US 3539034 A
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flnited States Patent  Inventor Carl 11. Tnfeen 186 Beach 137th St., Belle Harbor, New York 11694  Appl. No. 585,833  Filed Oct. 11, 1966  Patented Nov. 10, 1970 54] PARACERVICALBLOCK ANESTHESI ASSEMBLY 7 Claims, 12 Drawing Figs.  11.8. C1 128/221  1nt.Cl A61m 5/00  Field olSearch 128/2144, 215, 221, UK Digest). 347. 348, 350; 27/24.]
 References Cited UNITED STATES PATENTS 2,922,420 1/1960 Cheng 128/221 3,419,010 12/1968 Williamson 128/350 3,308,819 3/1967 Arp 128/215 F ORElGN PATENTS 135,689 5/1952 Sweden 128/221 707,333 4/1931 France 128/349 902,521 12/1944 France 123/347 1,064,445 12/1953 France 128/221 OTHER REFERENCES Cordis Corp, Hakim-Valve System for Ventriculo- Atriostomy. Oct. 5. 1965, P. 2. 128/350.
Primary Examiner- Richard A. Gaudet Assistant ExaminerChanning L. Pace Attorney-Kane, Dalsimer, Kane, Sullivan and Kurucz characteristics thereby to return to a normal state after introduction into body tissue and removal of the introduction means.
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llllllllll v INVENT BY... 1 wrm I 7 ATTORNE raaacaav csnarocxAnesthesia,ASSEMBLY Piesent day obstetrical practices indicate a ggaining releasably lock the member and the puncture means whenthe latter is axially moved from a first inoperative position to a second position'so that the puncture portion longitudinally widespread popularity of procedures for the continuous anesthesia,
Topractice any continuous anesthesia. procedure for the ad'- ministration-of liquids over prolonged periods it isnece's'sa'ry 1 either to cause separate punctures to. be made for each injection or else] provide a-catheter memberthat iscapable of being oriented within the region: of the, injection, and remain in situ for the period over which; many injectionsmay be, made. The former ni'ethodyis; not' practicedto any great. extent since it tends to cause undue trauma, thus being totally undesirable. Therefore, those practicing, within} the, medical profession have looked to the latter r'nethot'i.v
Present d'ay disvice'siemployed provide a catheter for the administration of anesthesiafor performing a paracervical block procedure. Whilejsu'ch devices are employed theindustry has not developed. a catheter. or paracervical block. anesthesia device which has distinguished itself apart from present device'sso as to attainwides'pr'eadrecognition;
Generally, present day catheters have been. difficult to use chiefly due toth'e complexity, of the, overall system by. which they are, introduced-arid locatedf ithin the.- region' to be anesthe'ti zed'and the catheters therri lvesfls're not capable, except with extreme; caution, of rem'ainlngilta fixediposition.
V during. patieribmovementlor,accidefltaljarring. Further, these catheters are found to. present; a. relatively-sharp. end. which may cause injury to ati ntand :bfaby.
it} is. therefore,an-objectito provide paracervic'al block. ap
pai'at'u's for per riningf parace'rvical block. procedures in which ajnestheti rig liquids. may be administered over prolonged period's. thrdujghouta total procedure without removal from the regionbeing anesthetized.
, Another object as thejprescnt'invention.is. to provide a catheter system which may, be us'edduring. prolonged or con?- tinu ous anesthetizing r procedures and which isofsimplified construction thereby being easy to use; whichmaybe conveniently oriented. anddue to its. particular configuration remain, withoutyextreniecaution, within a region in which an injectionior.injectionsare to, be made; and is of a substantially nontraum a producing. construction.
' it is a, furtherobject. to provide a 1 paracervical catheter which, inlay. be inexpensively: manufactured andfither'eby disposableafterasingleuse. 4 1 i ntages ofthe present invention will Other. objectsand ;ad va become: apparent detaileddescriltiien f el preferredembodimentof the inventi'onis. deyelt pd in 'broadtsehpertherinvention isrdirec'ted to a catheterassembly forr use} ins paracervic'al 'orother nerve. blocking.
procedures comprisingta tubularcatheterumentbfe'rof a flexible plastic material having plastic memory characteristics; The
catheter "mernber hasa iirst end through which fluids may be introduced andremoved and asecondend, to be insertedin the tissue, The posteribrkof the catheter imembcr adjacent said biiisssswns a, continuous paracervicalt block anesthesia ap-- par'atus; The apparatus comprises-acatheter assembly includirig aj fcatheterelementghavingla precui-ved distal end and a catheter stylet removablyreceivedwithin theeleinent thereby to straighten the distalcurve The apparatus alsocomprises a itskilled in they ,artas the following projects from'the member to provide a cut in the paracervieal .tissueThe catheter assembly is received within the puncture means and movable to a fitst nonprojecting' position, the
catheter assembly thereafter being movable to' a second tissue piercing position so that the catheter element penetrates thetissueand allows'tor' for the removal of the guide membergf FIG. 1 is an elevational view of the various structural components included in the preferred paracervical block anesthesia'assembly;
FIG. 1a is an elevational view partly in section of a second embodiment of a puncture needle;
FIGS". 2- 10- represent an operational sequence followed in using the components of FIG. I soas to produce a puncture and orient the catheter within the tissue of the paracervical block prior to an anesthetizing injection; and FIG. 11' is an elevationalview in section showi'ngthe assembledapparatusas seen along the line ll l l in FIG. 7.
Referring now to-the drawings and specifically to FIG. 1, there is shown a 'paracervical block anesthesia apparatus, denoted by the numeral 10. A preferred embodiment of the apparatus generally includes a catheter 12. a catheter stylet l4, aneedlc assembly including a needle support 16 together with a puncture needle stylet l8, and a needle assembly and catheter guide 20: Also included is a catheter adapter 22 and an. adapter plug 24, both of which are employed once the catheter 12 has, beenorientedand fixed in situ within the re- 1 gion that is tobe subjected to an anesthesia injection.
. second ,endlbeing norrnally; dispo'sedin a hook. shaped curve which can be. temporarily I straightened out when a stylet .70 guide niem'ber having a longitudinal. bore for receiving a puncture means includinga puncture portionrfor producing a; punctur e intthepajracervical tissue. Theguidemember is provided with a ,first,,-lock .means that is adapted :to cooperate witht'a second lock, means on the. puncture. means thereby to As shown in the FIG. the catheterll is in-the form of an elongated tube, one'end of which presents apreformed normally hook shaped curved portion 26]. The catheter is suitably fabricated of .a resilient, flexible and yielding material, such as a plastic, that displays goodmemory characteristics. While many plastics may be employed in'the fabrication of the catheter element, good results have been achieved through the use of TEFLON, a material which is inert to, both parenteral liquids and biological fluids that may pass therethrough. Beingsuch, TEFLON is preferred. t I
Thejdistal curve-26 may be conveniently formedin the catheterelementprior to usage, such'as, during the fabricationprocedure. As will be discussed, the distal curve and the memory to return to the curved configuration after straighteningis a feature of primeimportance in the present invention.
' This will be brought out in greater detail but generally, it is the curved distal portion. which maintains the catheter in a substantiallyfixedposition within the tissue of the paracervical region once being properly'applied and oriented.
While the physical'characteristics of the catheter may vary in -accordance with the operational characteristics and function of the overall apparatus, in the preferred embodimentas' shownin FlG.- l, thecatheter is formed with a relatively small r axialbore and is of'extended length. in accordance with acceptable tolerances, the catheter bore is of a diameter slightly in excess of the outer diameter of the catheter stylet and is of approximatelythe same length.
The catheter stylet is defined by an elongated shank portion 27 and a handle or hub portion 28; The hub is shaped to provideease-in handling. The stylet shank may be of solid construction presentinga constant outer diameter of a size so that it is' capable of i being. introduced within the bore of the catheter in close fitting relation- A relatively tight fit is desired so, that excessive amounts of cut tissue do notenter the catheter bore. Obviously, the tighterthe fit of the stylet the 'lesstissueis allowed to enter the bore but it should be noted that the fit should not be so tight as to hinder insertion and ease in removal. The shank is preferably ofa length that is substantially equal to the length of the catheter 12. Therefore, when received within the catheter bore to straighten the distal end 26, the tip 29 will be disposed substantially at the distal end of the catheter yet, will not project therefrom. Thus, the stylet will provide support for the catheter throughout its length but its rigid and unyielding tip will be covered by the catheter to prevent any harm to the patient.
As shown in FIG. I, a pair of indicator lines 31 located at points, respectively, 22.5 cm. and 24 cm. from tip 29 are etched or otherwise provided on the stylet shank. The function of these lines will be brought out below in conjunction with a discussion of the implementation of the apparatus as shown in FIGS. 2-10.
The apparatus also comprises an assembly which includes a needle support or guide 16 and a puncture needle stylet 18. The puncture needle stylet is defined by a shank portion 19 which terminates in tissue piercing portion 33. As shown in FIG. 1 the piercing portion is of cone shaped configuration presenting a sharply pointed tip or apex. It should be apparent that the tip may also be of bevelled configuration, for example, as choice determines. A handle portion 36 aids in gripping and manipulation so that a puncture may be made.
Needle support 16 is defined by a hub 38 which carries a longitudinal shank 40 having an axial bore (FIG. 11). The bore is dimensioned to receive the needle stylet 18 in close fitting relation. Shank 40 terminates in a frustoconical tip 42. In the embodiment of FIG. I, the tip configuration provides for a smooth flowing junction between the stylet tip 33 and the frustoconical surface 42. The puncture is produced by the needle stylet and in particular by the sharp pointed end 33. Therefore, the needle stylet is to be of a length which, when received within the needle support, is sufficient to allow the tip 33 to project beyond the end of support 16. In this disposition the wall of tip 33 will smoothly flow into the wall of portion 42 so that there is no discernible junction in which cut thromboplastin may collect.
An assembly guide 20 is furnished to support the aforementioned structure. The guide is similarly of elongated form and is provided with a hub and a longitudinal shank with an internal uniformly dimensioned bore (FIG. 11). This bore is substantially equal in dimension to the outer diameter of the needle support 16 thereby to hold the latter in a coaxial position when received in the former. A longitudinal channel or slot 30 is provided within the hub portion. The longitudinal slot terminates in a generally transverse and upwardly directed slot 32.
As shown in FIG. I a bulbous end 43, suitably of larger dimension than the shank dimension, is formed on the guide. Due to the enlarged bulbous end the guide may be rested on the tissue surface at the region to be pierced and anesthetized, thereby to support the apparatus. Further, the apparatus may be supported without a traumatic reaction.
Lug 34, formed in the shank of guide 16, cooperates with the slots 30 and 32 and this intercooperation provides a locking means for releasably locking the needle support within the assembly guide 20 in bayonet locking" fashion. The slot 30 is of a length such that the incision tip 33, upon the lug moving into the slot 32, projects beyond the bulbous end 42 as shown in FIG. 4. In such position the parts are locked. Therefore, when locating the area to be anesthetized, the needle support 16 is initially received within the assembly guide 20 and properly retained at an upper position. Thus, the lug 34 is allowed to rest on the upper wall 44 of the assembly guide 20 (FIG. 3).
A second embodiment of a needle is represented in FIG. 1a. The needle, indicated by the numeral 46, is generally similar to the needle support 16 and, as such, only a portion is shown. In the manner discussed, needle 46 is received within assembly guide 20 such that lug 34 cooperates with the surface 44 and slots 30 and 32 to suspend the needle in an upper inoperative position and a lower locked" position. Needle 46 is provided with a bevelled end 48 which is capable of producing a tissue puncture. In this case the need for a cutting needle stylet, such as stylet 18, is obviated although a stylet (not shown), which should be of a complementary bevelled configuration, may be received within the needle 46. The stylet should not project from the needle 46 and therefore, would not, of itself, produce an incision. Its function would be primarily to prevent any cut tissue from entering the needle bore 47.
Except as specifically discussed, the paracervical assembly as shown in FIG. l.is formed of rigid stainless steel or an equivalent material conveniently allowing for sterilization by known methods and subsequent reuse. If, however, the apparatus is to be a disposable unit it may be fabricated from any of the accepted plastics that are both rigid and inert to biological fluids. Such materials, to name a few, are polyethylene or polystyrene.
The interconnection of the various structural parts into the assembly as shown in FIG. 11 may best be described in conjunction with FIGS. 2-10. These FIGS. sequentially depict the operational technique followed in the use of a preferred form of the paracervical block anesthesia apparatus. Generally then, the FIGS. shown the method to produce an initial puncture of the paracervical tissue, the introduction of the catheter within the punctured region and the removal of all structure, aside from the catheter which is firmly embedded within the paracervical tissue for prolonged administration of anesthesia in the performance of a paracervical block procedure.
In the performance of such a procedure the catheter may be inserted into the patient at any time but medication is not injected until labor is definitely established and the cervix has dilated approximately 3 to 4 cm.
Referring to FIGS. 2--4, the assembly guide 20 with the needle assembly (needle support 16 and needle stylet 18) in the retracted position (FIG. 3) is directed between the middle and index fingers ofone hand which is positioned in the vagina in a manner such that the finger tips reach the vault on the right side between the fetal head and the puncture site. The guide 20 is advanced to a position such that its bulbous end 43 abuts the tissue, generally indicated at 50. When properly positioned the needle support is rotated and advanced into the hub of assembly guide 20. During this movement the lug 34 will move along the slot 30, thereafter being "locked" when fully advanced and rotated into slot 32. At this point (FIG. 4) the needle support and puncture stylet will have penetrated the paracervical space a distance of approximately one-half inch.
Once the puncture is accomplished the needle stylet is removed from the needle support. A sterile syringe (not shown) containing any local anesthetic, such as mepivacaine hydrochloride, is attached to the needle support by means of threads 52 and the puncture site is aspirated. If no blood enters the needle support 3 cc. of 1 percent mepivacaine hydrochloride is injected to distend the area.
Turning to FIGS. 5-7, the catheter assembly including the catheter 12 and catheter stylet 14, received therein to straighten the distal curve 26, is then introduced into the support 16 which remains "locked" within the assembly guide 20. The catheter assembly is initially received to a point at which the lower indicating line 31 (22.5 cm. line) is in coincidence with the upper surface 54 of the support 16. In such a position the catheter is substantially in line with the end of the frustoconical portion 42.
By increasing the forward pressure on the catheter assembly, the catheter will enter the tissue by an additional incremental amount. Pressure is exerted until the upper line 31 (24 cm. line) is in coincidence with surface 54 so that the catheter is located within the tissue as in FIG. 7.
FIGS. 8 and 9 represent the removal of the supporting apparatus. Thus, by gripping the upper end of the catheter 12, the stylet 14 may be removed (FIG. 8). Upon removal of the stylet the distal curve 26 will reform within the distended area thereby retaining the catheterin a fixed position within the paracervicaltissue. Thereafter, the needlesupport l6'and assembly guide 20 may be carefully removed as a unit (FIG. 9), with the catheter remaining in the tissue.
In FIG. 10 the catheter adapter 22 is shown received on the catheter at 56 in amanner such that rigid tube 58 of the adapter is tightly and frictionally supported with the bore of the catheter l2. a
The adapter 22 is provided with a threaded portion 60 and by means of cooperating threads (not shown) on the adapter plug 24 the distal end of catheter 12 is sealed.
Once the catheter has been located within the paracervical tissue and sealed, as above, it is properly secured to the lower abdomen of the patient by means of an adhesive strip or the equivalent.
The puncture site and the catheter positioning is preferably at the lateral fernix of the vagina within the 89 oclock and 3-4 o'clock positions.
. The foregoing describes the locating and seating of one catheter by positioning the assembly between the fingers of one hand and manipulating it with the other. Obviously, the second catheter is positioned and retained in fixed location in a similar manner but for convenience the hands are reversed for ease in operation.
Asnoted, the procedure may be carried out prior to the definite establishment of labor. Thus, having once oriented the catheters anesthetic injections, as required,may be administered when labor is established and continued over prolonged periods. Prolonged administration may be carried out with one catheter placement'since the distal curve in the catheter maintains it fixe'd in situwithin the paracervical tissue.
From the foregoing it should be apparent that the objects and advantages'ofthe invention are uniquely carried out. lt is seen that the invention provides a simplified, convenient and guide member having an axial bore, puncture means having a puncture portion at one'end for producing a puncture in the paracervical tissue, first lock means on said guide member,-
second lock means on said puncture means adapted to cooperate with said first lock means therebyreleasably to lock the guide member and puncture means when the latter is axially moved from a firstinoperative position to a second puncture making position, said puncture means being received within the bore of said guide member and movable from said first to said releasably locked position so that the puncture portion longitudinally projects from said guidemember to provide a cut in'said paracervical tissue, said catheter assembly being received within'said puncture means in a first nonprojectingposition and thereafter being movable to a second tissue piercing position with said catheter element penetrating thetissue so that said catheter stylet, guide member and puncture means may be removed therefrom to cause said catheter element distal end to return to its precurved configuration whereby the catheter element will remain fixed in situ and-a prescribed injection-may be introduced to-the paracervical block.
2. The apparatus of claim 1 wherein said puncture meansincludes a needle stylet having a sharp puncture producing end and a needle'stylet guide having a central bore, said needle stylet being received within said bore and positioned in a manner such that the puncture producing end projects beyond the support end, said needle stylet being removed from this dispositon when said paracervical puncture has been performed.
3. The apparatus of claim 1 wherein said puncture means has a sharp beveled cutting end to produce said paracervical puncture.
4. The apparatus of claim 1 comprising an adapter having tubular portion-and a hub portion, said tubular portion being received within said catheter bore after the'catheter is fixed in situ, and a sealing means sealing the hub.
5. The apparatus of claim 4 wherein said sealing means is a plug, said plug being removably received on said adapter hub thereby to seal the catheter during periods when no injections are being introduced to the paracervical region.
6. An anesthetizing apparatus useful in paracervical or other nerve block procedures comprising a tubular catheter member made of a flexible plastic material having plastic memory characteristics, said catheter member having a first end through which fluids may be introduced and removed and a second end to be inserted in the tissue, the portion of the catheter member adjacent said second end being normally disposed in a hook shaped curve, a stylet member having a gripping end portion and a longitudinal shank of a length substantially equal to the length of the catheter member connected to and projecting from the gripping portion, said stylet member being formed of a material which is relatively more rigid than said catheter member and having a shank diameter which is less than the bore of said catheter member so that said stylet member may be temporarily slidably received with the bore of said catheter member to straighten the hook shaped curve at said second end, a guide member having an axial bore, puncture means having a puncture portion at one end for producing a puncture in the paracervical tissue, said puncture means being received within the bore of said guide member and movable from a first inoperable position to a second puncturing position so that the puncture portion longitudinally projects from said guide member to provide a cut in said paracervical tissue, and cooperable lock means on said guide member and puncture means thereby to releasably lock the same in saidsecond position, said catheter and stylet members being received within said puncture means and located in a first nonprojecting position, and thereafter movable to a second tissue piercing position with said catheter member penetrating the paracervical tissue so that said catheter stylet member, guide member and puncture means may be removed therefrom to cause said catheter distal curve to return to its normal hook shaped configuration whereby the catheter will remain fixed in situ and prescribed injections may be introduced to the paracervical block over prolonged periods.
7. An anesthetizing apparatus useful in paracervical or other nerve blocking procedures comprising a tubular catheter member made of a flexible plastic material having plastic memory characteristics, said catheter member having a first end through which fluids may be introduced and removed and a second end to be inserted in the tissue, the portion of the catheter member adjacent said second end being normally disposed in a hook shaped curve, a stylet member having a gripping end portion and a longitudinal shank of a length substantially equal to the length substantially equal to the length of the catheter member connected to and projecting from the gripping portion, said stylet member being formed of a material which is relatively more rigid than said catheter member and having a shank diameter which is less than the bore of said catheter member so that said stylet member may be temporarily slidably received with the bore of said catheter member to straighten the hook shaped curve at said second end, a guide. member'having an axial bore, puncture means having a puncture portion at one end for producing a puncture in the paracervical tissue, said puncture being received within the bore of said guide member and movable from a first inoperable position to a second puncturing position so that the puncture portion longitudinally projects from said guide paracervical tissue so that said catheter stylet member, guide member and puncture means may be removed therefrom to cause said catheter distal curve to return to its normal hook shaped configuration whereby the catheter will remain fixed in situ and prescribed injections may be introduced to the paracervical block over prolonged periods.