Abstract:
The present invention provides a deflectable guide whose use results in protection of the hand of medical personnel holding a medical container during the activity of moving a hypodermic needle toward and pressing it through a septum of the medical container. The present invention further is adapted for use of the same syringe and deflector guide protected needle for injection or withdrawal of medical liquids from a septum end of medical catheter or intravenous tubing without removal of the deflectable guide.

Description:
This non-provisional application claims the benefit of priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application Ser. No. 61/281,468, filed Nov. 17, 2009, which is herein incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to withdrawal from septum vial or container and subsequent administration by hypodermic syringe of medically required liquids. More specifically, the invention relates to devices protecting medical personnel during such actions. 
     BACKGROUND OF THE INVENTION 
     Medical personnel are routinely required to inject and/or withdraw from medical containers, such as vials, bottles, and flexible bags, medically required liquids using a syringe engaged with a hypodermic needle or other septum puncturing means. Some of such medical containers have ready to use concentrates which must be withdrawn for injection into a larger volume of liquid in a separate medical container. Other such medical containers have ready to use liquids containing medication or flushing liquids to be administered directly to patients. Still other such medical containers have dry powders which must receive by injection a measured amount of liquid for reconstitution of a medical liquid to be used as a concentrate or ready to use liquid. 
     This activity of injection and withdrawal related to the above medical containers is deceptively simple. The time and emotional pressure typical of the medical treatment environment results in many improperly directed needle placements by medical personnel. A substantial focus of the prior art is made toward improving safety during the activity of hypodermic needle injection or withdrawal of fluids and liquids from a patient&#39;s veins, arteries, or other subcutaneous location. However, the present inventor has observed that doctors, nurses, pharmacists, and other healthcare professionals must, with one hand, hold such a medical container upside down and insert a hypodermic needle connected to a syringe through a rubber or elastomer septum of the medical container with the other hand, sometimes resulting in a needle puncture wound (sometimes quite deep) to the hand holding the medical container. Alternately, a needle puncture may occur to a medical tube conduit for intravenous fluids or to a flexible bag receiving injectable liquids from the syringe. The medical personnel administering or withdrawing liquids via syringe need only make a minor misalignment caused by lack of focus or an unsteady hand to cause such injury or damage. 
     It is well known that removal or covering of the hypodermic needle from the syringe upon completion of injection or withdrawal of medical liquids is most quickly and inexpensively achieved by re-inserting the hypodermic needle into a sheath from which it has been withdrawn originally, yet another maneuver which exposes medical personnel to needle sticks. This danger is so significant that OSHA has mandated that hypodermic needles should not be recapped in order to reduce the needle stick risk to the medical personnel. 
     The risks of accidental puncture wounds or misdirected punctures by hypodermic needles are well known in the art:
         The bodily fluids or tissues of the medical personnel wounded contaminate the needle exterior and internal bore toward the tip. The rushed, non-cognizant, or negligent medical personnel take further actions which result in their bodily fluids or tissues being injected into a patient or becoming a contaminant to bodily fluids withdrawn from a patient.   Medically significant quantities of medical liquids, some of which can be toxic, allergenic, or substantially radioactive, are injected into medical personnel, many times without actual knowledge of such personnel if the needle gauge is small and the puncture was swift.   Pathogens and bodily fluids located on the outside surface of protective gloves of medical personnel during a surgical or wound examination procedure may adhere to a hypodermic needle pressed through the glove and into the hand of the medical personnel holding the medical container.   It is common that one person will hold a medical container while another impresses a hypodermic needle into the septum, further increasing the risk of hypodermic needle puncture by way of a syringe holder not sensing proper alignment of the medical container.       

     Inherent dangers of injection and withdrawal of liquids from medical containers have resulted in development of “needleless” blunt-tipped plastic cannulas to replace sharp hypodermic needles. These cannulas have the advantage of being essentially far less capable puncturing human skin during typical medical procedures. However, blunt plastic cannulas are also inherently quite difficult to press into and through rubber septa, making loss or misalignment of the medical container a substantial risk. Dropping of a medical container during a needleless cannula piercing of a septum is a substantial risk and often renders the medical container contaminated beyond recovery, requiring instant disposal. 
     There is an immediate need for a device which is directed to essentially eliminating many of the risks of hypodermic needle puncture and/or misdirection of a hypodermic needle when pressed toward and through a rubber or elastomer septum of a medical container. 
     SUMMARY OF THE INVENTION 
     The present invention provides a deflectable guide whose use results in protection of the hand of medical personnel holding a medical container during the activity of moving a hypodermic needle toward and pressing it through a septum of the medical container. The present invention further is adapted for use of the same syringe and deflector guide protected needle for injection or withdrawal of medical liquids from a septum end of medical catheter or intravenous tubing without removal of the deflectable guide. 
     The invention deflectable guide has a plurality of arcuate sections oriented parallel to and spaced radially and uniformly from an operating axis defined by a bore of a hypodermic needle of a combination of said needle fixed to a tip of a syringe. Each arcuate section is fixed at an upper end by way of a radial spacing support to a top part of said needle or a lower part of the syringe. 
     When not in use as applied to medical containers, the arcuate sections of the invention deflectable guide are adapted to define a generally cylindrical or slightly frustro-conical medical container space by their inwardly directed surfaces. In one form of the invention, one or more slots are defined between downward edges of adjacent arcuate sections. In another form of the invention, edges of adjacent arcuate sections overlap but slide easily over one another when required to be flexed outward to accomplish the objects of the invention. 
     The present invention of a deflectable guide is effective upon cylindrical medical containers, which are the primary form of medical containers. Further, in a form of the invention adapted for outward deflection, it is intended that the outside diameter of such cylindrical medical containers must be greater than an effective cylindrical inside diameter of the medical container space defined by inside, generally opposing surfaces of the arcuate sections. 
     Further, it is intended that, to avoid needle wounds for medical staff, the hypodermic needle must be shorter in length than an effective downward extension of the lower ends of the arcuate sections and the medical container space. 
     For a hypodermic needle and syringe combination equipped with the invention deflectable guide, it is a primary object of the invention that a user shall apply lower ends of the arcuate sections generally uniformly upon an upper (usually sloped or shouldered) part of a cylindrical medical container and thereafter impress the needle end into the septum of the medical container. Arcuate sections are adapted to flex outward from their lower ends, embracing and impressing their inside surfaces uniformly upon an upper end of the cylindrical form factor of the medical container. Said arcuate sections are sufficiently rigid in their connection to the needle and syringe combination that impression of the deflectable guide upon the medical container results in automatic correction of alignment of a tip of said needle toward the septum of the medical container. 
     It is a further object of the invention to provide a self-correcting deflectable guide for a user of needle and syringe combination such that a user&#39;s hand is protected by arcuate sections against needle wounds during impression of the needle into a septum of a medical container. 
     It is yet a further object of the invention to provide means for arcuate sections to be integrally fixed to a top end of said hypodermic needle by way of the radial spacer support. In one form of the invention, a polymer syringe tip adapter of the needle is molded integrally with the radial spacer support extending radially to a top end of a further integrally molded arcuate section. In this form of the invention, a user will apply the syringe adapter of hypodermic needle to the tip of the syringe holding a top part of the deflectable guide, generally about the radial spacer support. When the hypodermic needle is so integrally fixed by its polymer or metal syringe adapter to the radial spacer support of the deflectable guide, the operating axis of the hypodermic needle is necessarily also the central operating axis of the deflecting arcuate sections. Thus, it is a preferred embodiment of the invention that the deflectable guide be integral with the syringe tip adapter of the hypodermic needle to maximize effectiveness of the objects of the invention as to self-directing the tip of the hypodermic needle to a septum of a medical container. 
     It is yet a further object of the invention to provide means for arcuate sections to be fixed to a top end of said hypodermic needle by way of the radial spacer support by way of a connection formed after the hypodermic needle is fixed to a tip of the syringe. In this form of the invention, a user shall fix a hypodermic needle to a tip of a syringe and thereafter fix the deflectable guide to the syringe tip adapter. This connection may be made by way of threaded connection with threads on the outside of surface of the syringe tip adapter of the hypodermic needle and mating threads on an inside surface of a central bore of the radial spacer support, whereby a user may pass the slender metal needle part of the hypodermic needle through the central bore of the deflectable guide until mating threads meet and are joined. One advantage of a later connectable deflectable guide is that hypodermic needles need not be sterilized and packaged with the large diameter deflectable guide integrally attached to the needle. The deflectable guide itself may, in some cases need not be sterilized for a connectable form of the invention. 
     The invention medication drawing system where the deflectable guide is effectively connected with a hypodermic needle and syringe combination allows for easy medication drawing via a shielded hypodermic needle. This novel assembled device aligns medical container&#39;s rubber or elastomer septum the tip of the hypodermic needle and its operating axis. The assembled device enables easy medication drawing and shields the tip of the hypodermic needle upon removal of the needle from the medical container such that accidental needle sticks cannot occur. The invention assembled device also allows for safe medication injection into inlet tubing rubber or elastomer ports without the risk of needle-stick wounds. 
     A further object of the invention is to provide a flexible shield inwardly deflectable at lower ends of the arcuate sections by a user&#39;s hand to impress inside surfaces of the arcuate sections upon a medical container smaller in diameter than the cylindrical or frustro-conical container space. Upon relatively slight impression of the arcuate sections upon the smaller diameter medical container by a user&#39;s thumb and forefinger, the hypodermic needle and syringe combination is easily impressed downward so the needle tip pierces the septum of the medical container, thereby protecting the hand of the user. 
     A further object of the invention is to provide a flexible shield inwardly deflectable at lower ends of the arcuate sections by a user&#39;s hand to impress inside surfaces of the arcuate sections upon a medical container so much smaller in diameter than the cylindrical or frustro-conical container space that said inside surfaces do not effectively engage the medical container. Some medical containers are of such small diameter and overall height that the deflectable guide effectively contains them within its container space. The invention deflectable guide still protects the user&#39;s hand by shielding the user&#39;s hand and providing a general axial guide for the septum of the small medical containers. 
     It is in general an object of the invention to protect a user&#39;s hand bearing a cylindrical medical container from needle wounds during impression of the tip of a needle of a combination of a syringe and a hypodermic needle into a septum. The invention assembled device comprises a deflectable guide, a hypodermic needle and a syringe. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an upward, perspective view of the deflectable guide of an assembled device forming a medication drawing system. 
         FIG. 2  shows the deflectable guide of  FIG. 1  fixed to a syringe and ready for use with a medical liquid container. 
         FIG. 3A  is a side view of the deflectable guide with an operating axis aligning it with a bottom view of the deflectable guide. 
         FIGS. 3B and 3C  are side views for the deflectable guide of  FIG. 3A  showing outward deflection of arcuate sections respectively without and with the presence of a large size cylindrical medical liquid container (shown in broken lines). 
         FIGS. 3D and 3E  are side views for the deflectable guide of  FIG. 3A  showing outward deflection of arcuate sections respectively without and with the presence of a medium size cylindrical medical liquid container (shown in broken lines). 
         FIGS. 3F and 3G  are side views for the deflectable guide of  FIG. 3A  a lack of or inward deflection of arcuate sections respectively without and with the presence of a small size cylindrical medical liquid container (shown in broken lines). 
         FIG. 4  is a top perspective view of the combination of a syringe and deflectable guide of  FIG. 2  showing deflection of arcuate sections as in  FIG. 3C or 3E . 
         FIG. 5  is the combination of a syringe and deflectable guide of  FIG. 2  showing use for injection of medical liquids into an intravenous tubing septum. 
         FIG. 6  is the combination of a syringe and deflectable guide of  FIG. 2  showing use for injection of medical liquids into specimen tube with a rubber septum. 
         FIG. 7A  is a side view of an operating axis cross section of another form of the deflectable guide similar to that of  FIG. 3A  but having arcuate sections separate but insertable into a radial spacer support. 
         FIG. 7B  is a side view of an operating axis cross section of another form of the deflectable guide as in  FIG. 7A  with its arcuate sections securely inserted into a radial spacer support. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention is now discussed with reference to the figures. 
       FIG. 1  is an upward, perspective view of the deflectable guide  10  of an assembled device forming a medication drawing system. Generally, a syringe tip adapter  25  (with a Luer lock connector  26 ) extends laterally and radially from an operating axis  29 , said axis  29  running the length of a bore of hypodermic needle  21  to form a radial spacer support  23 , which rigidly connects arcuate sections  11  and  12  at upper ends  13  and  16  respectively to adapter  25 . It will be appreciated that fixing adapter  25  to a syringe tip necessarily causes the sections  11  and  12  to be integrally fixed in orientation at their upper ends  13  and  16  with relation to said syringe as would be the case for needle  21 . It is critical to the objects of the invention that such rigid connection of upper ends  13  and  16  be maintained with respect to their orientation to adapter  15 , needle  21  (which is fixed in adapter  25  at portion  22 ), and a connected syringe. Sections  11  and  12  are deflectable outwardly in direction  19  or inward in direction  20 , such that lower ends  15  and  17  experience maximum deflection and ends  13  and  16  experience minimum deflection. Sections  11  and  12  define two slots  28  by their opposing edges  27 . These slots allow for deflection in directions  19  or  20  respectively of sections  11  and  12  as required for a user&#39;s interaction with a cylindrical medical liquids container. It will be appreciated that inside surfaces  14  and  18  are formed with a concave, arcuate shape to receive and embrace cylindrical medical liquid containers. Contact of a medical liquid container of greater outside diameter than the inside diameter between inside surfaces  14  and  18  first results in outwardly deflective contact between lower edges  15  and  17  and then with sliding upward contact with inside surfaces  14  and  18 , thereby forcing lower ends or edges  15  and  17  even farther apart. 
     Deflectable guide  10  comprises a radial spacer support  23  with an effective inside diameter preferably of from a smallest outside diameter of a smallest septum top (about 0.5 inches) to about 2.0 inches, with operating axis lengths of from 0.5 inches to 3-4 inches. Support  23  must generally be of moldable polymers typical of sterilizable and medical use, preferably of the same polymer as adapter  25  and sections  11  and  12 . Support  23  and sections  11  and  12  are preferably as thin as possible to minimize polymer used but preferably not thinner than 1 millimeter to preserve structural strength required for the objects of the invention and protection of a user from needle wounds from needle  21 . Further, polymers for sections  11  and  12  are preferably clear or somewhat translucent so that an outline of needle  21  or an inserted medical liquids container can be determined with clinic or hospital light shining through sections  11  or  12 . Visibility of needle  21  and/or such a medical liquids container can be achieved through slots  28  quite easily, but clear or translucent sections  11  and  12  provide additional visualization of those structures. 
       FIG. 2  shows syringe  30  (with Luer lock tip  33 , plunger  31  and barrel  32 ) connected by adapter  25  at connector  26  with a tip of syringe  30 , resulting in aligned orientation of needle  21 , barrel  32 , and sections  11  and  12 . Needle  21  is clearly visible through slots  28  as being axially aligned within a downward cylindrical space  34  between sections  11  and  12 . The tip of needle  21  is always within space  34  and preferably shorter than sections  11  and  12  by at least about one half the diameter of support  23 , whereby inward deflection of sections  11  and  12  without a solid object therein will still protect a user&#39;s hand from harm. 
     In approaching a design of a deflectable guide according to one form of the invention, the needle is made only long enough to pierce an intended septum thickness to provide fluid access to a medical container. Minimizing needle length accordingly reduces vertical length of arcuate sections needed for guidance of the needle and user protection. 
       FIG. 3A  is a side view of the deflectable guide  10  with an operating axis  29  aligning it with an axis of syringe  30  and bottom view of the deflectable guide  10  to show certain dimensions and orientations of the features. Distance  36  between lower ends of sections  11  and  12  and the tip of needle  21  shows that sections  11  and  12  will protectably collapse upon the tip of needle  21  on inward deflection of sections  11  and  12  if a user inadvertently grasps guide  10  without engaging it to a medical liquids container. While a medical liquids container is engaged with guide  10  as in  FIGS. 3C, 3E and 3G , it will be appreciated from inspection of the bottom view in  FIG. 3A  that a user&#39;s hand never comes closer to needle  21  than about half the diameter  35  and that the guiding effect of sections  11  and  12  inevitably result in needle  21  being guided into impression and piercing the septum of the engaged medical liquids container. 
     It is an object of the invention that the relative vertical lengths of the arcuate sections, slots between them, needle length, and effective inside diameter of cylindrical space defined within the arcuate sections be chosen with reference to these specific examples as a general guide, not as a specific limitation excepting to achieve the objects of the invention to protect a user from needle wounds. 
       FIGS. 3B and 3C  are side views for the deflectable guide  10  of  FIG. 3A  showing outward deflection  40  of arcuate sections  11  and  12  respectively without and with the presence of a large size cylindrical medical liquid container  37  (shown in broken lines). Shoulder contacts  50  are shown for  FIGS. 3C and 3E  between respectively medical liquid containers  37  and  38 , resulting respectively in lower end deflections of  40  and  41  in  FIGS. 3B and 3D . Septum caps  51  are shown identical for all the medical liquid containers in  FIGS. 3C, 3E, and 3G  but can be variable depending on the container. Referring to  FIGS. 3B and 3C , inside surfaces of sections  11  and  12  are shown in broken lines to indicate contact surfaces for medical liquid containers. A user&#39;s hand grasps the outside surfaces of deflected sections  11  and  12 , causing a frictional embrace and direction guiding effect for the engaged medical liquid containers. 
       FIGS. 3F and 3G  are side views for the deflectable guide  10  of  FIG. 3A  a lack of or inward deflection of arcuate sections  11  and  12  respectively without and with the presence of a small size cylindrical medical liquid container  39  (shown in broken lines) resulting in no or inward deflection  42 . If an outer diameter of container  39  is less than support  23 , sections  11  and  12  will inwardly deflect, with lower ends of sections  11  and  12  forming an embracing and frictional engagement to guide container  39  appropriately toward a septum of container  39 . 
       FIG. 4  is the combination of a syringe  30  and deflectable guide  10  of  FIG. 2  showing deflection of arcuate sections  11  and  12  as in  FIG. 3C or 3E . 
       FIG. 5  is the combination of a syringe  30  and deflectable guide  10  of  FIG. 2  showing use for injection of medical liquids into an intravenous tubing septum  45  fixed with Y-connector  44  and intravenous tubing  43 . The combination of a syringe  30  and deflectable guide  10  is rotated left or right so that slots  28  allow for passage of tubing  43  through them to allow septum  45  to engage with needle  21 . Further, connector  44  and tubing  43  are shown in broken lines in  FIG. 5  aligned so that a continuous portion of tubing  43  passes through a slot of guide  10  while septum  45  is aligned to be pierced by needle  21 . 
       FIG. 6  is the combination of a syringe  30  and deflectable guide  10  of  FIG. 2  showing use for injection of medical liquids into specimen tube  46  with a rubber septum  47 . 
     In general, the invention medication drawing system consists of a plastic winged enclosure surrounding a metal needle. The enclosure serves to guide and center a medication vial into the needle and to guard the needle tip so as to prevent accidental needle stick injury. The invention deflectable guide attaches to either Luer lock or Luer slip syringes that are used to draw the medication from a vial. The invention deflectable guide flanges are made of flexible plastic with a memory, allowing two semicircular flanges to flare out and then spring back to an original orientation. This deformation allows vials of different size and diameter to be inserted into the invention deflectable guide for medication drawing. Thus, a one-size invention deflectable guide will fit all medication vials. When a small vial is inserted into the invention deflectable guide, the flanges center the vial onto the metal needle, after which the medication is withdrawn. When larger vials are inserted, the vial expands the flexible flanges outward, thus accommodating the vial&#39;s larger diameter. As with smaller vials, the invention deflectable guide centers the vial onto the needle for easy and efficient medication withdrawal. 
     The invention deflectable guide needle is in one form shorter than a typical needle used to draw medications so that it does not protrude past the protective flanges and its tip remains within the inverted vial&#39;s neck upon use to ensure withdrawal of the entire liquid volume. 
     The invention deflectable guide&#39;s flanges extend beyond the length of the metal needle, such that it is nearly impossible to accidentally stick the needle into the hand that is holding the medication vial. The flanges guide and center the vial&#39;s rubber stopper to the needle, reducing accidental needle sticks. Even if the practitioner were to totally miss the vial when trying to insert the needle, the plastic flanges would guard the needle and thus prevent a needle stick. 
     During medication withdrawal with a standard needle there are two maneuvers that place the user at great risk of needle stick: 1) needle insertion into the vial&#39;s stopper, and 2) needle recapping. The insertion maneuver requires a long needle, usually 1.25 to 2.0 inches, to be inserted into the center of the vial&#39;s rubber stopper. Given that the needle is at the end of a syringe and the vial is held in the other hand, the maneuver requires hand eye coordination to puncture the center of the rubber stopper. Any lapse in concentration, loss of focus or balance, or external interference (such as another worker accidentally bumping one&#39;s hand) can lead to a needle stick of the hand that is holding the vial. In the operating room, where medications are drawn in close proximity to the patient and while wearing gloves, such punctures can introduce pathogens into the provider, as well as contaminate the patient with the provider&#39;s blood. Such activity can lead to transmission of blood borne pathogens such as HIV and Hepatitis, exacting a heavy toll on the individual and the healthcare system as a whole. Once a medication is drawn the needle is removed from the vial; in order to be removed it is recapped for 2 reasons: 1) to cover the sharp tip to prevent needle stick upon needle removal, 2) to facilitate grip of the needle for easier removal, especially from Luer lock syringes. The needle cap is bigger and has ridges, making it much easier to grab and unscrew from the syringe than an exposed needle. Unfortunately, the act of re-capping the needle is a dangerous one, often itself leading to the needle stick. It is for this reason that OSHA has mandated all providers to never recap needles using two hands, given the high needle stick risk of this maneuver. 
     The invention deflectable guide eliminates both of these sources of needle stick. The device&#39;s design centers the vial onto the needle, thus dramatically reducing the hand eye coordination needed to align the needle to the rubber stopper. However, should a misalignment occur regardless, the protective flange would impact the hand rather than the short guarded needle, thus preventing needle-stick. Furthermore, given the invention deflectable guide&#39;s physical size and design, which incorporates ridges to improve hand grip, removal from the syringe is simple, easy, and does not require needle recapping, thus removing this dangerous step and reducing needle-stick risk. One simply needs to grab the invention deflectable guide in one hand, the syringe in the other, and simply unscrew the invention deflectable guide from the syringe. 
     Sometimes providers need to inject the medication into rubber I.V. tubing ports during medical care. Such a maneuver is a high risk for needle-stick when performed with a sharp needle, again because any misalignment can cause the provider to miss the port and instead puncture one&#39;s hand. The invention deflectable guide can be used in such scenarios to prevent needle-stick, as it can connect to and puncture the I.V. port. The I.V. tubing and plastic port is simply inserted into the space between the flanges, allowing the needle to puncture the rubber port and access the patient. 
     Finally, there are times when practitioners are asked to draw blood samples from intra-arterial and intravenous catheters. These samples are drawn via syringes that are attached to the catheters or tubing lines that are connected to them; the blood is then transferred to the specimen tube, which is sent to the laboratory. Usually a needle is used to puncture the specimen tube to inject the blood from the syringe. This maneuver poses a very high risk of needle stick. Alternatively, some practitioners remove the rubber cap of the specimen tube to allow its filling without the use of a needle. However, this step has two drawbacks: 1) the vacuum is lost such that the cap can easily fall of during transport, with subsequent loss of the specimen, 2) the tube can be over or under filled as there is no vacuum to draw in the correct volume. The invention deflectable guide solves this problem by allowing safe injection of blood drawn from syringes into specimen tubes. Once the syringe is filled, the invention deflectable guide is attached; the blood can now be safely injected into the specimen tube via the invention deflectable guide guarded needle. The invention deflectable guide centers the specimen tube on the guarded needle while at the same time protecting the user from needlestick. 
       FIG. 7A  is a side view of an operating axis cross section of another form of the deflectable guide  10   a  similar to that of  FIG. 3A  but having arcuate sections  11   a  and  12   a  separate but insertable into a radial spacer support  23   a . Notched extensions  52  extend upward from a top edges of sections  11   a  and  12   a . Extensions  52  comprise straight pieces having a sharp inward ledge at a distal end, which are adapted to be inserted into square holes  53  defined in spacer support  23   a  until the ledges of extensions  52  emerge on a top side of spacer support  23   a , as shown in  FIG. 7B . Sections  11   a  and  11   b  in this form of the invention can be provided separately from the integral adapter  25   a  and spacer support  23   a  and attached to support  23   a  at or near the time that the invention assembly is used. 
       FIG. 7B  is a side view of an operating axis cross section of another form of the deflectable guide as in  FIG. 7A  with its arcuate sections securely inserted into a radial spacer support. 
     The above design options will sometimes present the skilled designer with considerable and wide ranges from which to choose appropriate apparatus and method modifications for the above examples. However, the objects of the present invention will still be obtained by that skilled designer applying such design options in an appropriate manner.