Patent Application
20190070364
This application claims priority to and benefit of U.S. patent application Ser. No. 15/697,640 entitled “MEDICAL INJECTION ASSEMBLIES FOR ONABOTULINUMTOXINA DELIVERY AND METHODS OF USE THEREOF” filed Sep. 7, 2017, the disclosure of which is incorporated herein in its entirety by this reference.
Approximately 16.0% of the United States population suffers from Overactive Bladder (OAB). Because OAB is a chronic condition, treatments must be administered on a periodic basis to control the systems. Injections of OnabotulinumtoxinA, marketed under the trade name Botox, have proven effective in treating OAB for longer periods of time with low incidence of adverse events. Current methods of delivering OnabotulinumtoxinA to the bladder involve inserting a cystoscope and needle through the urethra to the bladder and manipulating the entire assembly both laterally and along the axis of the urethra as a unit to inject the medication into the bladder wall. Because the cystoscope and needle are moved together during this procedure, current devices and their methods of use result in significant patient discomfort and possible damage to the urethra.
The placement and pattern of the multiple injections in the bladder are associated with significantly improved treatment outcomes. Thus, it is important that devices and methods of injecting OnabotulinumtoxinA into the bladder offer physicians performing the procedure precise control. However, it is difficult to create precise injection patterns using current devices and methods because the scope moves with the needle when aiming for a new injection site. Moreover, said devices are usually not disposable, and must be disassembled and sterilized after each use, making them difficult to maintain and increasing the risk of contamination or infection.
What is needed, therefore, is a device that can inject OnabotulinumtoxinA in precise patterns on the bladder wall while minimizing lateral movement of the device itself while in the urethra to decrease patient discomfort and probability of urethral injury. Furthermore, said device should be simple enough to keep manufacturing costs at a minimum so that the device may be disposable.
Furthermore, many procedures, including OnabotulinumtoxinA delivery, require intermittent delivery of specific dosages to multiple targets. Physicians using prior art syringes must typically look away from the needle and the target tissue when delivering a dosage to ensure that the correct dosage leaves the syringe. This increases the risk that the dosage is delivered to the wrong location, often requiring the physician to re-aim the needle several times during administration of the required dosage. If the physician does not wish to focus on the syringe to ensure correct dosage, the alternative is to employ an assistant to independently operate the syringe so the physician can maintain focus on the needle. Therefore, there is also a need for a syringe that can reliably deliver a specific dosage without visual feedback and may be operated with one hand.
The present invention relates to a medical injection assembly directed towards the treatment of Overactive Bladder by injecting OnabotulinumtoxinA into bladder tissue. The present invention is also directed towards a flexible cannula with high tensile strength and buckling resistance for use in said medical injection assemblies. The present invention is also directed towards novel incremental syringe plungers for the highly precise delivery of OnabotulinumtoxinA in said medical injection assemblies.
In one embodiment of the present invention, a medical injection assembly may include an introducer. The introducer may include a handle, a sheath, and a scope lumen extending from a first proximal end of the handle to a distal end of the sheath, wherein the scope lumen is configured to receive an endoscope at the first proximal end of the handle and hold the endoscope in a desired position. The introducer may further include a cannula lumen extending from a second proximal end of the handle to the distal end of the sheath, wherein the cannula lumen is configured to receive a cannula at the second proximal end of the handle and hold the cannula in a desired position. The introducer may further include a fluid line, wherein the distal end is in fluid communication with the scope lumen. The medical injection assembly may further include a cannula configured such that the distance between the distal tip of the cannula and the axis defined by the sheath of the introducer increases as the cannula is moved in a distal direction. The medical injection assembly may further include a syringe connected to the proximal end of the cannula.
In one embodiment of the present invention, the cannula may include a needle attached to a distal tip of the cannula. The cannula may further include a first fluid connector attached to a proximal end of the cannula. The cannula may be comprised of a biocompatible thermoplastic polymer and a distal portion of the cannula may maintain a predefined curvature in the absence of a deforming force.
In one embodiment of the present invention, wherein the diameter of the needle is less than the diameter of the cannula.
In one embodiment of the present invention, the needle may be a 23 gauge needle.
In one embodiment of the present invention, the biocompatible thermoplastic polymer may have a flexural modulus of about 595,000 psi.
In one embodiment of the present invention, the biocompatible thermoplastic polymer may be polyether ether-ketone (PEEK).
In one embodiment of the present invention, the predefined curvature may be defined by an inverse tangent function.
In one embodiment of the present invention, the medical injection assembly may further include an endoscope.
In one embodiment of the present invention, the endoscope may be a cysto scope.
In one embodiment of the present invention, the fluid line may further comprise a second fluid connector, and the fluid line may further comprise a pinch valve to control flow of fluid through the fluid line.
In one embodiment of the present invention, the syringe may include a syringe barrel and a plunger body having a first portion proximate the proximal end and a second portion proximate the distal end, wherein the first portion has a plurality of corresponding detentes on opposite sides of the first portion. The plunger body may further include a sealing cap attached to the distal end of the plunger body. The syringe may further include a finger grip including two paddles. The finger grip may be configured to be removably coupled to the plunger body and may further be configured to interact with the detentes to provide audible and tactile feedback to a user when the plunger body is pushed through the finger grip in a distal direction.
In one embodiment of the present invention, a syringe may include a syringe barrel, a finger grip disposed at the proximal end of the syringe barrel, a tab disposed inside the syringe barrel, and a plunger body having detentes, wherein the detentes are configured to interact with the tab to provide audible and tactile feedback to a user when the plunger body is pushed through the syringe barrel in a distal direction.
In one embodiment of the present invention, a syringe may further include a luer lock disposed at the distal end of the syringe barrel.
In one embodiment of the present invention, the finger grip may include at least two paddles.
In one embodiment of the present invention, the syringe may further include a sealing cap attached to the distal end of the plunger body.
In one embodiment of the present invention, the finger grip may be removably attached to the proximal end of the syringe barrel.
In one embodiment of the present invention, each unit of audible and tactile feedback may indicate that a predetermined volume of liquid has been ejected from the syringe barrel.
In one embodiment of the present invention, a method for treating overactive bladder may include inserting an endoscope into a scope lumen of an introducer. The method may further include inserting a cannula into a cannula lumen of the introducer, the cannula configured such that the distance between the distal tip of the cannula and the axis defined by the sheath of the introducer increases as the cannula is moved in a distal direction, wherein a syringe filled with OnabotulinumtoxinA is coupled to the proximal end of the cannula. The method may further include guiding the introducer through the urethra of a patient to the patient's bladder. The method may further include extending the distal portion of the cannula past the distal end of the introducer until a needle attached to the distal end of the cannula is placed at a desired radial distance from the axis defined by the sheath of the introducer. The method may further include rotating the introducer to position the needle at a desired position. The method may further include moving the introducer in a distal direction to insert the needle into the bladder. The method may further include activating the syringe to inject OnabotulinumtoxinA into the bladder. The method may further include moving the introducer in a proximal direction to remove the needle from the bladder. The method may further include repeating the extending, rotating, moving distally, activating, and moving proximally steps until a therapeutically effective amount of OnabotulinumtoxinA has been injected in a therapeutically effective pattern into the bladder.
Still other aspects, features, and advantages of the invention are readily apparent from the following detailed description when illustrated by a number of particular embodiments and implementations, including the best mode contemplated for carrying out the invention. The invention is also capable of other and different embodiments, and several details can be modified in various obvious respects, all without departing from the spirit and scope of the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.
These and other objects, features, and characteristics will become more apparent to those skilled in the art from a study of the following Detailed Description in conjunction with the appended claims and drawings, all of which form a part of this specification. While the accompanying drawings include illustrations of various embodiments, the drawings are not intended to limit the claimed subject matter.
In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the invention. One skilled in the art will recognize that the embodiments of the invention may be practiced without these specific details or with an equivalent arrangement. In other instances, well-known structures and devices are shown in block diagram form in order to avoid unnecessarily obscuring the embodiments of the invention.
The presently disclosed subject matter is presented with sufficient details to provide an understanding of one or more particular embodiments of broader inventive subject matters. The descriptions expound upon and exemplify particular features of those particular embodiments without limiting the inventive subject matters to the explicitly described embodiments and features. Considerations in view of these descriptions will likely give rise to additional and similar embodiments and features without departing from the scope of the presently disclosed subject matter.
Referring now to
The medical injection assembly 1 may further comprise a cannula 109 configured such that the distance between the distal tip of the cannula 109 and the axis defined by the sheath 102 of the introducer increases as the cannula 109 is moved in a distal direction. The medical injection assembly may further comprise a syringe 111 connected to the proximal end of the cannula 109.
The fluid line 105 may further comprise a second fluid connector 106. The fluid line 105 may further comprise a pinch valve 107 configured to control flow of fluid through the fluid line 105.
Referring now to
The cannula lumen 104 may be configured to receive a cannula 109 according to the present invention as further described herein. The diameter of the cannula lumen 104 should be sufficient to fit said cannulas 109. In preferred embodiments, the cannula lumen 104 may have a diameter of about 1 mm to about 2 mm. The walls of the sheath 102 are must be minimized so as to allow the introducer 100 to fit through a patient's urethra while maintaining its strength and rigidity. In preferred embodiments, the sheath walls may have a thickness of about 0.1 mm to about 0.4 mm. The sheath 102 may be comprised of polyether block amides, polyethylene, or other materials with similar rigidity characteristics.
Referring now to
The cannula lumen 104 may extend from a proximal end of the handle 101 and may be configured to receive a cannula 109 from a proximal end of the handle 101. A cannula seal 113 may be positioned at a proximal end of the handle 101 to engage a cannula 109. The cannula seal 113 may be comprised of a material with coefficient of friction sufficient to hold a cannula 109 in place. In preferable embodiments, the cannula seal 113 may be comprised of silicone.
The handle may further comprise a fluid line 105 in fluid communication with the scope lumen 103. The distal end of the fluid line 105 may connect to the scope lumen 103 via a watertight fluid connector. In yet other embodiments, the distal end of the fluid line 105 may be integrated directly into the scope lumen 103 via known manufacturing methods such as various molding techniques, welding, 3D printing, adhesives, etc. The fluid line 105 may comprise a second fluid connector 106. In preferred embodiments, the second fluid connector 106 may be a luer lock. The fluid line 105 may further comprise a pinch valve 107. The pinch valve 107 may control the flow of fluid form a fluid source through the fluid line 105 and into the scope lumen 103.
Referring now to
The needle 114 may be any commercially available hypodermic needle suitable for performing injections of OnabotulinumtoxinA. In preferred embodiments, the diameter of the needle 114 is less than the diameter of the cannula 109, and the needle 114 may be a 23 gauge needle and may extend past the cannula 109 about 1.0 mm to about 3.0 mm in length. In such configurations, the distal tip of the cannula 109 acts as a wall, preventing the needle 114 from penetrating into the target tissue past the distal tip of the cannula 109.
The biocompatible thermoplastic polymer may be any such polymer having a flexural modulus of about 595,000 psi. Importantly, such a flexural modulus allows the user of the device to insert the needle into bladder tissue without causing the cannula itself to bend or deform in a clinically significant manner. In preferred embodiments, the biocompatible thermoplastic polymer may be polyether ether-ketone (PEEK).
The cannula 109 may be configured such that the distance between the distal tip of the cannula 109 and the axis defined by the sheath 102 of the introducer 100 increases as the cannula 109 is moved in a distal direction. According to at least one embodiment of the present invention, such a configuration may be achieved by forming the cannula 109 such that a distal portion of the cannula 109 maintains a predefined curvature in the absence of a deforming force. Thus, as the distal portion of the cannula 109 exits the distal end of the introducer 100, it returns to a predefined curvature that causes the distal tip of the cannula 109 to move away from the axis defined by the sheath 102 of the introducer 100. In preferred embodiments, the predefined curvature may be defined by an inverse tangent function. But one of ordinary skill in the art will recognize that any predefined curvature that causes the distal tip of the cannula 109 to move away from the axis defined by the sheath 102 of the introducer 100 may be used in the present invention.
Referring now to
The second portion 118 may fit into commercially available syringe barrels with the sealing cap 120 forming a watertight seal within the syringe barrel. In preferred embodiments, commercially available 10 cc syringe barrels may be used. The finger grip 121 may be configured to clip on to the plunger body 116. The finger grip 121 may include tabs 123 on the interior of both paddles 122. The tabs 123 may fit into grooves between the detentes 119 on the first portion 117. When the user pushes the plunger body 116 in a distal direction into the syringe barrel, the detentes 119 provide resistance against the movement until the tabs 123 bend enough to clear a set of detentes 119 and fit into the next set of grooves. The detentes 119 may be spaced along the first portion 117 such that clearing one set of detentes 119 results in an ejection of a specific amount of fluid from the syringe. In preferred embodiments, clearing one set of detentes would result in the ejection of 1 cc of fluid from the syringe. When the user causes tabs 123 to clear a set of detentes 119 and the tabs 123 come to rest in the subsequent grooves, the user is provided with tactile and audible feedback to indicate that one such predetermined unit of fluid has been ejected from the syringe.
According to another embodiment of the present invention, a method for treating overactive bladder may comprise inserting an endoscope 110 into a scope lumen 103 of an introducer 100. The method may further comprise inserting a cannula 109 into a cannula lumen 104 of the introducer 100, the cannula 109 configured such that the distance between the distal tip of the cannula 109 and the axis defined by the sheath 102 of the introducer 100 increases as the cannula 109 is moved in a distal direction, wherein a syringe 111 filled with OnabotulinumtoxinA is coupled to the proximal end of the cannula 109. The method may further comprise guiding the introducer 100 through the urethra of a patient to the patient's bladder. The method may further include extending the distal portion of the cannula 109 past the distal end of the introducer 100 until a needle 114 attached to the distal end of the cannula 109 is placed at a desired radial distance from the axis defined by the sheath of the introducer. The method may further comprise rotating the introducer 100 to position the needle 114 at a desired position. The method may further comprise moving the introducer in a distal direction to insert the needle 114 into the bladder. The method may further include activating the syringe 111 to inject OnabotulinumtoxinA into the bladder. The method may further include moving the introducer 100 in a proximal direction to remove the needle 114 from the bladder. The method may further include repeating the extending, rotating, moving distally, activating, and moving proximally steps until a therapeutically effective amount of OnabotulinumtoxinA has been injected in a therapeutically effective pattern into the bladder.
Referring now to
Preferably, A is approximately 0.43 inches, B is approximately 0.8 inches, and C is approximately 1.2 inches.
By rotating the introducer 100 to position the needle rather than moving the introducer 100 laterally, the patient experiences less discomfort and possible injury from lateral stretching of the urethra.
Referring now to
The incremental syringe 3 may further comprise a luer lock 305 disposed at the distal end of the syringe barrel 300. The luer lock 305 may be connected to a corresponding luer lock on a cannula to form a water-tight connection between the incremental syringe 3 and cannula. Liquids ejected from the incremental syringe 3 may travel through the cannula to a target tissue.
The finger grip 301 may comprise at least two paddles 306, 307. The finger grip 301 allows for one-handed operation of the incremental syringe 3 when the user places at least one finger on each of the two paddles 306, 307 and uses the thumb to move the plunger body 303 in a distal direction.
The incremental syringe 3 may further comprise a sealing cap 308 attached to the distal end of the plunger body 303. The circumference of the sealing cap 308 forms a water-tight seal against the interior circumference of the syringe barrel 300. The sealing cap 308 may be comprised of rubbers, silicones, other high-friction deformable plastics known in the art, or combinations thereof.
The tab 302 in a first position is parallel to the plane defined by the cross-section of the syringe barrel 300 when it is aligned with one of the grooves adjacent to the detentes 304. However, when tab 302 is in a second position not aligned with one of the grooves adjacent to the detentes 304, the detentes 304 displace tab 302 such that it is not parallel to the plane defined by the cross-section of the syringe barrel 300. In operation, when the plunger body 303 is moved in a distal direction such that tab 302 moves from a second position to a first position, an audible and tactile “click” can be heard and felt by the user. Each unit of audible and tactile feedback indicates that a predetermined volume of liquid has been ejected from the syringe barrel 300. The spacing of the detentes 304 or the diameter of the syringe 3 may be adjusted to dispense varying amounts of liquid from the syringe 3.
The above description and drawings are illustrative and are not to be construed as limiting the invention to the precise forms disclosed. Persons skilled in the relevant art can appreciate that many modifications and variations are possible in light of the above disclosure. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description.
Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not other embodiments.
Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or any combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. The word “or,” in reference to a list of two or more items, covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list.
The teachings of the disclosure provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments.
These and other changes can be made to the disclosure in light of the above Detailed Description. While the above description describes certain embodiments of the disclosure, and describes the best mode contemplated, no matter how detailed the above appears in text, the teachings can be practiced in many ways. Details of the system may vary considerably in its implementation details, while still being encompassed by the subject matter disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the disclosure with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the disclosure to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the disclosure encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the disclosure under the claims.
The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Certain terms that are used to describe the disclosure are discussed above, or elsewhere in the specification, to provide additional guidance to the practitioner regarding the description of the disclosure. For convenience, certain terms may be highlighted, for example using capitalization, italics and/or quotation marks. The use of highlighting has no influence on the scope and meaning of a term; the scope and meaning of a term is the same, in the same context, whether or not it is highlighted. It will be appreciated that same element can be described in more than one way.
Consequently, alternative language and synonyms may be used for any one or more of the terms discussed herein, nor is any special significance to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any exemplified term. Likewise, the disclosure is not limited to various embodiments given in this specification.
Without intent to further limit the scope of the disclosure, examples of instruments, apparatus, methods and their related results according to the embodiments of the present disclosure are given below. Note that titles or subtitles may be used in the examples for convenience of a reader, which in no way should limit the scope of the disclosure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions will control.
Some portions of this description describe the embodiments of the invention in terms of algorithms and symbolic representations of operations on information. These algorithmic descriptions and representations are commonly used by those skilled in the data processing arts to convey the substance of their work effectively to others skilled in the art. These operations, while described functionally, computationally, or logically, are understood to be implemented by computer programs or equivalent electrical circuits, microcode, or the like. Furthermore, it has also proven convenient at times, to refer to these arrangements of operations as modules, without loss of generality. The described operations and their associated modules may be embodied in software, firmware, hardware, or any combinations thereof.
Finally, the language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of the embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently disclosed subject matter pertains. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the presently disclosed subject matter, representative methods, devices, and materials are now described.
Following long-standing patent law convention, the terms “a”, “an”, and “the” refer to “one or more” when used in the subject specification, including the claims. Thus, for example reference to “an additive” can include a plurality of such additives, and so forth.
Unless otherwise indicated, all numbers expressing quantities of components, conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the instant specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.
As used herein, the term “about”, when referring to a value or to an amount of mass, weight, time, volume, concentration, and/or percentage can encompass variations of, in some embodiments +/−20%, in some embodiments, +/−10%, in some embodiments +/−5%, in some embodiments +/−1%, in some embodiments +/−0.5%, and in some embodiments, +/−0.1%, from the specified amount, as such variations are appropriate in the disclosed products and methods.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15697640 | Sep 2017 | US |
| Child | 15834333 | US |
