US20040106892A1 - Medical injection apparatus - Google Patents

Abstract

An injection apparatus includes components that facilitate injection of relatively viscous materials into a patient. An injection apparatus may include a transition-bore needle apparatus, which has a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, in which the diameter of the proximal end is greater than the diameter of the distal end. An injection apparatus may include a hand-held injection facilitation apparatus, which may be coupled to a syringe. The hand-held injection facilitation apparatus can include a pivot arm and a body with a rod disposed within the body and coupled to the pivot arm. Movement of the pivot arm results in a proximal or distal movement of the rod within the body to effectively cause material to be expelled from the syringe. An injection apparatus may include a transition-bore needle apparatus and a hand-held injection facilitation apparatus in combination.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional Application No. 60/298,310, entitled INJECTION FACILITATION APPARATUS, and filed Jun. 14, 2001; and U.S. Provisional Application No. 60/298,620, entitled TRANSITION-BORE NEEDLE APPARATUS, and filed Jun. 14, 2001, the entire contents of which are hereby incorporated by reference.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• The present invention relates generally to medical devices and, more particularly, to injection apparatus that facilitate and improve the ability to pass viscous materials through lumens of small aperture.[0003]
• 2. Description of Related Art[0004]
• The term “stress urinary incontinence” refers to a functionally insufficient urinary tract of a patient. In a patient having this condition, the tissue relaxation of the sphincter mechanism, located at the urinary outflow of the bladder into the urethra, can cause a loss of bladder control. Cystoscopes are typically used to study the urethra and bladder and to evaluate, for example, a patient's urinary incontinence condition. A typical cystoscope may comprise a tubular instrument equipped with, for example, a visual channel and a working channel, and constructed to be inserted through the urethra for viewing of the urethra and bladder.[0005]
• Treatment of a urinary incontinence condition may comprise the injection of a filler material, such as collagen, into and adjacent to the urinary sphincter muscle at the bladder neck, to thereby bulk up the tissue and assist in the adequate closure of the urinary sphincter.[0006]
• Acid reflux is a digestive disorder which similarly involves the tissue relaxation of a sphincter mechanism. In the case of acid reflux, which is commonly known as gastroesophageal reflux disease (GERD) or heartburn, the lower esophageal sphincter connecting the esophagus to the stomach begins to malfunction.[0007]
• During proper operation of the lower esophageal sphincter, the lower esophageal sphincter opens to allow food to pass into the stomach and closes to prevent food and acidic stomach fluids from flowing back up into the esophagus. Gastroesophageal reflux occurs when the lower esophageal sphincter is weak or relaxes inappropriately, allowing the stomach's contents to retrograde or flow up into the esophagus.[0008]
• This retrograde flow of gastric contents back into the esophagus, through what should be a one-way valve into the stomach, can damage the esophagus. More particularly, the contents of the stomach are very acidic; and the lining of the stomach is specially designed to cope with the lower pH contents. The esophagus, on the other hand, is not suited for such exposure to highly acidic materials. Thus, when acid retrogrades from the stomach into the esophageal tissues, irritation and inflammation will often result to these tissues.[0009]
• The severity of tissue damage which can result from gastroesophageal reflux disease can depend on factors such as the dysfunctional level of the lower esophageal sphincter, the type and amount of fluid brought up from the stomach, and the neutralizing effect of the patient's saliva.[0010]
• Another factor, which may affect the severity of a particular gastroesophageal reflux disorder, is the patient's esophageal motility. Lack of esophageal motility can occur through either of two mechanisms. When incomplete emptying of the esophagus into the stomach after ingestion of liquids or solids occurs, the motility of the esophagus can be said to be affected, resulting in esophageal reflux. Also, esophageal reflux can occur when small amounts of gastric contents, which may be refluxed into the lower esophagus, are not rapidly emptied back into the stomach. Delays in the emptying of this material, caused by an esophageal motility disorder, for example, can lead to irritation of the esophageal mucosa and possibly to the sensation of heartburn or the development of esophagitis.[0011]
• Various tools and instruments have been used in the prior art for the treatment of urinary incontinence and acid reflux disease. Gastroscopes are typically used to study the esophagus and to evaluate, for example, a patient's acid reflux condition. A gastroscope typically comprises a flexible, lighted instrument that is inserted through the mouth and esophagus to view the stomach. Similarly, a cystoscope is typically inserted through a patient's urethra to facilitate evaluation of, for example, a urinary incontinence condition.[0012]
• Treatment of either of the above-mentioned disorders may include one or more injections of a viscous material, such as collagen, into the vicinity of either the lower esophageal sphincter (for treating acid reflux) or the sphincter of the urethra (for treating urinary incontinence). These injection procedures typically involve elongate catheters for the delivery of viscous materials through the body passages and to the target sites of injection. The force required to deliver a viscous material through the delivery lumen of an elongate catheter will naturally increase as the length of the elongate catheter increases. Moreover, the types of elongate catheters used with these surgical procedures will typically have delivery lumens of relatively small cross-sectional areas, thus further augmenting the force required to deliver the viscous material through the length of the elongate catheter.[0013]
• To compensate for the greater required force, it would be desirable to form the elongate catheter to have a lumen with a relatively large cross-sectional area to facilitate flow of the viscous material therethrough. Another design criterion is that the diameter of the needle tip should be relatively small to reduce tissue trauma at the injection site, to increase precision in some instances, and to reduce patient discomfort.[0014]
• In order to meet the objectives of both a relatively large delivery lumen and a relatively small needle tip, a juncture must be formed at some point along the length of the needle to transition the needle diameter from a relatively large size to a relatively small size. If the transition point is abrupt or too great in magnitude, optimal flow of the viscous material through the needle may be inhibited.[0015]
SUMMARY OF THE INVENTION
• An injection apparatus, as disclosed herein, may comprise a transition-bore needle apparatus to optimize the flow of viscous material from the injection apparatus. An injection apparatus, as disclosed herein, may comprise a hand-held injection facilitation apparatus which reduces the effort required to displace viscous material from the injection apparatus. The hand-held injection facilitation apparatus is structured to cooperatively interact with a syringe to cause displacement of viscous material from the syringe. An injection apparatus may comprise a combination of a transition-bore needle apparatus, and a hand-held injection facilitation apparatus, disclosed herein.[0016]
• A transition-bore needle apparatus is provided to optimize the flow of a viscous material through a decreasing-diameter lumen of a needle. The transition-bore needle apparatus comprises a proximal end and a distal end, and the lumen extends from the proximal end of the transition-bore needle apparatus to the distal end of the transition-bore needle apparatus. A diameter at a proximal portion of the transition-bore needle apparatus is greater than a diameter at a distal portion of the transition-bore needle apparatus.[0017]
• In accordance with one aspect of the present invention, the proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and the distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter. The first diameter is greater than the second diameter. The first needle comprises a proximal end, a distal end, and a first lumen extending through the first needle from the proximal end to the distal end, and the second needle similarly comprises a proximal end, a distal end, and a second lumen extending through the second needle from the proximal end of the second needle to the distal end of the second needle.[0018]
• The lumen of the transition-bore needle apparatus comprises both a portion of the first lumen of the first needle and a portion of the second lumen of the second needle. A juncture thus exists within the lumen of the transition-bore needle apparatus, where the diameter thereof transitions from the first diameter to the second diameter. At this juncture, the proximal end of the first needle terminates within the second lumen. In accordance with an aspect of the present invention, the proximal end of the first needle is beveled to improve a flow of viscous material through the lumen of the transition-bore needle apparatus. In accordance with another aspect of the present invention, the proximal end of the first needle is chamfered to improve a flow of viscous material through the lumen of the transition-bore needle apparatus. According to yet another aspect of the present invention, the proximal end of the first needle is both chamfered and beveled to improve a flow of viscous material through the lumen of the transition-bore needle apparatus.[0019]
• The transition-bore needle apparatus of the facilitates the injection of viscous filler material by optimizing a flow of the viscous material through the lumen of the transition-bore needle apparatus. The transition-bore needle apparatus may be used in conjunction with surgical instruments, such as endoscopes, cystoscopes, and gastroscopes, to aid in intraluminal injections of materials into body tissues within body lumens. When the body lumen comprises an esophagus, the gastroscope is inserted through the esophagus into a vicinity of the lower esophageal sphincter, and a long needle is used to inject a filler material into and adjacent to the lower esophageal sphincter tissues for the treatment of acid reflux. When the body lumen comprises a female urethra, the cystoscope is inserted through the urethra to the urinary sphincter adjacent to the bladder neck, and a long needle is used to inject a filler material into and adjacent to the urinary sphincter tissues for the treatment of stress urinary incontinence. The filler material may also be injected, for example, along a greater length of the urethra.[0020]
• The injection apparatus disclosed herein thus facilitates the injection of viscous filler materials, and may provide for increased speed, accuracy and efficiency in dispensing such materials. The injection of bulking agents into the respective tissues of body sphincters helps fortify the respective tissue structures and re-establish normal sphincter control. The transition-bore needle apparatus of the injection apparatus and associated methods of operation disclosed herein may be configured for and used on other body passages and tissues (e.g., wrinkles) as well in modified embodiments.[0021]
• An injection apparatus may comprise a hand-held injection facilitation apparatus to increase the precision of dispensing of a material from a syringe. The injection facilitation apparatus may be used in conjunction with surgical instruments, such as endoscopes, cystoscopes, and gastroscopes, to aid in transurethral injection for intraluminal injections of materials into body tissues, and to visualize tissue within a body lumen. When the body lumen comprises an esophagus, the gastroscope is inserted through the esophagus into a vicinity of the lower esophageal sphincter, and a long needle is used to inject a filler material into and adjacent to the lower esophageal sphincter tissues for the treatment of acid reflux. When the body lumen comprises a female urethra, the gastro cystoscope is inserted through the urethra into the urinary sphincter adjacent to the bladder neck, and a long needle is used to inject a filler material into and adjacent to the urinary sphincter muscle tissues for the treatment of stress urinary incontinence. The filler material may also be injected, for example, along the entire length of the urethra.[0022]
• The hand-held injection facilitation apparatus of the injection apparatus facilitates the injection of the viscous filler materials, and provides for increased accuracy in dispensing such materials. The injection of a urinary bulking agents into the respective tissues of body sphincters helps fortify the respective tissue structures and re-establish normal bladder sphincter control. The apparatus of the present invention and associated methods of operation disclosed herein may be configured for and used on other body passages as well in modified embodiments.[0023]
• In accordance with one aspect of the present invention, an injection facilitation apparatus is constructed for use in conjunction with a stainless steel needle tip catheter that can be introduced into a patient's urethra or esophagus in a treatment for urinary incontinence or gastro-esophageal reflux. The treatment for gastro-esophageal reflux disease may be fashioned to increase the strength or the length of the lower esophageal sphincter (LES) by depositing a viscous material around the lower esophageal sphincter. The suspension can be injected via a syringe and needle directly into the specific areas where the viscous agent is desired. A principal use of the exemplary embodiment is to accurately dispense the viscous material to thereby alter the physiological architecture of the patient's sphincter and adjacent tissues. Thus the bio-mechanical characteristics of the sphincter and surrounding tissues are altered to alleviate urinary incontinence and gastro-esophageal reflux.[0024]
• The subjects and objects of this disclosure relate to novel methods and instruments for facilitating the controlled dispensing of viscous material in the interior of the body, including but not limited to soft tissues, and lumen structures (e.g., esophagus, urethra).[0025]
• The present invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in connection with the accompanying illustrative drawings.[0026]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a transition-bore needle apparatus for use in the treatment of urinary incontinence in accordance with the present invention;[0027]
• FIG. 1A is a cross-sectional view of a proximal end of a distal needle with edges beveled at about a 45 degree angle from the longitudinal axis of the distal needle;[0028]
• FIG. 1B is a cross-sectional view of a proximal end of a distal needle with edges chamfered at about a 45 degree angle from the longitudinal axis of the distal needle;[0029]
• FIG. 2 illustrates a transition-bore needle apparatus for used in the treatment of gastro-esophageal reflux disease in accordance with the present invention;[0030]
• FIG. 2A is a cross-sectional view of a proximal end of a needle with edges chamfered at about a 30 degree angle from the longitudinal axis of the needle;[0031]
• FIG. 2B is a cross-sectional view of a proximal end of a needle with edges beveled at about a 30 degree angle from the longitudinal axis of the needle;[0032]
• FIG. 3 illustrates an injection facilitation apparatus with an attached syringe for use with a transition-bore needle apparatus;[0033]
• FIG. 4 shows a part cross-sectional view of the injection facilitation apparatus, showing the housing and its internal components;[0034]
• FIG. 5 is a part cross-sectional view of the injection facilitation apparatus wherein the handle is in a neutral position with no external force being applied to the handle;[0035]
• FIG. 5A is a side-elevational view of the housing of the injection facilitation apparatus of FIG. 5, taken along the line A-A of FIG. 5;[0036]
• FIG. 5B is a side-elevational view of an internal end of the pivot arm of the injection facilitation apparatus of FIG. 5, taken along the line B-B of FIG. 5;[0037]
• FIG. 6 is a part cross-sectional view of the injection facilitation apparatus of FIG. 5 after an initial application of external force has been applied to the handle;[0038]
• FIG. 7 illustrates the injection facilitation apparatus of FIG. 5 at a time of maximum application of external force to the handle; and[0039]
• FIG. 8 illustrates a gastroscope used in the urethra to treat urinary incontinence in accordance with the present invention.[0040]
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
• An injection apparatus that facilitates displacement of viscous materials from a catheter may comprise a transition-bore needle apparatus, a hand-held injection facilitation apparatus, or a combination thereof. The transition-bore needle apparatus and the hand-held injection facilitation apparatus, as disclosed herein, can reduce the effort required by a person to displace the viscous material from the injection apparatus. In general, the transition-bore needle apparatus can reduce the effort required to expel material from a catheter by graduating changes of the internal diameter of the lumens of catheters. The hand-held injection facilitation apparatus can reduce the effort required to expel material from a catheter by permitting a person to control the longitudinal displacement of a syringe plunger using a gripping action of the person's hand as compared to a digit action between the person's thumb and fingers, as is conventionally practiced.[0041]
• Referring more particularly to the drawings, FIG. 1 illustrates a transition-[0042]bore needle apparatus7 adapted for use in applications such as urethral injections, and having a distal needle8, anintermediate tube10, and aproximal tube13. Transition-bore needle apparatus7 is an element of an injection apparatus, as disclosed herein. It is to be understood that, as used herein, the term “proximal” means the end or part nearest to the operator of the instrument and the term “distal” means the end or part furthest from the operator. Thus, the front end of the instrument that enters the body canal is the distal end.
• The distal needle[0043]8 comprises aproximal end15, adistal end17, and alumen19 extending from theproximal end15 to thedistal end17. Thedistal end17 of the distal needle8 preferably comprises a cutting edge needle tip, which is suitable for puncturing skin and other soft tissues such as muscle tissue. In an alternative embodiment, thedistal end17 of the distal needle8 may comprise a round point needle tip for use in connection with more delicate surgical operations. Theintermediate tube10 comprises aproximal end22, adistal end23, and alumen26 extending from theproximal end22 to thedistal end23. Theproximal tube13 comprises aproximal end29, adistal end31, and alumen33 extending from theproximal end29 to thedistal end31.
• As presently embodied, the distal needle[0044]8, theintermediate tube10, and theproximal tube13 all comprise surgical stainless steel, such as 304 grade surgical stainless steel or316 grade surgical stainless steel. In accordance with one embodiment of the present invention, at least two needles (e.g., the distal needle8 and the intermediate tube10) are attached from larger to smaller diameter so as to create a transitional cone to facilitate the movement of viscous bulking material, such as material containing suspended beads or micro-spheres, through the transition-bore needle apparatus in a direction from the larger diameter tube to the smaller diameter needle. In the presently preferred embodiment, three needles (i.e., the distal needle8, theintermediate tube10 and the proximal tube13) are attached, preferably using an adhesive34, from larger to smaller diameters so as to create a transitional cone to facilitate the movement of viscous materials through the transition-bore needle apparatus in a direction from the larger diameter needle to the smaller diameter needles. Other modified embodiments may incorporate a greater number of needles.
• The lumen of the transition-[0045]bore needle apparatus7 comprises both a portion of thelumen19 of the distal needle8 and a portion of thelumen26 of theintermediate tube10, as can be seen in FIG. 1. A juncture thus exists within the lumen of the transition-bore needle apparatus7, where the diameter thereof transitions from a diameter of theintermediate tube10 to a diameter of the distal needle8. At this juncture, theproximal end15 of the distal needle8 terminates within thelumen26 of theintermediate tube10.
• In the illustrated embodiment, the distal needle[0046]8 comprises an inner diameter of about 0.008 inches and an outer diameter of about 0.016 inches. The distal needle8 fits into theintermediate tube10, which in the illustrated embodiment comprises an inner diameter of about 0.020 inches and an outer diameter of about 0.028 inches. In the presently preferred embodiment, the distal needle8 protrudes distally about 3 mm from theintermediate tube13.
• The[0047]intermediate tube10 fits into theproximal tube13, which as presently embodied comprises an inner diameter of about 0.50 inches, an outer diameter of about 0.032 inches, and a length of about 12 inches. Theproximal tube13 encloses theproximal end22 of theintermediate tube10. Theproximal tube13 preferably comprises three hypotubes, which may facilitate a tighter fit around theintermediate tube10 and/or greater rigidity of theproximal tube13.
• A[0048]tissue stop31 is preferably disposed about the distal needle8 next to thedistal end23 of theintermediate tube10. Thetissue stop31 preferably comprises a diameter, which is about the same as the diameter of theproximal tube13. In alternative embodiments, other diameters may be constructed. Thetissue stop31 preferably comprises a circular perimeter, but may have oval or rectangular perimeters in alternative embodiments. Thetissue stop31 preferably comprises a polymeric material, which is more flexible than, for example, stainless steel. In modified embodiments, thetissue stop31 may comprise surgical stainless steel.
• An angle between a plane of the[0049]tissue stop31 and a longitudinal axis of the transition-cone needle assembly7 is preferably less than ninety degrees and, preferably, less than about seventy-five degrees and, more preferably, about sixty degrees as shown in FIG. 1. The orientation of thetissue stop31 is preferably selected so that a planar surface of the tissue stop will align longitudinally with the axis of the particular lumen that is being treated. In other words, a planar surface of thetissue stop31 should rest flat on the surface of the tissue that is to be treated with the distal needle8. Thetissue stop31 will help to prevent the needle from penetrating deeper into the tissue than is required or desired. A surgeon performing an injection procedure using, for example, a cystoscope or the device disclosed in U.S. patent application Ser. No. 09/825,484, entitled URETHRA SURGICAL DEVICE, can view thetissue stop31 for assistance in performing the injection at the proper angle and at the proper depth.
• In a modified embodiment of the apparatus, the[0050]tissue stop31 may be omitted so that only the difference in outer diameters between the distal needle8 and theintermediate tube10 effectively operate as a tissue stop. In yet another modified embodiment, the tissue stop can be secured about theintermediate tube10, instead of being secured about the distal needle8, so that a distal planar surface of the tissue stop is flush with thedistal end23 of theintermediate tube15.
• According to another aspect of the present invention, the[0051]proximal end22 of theintermediate tube10 is beveled to improve a flow of viscous material through the lumen of the transition-bore needle apparatus7. FIG. 1A is a cross-sectional view of aproximal end22 with edges beveled at a 45 degree angle from the longitudinal axis of the distal needle8. The beveling may be performed by filing an initially square outer edge to an angle less than ninety degrees and, preferably, less than sixty degrees, and more preferably, about forty-five degrees. After theproximal end22 of theintermediate tube10 is beveled, theintermediate tube10 is then secured within thelumen33 of theproximal tube13, through the application of adhesive material between the outer surface of theintermediate tube10 and inner surface of theproximal tube13 at their contacting surfaces. In modified embodiments, the angle may be reduced to, for example, 30 degrees or even about 15 degrees from the longitudinal axis of theintermediate tube10.
• In accordance with another aspect of the present invention, the[0052]proximal end22 of theintermediate tube10 is chamfered to improve a flow of viscous material through the lumen of the transition-bore needle apparatus7. FIG. 1B is a cross-sectional view of aproximal end22 with edges chamfered at a 45 degree angle from the longitudinal axis of the distal needle8. The chamfering may be performed by filing an initially square edge on the interior side of the tubing to an angle less than ninety degrees and, preferably, less than sixty degrees, and more preferably, about forty-five degrees. In modified embodiments, the angle may be reduced to, for example, 30 degrees, or even about 15 degrees from the longitudinal axis of the distal needle8.
• In yet another aspect of the present invention, the[0053]proximal end22 of theintermediate tube10 is both chamfered and beveled, in accordance with the structures discussed in the preceding paragraphs, to thereby improve a flow of viscous material through the lumen of the transition-bore needle apparatus7. Theproximal end15 of the distal needle8 is preferably beveled and/or chamfered, similarly to that described above in connection with theproximal end22 of theintermediate tube10. In modified embodiments, only theproximal end15 of the distal needle8 is beveled and/or chamfered, and theproximal end22 of theintermediate tube10 is neither beveled nor chamfered.
• Turning now to FIG. 2, a transition-[0054]bore needle assembly37 is illustrated for use in applications such as lower esophageal injections of bulking material. The transition-bore needle assembly37 comprises aneedle39 connected to aflexible tube40. Theflexible tube40 may comprise a polymeric material, such as polyethylene terephthalate (PET). Theneedle39 comprises aproximal end42, adistal end44, and alumen47 extending between theproximal end42 and thedistal end44. Thedistal end44 of theneedle44 preferably comprises a cutting edge needle tip, which is suitable for puncturing skin and other soft tissues such as muscle tissue. As presently embodied, the cutting edge needle tip is formed at a 20 degree angle from a longitudinal axis of theneedle39. In an alternative embodiment, thedistal end44 of theneedle39 may comprise a round point needle tip. Theflexible tube40 similarly has a proximal end49, adistal end51, and alumen53 extending from the proximal end49 to thedistal end51.
• As presently embodied, the[0055]needle39 comprises surgical stainless steel, such as 304 grade surgical stainless steel or 316 grade surgical stainless steel. Theproximal end42 of theneedle39 is inserted into and attached to thedistal end51 of theflexible tube40, so as to create a transitional cone to facilitate the movement of viscous bulking material, such as material containing suspended beads or micro-spheres, through the transition-bore needle apparatus37 in a direction from theflexible tube40 to theneedle39. The lumen of the transition-bore needle apparatus37 comprises both a portion of thelumen47 of theneedle39 and a portion of thelumen53 of theflexible tube40, as can be seen from FIG. 2. A juncture thus exists within the lumen of the transition-bore needle apparatus37, where the diameter thereof transitions from a diameter of theflexible tube40 to a diameter of theneedle39. At this juncture, theproximal end42 of theneedle39 terminates within thelumen53 of theflexible tube40.
• In the illustrated embodiment, the[0056]needle39 has an inner diameter of about 0.012 inches and an outer diameter of about 0.020 inches, and theflexible tube40 has an inner diameter of 0.032 inches and an outer diameter of 0.056 inches. Awire60 is wrapped around theneedle39 and glued into place. In the gluing process, theglue38 is preferably allowed to dry and then heat cured. Another glue is then applied to the surfaces of the resultingwire60 andneedle39. The glue may comprise, for example, a lock-tight glue or a superglue. Theneedle39 is then gripped and held with, for example, a chuck, and screwed into theflexible tube40, which may comprise a polymeric tube having, for example, a smooth inner surface. Some glue will remain on thedistal end51 of theflexible tube40 to form a seal, after theneedle39 andwire60 are screwed in. Thewire60 around theneedle39 preferably deforms the smooth inner surface of theflexible tube40 for a frictional fit.
• According to another aspect of the present invention, the[0057]proximal end42 of theneedle39 is beveled to improve a flow of viscous material through the lumen of the transition-bore needle apparatus37. FIG. 2A is a cross-sectional view of aproximal end42 with edges chamfered at about a 30 degree angle from the longitudinal axis of thedistal needle39. The beveling may be performed by filing an initially square edge to an angle less than ninety degrees and, preferably, less than sixty degrees, and more preferably, about forty-five degrees. After theproximal end42 of theneedle39 is beveled and/or chamfered, theneedle39 is secured within thelumen53 of theflexible tube40. In modified embodiments, the angle may be reduced to, for example, 30 degrees or about 15 degrees.
• In accordance with another aspect of the present invention, the[0058]proximal end42 of theneedle39 is chamfered to improve a flow of viscous material through the lumen of the transition-bore needle apparatus37. FIG. 2B is a cross-sectional view of aproximal end42 with edges chamfered at about a 30 degree angle from the longitudinal axis of thedistal needle39. The chamfering may be performed by filing an initially square edge to an angle less than ninety degrees and, preferably, less than sixty degrees, and more preferably, about forty-five degrees. In modified embodiments, the angle may be reduced to, for example, 30 degrees, or even about 15 degrees. According to yet another aspect of the present invention, theproximal end42 of theneedle39 is both chamfered and beveled, in accordance with the structures discussed in this preceding paragraph, to thereby improve a flow of viscous material through the lumen of the transition-bore needle apparatus37.
• FIG. 3 illustrates an[0059]injection facilitation apparatus17 for use with the injection apparatus of the present invention.Injection facilitation apparatus17 may be used with the transition-bore needle apparatus disclosed hereinabove. Thehousing130 preferably comprises a molded polymeric material, generally in the shape of a hollow cylinder. In modified embodiments, other materials and shapes may be used. In the illustrated embodiment, thehousing130 comprises aproximal end142, adistal end144, afirst side139 and asecond side153.
• FIGS. 4 and 5 are additional views of the[0060]injection facilitation apparatus17. A portion of thehousing130 is preferably removed on the first side to accommodate asyringe140 therein. In modified embodiments, other means, such as a hinged door, may be incorporated for accommodating thesyringe140 into thehousing130. Thehousing130 comprises aslot133, extending in a direction from the first side to the second side into the housing and being configured to accommodate and hold afinger rest134 of thesyringe140 within the housing. An end view of thehousing130, taken in the direction of the arrow A-A of FIG. 5, is shown in FIG. 5A. A slot138 is disposed at thedistal end144 of thehousing130 for accommodating thesyringe140 therein. The slot138 extends from thefirst side139 of the housing in a direction toward thesecond side153, and terminates with a circular or rounded portion143 for accommodating and holding thesyringe140.
• A[0061]movable rod113 extends within thehousing130 from theproximal end142 to the distal end144 (in accordance with a fully extended position of the rod113). When therod113 pushes distally against thesyringe140, thesyringe140 will tend to move in the distal direction. Thefinger rest134 of thesyringe140, however, will press distally against theslot133, to thereby prevent distal movement of thesyringe140. Thus, only theplunger136 of thesyringe140 will move distally under the distal force of therod113. Distal movement of theplunger136, relative to the rest of thesyringe140, will result in theplunger136 expelling a portion of the syringe contents, which may comprise a viscous bulking agent, from thesyringe140 and into theelongate catheter141.
• The[0062]elongate catheter141 preferably comprises a length sufficient to extend through the relevant body passage and to the site of operation. For example, theelongate catheter141 may be constructed to have a length sufficient to extend through a cystoscope for operation on the urinary sphincter near the bladder. As another example, theelongate catheter141 may be configured to have a length (e.g., about one meter) sufficient to extend through a gastroscope for operation on the lower esophageal sphincter near the stomach. Theelongate catheter141 may comprise or be connected to theflexible tube13 of FIG. 1 or theproximal tube40 of FIG. 2.
• The force required for delivery of a viscous fluid through the[0063]elongate catheter141 and to the target site of injection will be proportionate to the length and cross-sectional area of theelongate catheter141. This force required to deliver the viscous material through the lumen of the elongate catheter will thus increase as the length of the elongate catheter increases, and further will increase as the cross-sectional area of the elongate catheter is decreased.
• The[0064]injection facilitation apparatus17 of the present invention facilitates the injection of viscous filler materials, and provides for increased accuracy in the amounts of such dispensed materials. An exemplary embodiment of the invention comprises an injection facilitation apparatus for use in conjunction with a needle tip stainless steel elongate catheter that can be introduced through a patient's urethra in the treatment of urinary incontinence. As another example, a treatment for gastro-esophageal reflux disease may be fashioned to increase the strength or length of the lower esophageal sphincter (LES) via the deposition of a viscous bulking material into surrounding tissues of the lower esophageal sphincter. An injection facilitation apparatus of the present invention is suitable for such use in conjunction with a needle tip, flexible, polymeric elongate catheter. The viscous suspension can be injected via a syringe and needle directly into the specific areas where the viscous agent is desired. Principal uses of the present invention are to accurately and conveniently dispense the viscous material to thereby alter the operational architecture of the patient's sphincter. Thus, the bio-mechanical characteristics of the sphincter are altered to alleviate the disorder.
• As shown in FIG. 3, a[0065]fastener128 comprises an aperture for accommodating therod113 therethrough, and is biased proximally against an inner surface of theproximal end142 of thehousing130. In the illustrated embodiment, the fastener28 comprises surgical stainless steel. Ahandle spring122 is disposed about therod113 between aninternal end110 of apivot arm18 and thefastener128. In addition to comprising aninternal end110, thepivot arm18 further comprises ahandle end111. Thehandle spring122 provides a proximal biasing force against thefastener128 and a distal biasing force against theinternal end110 of the pivot arm8. Thehandle spring122 may comprise, for example, surgical stainless steel.
• It can be seen from the figure that the[0066]handle spring122 biases an internal first end110aof thepivot arm18 distally, and the drivingspring119 biases an internal second end110bof thepivot arm18 proximally. The combination of thehandle spring122 and the drivingspring119 tend to rotate thepivot arm18 about thepivot pin132 in the clockwise direction shown by the arrow A1. An inward thrust by the hand of a user on thehandle end111 of thepivot arm18 causes thepivot arm18 to rotate about thepivot pin132 in the direction of the arrow A2. As thepivot arm18 pivots about thepivot pin132, the internal first end110aof thepivot arm18 moves generally in a proximal direction and the internal second end110bof thepivot arm18 moves generally in a distal direction. When the internal second end110bof thepivot arm18 moves distally in response to thehandle end111 moving in the direction of the arrow A2, thescrew head115, which is secured to the internal second end110b, applies a distal force against thebiased end126 of the of the drivingarm116.
• In the illustrated embodiment, the[0067]handle end111 is attached to theinternal end110 via two small identical screws150 (FIG. 5), and theinternal end110 rests on thehandle spring122. As can be seen best in FIG. 3, apivot pin132, preferably comprising a surgical stainless steel bar, passes through both thehousing130 and theinternal end110 of thepivot arm18. Thepivot arm18 thus pivots about thepivot pin132 in both clockwise and counter-clockwise directions, as shown in FIG. 3 by the arrows A1 and A2, respectively.
• A[0068]ring112, which preferably comprises surgical stainless steel, is disposed around therod113 between theinternal end110 and adriving arm116. Thering112 preferably comprises a loosely fitted and movable stainless steel washer. The drivingarm116, preferably comprising stainless steel, rests on top of thering112. In between the drivingarm116 and theinternal end110 also rests ascrew head115, positioned on a distal side of theinternal end110. Thescrew head115 is secured onto theinternal end110 of thepivot arm18 with anut121, as can be seen from FIG. 5b. Distally of the drivingarm116 rests the drivingspring119, which is held in place by analignment protrusion151 that preferably comprises a knob (not shown) formed on ahousing wall155 of thehousing130
• The[0069]rod113 extends through thefastener128, thehandle spring122, thepivot arm18, thering112, and drivingarm116. Theinternal end110 of thepivot arm18 and the drivingarm116, in combination with thefastener128, work together to provide slidable alignment to therod113. Therod113 comprises aproximal rod disk137 connected at a proximal end of therod113 and adistal rod disk135 connected at a distal end of therod113. As presently embodied, therod113 is removably attached to at least one of theproximal rod disk137 and thedistal rod disk135. In the illustrated embodiment, therod113 is permanently secured to or integrally formed with theproximal rod disk137 and is removably connected (e.g., threaded) to thedistal rod disk135.
• The[0070]injection facilitation apparatus17 contains a pivot mechanism that forces therod113 distally within thehousing130 toward theslot133, where thesyringe140 is held and positioned, as illustrated in FIG. 3. A clear depiction of theslot133 can be seen in FIG. 4. When thesyringe140 is positioned within and held by thehousing130, a base of the syringe,plunger136, rests flat against thedistal rod disc135.
• FIGS.[0071]3-5 depict theinjection facilitation apparatus17 at rest, wherein no external force is applied to thehandle end111 of thepivot arm18. In the relaxed or resting position of FIGS.3-5, there is no gap between the drivingarm116 and thering112, which rests on theinternal end110 of thepivot arm18. It can be seen from the figure that without an external force applied to thehandle end111 of thepivot arm18, theinternal end110 of thepivot arm18 rests between thehandle spring122 and a combination of thering112 and the drivingarm116. Thehandle spring122 biases an internal first end110aof thepivot arm18 distally, and the drivingspring119 biases an internal second end110bof thepivot arm18 proximally.
• The combination of the[0072]handle spring122 and the drivingspring119 tend to rotate thepivot arm18 about the pivot pin32 in the clockwise direction shown by the arrow A1. However, in accordance with an aspect of the present invention, a rotation-limiting structure prevents thepivot arm18 from rotating clockwise past the orientation shown in FIG. 3 and FIG. 5. For this reason, the orientation of thepivot arm18 shown in, for example, FIG. 3 is referred to as being in the relaxed position. Application of a force by the hand of an operator to pivot thehandle end111 of thepivot arm18 in the counter-clockwise direction shown by arrow A2 will move the assembly out of the relaxed position and move therod113 distally.
• Regarding the rotation-limiting structure and with reference to FIG. 5, the[0073]handle spring122 applies a distal force onto the internal first end110a, resulting in the generation of a rotational force or moment arm on theinternal end110 which would cause theinternal end110 to rotate about thepivot pin132 in the direction of the arrow A1. If thepivot pin132 were to rotate in the direction of the arrow A1, the internal first end110awould pivot distally about thepivot pin132 and the internal second end110bwould pivot proximally about thepivot pin132. When theinternal end110 of thepivot arm18 is in the resting position as shown in FIGS.3-5, however, anaperture123, which is disposed on theinternal end110 of thepivot arm18 for accommodating therod113 therethrough, prevents rotation in the direction of the arrow A1. An end view of theinternal end110, taken in the direction of the arrow B-B of FIG. 5, is shown in FIG. 5B. Theaperture123, which serves as a rotation-limiting structure, is shaped to (1) allow pivoting of theinternal end110 from the position shown in FIGS.3-5 in the direction of the arrow A2, and (2) prevent pivoting of theinternal end110 from the position shown in FIGS.3-5 in the direction of the arrow A1.
• More particularly, the[0074]aperture123 comprises an elongate shape having a width that is about the same dimension as a diameter of therod113 passing through theaperture123, and having a length that is appreciably greater than the diameter of therod113 passing through theaperture123. For example, the length should be at least 1.25 times the diameter of therod113 passing through theaperture123 and, preferably, should be at least about 1.5 times, and more preferably, should be about 2 times the diameter of therod113 passing through theaperture123.
• Now, regarding the orientation of the[0075]aperture123 relative to therod113 passing therethrough, in the position shown in FIG. 5 the portion of theaperture123 closest to the internal first end110aof thepivot arm18 contacts therod113 to prevent further movement of thepivot arm18 in the direction of the arrow A1. However, in the same position shown in FIG. 5, the portion of theaperture123 closest to the internal second end110bof thepivot arm18 does not contact and is spaced from therod113 to facilitate movement of thepivot arm18 in the direction of the arrow A2. Thus, the engagement of the portion (e.g., edge) of theaperture123 closest to the internal first end110awith therod113 serves to limit rotational movement of thepivot arm18 in the direction of the arrow A1. In modified embodiments, other constructions may be used to limit rotational movement of thepivot arm18 in the direction of the arrow A1, such as a protrusion on thesecond side153 of thehousing130 to contact the internal second end10band prevent that end from moving proximally from the position shown in FIG. 5.
• The effect of a pivoting force applied by the hand of a user on the[0076]pivot arm18 of theinjection facilitation apparatus17 can be seen through a comparison of FIGS.5-7. An inward thrust by the hand of a user on thehandle end111 of thepivot arm18 causes thepivot arm18 to rotate about thepivot pin132 in the direction of the arrow A2. As thepivot arm18 pivots about thepivot pin132, the internal first end110aof thepivot arm18 moves generally in a proximal direction and the internal second end110bof thepivot arm18 moves generally in a distal direction. When the internal second end110bof thepivot arm18 moves distally in response to thehandle end111 moving in the direction of the arrow A2, thescrew head115, which is secured to the internal second end110b, applies a distal force against thebiased end126 of the of the drivingarm116.
• As the[0077]screw head115 moves generally distally, while rotating about thepivot pin132, thescrew head115 slides against the drivingarm116 in a direction toward therod113. The component of movement of thescrew head115 in the distal direction, as it slides on the drivingarm116, moves thebiased end126 of the drivingarm116 distally against the proximal bias of the drivingspring119. The changes in position of thepivot arm18 and the drivingarm116 can be seen through the progression of FIGS.5-7.
• The initial distal movement of the[0078]screw head115 is applied to thebiased end126 of the drivingarm116, which generates a moment arm. The moment arm tends to cause the drivingarm116 to pivot generally in the direction of the arrow A2 and generally about a pivot point defined by the interaction of therod113 and the drivingarm116.
• A rod-clamping[0079]end125 of the drivingarm116 comprises an aperture for accommodating therod113 therethrough. The cross-sectional area of the aperture is shaped to be slightly larger than the cross-sectional area of therod113, so that therod113 can freely move through the aperture when the drivingarm116 is oriented at a predetermined orientation (corresponding, for example, to an orientation when thepivot arm18 is in the relaxed position). As presently embodied, therod113 can freely move through the aperture of the drivingarm113, with little or reduced friction relative to other orientations, when the drivingarm113 is substantially perpendicular to an axis of therod113. In modified embodiments, other angular positions may be implemented.
• As the driving[0080]arm116 moves under the influence of thescrew head115 from its perpendicular orientation in an approximate direction of the arrow A2,biased end126 of the drivingarm116 will move slightly distally so that the orientation of the driving arm d116 changes and so that therod113 can no longer freely slide (or slide with reduced friction) through the aperture of the drivingarm116. Thus, the clampingend125 of the drivingarm116 will be somewhat locked onto therod113 at the angle of contact (which as presently embodied is an angle of about one to a about five degrees from 90 degrees). At this position, shown in FIG. 6, there will be a small gap betweeninternal end110 and drivingarm116.
• Further movement of the[0081]handle end111 in the direction of the arrow A2 is depicted in FIG. 7. During this extended push onpivot arm18 the distance betweeninternal end110 and drivingarm116 will increase to its maximum separation. Thescrew head115 continues to move the drivingarm116 distally. Since the drivingarm116 has already rotated slightly to clamp therod113, the drivingarm116 will not rotate further as thescrew head115 pushes further and further distally against the drivingarm116. Thus, continued movement of thescrew head115 against the drivingarm116 moves the drivingarm116, which in turn moves the clampedrod113 forward.
• As the driving[0082]arm116 moves forward, the drivingspring119 is compressed against thehousing wall155, and thehandle spring122 is compressed proximally against thefastener128 by proximal movement of the internal first end110a. In the illustrated embodiment, movement of thepivot arm18 in the direction of the arrow A2 will cease when thehandle end111 contacts the surface of thehousing130.
• In modified embodiments of the invention the length of the[0083]internal end110 can be altered. Varying the length of theinternal end110 can vary the amount of material expelled from the catheter-syringe within the injection facilitation apparatus. For example, theinternal end110 can be lengthened such that the new added length protrudes out of the housing on thesecond side153, which will cause a proportional increase in the range of movement of thehandle end111. In accordance with another modification, the angle formed between thehandle end111 and theinternal end110 can be increased so that thehandle end111 can be moved further in the direction of the arrow A2 for a corresponding greater movement of therod113. In accordance with one aspect of the present invention, the injection facilitation apparatus is engineered so that a full compression of thehandle end111 will eject an exact amount of filler material, such as a specific volume amount to generate one mucosa bulge near a urinary sphincter.
• As the angle between the[0084]handle end111 and theinternal end110 increases, the amount of distance created between theinternal end110 and the drivingarm116 at maximum compression of thehandle end111 is also intensified. This translates into a greater range of push movement on therod113, and thus a greater amount of viscous material being expelled from the syringe as theplunger136 receives the additional push from therod113.
• In other words, the[0085]screw head115 moves generally distally, to thereby move thebiased end126 of the drivingarm116 distally against the proximal bias of the drivingspring119. The initial distal movement of thescrew head115 is applied to thebiased end126 of the drivingarm116, which generates a moment arm. The moment arm tends to cause the drivingarm116 to pivot generally in the direction of the arrow A2 and generally about a pivot point defined by the interaction of therod113 and the drivingarm116. As the drivingarm116 moves under the influence of thescrew head115 from its perpendicular orientation in an approximate direction of the arrow A2. Thebiased end126 of the drivingarm116 will move slightly distally so that the orientation of the drivingarm116 changes and so that therod113 can no longer freely slide (or slide with reduced friction) through the aperture of the drivingarm116. Thus, the clampingend125 of the drivingarm116 will be somewhat locked onto therod113 at the angle of contact (which as presently embodied is an angle of about one to a about five degrees from 90 degrees). Continued movement of thescrew head115 against the drivingarm116 moves the drivingarm116, which in turn moves the clampedrod113 forward.
• Although the[0086]injection facilitation apparatus17 is designed to facilitate accurate dispensing of viscous materials from a syringe, such as filler materials, theinjection facilitation apparatus17 further may be used to accurately dispense other materials and fluids as well. In the illustrated embodiment, the filler material comprises collagen and/or micro-spheres, such as disclosed in U.S. Pat. No. 5,344,452, the contents of which are expressly incorporated herein by reference, or, for example, any other type of injectable bulking agent.
• Another alternative embodiment would comprise a longer housing[0087]120, with a correspondinglylonger rod113, such that the length of the rod114 would extend proximally an additional distance equal to about a length of thehandle end111. Thehandle end111 would then be attached viascrews150 to theinternal end110 in an inverted position, so that thehandle end111 extends proximally instead of distally. The handle can be formed of another shape to accommodate the different direction of action, and the mechanism of action and other components would remain substantially the same.
• The[0088]injection facilitation apparatus17 can increase the precision of dispensing fluids from thesyringe140, as it can be calibrated to permit a specific concentration of material to be dispensed from the syringe corresponding to a certain range of movement of thehandle end111. This is especially important due to the high level of viscosity of the material being passed through the syringe, the distance of theelongate catheter141, and the general need for surgical precision when injecting bulking agents. Further, theinjection facilitation apparatus17 can facilitate effective dispensation by reducing the amount of strength or effort required to secrete the viscous material out the syringe.
• The treatment for gastro-esophageal reflux disease may be fashioned to increase the strength or the length of the lower esophageal sphincter (LES) by depositing a viscous material around the lower esophageal sphincter. The suspension can be injected via a syringe and needle directly into the specific areas where the viscous agent is desired. A principal use of the exemplary embodiment is to accurately dispense the viscous material to thereby alter the physiological architecture of the patient's sphincter and adjacent tissues. Thus the bio-mechanical characteristics of the and sphincter surrounding tissues are altered to alleviate urinary incontinence and gastro-esophageal reflux.[0089]
• The transition-[0090]bore needle apparatus17 of the present invention facilitates the injection of the viscous filler material, by optimizing a flow of the viscous material at the junctions of the needles used for intraluminal injections. The transition-bore needle apparatus17 may be used in conjunction with surgical instruments, such as endoscopes, cystoscopes, and gastroscopes, to aid in intraluminal injections of materials into body tissues within body lumens. When the body lumen comprises an esophagus, the gastroscope is inserted through the esophagus into a vicinity of the lower esophageal sphincter, and a long needle is used to inject a filler material into and adjacent to the lower esophageal sphincter tissues for the treatment of acid reflux. When the body lumen comprises a female urethra, the cystoscope is inserted through the urethra to the urinary sphincter adjacent to the bladder neck, and a long needle is used to inject a filler material into and adjacent to the urinary sphincter tissues for the treatment of stress urinary incontinence. The filler material may also be injected, for example, along a greater length of the urethra.
• FIG. 8 illustrates a[0091]gastroscope158 inserted through anesophagus159 of a patient. Thegastroscope158 is positioned near the patient's loweresophageal sphincter164 just above the body of thestomach166. Theinjection facilitation apparatus17 of the present invention is used in conjunction with a syringe and thegastroscope158 of FIG. 8.
• The[0092]gastroscope158 in the illustrated embodiment is constructed to be flexible and to be capable of bending, for example, one hundred eighty degrees. Although other scopes and surgical devices suitable for insertion and manipulation within body passages may be used in accordance with the present invention, the presently illustrated surgical device comprises agastroscope158 having a flexible, cylinder body with adistal end168 for facilitating surgical procedures within a body passage. In the illustrated embodiment, thegastroscope158 comprises an Olympus GIF-K Gastroscope.
• The[0093]distal end168 in the illustrated embodiment comprises five openings, but as few as two openings may be incorporated in modified embodiments. Anobjective lens160 is enclosed in a first one of the openings to provide a visual pathway through the lumen and of the surgical site of interest. Thegastroscope158 further comprises another opening for providing a suction and/or working channel165. Also provided at thedistal end168 is a channel for accommodating a light guide162, which carries light to thedistal end168 for facilitating viewing of the treatment area through the visual passageway. The light guide162 preferably comprises a fiber optic light guide. Alternatively a LED, or other bulb, or other light source may be incorporated. A water-feedingnozzle169, which directs pressurized water across theobjective lens160 to clear debris and an air-feedingnozzle167 are also housed within two respective channels of thegastroscope158. The air-feedingnozzle167 can be used to direct pressurized air across theobjective lens160 to remove moisture and to provide, in accordance with one application, distension of the cavity being examined.
• An elongated catheter, such as that shown at[0094]141 in FIG. 3, is inserted through the working channel165 for dispensing a somewhat viscous material into the surgical site, which in FIG. 8 comprises a vicinity of the loweresophageal sphincter164. In the presently preferred embodiment, theelongate catheter141 may have a length of, for example, about 1 meter to allow the elongate catheter to extend through the esophagus and to the loweresophageal sphincter164.
• The user presses the[0095]handle end111 to thereby move therod113 distally against thesyringe plunger136. Distal movement of theplunger136 forces viscous material within thesyringe140 distally out of thesyringe140 and through theelongate catheter141. Theelongate catheter141 in the illustrated embodiment comprises a flexible material, such as a polymeric material, to facilitate maneuverability of thegastroscope158. When theelongate catheter141 is used in connection with a urethra procedure, such as the injection of bulking or filling material into a vicinity of a urinary sphincter, theelongate catheter141 preferably comprises a surgical stainless steel. Injection procedures and apparatus, which utilize an elongate catheter and an accompanying syringe for treating, for example, urinary incontinence, and which are suitable for use with theinjection facilitation apparatus17 for urethral applications, are described in co-pending U.S. application Ser. No. 09/825,484, entitled URETHRA SURGICAL DEVICE, filed Apr. 2, 2001, the contents of which are expressly incorporated herein by reference.
• A[0096]needle173 is disposed at a distal end of theelongate catheter141 for transferring viscous or other material from theelongate catheter141 into tissue. Theneedle173 penetrates into the tissue near the lower esophageal sphincter to inject abulge175 of bulking agent, as shown in FIG. 8. Additional bulking agent injections are formed around the loweresophageal sphincter164 to thereby bulk up the tissue in the vicinity of the lower esophageal sphincter.
• The needle preferably penetrates through the mucosa but not through the muscle layers of the lower[0097]esophageal sphincter164, to thereby enable the injection of bulking material between these tissues. In modified embodiments, the needle may further be placed into the layers of muscle of the lower esophageal sphincter to facilitate the injection of bulking agent into these tissues as well. In urethral procedures, the needle preferably penetrates through the mucosa but not through the muscle layers of the urinary sphincter, to thereby facilitate the injection of bulking material between these tissues; and in modified embodiments, the needle is further inserted into the layers of muscle of the urinary sphincter to facilitate the injection of bulking agent into these tissues as well. Uses of theinjection facilitation apparatus17 are not limited to the above examples; the invention encompasses other foreseeable uses such as injections of viscous or other materials through elongate catheters into the colon, vagina, vessels, and other lumen structures.
• Although an exemplary embodiment of the invention has been shown and described, many other changes, modifications and substitutions, in addition to those set forth in the above paragraphs, may be made by one having ordinary skill in the art without necessarily departing from the spirit and scope of this invention.[0098]

Claims (20)

What is claimed is:

1. An injection apparatus, comprising:

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein the proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter.

2. The apparatus ofclaim 1, wherein the first needle is glued to the second needle.

3. The apparatus ofclaim 1, wherein the first diameter is greater than the second diameter.

4. The apparatus ofclaim 1, wherein the first needle comprises a proximal end, a distal end, and a first lumen extending through the first needle from the proximal end to the distal end, and wherein the second needle comprises a proximal end, a distal end, and a second lumen extending through the second needled from the proximal end of the second needle to the distal end of the second needle.

5. The apparatus ofclaim 1, wherein the transition-bore needle apparatus comprises a portion of the first lumen of the first needle and a portion of the second lumen of the second needle, and a juncture in the lumen of the transition-bore needle apparatus, where the diameter thereof transitions from the first diameter to the second diameter.

6. The apparatus ofclaim 5, wherein the proximal end of the first needle terminates within the second lumen, and where the termination is at the juncture of the transition-bore apparatus.

7. The apparatus ofclaim 1, wherein the proximal end of the first needle is beveled to improve flow of viscous material through the lumen of the transition-bore needle apparatus.

8. The apparatus ofclaim 1, wherein the proximal end of the first needle is chamfered to improve a flow of viscous material through the lumen of the transition-bore needle apparatus.

9. The apparatus ofclaim 1, wherein the proximal end of the first needle is beveled and chamfered to improve a flow of viscous material through the lumen of the transition-bore needle apparatus.

10. The apparatus ofclaim 1, further comprising a tissue stop disposed around a perimeter of the transition-bore needle apparatus.

11. An injection apparatus, comprising

a hand-held injection facilitation apparatus, which comprises a body that retains a syringe;

a rod disposed in the body, the rod comprising a distal end that contacts a proximal end of a plunger of the syringe; and

a pivot arm coupled to the rod and extending from the body so that movement of the pivot arm effects longitudinal displacement of the plunger of the syringe.

12. The injection apparatus ofclaim 11, wherein the body comprises a slot that accommodates a finger rest of the syringe.

13. The injection apparatus ofclaim 11, wherein the rod comprises a proximal end that has a spring disposed therearound, the spring being disposed between a proximal end of the body and an end of the pivot arm.

14. The injection apparatus ofclaim 11, wherein the pivot arm comprises an internal end disposed between two springs within the body, each of the springs providing opposing forces on the internal end of the pivot arm.

15. The injection apparatus ofclaim 11, wherein the rod has an end that extends from a proximal end of the body.

16. The injection apparatus ofclaim 11, further comprising a transition-bore needle apparatus coupled to the hand-held injection facilitation apparatus, wherein the transition-bore needle apparatus and the hand-held injection facilitation apparatus reduce the effort exerted by a person to eject a viscous material from the injection apparatus as compared to a syringe and catheter combination without a transition-bore needle apparatus and hand-held injection facilitation apparatus.

17. An injection apparatus for dispensiong a viscous material, comprising

a transition-bore needle apparatus, which comprises a needle at a distal end of the transition-bore needle apparatus, the needle having an outer diameter, and a proximal and distal end; and at least one catheter having a distal end, the distal end of the at least one catheter sealingly attached to the proximal end of the needle so that fluid is displaced through a lumen of the catheter and a lumen of the needle without being displaced between the engagement of the catheter and the needle; and

a hand-held injection facilitation apparatus coupled to the at least one catheter, the hand-held injection facilitation apparatus comprising a hollow body that retains a syringe that is attached to the catheter; a longitudinally displaceable rod disposed within the body, wherein a distal end of the rod contacts a proximal end of a plunger of the syringe; and a pivot arm coupled to the rod and extending from the body so that movement of the pivot arm causes longitudinal movement of the plunger of the syringe.

18. The injection apparatus ofclaim 17, further comprising a tissue stop disposed around the transition-bore needle apparatus so that the needle of the transition-bore needle apparatus is inserted a predetermined distance into a patient.

19. The injection apparatus ofclaim 17, further comprising a plurality of springs disposed on opposite sides of an internal end of the pivot arm to provide opposing forces to the internal end of the pivot arm.

20. The injection apparatus ofclaim 17, further comprising a slot within the body of the hand-held injection facilitation apparatus, the slot dimensioned to receive a finger rest of the syringe and to prevent distal displacement of the syringe from the hand-held injection facilitation apparatus.

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