Claims for Patent: 10,456,164

Summary for Patent: 10,456,164

Title:	Anti-microbial medical injection assemblies for onabotulinumtoxina delivery and methods of use thereof
Abstract:	A medical injection assembly is provided and includes an introducer with a handle, a sheath, a scope lumen configured to receive an endoscope at a first proximal end of the handle and hold the endoscope in a desired position, a cap attached to the distal end of the scope lumen configured to isolate the scope lumen from the external environment, and a cannula lumen configured to receive a cannula at a second proximal end of the handle and hold the cannula in a desired position. The medical injection assembly includes 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 and a syringe.
Inventor(s):	Snoke; Phillip Jack (Winston-Salem, NC), Allred, III; Philip Morrison (Kernersville, NC), Smith; John Joseph (Winston-Salem, NC)
Assignee:	URO-1, INC. (Winston-Salem, NC)
Application Number:	15/722,168
Patent Claims:	1. A medical injection assembly comprising: an introducer comprising: a handle; a sheath extending distally from said handle along a longitudinal axis; a scope lumen in said sheath, extending along said longitudinal axis and configured to receive an endoscope at a first proximal portion of the handle and hold the endoscope in a desired position; an optically-clear, fluid-tight cap attached to a distal end of the scope lumen and configured to isolate the scope lumen from the external environment; said cap having a distal end that conforms to a plane angled at about 60 degrees to said longitudinal axis; a cannula lumen in said sheath, extending along said longitudinal axis and configured to receive a cannula at a second proximal portion of the handle and hold the cannula in a desired position; at least one fluid lumen in said sheath, extending along said axis and configured to channel fluid to and from a distal end of the sheath; a cannula slidingly received in said cannula lumen and configured such that the distance, in a direction transverse to said longitudinal axis, between a distal tip of the cannula and said longitudinal axis increases as the cannula is moved in a distal direction out of the cannula lumen, wherein said distance increases over at least a part of the motion of the cannula tip after emerging from the cannula lumen; an injection needle affixed to the distal tip of the cannula; a first fluid connector attached to a proximal end of the cannula; wherein the cannula is comprised of a biocompatible thermoplastic polymer; and wherein a distal portion of the cannula, after said distal portion of the cannula has been pushed distally out of the cannula lumen, reverts to and maintains a predefined curvature shaped as an inverse tangent function in the absence of a deforming force; and a syringe connected to the proximal end of the cannula. 2. The medical injection assembly of claim 1, wherein the optically-clear, fluid-tight cap is comprised of silicon. 3. The medical injection assembly of claim 1, wherein the optically-clear, fluid-tight cap is configured to deform to the shape of the endoscope without distorting the optical properties of the endoscope. 4. The medical injection assembly of claim 1, wherein the optically-clear, fluid-tight cap is over molded to the distal end of the scope lumen. 5. The medical injection assembly of claim 1, wherein the diameter of the needle is less than the diameter of the cannula. 6. The medical injection assembly of claim 1, wherein the needle is a 23-gauge needle. 7. The medical injection assembly of claim 1, wherein the biocompatible thermoplastic polymer has a flexural modulus of about 595,000 psi. 8. The medical injection assembly of claim 7, wherein the biocompatible thermoplastic polymer is polyether ether-ketone (PEEK). 9. The medical injection assembly of claim 1 further comprising: an endoscope. 10. The medical injection assembly of claim 9, wherein the endoscope is a cystoscope. 11. A medical injection assembly comprising: an introducer comprising a handle and a sheath extending distally from the handle along a longitudinal axis and having: a scope lumen configured to receive an endoscope at a first proximal portion of the handle, said scope lumen extending distally in the sheath, along said longitudinal axis, and further configured to hold the endoscope in a desired position; and a cannula lumen configured to slidingly receive a cannula at a second proximal portion of the handle and extending in the sheath, along said longitudinal axis; an optically-clear, fluid-tight cap attached at a distal end of the scope lumen and configured to isolate the scope lumen from the external environment; wherein said cap has a planar distal end inclined relative to said longitudinal axis at an angle of approximately 60 degrees; a cannula configured to slide inside the cannula lumen along said longitudinal axis and having a distal portion terminating in a distal end; wherein the entirety of the cannula is a continuous tube of a biocompatible polymer; an injection needle affixed to and extending distally from the distal end of the cannula; said distal portion of the cannula reverting to a predefined curvature after exiting the cannula distally during said sliding motion and thereby causing said needle to move in a direction transverse to said longitudinal axis as the cannula slides out of the cannula lumen, wherein said distance increases over at least a part of the motion of the cannula tip after emerging from the cannula lumen; wherein said predefined shape to which the cannula reverts after exiting the cannula lumen in a distal direction is defined by an inverse tangent function. 12. The medical injection assembly of claim 11, in which said cannula is configured to insert said injection needle into a patient's bladder to inject Botox therein when pushed in the distal direction. 13. The medical injection assembly of claim 11, in which said cannula is make of a PEEK material. 14. The medical injection assembly of claim 13 in which said cannula has a flexural modulus of about 595,000 psi.

Details for Patent 10,456,164

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Allergan, Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	12/09/1991		2039-11-21
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000	12/09/1991		2039-11-21