GATTURNA ROLAND F (US)
GATTURNA ROLAND F
| US4103690A | 1978-08-01 | |||
| US4405314A | 1983-09-20 | |||
| US4349033A | 1982-09-14 | |||
| US4327722A | 1982-05-04 | |||
| US4401124A | 1983-08-30 |
| 1. | A method of locating a lesion, especially a method for locating presyπptomatic, nonpalpable breast lesion, ccπprising the steps of: (A) rτ_~~τograρhically determining the probable location of such lesion (B) • selecting a probe wire that has at its distal end a relativel small memory hook and a predetermined degree of soft flexibility; (C) sheathing the probe wire in a needle cannula whereat the wir assumes the straight configuration of the cannula and the distal ends of th wire and cannula are in a predetermined relationship as evidenced by observatio of graduated scale markings on the proximal portion of th ' ire; (D) maintaining such predetermined relationship and initiall inserting the assembled cannula and probe wire unit into the body tissue to depth whereat said distal ends are at about the site of said lesion; (E) ~__n~nographically determining if placement of such distal ends i within a predetermined spacing with regard to the lesion; (F) repositioning the unit and m__ι~rιographically determining eac aforedescribed placement of said unit until the desired accuracy is achieved; (G) solely moving the probe wire forwardly to an extent, as determine by further observation of said graduated scale markings, whereby to only fre the distal end portion having the memory hook and whereby the distal end of th probe wire assumes the hook configuration to thereby anchor itself in th tissue; (H) πsmographically determining the spatial relationship of th anchored end of the probe wire to the lesion with regard to a desired accurac thereof; (I) relying on said characteristic of soft flexibility of the prob wire, manually actuating the probe wire to release and easily slide from it anchored position in the tissue to a fully sheathed location within the cannul at said predetermined relationship of the distal ends without injury to th tissue when said desired accuracy has not been effected; and (J) repositioning the unit as aforedescribed, reanchoring the prob wire as aforedescribed, and repeating the aforedescribed mammographi determinations until the desired accuracy of the spatial relationship of th anchored end of the probe wire to the lesion site is effected. |
| 2. | The method of claim 1 comprising the additional steps of: (K) ccmpletely withdrawing and removing the cannula needle; and (L) fixing the probe wire by clamping a lock means onto the wire and simultaneously in a position whereat one surface of the lock means bears on th ■ body containing the lesion; whereby, during subsequent transportation and handling of the body, t further inhibit dislodgement of the probe wire and to prevent the body tissu from covering the proximal portion of the probe wire that may have becom nonsterile. |
| 3. | The method of claim 1 wherein the depth of unit insertion, a described in (D), is guided ty observation of graduated scale markings on th cannula needle. |
| 4. | A method of lesion excision comprising: locating the lesion ty the method of claim 1; and during surgical removal of the lesion, being guided ty observatio of graduated scale markings on the distal portion of the anchored probe wire. |
| 5. | A probe unit adapted for location of a lesion, and especially fo location of a presyπptc atic, nonpalpable breast lesion, comprising: (A) a tubular needle cannula adapted for insertion into a body to th site of said lesion; (B) a probe wire adapted to closely fit and be freely slidable throug the cannula; (C) said probe wire possessing a memory hook at its distal end whereb such end assumes the straight configuration of the cannula when sheathed therei but assumes the hook configuration when pushed through the cannula to thereb anchor itself in the tissue at the lesion when the probe unit of cannula an probe wire therein has previously been inserted into the body at about th lesion site; (D) said probe wire possessing the further characteristic of predetermined degree of soft flexibility whereby said wire is adapted to b manually actuated to release and easily slide from a said anchored location to fully sheathed disposition within the cannula and without undue destruction o surrounding tissue; (E) whereby the probe unit may be relocated within the body and th probe wire reanchored within the tissue until a desired accuracy is attaine with respect to lesion location; and (F) the cannula needle being completely withdrawable from the body an operative association with the probe wire. |
| 6. | A probe unit as in claim 5 having in combination therewith a fixing clamp comprised of: (G) a member having a first aperture axially therethrough and adapted to acccπmodate the proximal portion of an anchored probe wire when a cannula needle is withdrawn from the body and removed from operative association with the wire; (H) a threaded aperture disposed generally normal to and intersecting the first aperture;, (I) a clamping screw operatively associated with the threaded aperture; and (J) a distal face of the member adapted to ear against the bod surface through which the anchored probe wire would extend, whereupon the clamp screw would be adapted to lock the proximal portion of said wire and the bod surface would be prevented frcm rising over said extending proximal probe wire portion that may have become nonsterile. |
| 7. | A probe unit as in claim 5 wherein the cannula needle has graduated scale markings thereon whereby to determine depth of cannula or probe uni insertion into the body. |
| 8. | A probe unit as in claim 6 wherein the cannula needle has graduate scale markings thereon whereby to determine depth of cannula or probe uni insertion into the body. |
| 9. | A probe unit as in claim 5 wherein the probe wire has graduated scal markings on the proximal portion thereof wherety to deterrnine alignment of th distal ends of the assembled cannula and probe wire and whereby to determine th extent to which the probe wire need be pushed through the cannula to only fre the memory hook portion for its anchoring function. |
| 10. | A probe unit as in claim 6 wherein the probe wire has graduated scale markings on the proximal portion thereof whereby to determine alignment of th distal ends of the assembled cannula and probe wire and wherety to determine th extent to which the probe wire need be pushed through the cannula to only fre the memory hook portion for its anchoring function. |
| 11. | A probe unit as in claim 7 wherein the probe wire has graduated scal markings on the proximal portion thereof vΛiereby to dete_~r_lne alignment of th distal ends of the assembled cannula and probe wire and whereby to determine th extent to which the probe wire need be pushed through the cannula to only free the memory hook portion for its anchoring function. |
| 12. | A probe unit as in claim 5 wherein the probe wire has graduated scal markings on the distal'portion thereof whereby during excision of a lesion th surgeon is guided. |
| 13. | A probe unit as in claim 6 wherein the probe wire has graduated scal markings on the distal portion thereof whereby during excision of a lesion th surgeon is guided. |
| 14. | A probe unit as in claim 7 wherein the probe wire has graduated scal markings on the distal portion thereof whereby during excision of a lesion th surgeon is guided. .. |
| 15. | A probe unit as in claim 9 wherein the probe wire has graduated scal markings on the distal portion thereof whereby during excision of a lesion th surgeon is guided. |
| 16. | A probe unit as in claim 5 wherein the probe wire is coated with a inert material having predetermined lubricity and electrically insulativ values. |
| 17. | A probe unit as in claim 7 wherein the probe wire is coated with a inert material having predetermined lubricity and electrically insulati values. |
| 18. | A probe unit as in claim 9 wherein the probe wire is coated with a inert material having predetermined lubricity and electrically insulati values. |
| 19. | A probe unit as in claim 12 wherein the probe wire is coated with a inert material having predetermined lubricity and electrically insulati values. |
| 20. | A probe wire adapted for use with a cannula needle for location of lesion, and especially for location of a presyπptcmatic, nonpalpable brea lesion, comprising: a wire of the type possessing a relatively small m~mory hook its distal end wherety being adapted to anchor in tissue at a lesion site wh such end is pushed frcm a sheathing cannula needle that has been inserted into body containing such lesion; and said wire having a relatively soft flexibility characterist whereby said distal end when anchored is adapted to be manually actuated release and slide from such an anchored postion to a sheathed location in sa cannula without undue damage to the tissue. |
| 21. | A probe wire as in claim 20 wherein graduated scale markings ar disposed at the proximal portion of the wire wherety to facilitate location o ' the wire's distal end with respect to the distal end of a cannula needle to b used therewith and wherety to determine the extent to which the wire need b pushed tlirough a said cannula needle in order to free only the memory hoo portion for its anchoring function. |
| 22. | A probe wire as in claim 20 wherein graduated scale markings ar disposed at the distal portion of the wire whereby with the wire properl located and anchored, the markings are adapted to guide a surgeon durin excision of a lesion. |
| 23. | A probe wire as in claim 21 wherein graduated scale markings ar disposed at the distal portion of the wire whereby with the wire properl located and anchored, the markings are adapted to guide a surgeon durin excision of a lesion. |
| 24. | A probe wire as in claim 20 being coated with an inert material havin predeteirπined lubricity and insulative values. |
| 25. | A probe wire adapted for use with a cannula needle for location of lesion, and especially for location of a presymtcmatic, nonpalpable breas lesion, comprising: a wire of the type possessing a relatively small memory hook a its distal end whereby being adapted to anchor in tissue at a lesion site whe such end is pushed from a sheathing cannula needle that has been inserted into body containing such lesion; and said wire having graduated scale markings at its proximal portio wherety to facilitate location of the wire's distal end wj.th respect to th distal end of a cannula needle to be used therewith and whereby to determine th extent to which the wire need be pushed through a said cannula needle in orde to free only the memory hook portion for its anchoring function. |
| 26. | A probe wire as in claim 25 wherein graduated scale markings ar disposed at the wire's distal portion wherety with the wire properly located an anchored, the markings are adapted to guide a surgeon during excision of a sai lesion. |
| 27. | A probe wire as in claim 25 that is coated with an inert materia having predetermined lubricity and insulative values. |
The present invention- "relates to ]esion location within the body and is especially adapted to detection and location of a presyiηptcmatic, non-palpable lesion v/itliin the female breast. BACKGROUls-D OF THE I-WI-STION
It is known to rely on E-π ography in conjunction with a needle cannula having a probe wire therein for localization of a presyirptcmatic, non-palpable breast lesion. In such procedure, a needle cannula having a wire sheathed therein is inserted so that the distal end of the needle is located at about the tissue area of pathological alteration; desirably at less than 2 an from the lesion. A rnaπrnogra-. is then taken to confirm the probe position. If the probe does not accurately relate to the lesion, then the probe is relocated, or an additional probe may be inserted, and a further marn ~ ogra ~ . is taken. When the probe location is acceptable, then the cannula needle is removed-,and the patient transferred to surgery for lesion excision.
Obviously, removal of the lesion with minimal tissue damage will relate to maintenance of the wire's distal end as determined by the final mam-ographic examination.
In the instance of a straight wire probe, as for instace the Bueno Probe manufactured by Micro-Machining of d-ureinont. New Hampshire, taping-down or otherwise fixing an extending portion of the wire does not prevent movement of the wire's distal end upon breast movement and expansion after the initial probe procedure.
It is known to use a probe wire hav._ng a bend at its distal end whereby when the cannula needle is removed, the bend or hook portion anchors in the tissue. Such known bent or hooked probe wires are for instance the Frank Breast Biopsy Probe manufactured by Randall-Faichney of Avon, Massachusetts, and the Kopans Probe manufactured by Oook, Inc. of Bloomington, Indiana.- These known, hooked type localization probes have a disadvantage in that once the wire is anchored it can only be removed by resection. Thus, the Kopans Probe would have to be maπτnographically finally positioned while its wire element is ccπpletely sheathed in the cannula needle. If, after cannula removal, the resultant hook location is unsatisfactory, then another probe means must be inserte . Hence, the known bent or hooked probe wires have in effect a one-time anchoring use. Further, if more than one wire is relied on, then each anchored
wire must be surgically ranoved with consequent excision of tissue in additio to that of the lesion. ' ■ ' SUMMABY OF THE I_ ~~ _E~-TCN
The present invention is especially directed to improved means and metho for confirming location of a presymptαnatic, non-palpable breast lesion b placement and manipulation of a probe comprised of a cannula needle and prob wire therewith.
It is an object of the present invention that the probe wire be of nove construction.
It is a further object of the invention that the novel probe wire coπpris inherent anchoring means that inhibit accidental dislodgement of the wire upo ordinary and conventional movement of the body containing the lesion.
It is another object of the invention that the anchoring means comprise yieldable memory device that is manually retractable frcm ah" anchored locatio to a sheathed location within the cannula; as for relocation with respect to th lesion.
It is a further object of the invention that the novel probe wire bea graduated scale markings at its distal and proximal end portions.
It is yet another object of the invention that a positive lock means b provided at the proximal end of the probe wire.
It is an object of the invention that the novel and improved cannula needl and wire probe therewith be an uncomplicated combination of s iπple structura elements, inexpensive and easy to manufacture and simple to manipulate in lesio localization.
For a more fully developed presentation of the invention, and a preferre embodiment thereof, reference is made to the following descriptive matter an attached drawings. BRIEF DESCRIPTIOiJ OF THE DRAWINGS
FIG. 1 is a view of the probe wire of the invention assembled with longitudinal section of the cannula and, for clarity of display, in a exaggerated dimensional relationship.
FIG. 2 is a view of the self-actuating hook or memory portion of the prob wire pushed through the cannula as at an anchored location;
FIG. 3 is a view of a preferred eπibodiment of the probe wire showin graduated scale markings thereon; and
FIG. 4 is an exploded view of a probe wire clamp member.
3
DETAILED DESCRIPTION OF THE INVENTION
Referring ' to the- drawings which show a preferred embodiment of th - invention and wherein like numerals indicate like elements of structure, ther is shown in FIG. 1 a conventional probe cannula 10 and an improved probe wire 1 in assembled relationship preparatory to insertion of the unit into the bod tissue for lesion location. For purposes of clarity, the dimensiona relationship of the cannula and probe wire are exaggerated. In actuality, th wire has a close but easily slidable fit; the wire being for instanc approximately 0.015 inches in diameter and the cannula being of 20 gauge Preferably, the wife is coated, as with a silicone or teflon, for purposes lubricity and electrical insulation.
As shown in FIG. 1, the probe wire lies straight in ; ,its cannula sheathi and as so assembled, the unit is inserted into the body tissue to a locati whereat the distal end lies hopefully at about 2 cm from the lesion previously determined by manmography. The latter is repeated to confirm t accuracy of the probe location. If the desired accuracy is not confirmed, th the probe unit is repositioned and the steps repeated until the desir confirmation is attained.
Following such confirmation, the wire probe end is pushed forward of i sheathed position as illustrated in FIG. 2. Note that the freed wire end 14 h assumed the shape of a relatively small curl or hook whereby the probe wi anchors itself in the tissue at the lesion site.
The probe wire is preferably manufactured of a material having the mer-o characteristic of such relatively small curl or hook at its freed distal, end.
Materials broadly possessing such a memory characteristic and suitable f the inventive purpose are known; as for instance Nitinol, a NiTi alley produc fcy Raychem Oorp. of Menlo Park, California. Such titanium or titanium all materials have additional characteristics of being sufficiently rigid wherety inhibit dislodgement upon subsequent normal and ordinary movement and handli of the body portion in which the lesion is located; are difficult to cut; a will not easily break whereas accidental rupture of the probe wire, as is kno to occur with prior art wires, would severely complicate the procedure of lesi excision with miniiπal damage to the containing tissue. The probe wire cou also be formed of a bimetal material that is normally straight but is responsi to body heat for actuation to the hook formation.
In continuation of the localization procedure, a m-_ ~~ xjraphic determinatio is made to confirm accuracy of the anchored distal end of the probe wire to les than 2 cm from the lesion site.
Assuning that such accuracy is not confirmed, a relocation of the prob wire is desirable in order to effect an optimum surgical result. Obviously, with prior art one-time anchoring usage, such relocation is impossible; eithe the surgeon proceeds with the less than optimally desirable locater guide or new round of probe unit insertion/m-_-mographic confirmation is initiated.
However, in the instant case such relocation is possible. Th aforedescribed probe wire which is strong enough to prevent accidenta dislodgement and breaking, and is tough to cut also has an additional an critical characteristic of being flexibly soft and responsive to manual urgin wherety the anchored distal end will release and easily slide from its grasp o tissue and retract into its fully sheathed location within the cannula withou further tissue damage.
It is precisely such latter characteristic that most significantl distinguishes the instant probe wire from the prior art. In this connection, i is of interest that the U.S. Patents to Finney— ,307,723 and Tafeen—3,539,03 each disclose a catheter whose distal end possesses a memory characteristic that Vfoo—3,943,932 discloses an acupuncture needle that may possess a memor characteristic and that Hawkins—4,230,123 discloses what is described as J-wire which is inserted through a cannula for fixing the distal end of sai cannula.
Having finally located the probe wire with confirmed accuracy, the cannul is removed. As is known in the art, one may then tape down the proximal portio of the probe wire that extends from the body to therety further inhibit wir displacement upon subsequent body handling and transportion. However, it i preferred that a more positive means be relied on to both further inhibit wir displacement and to prevent tissue frcm rising over a section of such extendin proximal wire that due to prior manipulation may have become non-sterile.
Such a more positive means may comprise a biased clip type member but preferred clamp means is illustrated in FIG. 4 wherein member 16 has an apertur 18 axially therethrough and a threaded aperture 20 extending normal to apertur 18 and intersecting same. A threaded clamp-screw 22 operatively associates wit aperture 20. The cross-sectional configuration of said clamp means is broadl not material except that, to facilitate handling, the peripheral surface may b
ribbed or knurled or, as shewn, may be provided with flange portions 30. I use, the clamp means is positioned with the proximal portion of the finall anchored probe wire extending through the axially disposed aperture, the en face 24 of the clamp is brought to bear on the body surface, wherety to preven body tissue from rising over any of such proximal portion extending frctn th body, and the screw tightened to thereby fix the parts.
Graduations 26 are provided on the proximal extent of the probe wire These markings indicate both the depth of the probe wire's distal end whe anchored and the depth of the probe unit's distal end when the wire is properl sheathed in the cannula.
Graduations 28 on the extended distal portion of the probe wire are a indicatic-n to the surgeon as to relation of incision to the distal end of th wire. Such graduations 28 may extend further along the distal end than i illustrated in FIG. 3.
Graduations 11 on the cannula are provided whereby to indicate the depth o cannula penetration into the body.
Such graduations may be etchings and may be color coded.
The embodiments shown and described are only illustrative of the presen invention and are not to be construed as being delimitive thereof; since onc apprised of the invention, changes in structure would be readily apparent to on skilled in the art. Hence, the present invention includes all modifications o structure encompassed within the spirit and scope of the following claims.