CA2217481A1 - Improved devices for removing fibrin sheaths from catheters - Google Patents

Improved devices for removing fibrin sheaths from catheters Download PDF

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Publication number
CA2217481A1
CA2217481A1 CA002217481A CA2217481A CA2217481A1 CA 2217481 A1 CA2217481 A1 CA 2217481A1 CA 002217481 A CA002217481 A CA 002217481A CA 2217481 A CA2217481 A CA 2217481A CA 2217481 A1 CA2217481 A1 CA 2217481A1
Authority
CA
Canada
Prior art keywords
wire
tubular member
distal end
medical device
snare
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
CA002217481A
Other languages
French (fr)
Inventor
Paul V. Suhocki
Mark T. Ridinger
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.)
Duke University
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 CA2217481A1 publication Critical patent/CA2217481A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions

Abstract

A medical device (10) adapted especially to remove biological material (e.g., fibrin sheath) from the distal end of a patient internal catheter that includes a tubular element (12), a central wire (14) positioned within the tubular element, a snare wire (16) attached at one end (16a) to the central wire so as to form an acute angle therewith, and at its other end (16b) to the tubular member. The snare wire includes a proximally extending segment which follows a course of about 360 degrees about the distal end (12a) of the tubular member, and thus may be positioned adjacent the catheter's distal end. By effecting relative rotation between the central wire and the tubular member (for example, by rotating the central wire about its longitudinal axis while maintaining the tubular member stationary) will cause the snare wire segment to wrap around the catheter's distal end. Thereafter, manipulation of the device so as to advance the wrapped snare wire segment in a distal direction will strip the biological material from the distal end of the catheter.

Description

W O96~1162 PcT/u~tO~799 IMPROVED DEVICES FOR REMOVING FIBRIN SHEATHS
FROM CATI~ETERS

RELATED APPUCATIONS
5This aprlir~on may be deemed to be related to U.S. Patent Aprlic~ion Serial No. ---,--- (Atty. Dkt. 1579-79) filed even date h~l~wil~ in the name of the same il~v~ uls as the present aprlic~hon, the entLre cn~ . of which is expressly incorporated he. ~i. Lo by lefe. ~..ce.

FIELD OF INVENTION
The present l--v~--Lion relates generally to the field of medical devices. More particularly, the present illve~Lion relates to the field of snares used during medical procedures to remove nl~tP~l from a 15 patient. ~ its ~ler~.led embodiments, the present ive~Lion is especially adapted to remove fibrin .she~th.s from the distal ends of dvascular catheters.

BACKGROUND AND SUMMARY OF ~HE INVENTION
20Catheters formed of a biocompatible plastics m~t~ri~l are sometimes imp~nted in p~h~n~s to relieve various by~u..~.s and/or to assist in medical procedures. For ~mple, central venous catheters _ave been imp]~nted into a p~h~nt;'s vein during vascular y. One problem associated with such im~l~nted catheters, 25 how~ve., is that a fibrin .she~fh (which is a deposit of fibrin and platelets) may form on the imrl~nted catheter, initially at the entrance site into the vein and then along the length of the catheter.

-W O96/31162 PCTrUS96/04799 W~ile it us l~lly takes weeks to m~nth.c for the fibrin ch~t~ to form, it has been reported to form in as little as 24-48 hours following im~ n1~

The fibrin .ch~th can cause catheter dysft.n~h-m, usually being manifested by the physician being able to infilse through, but not to aspirate from, the catheter. Intralllmin~l urolrin~.ce may then be :~mini.ctered several times to e2clude the ps.c.cihility of intrall.min:~l clotting. If intral~rnin~l urokinase tre~ nt is ineffective, fluoroscopy may then be performed to allow the physician to evaluate catheter tip location and to obts~in evidence of fibrin .che~th fo~rn~ on Once the presence and e2tent of the fibrin she~th have been i~n~ified, the physician must take the necessary steps to remove the .qhe:~h from the implanted catheter. W~ile it is conceivable that the imrl~n~ed catheter may be removed and replaced surgically, it is more desirable for the fibrin .ch~h to be removed without surgical removal of the impl~nterl catheter.
Presently, there are b~.cic~lly two approaches which may be employed without removal of the impl~nted catheter. The first approach involves introducing p~ . .eously a goose-neck snare (e.g., a snare device generally disclosed in U.S. Patent No. 5,171,233 to Amplatz et al, the entire co. . ~elLt of which is incorporated expressly hereinto by lef~l~..ce) into the patient's groin area. The snare is then advanced through the patient's femoral vein to the catheter impl~nt -W O96131162 PCTrUS96/04799 site, at which time it is manipulated so that the snare encircles the distal end of the imrl~nte~l catheter so that the fibrin she~t~ may be stripped the.~eLu~. While the fibrin .sh~th which is stripped from the distal end ûf the imr1~nted catheter travels to the patienPs lullg, 5 surgical removal has been shown to result in emb~ hon as well.

Another technique that has been employed to strip fibrin ehe~th.e from the distal ends of imr1~nted catheters is to introduce a J-tipped wire intralllmin~lly through the imrl~nted catheter.
10 Rotation of the J-tipped wLre about the distal end of the imrl~nted catheter will thus strip a portion of the fibrin sheath thel ~L o.~ ..
VV~ile this te~hnique is adv~lageous since the imrl~nted catheter serves as a guide p~CC~eway (i.e., separate in~ jon.C to access the femoral vein are unnecessaIy), the J-tipped wire is typically or~ly 5 capable of removing less than all of the fibnn she~th from the irnrl~nte~ catheter due to its size lin~it~t.it~n.c.

What has been needed in this art, therefore, is a medical device which is capable of being guided intral11min~11y through an 20 imrl~nted catheter, but which is capable of removing subst~nf:i~11y all of the fibrin sh~th that may have formed at the catheter's distal end. It is towards fi11fi11in~ such a need that the present invention is directed.
1. .
Broadly, the present invention is embodied in medical devices having a snare loop for removing patient-internal biological m~tP~1 from an jmr1~nted catheter (e.g., a fibrin ~he~t.h which may form at W O96~1162 PCTrUS96/04799 the distal end of a venous catheter) which may be inserted intrall~minAlly through the c~thetPr during a me~icAl procedure. The tubular member has a length sl7ffiriPnt to allow its distal end portion e~tend beyond the distal end of the patient-intPrnAl catheter. A
5 central wire ~lPmPnt is movably po.cition~rl wi~hin the elongate tubular member and has a sl~ffiri~nt length so that its ~ Al end portion e~tends distally beyond said distal end of said tubular member.

0 Impol L~lly, a snare wire is provided such that one of its ends is attached to the central wire with the other end At~rh~d to the distal end of said tubular member after completing a~ x;..-:~tPly 360~ wrap around the tubular member between the ends. The snare wire, between its Att~rhPd ends, will include a se~mPnt which 15 extends ~. vx...~Ally at an acute angle and may therefore be located upon m~nipulation of the device adjacent the distal end of the patient-internal catheter. Relative rotation between the central wire and the tubular member ~e.g., by lo~ g the central wire about its longitll~in~l ~Yis while m~i.~l~i..i,lF the tubular member stationary 20 or vice versa) causes said snare wire segTnent to be wrapped around said distal end of the patient-internal catheter. Distal advancPm~nt of this wrapped snare wire seFrnPnt relative to said distal end of the patient-internal catheter will thelerwe strip the biological matPriAl the. eL o , W O96~1162 PCTrUS96/04799 Fur~er aspects and a.lv~tages of this ~v~ Lion will become more clear after r~reful con.ci-~eration is given to the following det~iled ~Ps~rr~ption of the ~l~r~ d P~Pmrl~ry embo~imPnt. thereo~

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will hereinafter be made to the ~ccomr~nying drawings wherein like l er~ ce numerals throughout the various ~ .
FIGURES denote like structural P1ement~, and wherein;
FIGURE 1 is a srh~m ~hc perspective view of a ~ lled m e~irzll snare device embodying the present i I'v~- ~Li~n; and FIGURES 2A-2C are srhPm~hc elev:~tion~l views showing a sequence of the device depicted in FIGURE 1 during use.

DETAILED DESCRlPTlON OF THE PREFERRED
EXEMPLARY EMBODIMENTS
One preferred embo~im~nt of a medical snare device 10 accol.1;l,g to the present i~ vellLion is shown in accompanying FIGURE 1. The snare device 10 is depicted srhPm~c~11y as being positioned intral1~min~11y wi~ a venous cat~eter VC, it being - 25 understood that the distal end region of venous catheter VC will inuse be impl~nted Wil~lill a patient's vein. The dist~l end section of the venous catheter VC is depicted in accompanying FIGURE 1 as W O96~1162 PCTrUS96/04799 , having a fibrin chP~h FS Ç~.n~ing ~luxi~ lly along the catheter's rinr snrf~e The snare device 10 is generally co...". i.ced of an elongate 5 tubular member 12 and a central wire PlPmPnt 14 which is movably pociti~ned wil~li.l the lumen of the tubular member 12. Each of the tubular member 12 and central w1re PlPmPnt 14 is of sllffiriPnt length to allow the physician to intralllm;n~lly insert them as a unit t.hrough the venous catheter VC so that the distal end 12a of the 0 tubular body 12 is capable of e~tPn~ing dista~ly beyond the distal end of the venous catheter VC, and so that the ~eL~ al end 14a of the cenhral wire PlP~mPnt 14 is c~p~hle of being e~t~n~e~ beyond the distal end 12a of the tubular member (e.g., to achieve relative posihnning as show.. in FIGURE 1).
1!;
Important to the present ...v~.~l;nn, the snare device 10 includes a snare wire 16 formed of a flP~ihle metal or plastics wire, thread or the like. The snare wile 16 has its distal end 16a physically ~ rhed to the cenhral wire PlPm~nt 14 so as to form an 20 acute angle therewith and its pro~im~l end 16b physically attached (e.g., via biocompatible epo~y, heat-welding, imbedding or the like) to the tubular member 12 at or near its distal end 12a. The ends 16a, 16b are thus ~nally separated from one another along the length of the device 10 so as to form a snare loop collectively with the terminal 2~ end 12a of the tubular member and that length of the central wire ~lPmPnt 14 egt~n~lin~ therebeyond. As shown, the snare wire 16, between the ends 16a and 16b is preferably wrapped appro~im~ ly W O 96/31162 PCTnUS96/04799 360~ around the tubular member 12 so that the end 16b faces distally.

The relative diameters of the central wire 14 and the snare 5 wire 16 are depentlPnt. in large part upon the particl lar medical procedure in which the device 10 of this i~lv~:..Lion is in~n~ed to be employed. It is ~lerelled~ how~v~:l, that the diameters of the central wire 14 and the snare wire 16 each be within the range of about 0.001 to about 0.040 inch. Moreover, it is ~lefel. ed that the snare 0 wire 16 have a lesser diameter as comp~red to the central wire m~nt 16 so that the former is relatively more fle~ible, while the latter is relatively more stiff. Thel~role, it is ~ler~lled that the ratio of the central wire diameter to the snare wire dia~neter be between about 1.1:1 to about 10.0:1.
The snare wire 16 is of s~.ffiri~nt length between its ends 16a, 16b such that a segm~nt 16c thereof may be positioned pro~imzllly of the end 16b adjacent the distal end of the venous catheter. With the snare wire segm~nt 16c po.cihoned in such a m~nn~r, the physician 2~ may rotate the central wire el~m-ont 14 about its longitl~in~ is wi~ the lumen of the tubular member 12 as showrl by arrow Al in FIGURE 2A. Relative rotation bet~,veen the central wire element 14 and the tubular member 12 (e.g., rotation of the central wire element 14 while ~nz?int~ining the tubular member 12 stationary) will thereby 25 cause the snare wire se~ nt 16c to be wrapped or twisted more or less h~lir~lly about the e~terior surface of the venous catheter's distal end as shown in FIGURE 2B. The several turns of the wrapped W O96~1162 PCT/U'9G/01799 snare wire se~rn~nt 16c Will thus be brought into contact with the fibrin .che:~h FS at the distal end of the venouc catheter VC. Ac such, adv~nl Pm~nt of the central wire 14 and/or the tubular member 12 in a distal direction (arrow A2 in FIGURE 2C) wi~l, in turn, cause 5 the wrapped snare wire segm~nf; 16c to be moved distally along the e2terior surface of the distal end of the venous catheter VC thereby sLi~i. g the fibrin che~t.h FS thel~:L.~

Although the central wire element 14 has been depicted in the 0 ~rComranying drawing FIGURES as including an eyelet 14a at its ~e....i..al end, it will be appreciated that the eyelet 14a is not critically necessary since the end 16a of the snare wire 16 may be bonded to the central wire's Lel,..;..al end via biocompatible epoxy, solder, or the like. Furthermore, the central wire 14 and the snare 15 wire 16 may be formed as a single (unitary) mnnnfil~m~nt wire, instead of the separate, but cormected, wires as shown in the accompanying drawing FIGURES.

Thelefo.e, while the i. v~Lionhas been describedin conn~c~on 20 with what is presently considered to be the most pr~ cz~l and preferred embor~imen~ it is to be understood that the i~vellLion is not to be limited to the disclosed embo~im~nt but on the co..l~ , is int~ncled to cover various mo~ific~t~inn.c and equivalent arrang~ment-~included wiL~i~ the sp~Iit and scope of the appended cl~im.c.

Claims (22)

WHAT IS CLAIMED IS:
1. A medical device comprising:
an elongate tubular member;
a central wire positioned within said tubular member;
a snare wire having one end attached to a terminal end of said central wire to form an acute angle therewith, and another end attached to a distal end of said tubular member, said snare wire between said one and another ends being wrapped about an exterior surface of said distal end of said tubular member, wherein relative rotation between said central wire and said tubular member causes said snare wire to wrap around said distal end of said tubular member.
2. A medical device as in claim 1, wherein said snare wire is wrapped about 360° about said distal end of said tubular member.
3. A medical device as in claim 1, wherein said central wire is axially and rotationally moveable within said tubular member.
4. A medical device as in claim 1, wherein said snare wire has a length sufficient to establish a segment between said one and another ends which extends proximally of said distal end of said tubular member.
5. A medical device as in claim 1 or 4, wherein said one end of said snare wire is bonded to a terminal end of said central wire.
6. A medical device as in claim 1 or 4, wherein said terminal end of said central wire includes an eyelet, and wherein said one end of said snare wire is attached to said eyelet.
7. A medical device as in claim 6, wherein said one end of said snare wire is bonded to said eyelet.
8. A medical device as in claim 1, wherein said central wire and said snare wire are unitary.
9. A medical device as in claim 1, wherein said central wire and said snare wire each have a diameter in the range between about 0.001 to about 0.040 inch.
10. A medical device as in claim 9, wherein a ratio of the central wire diameter to the snare wire diameter is between about 1.1:1 to about 10.0:1.
11. A medical device for removing biological material from a distal end of a patient-internal catheter comprising:
an elongate tubular member for intraluminal insertion within the patient-internal catheter and having a length sufficient to allow a distal end portion of said tubular member to extend beyond the distal end of the patient-internal catheter;
a central wire element positioned within said elongate tubular member and having a terminal end portion which extends distally beyond said distal end of said tubular member;
a snare wire having one end attached to said central wire to form an acute angle therewith, and another end attached to said distal end of said tubular member at a position proximally of said one end;
wherein said snare wire includes a segment thereof between said one and another ends which follows a course which is wrapped about said tubular member and extends in a proximal direction so as to be located adjacent the distal end of the patient-internal catheter; and wherein relative rotation between said central wire and said tubular member causes said snare wire segment to be wrapped around said distal end of the patient-internal catheter such that distal advancement of said wrapped snare wire segment:
relative to said distal end of the patient-internal catheter strips the biological material therefrom.
12. A medical device as in claim 11, wherein said segment of said snare wire follows a course so as to be wrapped about 360° about the tubular member.
13. A medical device as in claim 11, wherein said one end of said snare wire is bonded to a terminal end of said central wire.
14. A medical device as in claim 11, wherein said central wire includes an eyelet at a terminal end thereof, and wherein said one end of said snare wire is attached to said eyelet.
15. A medical device as in claim 14, wherein said one end of said snare wire is bonded to said eyelet.
16. A medical device as in claim 11, wherein said central wire and said snare wire are unitary.
17. A medical device as in claim 11, wherein said central wire and said snare wire each have a diameter between about 0.001 to about 0.040 inch.
18. A medical device as in claim 17, wherein a ratio of the central wire diameter to the snare wire diameter is between about 1.1:1 to about 10.0:1.
19. A procedure for removing a fibrin sheath from a distal end of a venous catheter comprising:

(i) intraluminally advancing a medical device having a tubular member, a central wire positioned within said tubular member and a snare wire connected at one end to said central wire and at another end to said tubular member;
(ii) manipulating said medical device to position a segment of said snare wire proximally of said another end thereof adjacent the fibrin sheath at the distal end of the venous catheter;
(iii) effecting relative rotation between said central wire and said tubular member to cause said snare wire segment to wrap around the distal end of the venous catheter; and then (iv) causing said wrapped snare wire segment to advance in a distal direction relative to the distal end of the venous catheter to thereby strip the fibrin sheath therefrom.
20. The procedure as in claim 19, wherein step (iii) is practiced by rotating said central wire about its longitudinal axis while maintaining said tubular member stationary.
21. The procedure as in claim 19, wherein step (iv) is practiced by advancing cat least one of said central wire and said tubular member in a distal direction.
22. The procedure as in claim 19, wherein step (iv) is practiced by advancing said central wire in a distal direction while maintaining said tubular member stationary.
CA002217481A 1995-04-05 1996-04-05 Improved devices for removing fibrin sheaths from catheters Abandoned CA2217481A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/417,018 1995-04-05
US08/417,018 US5556380A (en) 1995-04-05 1995-04-05 Method for removing fibrin sheaths from catheters

Publications (1)

Publication Number Publication Date
CA2217481A1 true CA2217481A1 (en) 1996-10-10

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Family Applications (1)

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CA002217481A Abandoned CA2217481A1 (en) 1995-04-05 1996-04-05 Improved devices for removing fibrin sheaths from catheters

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US (2) US5556380A (en)
EP (1) EP0963179B1 (en)
JP (1) JPH11503055A (en)
AT (1) ATE232698T1 (en)
AU (1) AU704987B2 (en)
CA (1) CA2217481A1 (en)
DE (1) DE69626327D1 (en)
WO (1) WO1996031162A1 (en)

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Also Published As

Publication number Publication date
EP0963179A4 (en) 1999-12-15
EP0963179A1 (en) 1999-12-15
AU5537696A (en) 1996-10-23
WO1996031162A1 (en) 1996-10-10
AU704987B2 (en) 1999-05-13
US5800444A (en) 1998-09-01
US5556380A (en) 1996-09-17
DE69626327D1 (en) 2003-03-27
ATE232698T1 (en) 2003-03-15
JPH11503055A (en) 1999-03-23
EP0963179B1 (en) 2003-02-19

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