CA2010895A1 - Atherectomy system with a clutch - Google Patents

Atherectomy system with a clutch

Info

Publication number
CA2010895A1
CA2010895A1 CA002010895A CA2010895A CA2010895A1 CA 2010895 A1 CA2010895 A1 CA 2010895A1 CA 002010895 A CA002010895 A CA 002010895A CA 2010895 A CA2010895 A CA 2010895A CA 2010895 A1 CA2010895 A1 CA 2010895A1
Authority
CA
Canada
Prior art keywords
catheter
flexible
cutting
vessel
rotary
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.)
Abandoned
Application number
CA002010895A
Other languages
French (fr)
Inventor
Samuel Shiber
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2010895A1 publication Critical patent/CA2010895A1/en
Abandoned 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • 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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C1/00—Flexible shafts; Mechanical means for transmitting movement in a flexible sheathing
    • F16C1/02—Flexible shafts; Mechanical means for transmitting movement in a flexible sheathing for conveying rotary movements
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16D—COUPLINGS FOR TRANSMITTING ROTATION; CLUTCHES; BRAKES
    • F16D7/00—Slip couplings, e.g. slipping on overload, for absorbing shock
    • F16D7/02—Slip couplings, e.g. slipping on overload, for absorbing shock of the friction type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • 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
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/031—Automatic limiting or abutting means, e.g. for safety torque limiting
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C2202/00—Solid materials defined by their properties
    • F16C2202/20—Thermal properties
    • F16C2202/28—Shape memory material
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16C—SHAFTS; FLEXIBLE SHAFTS; ELEMENTS OR CRANKSHAFT MECHANISMS; ROTARY BODIES OTHER THAN GEARING ELEMENTS; BEARINGS
    • F16C2316/00—Apparatus in health or amusement
    • F16C2316/10—Apparatus in health or amusement in medical appliances, e.g. in diagnosis, dentistry, instruments, prostheses, medical imaging appliances

Abstract

ABSTRACT
An atherectomy system for cutting an obstruction in a patient's vessel, comprising a flexible guide-wire insertable into the vessel, a flexible rotary-catheter being rotatably disposed and insertable into the vessel, over the flexible guide-wire, a cutting means for cutting the obstruction, at a distal end of the flexible rotary-catheter, coupling means at the proximal end of the flexible rotary-catheter for engaging a drive means and at least one torque limiting clutch interposed between the drive means and the cutting means, limiting the torque transmitted distally.

Description

A~lERa`~l`OMY SYSTEM WIlII A CLUTCII ,~

CROSS REIII,LNCiA T~) nl~ I'ILl(`~TIONS

This application is a C~n~illU~.iOIl in palt (CI1) of applic~ion SN
Ot/~6 5~9 filed 12/19/88 which i~ u CIP of al)plica~ion SN 07/2/13 9~0 filed 9/13/88 whicil is a CIP of three apl)licati(?lls~ applicdtion SN 07/~78,042 filed 7/~7/~7 apl)lication SN 07/2~5 479 rilcd ~ 88 alld application 07/225 880 rileù 7/29/88. These three ul)l)liuaLivlls ur( Clls Or applicatioll SN 07/018 083 filed 2/24/19~7, which is a ClP of applicatioll SN OG/874,546 filed 6/16/1986 (now patent 4 732 154) which is a CIP of appiicatioll SN 06/609 846 filed 5/14/19~4 (abandoned).
All the above applications are being incorporated herein by reference.

BACKGROUND AND SU~MARY OF rHE INVENTION

With age a large percentage uf the population develops atherosclerotic arterial obstructions resulting in a diminished blood circulation and a variety of related disorders. rrosellLly su( h ol~trllcLiolls are circumvented by surgically grafting a bypass or they are tre.~ted by a catheter equipped with a balloon which is inserted throu~h the arterial system, over a flexible guide-wire into the obstruction and tllen inflated to e~pand the obstruction's lumen (Angioplasty). Some of the prob1e~ wi~h Au~iop1asLy are that it injures the urterial wu11 it creates a rou~h lumell allll irl ~ul)stullLial number of the cases iL is ineffective. Further Angiol~llsty does no~ ca~ture and remove the ~bstruction material out of the arterial system therefor Angioplasty carries he risk Or dislodging obstruction ma~erial ~n-l allowing it to move down s~ream creating additi~nal bloc~ages.
¦ An objec~ive of the presen~ inven~i~n i.~ L~ provi(le an over a guide-wire rotary Atherect~my catheter system which cuts and renoves the obstruction material and which is equipped wiLh torque limiting clutch means to preYent ~mage to the arterial system. The system nay be introduce;~ into the arterial ~ystem a~ e groin area through a she~th to reach a work site in the P~

~Ul(~8~95 curonar~ arLeries, whicll requil-os a iong c.-iLII~tcr wi~h an elastic, supple, ~ aLal sectiun, ~ stable diame~ric,ll cross section and a torque transmitting ability through the various artel-ics it is passed thruugh. Meeting these u~sign objectives simultaneously, limits thr strength of the disLal section i shown in l`IGURE 1, the athorec-omy sys--m comprise~i several elongated ~urts in a nested relationship, and their en(ls or sections shall be referred to as "distal" meaning the end ~hich goes into the ~essel and "yroximal"
meaning the other end, thus, "distal direction" or "~istally" shall indicate a Oeneral direction from the proximal end to thc distal end, and "proximal ~irection" or "proximally" shiill rerer to an opposiLe direction).
The rotary cutting action whicll ~akes plJ~e aL the distal eîld of the ~lexible rotary-catheter requires a certain i~mount of net torque and rotation.
To provide it, the flexible rotary-catheter is ~riven at its proximal end by a no~or, however, due to friction~il losses alol,~ the len~th of the flexible ro~ary-catheLer the gross torquo Lh~l~ is requiro(l al Llle proximal en~ is sul)stantially larger than the net tor4ue. To wiLhsLan~i the gross torque the proximal section is strengthenc(J, ~or exanlplo, ~y increasing its wall Lhickness or by reinforcing it, ancl since the proximal section is oftPn ~lisposed in relatively straighL ar~eries, iL.~i increase~l stiffness is iicceptable. However, due to varioui unpredictable and uncontrollable variations that may occur durin~ ~n individual procedure, such as changes in coeificient of friction between the rotating pdrLs of the system and the ~iLationary parts of the systenl Gr Or thc ar~ery, or ch~illges in the forces inducing the friction which may occur due to misa]ignment of parts of the system, or a spasm in the artery which may lock the artery onto the rotary flexibl2 rotary catheter ~atheter, the pattern of torque (iis~ributioll;llollg the ./ may be altered, andiL is an important objective oJ Lhi'i invellLioll, eveli un(ler such circumstances, Lo protect the arteries against injllry by eith-l ~ver torquing the artery uirectly or by over torquing and fracturing the ~lexible rotary-catheter which may in turn cause injury to the artery.
A numerical example may b~ helprul: Asslllllillg thal the required net and ~ross torquci are 1 in-h-ounce ~ in(:h-~ull(l, rcsl~e(:Lively, an~l that the ul~imate stron~th of the d;SL~ nl(l l)ro~iim;JI ~ I iOn~i is 3 inch-oullce aod 9 ...Ch-OUIICe, I-CSI)('CtiV('ly, ~:Ul~l I Ul th('r cJ~SUlllillg Lba~ Lh~ motor drive can deliver 7 inch-~ullce aL sLall ~uL because r~l inll~rellL Lorque/sp~crl .haracLerisLics it will deli-~er- ~IS nluctl us ~ ' incll-()ull^e while Lurnill~. Ttlus, i~ can be seell that if due to ull arLcria.l spa~ r oLher cause he blade became loc~ed in the artery, e~en moDentary, Lhe motor may deliver close to 12 inch-ounce of torque to the blade (as previuusl)~ discussed the frictional l(jsses along the flexible rotary-caLheLer may occasionally be very small~
iracturin~ the distal section, cdusing ser.inu~ complications. If the spasm occurs at a point along the pr~,~im~l secti~n .it can h~ve the same undesirable results. To prevent such complications a lirst torque limiting clutch rated aL 2 inch-ounce is interposed between the distal section and the proximal section and a second torque limiting clutch rated at 6 inch-ounce is interposed be~ween the motor ~nrl tllc drivc's ~uLput shaft. The rirst to~que limiting clutch enables suficicnt working torque to be transmiL-ted the distal section but prevents destructive tor(~uc from redchillg it, the second torque limiting clutch does the same for thc proxim~l section.

BRIEF DESCRlPTIO~ OF rll~ FIGURES

FICURE l schematically sh~ws a ~eneral ~iew of an atherectomy system according to the present inventi~n, introdu~.e~ int~ an arterial system of a patient to cuL and remove an ~hstruction in llis henr~'s artery. The heart outline is sllr~wn in phantom liu(~.
FIGURI. ' show~, on a lar~-r s(~lc, u di,~;ll S~(ti~ and a p~rt of the proximal secLion of the flexi~l- ru~ry-cathcLcr, witl~ a torque limiting clutch interposed between the secti~ns.

DETAILED DESCR:[PTION ()I TH~ FICURES

FIGURE l schematically shows a general view of the atherectomy system lO
inserted at the groin area of a p~Lient thrnugh a sheath 32, through his arterial system ll into a coronary nrtery 12 for removing an obstruction 13 .hcrefrom. The system lO compri.~-s:

~0~08~5 A ~le.\i~le guide-wire 14, iu~olLa~le il~C~ Lhe v~sel, a flexible rotary-catheLel 15, rotata~Jy dispose(l and inserLable into the v~ssel, over the flexible gui~ wirc, a cutLin~ mcans 1~, at ~ iL~l ell~ xil)le rotary-(atheter, for cuLtin~ tlle obsLruction, coupling means 17 at the l)roximal end ol the fl~xible rotary-catheter dcfining a tapered seat for en~a~ing a drive nle~lls l20.
A first torque limitin~ c~.utch 18, showll also in FIGURE 2, is interposed b~weell proximal and distal ~e(~tiolls 19 und 'U, re~l)ectively, uL the flexible loLary-catheLer The cluLch J8 .is ~'orme~ b~ l'i.Ltillg lhe proximul end of s~ction 20 inLo the dist~l en-l /)r .~ecLio~ L(l C.~LJ~I ish friction~1 ellgagement between the two secLions which limits the Lc,rque capacity of the clutch to a certain permissibl~ value beyon(l ~llich Lhe clutch slips, thereby ~imiting the torque that is trallsmi~te(l disLul Lo tlle clutch and protecting ~lle disLal scction from darnag~ b~ un occasioll.ll trullsler of higher torques Lhat may be applied to the proximal ell~ ol' s~cLion 19. A lock-ring 24 formed on section 2~ which fits in a correspondin~ uroove 24' defined by section 19, prevents a relative longitudinal displacemellt between the sections but allows Lllem to rotate relative to onc ~noLher when llle cluLcll slips.

The drive means 120 has a housing 43 whicll roLiltably supports a hollow shaft 21 through which the gui(le-wire passes allcl exLends, the distal end of t.he hollow shaft has a taper for fitting int~ and engaging with the tapered ieat of the coupling means. A mucor 2'~ is ~uple(l Lo the hollow shaft through d second torque limiting clutch 23. The cluLch 23 is made of a gear wheel 25 wllich is sandwiched between and I ricLic,nall) ~n~ged with a shoulder 26 formed ~n the shaft and a pressure plaLe 27 which is ellerg.i~ed against the gear wheel l)y a compression sprin~ 28 whicll is sul-r)orl~d by u Jlallge 29 which is affixed Lo the shart. A pinion 30 which .i~ conrlec~o~l Lo alld clriven by clle motor 22 is æugaged with the gear wheel. Thc ~iuLch ~imiLs Lhe torque delivcred to the shaft by the gear wheel 25 by sliding betweell the shoulder and pressure plate en cerLain ~or(~ue is rcached ~h(l~l)y linlilin~ LhL' lor~lue thaL the drive 120 LrunsmiLs ~ Lhe proximal secli~n.
A battcry 33 is wired to Llle InoLor throll~h a switch 37 by wires 34, 35 ~age 4 9~
,u(I 36. Wh.Il ~he sw~ is d~ s(~d it conI~ n ~ ctric~l cirluit hiclI suI)pIies c1ec~l-ical cur-reIll Io ~hc m~ " lo dIiv~ it.
The I~ousing 43 defines all n~ uIur cavily ~U and a passage lor cuJInecting hollow shaft to a por~ 42 I"r intro(IuciIlg sucti()n or fluids into the llcxible roLary-catheter througII LhL l1OI1LW shciit. A seal 41 seals the unIlular cavity while allowing Lhe f1exible gui(le-wire to slidingly extend ~hrough the hollow shaft and ouL ~f ~he hou.siIlg~
The atherectomy system can be maIlufactureLl in d-ifferent di~meters and Iengths depending on the size ~I,d s-ite of artery that it is intended for and IQ ~n whether the system is to be used`percutau~ous1y (that is through the skin) or intra-operatively (that is whcn the ves~cI is sur~ically exposed for ir,serting the system into the vcsseI).
While the present inventioIl has been illus~ratcd l,y one emboLliment~ it should be understood that various m~LlificatioIls and substitutions may be made i.i~hout departing from the spiri~ of ~hc inveIl~ or ~he scope of the claims.

~ 5

Claims (3)

1. An atherectomy system for cutting an obstruction in a patient's vessel, comprising in combination:
a flexible guide-wire insertable into the vessel, a flexible rotary-catheter being rotatably disposed and insertable into the vessel, over said flexible guide-wire, a cutting means, at a distal end of said flexible rotary-catheter, for cutting said obstruction, coupling means at the proximal end of said flexible rotary-catheter for engaging a drive means having a motor, wherein at least one torque limiting clutch is interposed between said motor and said cutting means, limiting the torque transmitted distally.
2. An atherectomy system as in claim 1, wherein said torque limiting clutch is interposed between a proximal section of said flexible rotary-catheter to a distal section of said flexible rotary-catheter.
3. An atherectomy system as in claim 1, wherein said drive means have a hollow shaft through which said guide-wire can pass and extend, a distal end of said hollow shaft engagable with said coupling means, a motor coupled to said hollow shaft through torque limiting clutch.
CA002010895A 1989-03-13 1990-02-26 Atherectomy system with a clutch Abandoned CA2010895A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/323,328 1989-03-13
US07/323,328 US5002553A (en) 1984-05-14 1989-03-13 Atherectomy system with a clutch

Publications (1)

Publication Number Publication Date
CA2010895A1 true CA2010895A1 (en) 1990-09-13

Family

ID=23258734

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002010895A Abandoned CA2010895A1 (en) 1989-03-13 1990-02-26 Atherectomy system with a clutch

Country Status (5)

Country Link
US (1) US5002553A (en)
EP (1) EP0387980B1 (en)
JP (1) JPH02279149A (en)
CA (1) CA2010895A1 (en)
DE (2) DE69022868T2 (en)

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DE69022868D1 (en) 1995-11-16
DE387980T1 (en) 1991-04-11
US5002553A (en) 1991-03-26
DE69022868T2 (en) 1996-04-04
EP0387980A1 (en) 1990-09-19
JPH02279149A (en) 1990-11-15

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