Patent Application
20060184120
1. Field of the Invention
The present invention relates generally to medical devices and, more particularly, to syringes and needles.
2. Description of Related Art
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 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. 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.
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. 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. 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.
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. 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 effected, 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.
Various tools and instruments have been used in the prior art for the treatment of types of conditions such as the above-mentioned 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.
A material having relatively high viscosity, such as collagen, may be injected into the vicinity of either the lower esophageal sphincter (for acid reflux) or the sphincter of the urethra (for urinary incontinence) to treat either of these disorders. Injection procedures typically involve elongated catheters for delivery of therapeutic materials through body passages to target sites of injection. The force required to deliver a highly viscous material through a delivery lumen of an elongated catheter increases as the average viscosity of the material being delivered increases and as the length of the elongated catheter increases.
The invention herein disclosed comprises, according to one embodiment, an injection apparatus having a first body portion with a first stopper disposed therein. The first body portion may be capable of receiving a first material in a portion thereof distal to the first stopper. The embodiment further comprises a second body portion operatively coupled to the first body portion. The second body portion includes a second stopper disposed therein. The second body portion may be capable of receiving a second material in a portion thereon distal to the second stopper and of receiving the first material in a portion thereof proximal to the second stopper.
Another embodiment of the present invention may comprise a syringe adapted for injecting therapeutic material into a patient. The syringe may comprise a first body portion and a second body portion operably coupled to the first body portion. A first stopper may be disposed in the first body portion, the first stopper being attached to a plunger rod capable of moving the first stopper. The embodiment further may include a second stopper disposed in the second body portion.
While the apparatus and method have or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 U.S.C. 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 U.S.C. 112 are to be accorded full statutory equivalents under 35 U.S.C. 112.
Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one skilled in the art. For purposes of summarizing the present invention, certain aspects, advantages and novel features of the present invention are described herein. Of course, it is to be understood that not necessarily all such aspects, advantages or features will be embodied in any particular embodiment of the present invention. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims that follow.
Reference will now be made in detail to the presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used in the drawings and the description to refer to the same or like parts. It should be noted that the drawings are in simplified form and are not to precise scale. In reference to the disclosure herein, for purposes of convenience and clarity only, directional terms, such as, top, bottom, left, right, up, down, over, above, below, beneath, rear, and front, are used with respect to the accompanying drawings. Such directional terms should not be construed to limit the scope of the invention in any manner.
Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation. The intent of the following detailed description, although discussing exemplary embodiments, is to be construed to cover all modifications, alternatives, and equivalents of the embodiments as may fall within the spirit and scope of the invention as defined by the appended claims. The present invention may be practiced in conjunction with various injection devices that are conventionally used in the art. For purposes of illustration, the present invention may be adapted to an injection device incorporating a medical injection or injection facilitation apparatus as disclosed in the above-referenced U.S. Pat. No. 6,666,848 (the '848 patent). As another example, an elongated or elongated flexible syringe as described in the above-referenced U.S. Pat. No. 6,929,623 (the '623 patent) may be modified to include aspects of the present invention.
Referring more particularly to the drawings,
In the exemplary embodiment illustrated in
In a representative application, a portion of the second body portion 120 that is distal to the second stopper 135 may be adapted to receive a first material to be administered to a patient as a therapeutic agent. Examples of a first material may include a relatively high-viscosity material such as collagen and/or microspheres, as is disclosed in U.S. Pat. No. 5,344,452, the contents of which are expressly incorporated herein by reference. In the same representative application, a portion of the second body portion 120 that is proximal to the second stopper 135 and a portion of the first body portion 115 that is distal to the first stopper 125 may be adapted to receive a second material capable of causing movement of the second stopper 135 in, for example, a distal direction when the first stopper 125 is moved distally. The second material may comprise, for example, a fluid having a relatively low viscosity compared, for example, to a viscosity of the first material. In modified embodiments, the second material may comprise a higher viscosity material, a gel, a flexible solid or semi-solid material, and/or a hard or semi-hardened material such as silicone rubber.
In yet another embodiment, the first stopper 125 may take or resemble a shape (and/or a functionality or the like) of one or more of the distal rod end 79 and the driving piston 80 as shown in
In another implementation, the plunger rod 130 can correspond to a movable plunger 136 of, for example, an injection facilitation apparatus 17 as disclosed in, for example,
Indeed, according to another aspect of the present invention, a user can remove plunger rod 130, which may correspond, for example, to a movable rod 113 or a movable plunger 136 of the injection facilitation apparatus 17 as disclosed in
The second stopper 135 can be configured similarly to the first stopper 125 in any suitable shape and/or of any suitable material so that the second stopper 135 maintains a sealed (e.g., sterile) barrier to the contents of the second body portion 120 when the plunger rod 130 is removed. For example, the second stopper 135 can take or resemble the shape (and/or functionality, or the like) of element 99 (even to the extent such element may be disclosed therein as having a different function) in
The injection apparatus 200 may be operable to be loaded into the injection facilitation apparatus 17 described in
The present invention may be configured in other ways. For example, in the configuration illustrated in the cross-sectional view of
A first material may be disposed in a movable portion of the injection apparatus 300 lying proximal to the second stopper 335 and distal to the first stopper 325. A second material may occupy a portion of the elongate catheter 322 lying distal to the second stopper 335. The second stopper 335 thereby may provide a movable barrier (i.e., a seal) between the first material and the second material. The elongate catheter 322 may be fitted with a hollow needle 323 that may, in some applications, be used to inject the second material into a patient.
According to one example, the first material (e.g., a saline solution) has a relatively low viscosity so that relatively little force need be applied to the plunger rod 330 in order to cause distal movement of the first stopper 325. Moving the first stopper 325 distally can increase pressure applied to a proximal side of the second stopper 335, thereby tending to cause the second stopper 330 to move distally, which movement may cause, for example, therapeutic material (e.g., the second material) to pass from the elongate catheter 322 through the hollow needle 323 and into tissue of a patient.
According to another implementation of the present invention, an embodiment as illustrated in
In view of the foregoing, it will be understood by those skilled in the art that the methods and devices of the present invention can facilitate formation of injection apparatuses. The above-described embodiments have been provided by way of example, and the present invention is not limited to these examples. Multiple variations and modification to the disclosed embodiments will occur, to the extent not mutually exclusive, to those skilled in the art upon consideration of the foregoing description. For example, the first body portions of the examples described herein may have cross-sections smaller than cross-sections of the second body portions. Body portions may have cross-sections that are substantially circular, elliptical, rectangular, or the like, or that take other types of shapes altogether. Transitions between first body portions and second body portions may be abrupt as illustrated herein, or graduated (e.g., tapered) to facilitate, for example, inter-body-portion fluid flow. Bevels and/or chamfers, for example, may be introduced as disclosed, for example, in the above-referenced '848 patent. While exemplary embodiments having two body portions, two stoppers and/or two diameters (e.g., the same or different) have been disclosed herein, other embodiments in accordance with the present invention may comprise, for example, three or more body portions, three or more stoppers and/or three or more diameters (e.g., the same or different). Additionally, other combinations, omissions, substitutions and modifications will be apparent to the skilled artisan in view of the disclosure herein. Accordingly, the present invention is not intended to be limited by the disclosed embodiments, but is to be defined by reference to the appended claims.
This application claims the benefit of U.S. Ser. No. 60/641,570, filed Jan. 4, 2005. The entire contents of the aforementioned application is expressly incorporated herein by this reference.
| Number | Date | Country | |
|---|---|---|---|
| 60641570 | Jan 2005 | US |
