WO2009070837A1 - Ensemble de cathéter à retour de force - Google Patents

Ensemble de cathéter à retour de force Download PDF

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Publication number
WO2009070837A1
WO2009070837A1 PCT/AU2008/001789 AU2008001789W WO2009070837A1 WO 2009070837 A1 WO2009070837 A1 WO 2009070837A1 AU 2008001789 W AU2008001789 W AU 2008001789W WO 2009070837 A1 WO2009070837 A1 WO 2009070837A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip electrode
catheter sheath
assembly
force
distal end
Prior art date
Application number
PCT/AU2008/001789
Other languages
English (en)
Inventor
Neil Lawrence Anderson
David Ogle
Original Assignee
Cathrx Ltd
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 Cathrx Ltd filed Critical Cathrx Ltd
Publication of WO2009070837A1 publication Critical patent/WO2009070837A1/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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069—Tip not integral with tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • 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
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/054—General characteristics of the apparatus combined with other kinds of therapy with electrotherapy
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • This invention relates, generally, to catheters and, more particularly, to a force feedback catheter assembly.
  • a force feedback catheter assembly which includes a catheter sheath; a tip electrode arranged at a distal end of the catheter sheath to be displaceable axially with respect to the distal end of the catheter sheath; and a force feedback mechanism at least a part of which is arranged between the tip electrode and the distal end of the catheter sheath, the force feedback mechanism having at least two feedback settings, a first setting to indicate when adequate force is exerted by the tip electrode on tissue at the site to enable a procedure to commence and a second setting to indicate when the force exerted by the tip electrode reaches a level at which undesirable tissue damage could occur.
  • the procedure may be an ablation procedure in the treatment of heart arrhythmias.
  • tissue damage by ablation is intended.
  • excessive force exerted by the tip electrode on the tissue could result in tissue perforation and such tissue damage is undesirable.
  • the assembly may include an urging element acting on the tip electrode for urging the tip electrode to a rest position relative to the catheter sheath.
  • the tip electrode may comprise a crown portion and a skirt portion depending from the crown portion, at least the crown portion being conductive.
  • the skirt portion may overly the distal end of the catheter sheath, a sealing arrangement being interposed between the skirt portion and the distal end of the electrode to inhibit the ingress of foreign matter into the catheter sheath.
  • the catheter sheath may be a tubular element defining a lumen, the force feedback mechanism being contained substantially within the lumen of the catheter sheath.
  • the force feedback mechanism may have a conductive member carried by the tip electrode and at least one conductive element arranged in the lumen of the catheter sheath, the arrangement being such that, when the conductive member and the at least one conductive element make electrical and mechanical contact, an indication is given that a predetermined force is being exerted by the tip electrode on the tissue, in use.
  • the force feedback mechanism may include a plurality of conductive elements to provide the at least two force feedback settings, the conductive elements being engageable sequentially by the conductive member of the tip electrode, the arrangement being such that, when a first one of the conductive elements is engaged by the conductive member, a first indication is given that a predetermined force is being exerted by the tip electrode on the tissue and, if a further, following conductive element is engaged by the conductive member, a further indication is given that a higher force is being imparted to the tissue by the tip electrode.
  • an electrical circuit may also be completed so that electrical energy, such as radio frequency (RF) energy for ablation purposes, is supplied to the tip electrode.
  • RF radio frequency
  • an alarm signal may be generated to warn the clinician of the danger of imminent undesirable tissue damage.
  • One of the conductive member and the conductive element may carry a current carrying contact element to facilitate electrical contact between the conductive member and the conductive element.
  • the force feedback mechanism may include a mechanical linkage which is stiff in compression and which extends from the tip electrode, the linkage being connected to a marker in a handle of the catheter assembly.
  • the handle of the catheter assembly may have markings to indicate to a clinician the force being exerted by the tip electrode on the tissue.
  • a force feedback catheter assembly which includes a catheter sheath; a tip electrode arranged at a distal end of the catheter sheath to be displaceable axially with respect to the distal end of the catheter sheath, the tip electrode comprising a crown portion and a skirt portion depending from the crown portion, the skirt portion overlying the distal end of the catheter sheath; and a force feedback mechanism at least a part of which is arranged between the tip electrode and the distal end of the catheter sheath, the force feedback mechanism having at least one feedback setting to provide an indication of the force exerted by the tip electrode on tissue at a site of a patient's body.
  • the assembly may include a sealing arrangement interposed between the skirt portion and distal end of the electrode to inhibit the ingress of foreign matter into the catheter sheath.
  • Fig. 1 shows a side view of a distal part of a first embodiment of a force feedback catheter assembly in a first condition
  • Fig. 2 shows a sectional side view of the distal part of the catheter assembly of Fig. 1 in its first condition
  • Fig. 2A shows, on an enlarged scale, the part of the catheter assembly encircled by Circle 'A' in Fig. 2;
  • Fig. 3 shows a side view of the distal part of the force feedback catheter assembly in a second condition
  • Fig. 4 shows a sectional side view of the distal part of the catheter assembly of
  • Fig. 3 in its second condition
  • Fig. 5 shows a sectional side view of a distal part of a second embodiment of a force feedback catheter assembly in a first condition
  • Fig. 6 shows a sectional side view of the distal part of the force feedback catheter assembly in a second condition; and Fig. 7 shows a three dimensional view of the second embodiment of the catheter assembly.
  • a first embodiment of a distal part of a force feedback catheter assembly is illustrated and is designated generally by the reference numeral 10.
  • the catheter assembly 10 includes a catheter sheath 12.
  • a tip electrode 14 is displaceably arranged, in an axial direction, at a distal end 16 of the catheter sheath 12.
  • An urging element in the form of a coil spring 18 (Fig. 2) is arranged between the tip electrode 14 and a shoulder 20 defined slightly inwardly of the distal end 16 of the catheter sheath 12.
  • the catheter sheath 12 is tubular defining a lumen 22.
  • the shoulder 20 projects radially inwardly into the lumen 22.
  • a force feedback mechanism 24 is arranged between the tip electrode 14 and the distal end 16 of the catheter sheath 12. More particularly, the force feedback mechanism is arranged at a distal end 16 of the catheter sheath 12, distally of the shoulder 20.
  • the tip electrode 14 has a conductive crown portion 26 with a skirt portion 28 depending from the crown portion 26.
  • the skirt portion 28 can, optionally, be conductive or insulating.
  • the skirt portion 28 overlies the distal end 16 of the catheter sheath 12 as illustrated more clearly in Fig. 2 of the drawings.
  • a plurality of axially spaced, circumferentially extending seals 30 are arranged about the distal end 16 of the catheter sheath 12 for inhibiting ingress of foreign material and bodily fluids into the lumen 22 of the catheter sheath 12.
  • the coil spring 18 is constrained in a sleeve 32 depending from an interior surface of the crown portion 26 of the tip electrode 14.
  • a free end of the sleeve 32 carries a conductive member in the form of a collar 34.
  • the collar 34 being of a conductive material, forms part of the force feedback mechanism 24.
  • the force feedback mechanism 24 further includes a plurality of axially spaced conductive elements 36.
  • Each conductive element 36 comprises a channel shaped member defining a channel in which a current carrying conductive element or conductor 38 is received.
  • the conductor 38 is in the form of a canted coil spring arranged in an annular configuration and received in the channel of its associated conductive element 36.
  • the assembly comprising the conductive member 34, the conductive element 36 and the conductor 38 is, for example, of the type available from BaI Seal Engineering, Inc. of 19650 Pauling, Foothill Collins, CA, 92610-2610, USA.
  • the force feedback mechanism 24 comprises three conductive elements 36 arranged in axially spaced relationship at the distal end 16 of the catheter sheath 12 to provide at least two feedback settings.
  • Each conductive element 36 has an electrical lead (not shown) associated with it.
  • the electrical lead of each conductive element 36 can either extend through the lumen 22 of the catheter sheath 12 or, instead, could be embedded in a wall 40 of the catheter sheath 12. In the latter case, the catheter sheath 12 is manufactured in accordance with the manufacturing techniques described in the Applicant's International Patent Application No. PCT/AU01/01339 dated 19 October 2001 and entitled "An electrical lead".
  • each conductive element 36 can be of varying mechanical strength so that different forces are required to cause mechanical and electrical engagement of the conductive member 34 with each conductive element 36.
  • the conductive member 34 is in mechanical and electrical engagement, or latched, with the distal conductive element 36.
  • This is a rest condition of the tip electrode 14 relative to the catheter sheath 12.
  • the conductive elements 36 are connected via electrical leads to electrical equipment, illustrated schematically at 56 in Fig. 7 of the drawings, associated with the catheter assembly 10. (although Fig. 7 illustrates a second embodiment of the catheter assembly 10, the electrical equipment 56 is applicable also to the catheter assembly 10 of the first embodiment.).
  • the electrical equipment When the tip electrode 14 is in its rest position relative to the catheter sheath 12, the electrical equipment may be quiescent or idling. In other words, no signal emanates from the electrical equipment 56.
  • the tip electrode 14 When the tip electrode 14 is brought into contact with tissue at a site in a patient's body and pressure is exerted on the tip electrode 14, it is displaced with relatively little resistance from the distal conductive member 36. For example, a force of less than approximately 1Og may be sufficient to displace the tip electrode 14 from the first conductive element 36 of the force feedback mechanism 24. When a greater force is exerted on the tip electrode 14, the conductive member 34 latches to the centre conductive element 36. As indicated above, the force at which this occurs can be selected by appropriate selection of the conductor 38. Typically, a force of about 2Og is required to latch the conductive member to the conductive element 36. When this occurs, a circuit is closed and an enunciator of the electrical equipment 56 is activated.
  • the supply of RF energy automatically ceases. If the conductive member 34 then engages the proximal conductive element 36 and latches to it, a further signal is generated by the electrical equipment 56. This is an alarm signal which alerts the clinician to the fact that tissue perforation or other undesirable tissue damage is imminent. As an example, if a force exceeding 4Og is brought to bear on the tip electrode 14, this causes latching of the conductive member 34 with the proximal conductive element 36 and causes generation of the alarm signal. It will be appreciated that the alarm signal could be any suitable enunciator and could be an audible alarm, a visual alarm or both.
  • the force required to cause latching of the conductive member 34 with the proximal conductive element 36 is of the order of 4Og but this will be dependent on the application of the catheter assembly 10 and by the appropriate selection of the conductors 38.
  • a second embodiment of a catheter assembly 10 is illustrated.
  • like reference numerals refer to like parts, unless other wise specified.
  • a support member in the form of an axially extending pin 42 extends proximally from an inner surface of the crown portion 26 of the tip electrode 14.
  • the pin 42 is surrounded by the coil spring 18.
  • a mechanical linkage 44 which is stiff in compression projects from the pin 42 and extends through the lumen 22 of the catheter sheath 12 to be received in a handle 46 (Fig. 7) of the catheter assembly 10.
  • the linkage 44 is connected to a marker 48 which is displaceably arranged in the handle 46 to be displaceable in the direction of arrows 50.
  • the marker 48 projects through, or is visible in, a window 52 of the handle 46.
  • Gradations or marks 54 are applied to the handle 46 alongside the window 52.
  • an electrical connection can also be made so that, when the marker reaches mark 54.1 or 54.2, as the case may be, the RF energy is automatically supplied or an alarm condition is automatically generated, respectively.
  • These electrical connections can be effected by means of components similar to components 34, 36 and 38 described above with reference to the first embodiment. Instead, the electrical connections could be effected by substituting the seals 30 with conductive electrodes and electrically connecting such electrodes to the electrical equipment illustrated schematically at 56 in Fig 7 of the drawings. The spring force of the coils spring 18 is then selected to give the relevant force values.
  • a catheter assembly 10 which provides force feedback to a clinician while the clinician is using the catheter assembly 10.
  • the force feedback can be used to commence the supply of electrical energy to the tip electrode 14 of the assembly 10 automatically and/or generate an alarm when tissue perforation is imminent. This is therefore of benefit, both when the catheter assembly 10 is being steered through the vasculature of the patient's body and when a procedure is being effected at a site in the patient's body at which perforation is a constant danger.
  • the catheter assembly 10 can be operated remotely. This is beneficial as the clinician can then remove himself/herself from the field of potentially harmfully X-ray radiation during the procedure.

Abstract

L'invention porte sur un ensemble de cathéter à retour de force (10) qui comprend une gaine de cathéter (12). Une électrode à pointe (14) est agencée à une extrémité distale de la gaine de cathéter (12) pour pouvoir être déplacée axialement par rapport à l'extrémité distale de la gaine de cathéter (12). Un mécanisme à retour de force (24) comporte au moins une partie qui est agencée entre l'électrode à pointe (14) et l'extrémité distale de la gaine de cathéter (12). Le mécanisme à retour de force (24) possède au moins deux réglages de retour, un premier réglage servant à indiquer lorsqu'une force adéquate est exercée par l'électrode à pointe (14) sur un tissu situé au niveau du site pour permettre de commencer une intervention, et un second réglage servant à indiquer lorsque la force exercée par l'électrode à pointe (14) atteint un niveau auquel un endommagement tissulaire non souhaitable pourrait apparaître.
PCT/AU2008/001789 2007-12-07 2008-12-03 Ensemble de cathéter à retour de force WO2009070837A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US1215007P 2007-12-07 2007-12-07
AU61/012,150 2007-12-07

Publications (1)

Publication Number Publication Date
WO2009070837A1 true WO2009070837A1 (fr) 2009-06-11

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ID=40717195

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2008/001789 WO2009070837A1 (fr) 2007-12-07 2008-12-03 Ensemble de cathéter à retour de force

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350423B2 (en) 2016-02-04 2019-07-16 Cardiac Pacemakers, Inc. Delivery system with force sensor for leadless cardiac device
WO2019226563A1 (fr) * 2018-05-21 2019-11-28 Boston Scientific Scimed, Inc. Dispositif de cautérisation destiné à être utilisé avec des endoprothèses

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5396887A (en) * 1993-09-23 1995-03-14 Cardiac Pathways Corporation Apparatus and method for detecting contact pressure
WO2001070117A2 (fr) * 2000-03-23 2001-09-27 Microheart, Inc. Capteur de pression pour dispositif d'administration therapeutique et procede correspondant
WO2007070919A1 (fr) * 2005-12-23 2007-06-28 Cathrx Ltd Unite de retroaction de pression pour un catheter
US20070191829A1 (en) * 2006-02-15 2007-08-16 Boston Scientific Scimed, Inc. Contact sensitive probes with indicators

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5396887A (en) * 1993-09-23 1995-03-14 Cardiac Pathways Corporation Apparatus and method for detecting contact pressure
WO2001070117A2 (fr) * 2000-03-23 2001-09-27 Microheart, Inc. Capteur de pression pour dispositif d'administration therapeutique et procede correspondant
WO2007070919A1 (fr) * 2005-12-23 2007-06-28 Cathrx Ltd Unite de retroaction de pression pour un catheter
US20070191829A1 (en) * 2006-02-15 2007-08-16 Boston Scientific Scimed, Inc. Contact sensitive probes with indicators

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350423B2 (en) 2016-02-04 2019-07-16 Cardiac Pacemakers, Inc. Delivery system with force sensor for leadless cardiac device
WO2019226563A1 (fr) * 2018-05-21 2019-11-28 Boston Scientific Scimed, Inc. Dispositif de cautérisation destiné à être utilisé avec des endoprothèses
US11801089B2 (en) 2018-05-21 2023-10-31 Boston Scientific Scimed, Inc. Cauterizing device for use with stents

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