-03-05 Canule aortique

Country Status (2)

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AU (1) AU6683998A (fr)
WO (1) WO1998039039A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000056234A1 (fr) * 1999-03-19 2000-09-28 Edwards Lifesciences Corporation Procede et dispositif d'incision aortique
WO2002069810A2 (fr) * 2001-03-05 2002-09-12 Edwards Lifesciences Corporation Systeme de canule a acces scellable
WO2016069936A1 (fr) * 2014-10-29 2016-05-06 Cedars-Sinai Medical Center Appareils, systèmes et procédés pour l'administration contrôlée d'agents thérapeutiques et de substances apparentées
US10512506B2 (en) 2013-04-30 2019-12-24 Cedars-Sinai Medical Center Stabilization apparatuses and methods for medical procedures
WO2021222349A1 (fr) * 2020-04-29 2021-11-04 The Children's Hospital Of Philadelphia Système d'insertion de canule et ses procédés d'utilisation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1213001A (en) * 1916-05-02 1917-01-16 Ralph S Philips Therapeutic apparatus.
US4978334A (en) * 1988-09-08 1990-12-18 Toye Frederic J Apparatus and method for providing passage into body viscus
US5242410A (en) * 1991-04-15 1993-09-07 University Of Florida Wireless high flow intravascular sheath introducer and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1213001A (en) * 1916-05-02 1917-01-16 Ralph S Philips Therapeutic apparatus.
US4978334A (en) * 1988-09-08 1990-12-18 Toye Frederic J Apparatus and method for providing passage into body viscus
US5242410A (en) * 1991-04-15 1993-09-07 University Of Florida Wireless high flow intravascular sheath introducer and method

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000056234A1 (fr) * 1999-03-19 2000-09-28 Edwards Lifesciences Corporation Procede et dispositif d'incision aortique
WO2002069810A2 (fr) * 2001-03-05 2002-09-12 Edwards Lifesciences Corporation Systeme de canule a acces scellable
WO2002069810A3 (fr) * 2001-03-05 2003-01-16 Edwards Lifesciences Corp Systeme de canule a acces scellable
US10512506B2 (en) 2013-04-30 2019-12-24 Cedars-Sinai Medical Center Stabilization apparatuses and methods for medical procedures
US11877896B2 (en) 2013-04-30 2024-01-23 Cedars-Sinai Medical Center Stabilization apparatuses and methods for medical procedures
WO2016069936A1 (fr) * 2014-10-29 2016-05-06 Cedars-Sinai Medical Center Appareils, systèmes et procédés pour l'administration contrôlée d'agents thérapeutiques et de substances apparentées
US11253645B2 (en) 2014-10-29 2022-02-22 Cedars-Sinai Medical Center Apparatuses, systems and methods for controlled delivery of therapeutics and related substances
WO2021222349A1 (fr) * 2020-04-29 2021-11-04 The Children's Hospital Of Philadelphia Système d'insertion de canule et ses procédés d'utilisation

Also Published As

Publication number Publication date
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