US3470876A - Dirigible catheter - Google Patents

Description

Oct. 7, 1969 J. BARcHlLoN DIRIGIBLE CATHETER 4 Sheets-Sheet 1 Filed Sept. 28, 1966 INVENTOR BmfcMon John 3f Momo/Mq DI w wg ATTORNEYS Oct. 7, 1969 J. BARCHILON DIRIGIBLE CATHETER 4 Sheets-Sheet 2 Filed Sept. 28, 1966 John Boxdmbh BY .910160 wwbxqww ATTORNEYS Oct. 7, 1969 J. BARcHlLoN DIRIGIBLE CATHETER 4 Sheets-Sheet 5 Filed sept. 2a. 196e INVENTOR Bcxvch \ov1 John BY Dafo ATTORNEYS Oct. 7, 1969 J. BARcHlLoN DIRIGIBLE CATHETER 4 Sheets-Sheet 4 Filed Sept. 28, 1966 INVENTOR BY ma@ a www@ ATTORNEYS United States Patent O 3,47 0,876 DIRIGIBLE CATHETER John Barchilon, 436 E. 69th St., New York, N.Y. 10021 Filed Sept. 28, 1966, Ser. No. 582,624

Int. Cl. A61m 25 00; A61b 5/10 U.S.y Cl. 128--348 `9 Claims ABSTRACT F THE DISCLOSURE This disclosure relates to a dirigible catheter having This invention relates to catheters, and more particularly relates to dirigible catheters.

A catheter is basically a tube-like member insertable into a body passage or cavity which may be used for drawing off samples, or for other medical purposes. This invention relates to such devices and providesI a new and improved catheter which is guidable through 360 degrees.

Cathetens which have been capable of some guidance in direction of the distal end from the proximal end have heretofore been proposed. Such proposed guidance was usually accomplished by one tensioning member in the form of a wire or cord which extended along the length of the catheter within its innerv channel or bore, Wasattached adjacent the distal end of the catheter, and tensioning the cord from the proximal end of the catheter would bend the tip or distal end of the catheter in one direction.

Additionally, some 'catheters have been proposed which require such a tensioning cord as a guide means .but offset the bore of the catheter. Such construction resulted in extremely thick walls of the catheter and, therefore, reduced the bore thereof and its usefulness.

A catheter must be highly flexible so that it can be turned upon itself, yet sufficiently rigid to be Ipushed from its proximal end without kinking upon itself. Its external diameter is limited both by the passage in whichl it must be inserted and by the requirements for strength and longitudinal rigidity required for insertion and manipulation.

The present invention provides a new and improved thin-walled catheter which has a high ratio of bore or lumen dimension to overall diameter. Tlhe structure of this catheter is such that :both the outer walls and the inner walls la-re smooth and cylindrical, and the bore is concentric with the outer cylindrical walls. However, the walls have such strength as to Ireceive a plurality of tension means therein Ito allow the distal end thereof to be guided from the proximal end through 360 degrees freedom of motion.

Moreover, the construction is such that the guide lines may be simultaneously manipulated to easily guide the distal end of the catheter. The structure is further such that the walls may be made thin to maximize the ratio of the external diameter to the internal diameter. The invention Ifurther provides a catheter having a continuous bore of constant diameter concentric with the lou-ter walls and having no obstructions therein which would hinder maximum utilization of the catheter.

Accordingly, an object of this invention is to provide a new and improved catheter.

Anotlher object tof this invention is to provide a new and improved catheter having an increased ratio of internal diameter to `external diameter.

A further object of this invention is to provide a new and improved catheter having a distal end which is Idirigible through 360 degrees of motion.

Another object lof this invention is to provide new and improved means lfor guiding the distal end of a catheter from the proximal end thereof.

Further objects and `advantages of the invention will in part Ibe pointed out and in part be made apparent from the following description.

The features of the invention which are believed to be novel are set forth with particularity and Idistinctly claimed in the concluding portion of this specification. However, the invention both as to its organization and operation, together with further objects and advantages thereof may best be appreciated by reference to the following detailed description taken in conjunction with the drawings, in which:

FIG. l is a view in longitudinal section of a catheter embodying the invention;

FIG. 2 is 'a `sectional View seen in lthe plane of lines 2-2 of FIG. 1;

FIG. 3 is a view of a catheter embodying the invention together with the guidance mechanism therefor;

FIG. 4 is an enlarged view of the operating mechanism of the catheter of FIG. 3 shown partly in section;

FIG. 5 is a view seen in the plane of lines 5-5 of FIG. 4;

FIG. 6 is a view seen in the plane of lines 6 6 of FIG. 4;

FIG. 7 is an enlarged view of a portion of the operating mechanism shown in FIG. 4;

FIG. 8 is a lsectional view seen inthe plane of lines 8 8 of FIG. 7;

FIG. 9 is a view in half section of another operating mechanism Ifor t-he catheter of FIG. 1;

FIG. 10 is a sectional view seen in the plane of lines 10--10 of FIG. 9;

FIG. 11 is a view in section of a portion of the operating mechanism of FIG. 9; and

FIG. 12 is a schematic diagram showing the circuit connections for the operation of the mechanism of FIG. 9.

A catheter embodying the invention is generally indicated by the reference numeral 10 and comprises an outer cylindrical wall member 11 which is continuous along the length of the catheter 10. At the distal end 12 of catheter 10 is a tip or end piece 13 of fairly rigid material having an inwardly directed flange-like portion 14 which ts over the end of the inner catheter tube 15, and which further has a cylindrical portion 16 surrounding the inner catheter tube 15 at the distal end thereof and wlhich is bonded thereto. The member 13 further 'has a flange 17 thereon which receives guiding or tensioning cords 18a, 18b, 18C and 18d. These cords or lines are fastened to ange 17 to prevent being pulled therefrom, as by enlargement of the ends thereof by knotting of end pieces attached thereto. The cords extend through tube-like members, 19a, 1911, 19e and 19d, disposed at 90 degrees with respect to eacih other within the catheter body. A nose piece 20 is disposed about member 13 and extends back to a body member 21. Member 20 may be recessed as at 22 to enhance freedom of movement of the cords 18. Body member 21 may be formed with a shoulder 23 adapted to receive thereon the end of nose piece 20, and provide a continuous outer diameter therewith.

The catheter 10 is assembled by disposing tubes 19a and 191) about inner catheter tube 15 at 90 degrees around Uhe circumference of tube 15. This assembly is then molded within member 21 which is of a suitable exible material. One such material which has been found to have been satisfactory is a silicone compound RTV 11 of the General Electric Company. The inner tube 15 and tubes 19a- 19d'are chosen to be exible, and suitable materials have been found to be polyethylene or vinyl. During this molding operation a reinforcing sleeve of a suitable mesh material 24 is preferably disposed about the catheter tube 15 and the guide tubes 19a-19d and molded within member 21 to provide reinforcing if deemed necessary.

The member 13 is then fitted over the distal end of tube 15 and the guide or tension cords 18 may be attached and threaded through tubes 19. Member 20, which has previously been molded of similar compound as member 21, is then iitted over member 13 and extended into the shoulder 23 on member 21. Then the outer tubing 11 which has been separately molded is slipped over members and 21 to provide a smooth outer surface which is continuous throughout its length.

This construction provides a catheter which is continuous and of constant cross-section throughout its length except for the rounded distal end 12. Further, the inner tube 15 is of constant cross-section throughout its length with no obstructions therein and defines the inner catheter passage or lumen 26.

The catheter tube described may be varied in length from less than one foot to more than thirty feet, depending upon its usages which may be to inject radiopaque dyes quickly to points where lesions are suspected. Barium can be squirted directly in the region of the duodenal bulb, or the ascending colon. The catheter is further ideal for transporting a highly flexible, but rather unwildy, fiberscope. For example, a catheter could be passed into the tracheobronchial tree and with the berscope, a suspected epithelial lesion could be located. Furthermore, when the catheter is in the proper position, suction could be applied and cells can be aspirated for a cytological examination.

The cross-sectional diameter may vary from between one-eighth inch up to two inches, again depending upon its desired use. The inner diameter will vary correspondingly, but will generally be about sixty percent or more of the outer diameter.

The materials of the catheter tube are made of flexible compounds such that it can be bent and turned on itself to make right angle turns and conform to pretzel congurations. Its tiexibility range is such that it is suliiciently rigid to be pushed from its proximal portions -without kinking on itself, and at the same time exible enough to make the above-mentioned bends. The specific flexibility of the material will vary depending on its intended use. The previously mentioned General Electric Company RTV 1l silicone compound has a durometer of 48. The catheter tube itself is not subjected to tension greater than that required to pull or push it. The guide lines 18 running within its walls may be subjected to approximately twenty pounds of pull, depending upon the use of the catheter. These guide lines 18 may be made of wire, nylon, surgical silk or other suitable materials. It has been determined that the above-mentioned material can be autoclaved at 250 degrees Fahrenheit for forty-five minutes, which is more than sutlicient to assure its sterility.

Returning to FIGS. l and 2, it may be seen that tensioning one or more of the guide cords 18 will produce bending of the distal end of the catheter 10 as represented by the broken line 27. For example, the bending of the distal end shown in FIG. 1 may result from merely applying tension to the 180 degree line 18e which would exert a pull downwardly as shown in FIG. l on the ange 17 of member 13. By selectively tensioning different ones of lines 18a-18d the distal end may be directed in any direction throughout 360 degrees with respect to a plane perpendicular to the axes thereof.

Reference is now made to FIG. 3 which shows the Catheter 10 mounted to a manipulating device 30 which contains a mechanism for selectively operating `the cords 18a-18d. The manipulating device is exemplified in the form of a member having a pistol grip 31 which has a passage 32 defined therethrough which is coaxial and of essentially the same size as lumen 26.

The catheter `tube 11 is coupled to the `assembly 31 by means of an adaptor 34. Adaptor 34 at one end thereof has longitudinally extending lfingers 35 defined by longitudinally extending slits 36 therein, and is threaded at 37 to receive a chuck-like member 38. Adaptor member 34 further includes a collar-like member 39 received in an undercut 40 therein which has internal threads 41 adapted to mate with threads 42 on the exterior of barrel 43. To assemble the catheter tube to the handle and operating assembly, the lines 18a-18d are connected to mating lines 18a-18d' extending from an operating mechanism, hereinafter described, as by means such as hook and eye connectors 44. Then adaptor 34 is fitted to barrel 43 and has an intercocking tit as indicated at 45 therewith. Then the collar-like member 39 is threaded on t-o handle member 30 and the adaptor is made fast to handle `30.

Then the catheter tube is pulled outwardly of adaptor 34 to tension the lines 18a-18d so that there is no slack therein, and all lines are equally tensioned with the distal end of the catheter tube unbent. At this time, chuck-like member 38 is threaded tightly on to adaptor 34 so that the inclined portion 38a of chuck-like member 38 rides up over lingers 35 and compresses lingers 35 about the catheter tube. This compression of the fingers 35 about catheter tube 11 `holds it securely in place and prevents either longitudinal or rotational movement thereof with respect to barrel 43.

The lumen of catheter 10 is now coaxially aligned with the passage 32 dened in 'barrel 43.

Disposed within barrel 43 is a bushing or sleeve-like member 46 which acts as a guide for lines l8a'-18d extending from a guiding cont-rol mechanism 47. The function of sleeve 46 is to space the guide lines 18a-18d' as they change from a generally inclined direction with respect to the lumen of the catheter to a direction which is parallel of the axis -of the lumen of the catheter. This further provides a clear access to the lumen through the barrel 43. This is more clearly shown in FIG. 6. It will be noted that the line 18a must cross passage 32 without adding an obstruction thereto. This is done by gently curving line 18a in a helical path about the bushing or sleeve 46, and for this purpose such Ia path may be dened therein. In this manner, appropriately contoured passages may be defined in the exterior periphery thereof yfor any yor all of line 18a18d as may `be required.

The catherter guidance mechanism 47 is more clearly shown in FIGS. 6-8. This mechanism provides a means for guiding the distal end of the catheter through 360 degrees projected on one plane.

The lines or cords 18a and 18C', and 18b' and 18d are in continuous pairs, each pair disposed about a wheel which upon rotation thereof tensions one line of a pair and releases tension in the other line of the pair.

The guidance mechanism 47 comprises a base member in the form of a plate 49 having `an aperture defined therethrough which receives a ball 50. Ball `50 is vrotatable in plate 49 and retained in position with respect thereto by upper and lower -retaining plates 51 and 52. Extending through ball 50 is 1a shaft 53 having a trimble-like end piece 54 adapted to receive a iinger for manipulation of shaft 53.

Shaft 53 extends through an opening 55 delined by two pairs of half ring members 56, 57; and `58, 59, disposed perpendicular to each other. Members 56 and 57 are secured at their ends to coaxi-al shafts `and 61 which are rotatably carried in brackets 62 and 63, respectively, which are in turn carried on plate 49. Similarly, members 58 and 59 are secured to shafts 64 and 65, rotatably carried in briackets 66 and 67, mounted on plate 49.

Mounted to shafts 61 and 65 are gears 68 and 69, respectively. Also rotatably carried in brackets 62 and 67 are shafts and 71, respectively. Mounted to shaft 70 is a gear 72 in meshing engagement with gear 68. When vgear 72 is driven by gear 68 it'rotates a sheave 'or wheel 73. Mounted to shaft 71 is a gear 74 and wheel 7S. When gear 69 rotates gear 74 it also rotates a sheave or wheel 75.

Disposed about wheel 73 are lines 18b' and 18d. Disposed about Wheel 75 are lines 18a and 18e.

In operation, it may be seen that when 'shaft 53 is manipulated it will act against one or both pairs of members 56, 57 or 58, 59 and produce rotation of'one or both of shafts -61 and/or 65. This will produce resultant rotation of one or both of wheels 73 and 75.l Wheel 73, about which is wound lines 18b and 18d, upon rotation thereof, will tension one of the lines and provide slack in the other of the lines. Similarly, rotation of wheel 75 will tension oneA of lines 18a or 18e and provide slack in the other of the lines. "llherefore, any two of lines 18a through 18d residing at righ-t angles to each other may be simultaneously tensioned to exert a pulling force on member 1,3 and, therefore, bend and guide the distal end of the catheter through 360 degrees.

It may thus be seen that this operating mechanism, While providing 360 degrees of motion at the `distal end of the catheter tube, allows the gui-de lines which are 180 degrees apart to be tensioned and slacked simultaneously, and fur-ther provides that varying amounts of tension may be applied to the guide lines which are 90 degrees apart .to bend and position the distal end of the catheter Iat any angle.

While the degree of motion has been spoken of as 360 degrees, it will be understood that this refers to 360 degress in one plane which is perpendicular to the axis of the catheter in its relaxed position, and further provides for three-dimensional positioning of the distal end of the catheter with respect to such 360 degrees.

Other techniques of selectively tensioning one of a pair of the guide lines may be utilized. FIG. 9 shows an alternate embodiment 4which works on 4an electromagnetic principle. In FIG. 9 each of the lines '18a-18d are connected to the plungers 80er-80d of electromagnets having coils 81a-81dgDependent upon the magnitude of energization of the coils, the plungers therein will either advance as shown in FIG. 9 or be retracted towards the left. Each of the electromagnets is disposed 90 degrees with respect t-o the axis of the catheter within a housing member 82 having Aa bore 83 coaxial with the catheter lumen.

The electromagnets are selectively energized through a mechanism similar to that shown in FIGS, 6-8. This mechanism lis illustnated in fFIG. 11 and like reference numerals to those used in FIGS. 6-8 identify like elements in FIG. 11. In the mechanism 84, the shaft 61 has mounted thereto the contact arm 85 of a potentiometer 86. The shaft 65 carries a contact arm 87 of a potentiometer 88.

The circuit connection to the potentiometers 86 and 88 with coils 81a-81d are shown in FIG. 12. It will be noted that the current from va-source such as battery 89 is applied to both of the contact arms 85 and 87, and when these contact arms are on the midpoint of the resistance of potentiometers -86 and 88 all coils will be equally energized and the tension in all 0f lines 18a-18d will -be equal. However, when the contact arms are displaced as 'shown in FIG. l2, coils 81a and 81b will receive more current than coils y81C and 81d, respectively. Therefore, lines 18a and 18d will be tensioned with respect to other lines and the distal end of the catheter will be guided in a quadrant dened by the lines 18a and 18b.

It may thus be seen that by proper manipulation of shaft S3 with one tinger, the distal end of the catheter may be guided through 360 degrees, and provides continuous three-dimensional vectonal resolution to coordinate axes. Preferably, a pistol-type grip las illustrated is used to handle the manipulation assembly so that the distal end of the catheter may be guided through use of one dinger.

The disclosed catheter may have many applications. 'For example, in radiology, the catheter provides a means by way of which radiopaque dyes can be injected quickly to points where lesions are suspected. The disclosed catheter is ideal for transporting the highly flexible, but rather unwieldy fiberscope. In another embodiment of the invention a Ifiber-scope could be incorporated into the walls of the catheter and the catheter lumen would be then used for providing instrumentation. For example, the catheter with la built-in iiberscope could be passed into the tracheobronchial tree and a suspected epithelial lesion located. Then suction could be applied to the region in question and cells coul-d be aspirated for cytological examination. Further, this catheter would be useful in pulmonary embolectorny. Once the ldisclosed catheter, for example, with a fiberscope therein is utilized to locate an embolus (cardiac catheterization and injection of radiopaque dye under iiuoroscopy) a second catheter, the embolectomy catheter, which consists of a small plastic drill piece Iwould be utilized to break up and drive the thrombus linto the catheter. Suction applied :at pressures greater than right ventricular systole would cause bits of thrombus to be sucked back through the embolectomy catheter. Additionally, the embolectomy catheter could be utilized for taking small samples which would be drawn back into the disclosed catheter.

From the foregoing disclosure, it may be seen that the objects of the invention set lorth as well as those made apparent `from the preceding `description are ediciently attained. While presently preferred embodiments of the invention have been set -forth for purposes of disclosure, other embodiments of the invention and modilications to the disclosed embodiments which do not deplamt from the spirit and scope of this invention may oc cur to others skilled in the art. Accordingly, the appended claims are intended to cover all embodiments of the invention as well als modifications to the disclosed embodiments of the invention which do not depart from the spirit 'and scope thereof.

What is claimed Lis:

1. A catheter comprising a flexible elongated tube hav ing a proximal end and a distal en-d adapted to be inserted into a body passage, said tube having a continuously smooth outer `surface `and continuously smooth inner walls defining a continuous unobstructed passage from said proximal end to said distal end, a plurality of guide lines anchored adjacent the distal end of said tube and equiangularly between the walls defining the passage and the outer surface of the catheter, said lines being longitudinally movable with respect to said tube, said lines being four in number and disposed degrees about said catheter, the lines degrees apart forming a pair, to means for tensioning said lines including means for simultaneously tensioning one line of a pair and releasing tension in the other line of a pair.

2. The catheter of claim 1 wherein said catheter -further comprises an inner tube derning the continuous passage 'and an |outer |tube defining said outer surface spaced from said inner tube, said lines being disposed .about said inner tube, means secured to said inner tube adjacent the distal end thereof, land said lines being anchored to said coupling means.

3. The catheter of claim \1 wherein said means for tensioning comprises electrornagnetically operated means connected to each of said lines, energizing means for said electromagnetically operated means, said energizing means being differentially connected so that as the tension in one of said lines of a pair is increased the ten-sion in the other of the line of a pair is decreased.

4. An elongated tube-like member comprising -an inner exible tube member having a smooth, continuous inner wall, an outer flexible tube member disposed about said inner tube and having a s-mooth continuous outer surface, means coupling said tubes at the distal ends thereof, our `guide lines disposed at 90 degrees with respect to each 7 other between said tubes and securedlto Said coupling means, and means `for selectively tensioning two lines and releasing 'tension the lines 180 `degrees therefrom.

5. The apparatus of claim 4 wherein said coupling means comprises a member disposed about and secured to said inner tube and having an annular flange adapted to receive said lines.

6. A catheter comprising an elongated flexible tube member having proximal and distal ends, two pairs of force-producing lines extending alongsaid member between said proximal and distal ends, the lines of said pairs being spaced substantially 180 degrees apart so that Said exible member may be caused to bend by exerting a force on one line of a pair and releasing force on the other line of a pair, electromagnetically operated force-producing means for each of said lines, means connecting each of said lines to one of Said electromagnelically operated means, and energizing means for simultaneously operating two of said electromagnetically operated means to release forced on one line of a pair and apply force to another line of a pair.

7. The apparatus of claim 6 further including means for simultaneously energizing all of said electromagnetically operated means in pairs.

8. The apparatus of clairn 6 wherein Said electromagnetically operated means comprise two pairs of electromagnets having magnetic elements movable in a direction and magnitude dependent on the strength of a magnetic eld applied thereto, means for producing magnetic elds for each of said magnetic elements and means for simultaneously Strengthening the field of one electromagnet of a pair and weakening the field of the other electromagnet of a pair.

9.*The apparatus' of claim 6 wherein said energizing means for each pair of lines includes a potentiometer having a resistance and contact arm, each pair of energizing means` being .connected to opposite ends of one potentiometer resistance and differentially energized therethrough dependent of the position` of the Contact arm on said re- Sistance, and means connected to Said contact arms to allow simultaneous and independent movement of the contact arm of each potentiometer.

References Cited UNITED STATES PATENTS 2,432,869 12/1947 Elmer 244-87X 2,453,862 11-/1948 Salisbury 128-9 2,498,692 2/1950 Mains 128-348 2,836,253 5/1958 Lovell 18o-27 2,975,785 3/1961 Sheldon 128-6 3,058,473 10/1962 Whitehead 128-349 3,091,235 5/1963 Richards 128-6 3,183,410 5/1965 Fiora 335-268 x 3,190,286 6/1965 Stokes 128-6 3,162,214 12/1964 Bazinet 128-4 `FOREIGN PATENTS 548,462 10/1942 Great Britain.

DALT ON L. TRULUCK, Primary Examiner U.S. Cl. X.R.

'(gjtlgo UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 3, l470 876 Dated October 7 1969 Invencor(s) John Barchi lon It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:

r- Column 6, line 52, after "pair," delete the word "to" and substitute therefor and Column 7, line 20, delete "forced" and substitute therefor force SIGNED ND SEALED JUN 9 1970 'ximvvjl'Ufnn'a f. r. .jgmgj' ,mxm (SEAL) Auen:

WIIILIAM E? ISGHUYIIER, J'R. r. Edvard Mjitcher'] Commissioner of Patents Atteating cer

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