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Last Updated: March 28, 2024

Claims for Patent: 10,286,159


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Summary for Patent: 10,286,159
Title: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, 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 includes 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 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.
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:15/697,640
Patent Claims:1. A medical injection assembly for injecting onabotulinumtoxina at plural injection sites in a patient's bladder wall to alleviate an overactive bladder condition, without requiring a lateral motion that may stretch the patient's urethra, said assembly comprising: an introducer configured for insertion into the patient's bladder through the urethra and having a cannula lumen; a hollow cannula that is made of a biocompatible thermoplastic polymer and is inserted in said cannula lumen for sliding motion therein; a hollow injection needle affixed to and extending distally from a distal tip of said cannula; wherein a distal portion of said cannula: (i) extends along a straight axis when in the cannula lumen and (ii) progressively returns to a predefined curvature defined by an inverse tangent function that it had before being inserted in the cannula lumen, as the cannula moves distally relative to the introducer and the cannula tip distally moves out of and away from the cannula lumen; and wherein a radial distance from the cannula tip to said axis changes as the cannula tip moves distally away from said cannula lumen; wherein said injection needle points to injection sites in the bladder wall that are radially spaced from each other depending on a distance by which the cannula tip and said needle have moved away distally from said cannula lumen and are circumferentially spaced from each other depending on rotation of at least one of the introducer and cannula, without requiring a lateral introducer motion relative to the patient's urethra that may stretch the patient's urethra; and wherein said distal portion of the cannula has a flexural modulus sufficient for inserting said injection needle into the bladder wall at said plural injection sites, including when said distal portion of said cannula has returned to said curvature defined by an inverse tangent function, but is sufficiently flexible to extend along said straight axis when in the cannula lumen.

2. The medical injection assembly of claim 1, further including a syringe operatively coupled with said cannula and configured to inject through said cannula and needle a succession of predetermined amounts of said onabotulinumtoxina and to provide both an audible and a tactile indication for each of said amounts.

3. The medical injection assembly of claim 2, in which said syringe comprises a plunger body with detents along a length thereof, tabs configured to slide along said plunger and provide said indications by engaging with and disengaging from said detents, and laterally extending paddles configured to slide, with said tabs, along said plunger and provide a finger grip to facilitate pushing the plunger for motion relative to the tabs and paddles.

4. The medical injection assembly of claim 1, which said introducer further comprises an endoscope lumen configured to accept an endoscope for viewing the bladder.

5. The medical injection assembly of claim 4, further comprising a scope seal positioned at a proximal portion of said endoscope lumen, said scope seal being comprised of a material with a coefficient of friction sufficient to hold in place an endoscope inserted in said endoscope lumen to view the bladder.

6. The medical injection assembly of claim 1, further comprising a cannula seal positioned at a proximal portion of said cannula lumen, said cannula seal being comprised of a material with a coefficient of friction sufficient to hold said cannula in place.

7. The medical injection assembly of claim 1, in which said cannula is made of a polyether ether-ketone (PEEK).

8. A medical injection assembly comprising: an introducer having a cannula lumen; a hollow cannula at least a distal portion of which is made of a biocompatible thermoplastic polymer and is slidingly received in said cannula lumen; a hollow injection needle affixed to and extending distally from a distal tip of said cannula; said distal portion of the cannula being configured to maintain a first shape when subjected to a deforming force exerted thereon by said cannula lumen but to progressively return to a predefined curvature that is defined by an inverse tangent function and is different from said first shape as said distal tip of the cannula moves distally out of and away from said cannula lumen when the cannula is pushed in a distal direction relative to the cannula lumen; wherein a radial distance from said cannula tip to a long axis of the cannula lumen changes depending on a distal motion of said tip and injection needle out of and away from the cannula lumen; and wherein said distal portion of the cannula has a flexural modulus sufficient for inserting the needle into a bladder wall for injecting at plural injection sites, including when the distal portion of the cannula has returned to said curvature defined by an inverse tangent function, but is sufficiently flexible to assume said first shape when in the cannula lumen.

9. The medical injection assembly of claim 8, in which at least a portion of the cannula lumen matching in length said distal portion of the cannula extends along a linear axis.

10. The medical injection assembly of claim 8, in which said biocompatible thermoplastic polymer is a polyether ether-ketone (PEEK).

11. The medical injection assembly of claim 8, further including a syringe operatively coupled with said cannula and configured to inject a succession of predetermined amounts of onabotulinumtoxina through said cannula and needle and to provide both an audible and a tactile indication for each of said amounts.

12. The medical injection assembly of claim 11, in which said syringe comprises a plunger body with detents along a length thereof, tabs configured to slide along said plunger and provide said indications by engaging with and disengaging from said detents, and laterally extending paddles configured to slide along said plunger with said tabs and provide a finger grip to facilitate pushing the plunger for motion relative to the tabs and paddles.

13. The medical injection assembly of claim 12, in which said introducer further comprises an endoscope lumen configured to accept an endoscope for viewing the bladder.

14. The medical injection assembly of claim 13, further comprising a scope seal positioned at a proximal portion of said endoscope lumen, said scope seal being comprised of a material with a coefficient of friction sufficient to hold in place an endoscope inserted in said endoscope lumen to view the bladder.

15. The medical injection assembly of claim 8, further comprising a cannula seal positioned at a proximal portion of said cannula lumen, said cannula seal being comprised of a material with a coefficient of friction sufficient to hold said cannula in place.

16. A medical assembly comprising: a hollow cannula having a distal portion with a predefined curvature relative to a straight axis in the absence of a deforming force acting thereon, wherein said predefined curvature is defined by an inverse tangent function; wherein said distal portion is made of a biocompatible thermoplastic polymer and; (i) conforms to said straight axis in the presence of said deforming force but (ii) progressively returns to said predefined curvature as a distal tip of the cannula progressively moves distally out of and away from said deforming force; a hollow injection needle affixed to and extending distally from said distal tip of the cannula; wherein said injection needle points to injection sites that are radially spaced from each other depending on a distance of the cannula tip and the injection needle from said deforming force and are circumferentially spaced from each other by cannula rotation; and wherein said distal portion of the cannula has a flexural modulus sufficient for inserting the needle into a bladder wall at said injection sites, including when said distal portion of the cannula has returned to said curvature defined by an inverse tangent function, but is sufficiently flexible to extend along said straight axis when in the cannula lumen.

17. The medical assembly of claim 16, further comprising an introducer having a cannula lumen at least a distal portion of which extends along said straight axis and which confines the cannula and exerts said deforming force thereon when said distal portion of the cannula is in said cannula lumen.

18. The medical assembly of claim 17, in which said introducer further comprises an endoscope lumen configured to view a patient's bladder when a distal portion of the introducer is in the bladder.

19. The medical assembly of claim 17, in which an entirety of the cannula lumen extends along said straight axis.

20. The medical assembly of claim 17, in which at least a portion of the cannula lumen matching in length said distal portion of the cannula extends along a linear axis.

21. The medical injection assembly of claim 16, in which said biocompatible thermoplastic polymer is a polyether ether-ketone (PEEK).

22. A method for treating a patient's overactive bladder comprising: (a) inserting an endoscope into a scope lumen of an introducer; (b) inserting a hollow, thermoplastic polymer cannula with a hollow needle affixed to and extending distally from a distal end thereof into a cannula lumen of the introducer, thereby causing a least a distal portion of the cannula to conform to a first shape while in the cannula lumen; (c) coupling a syringe containing onabotulinumtoxina to said cannula; (d) guiding the introducer through a patient's urethra to the patient's bladder; (e) distally moving the cannula along the cannula lumen to cause a distal tip of the cannula to extend distally a first selected axial distance away from said cannula lumen, thereby causing a distal portion of the cannula that has moved distally out of the cannula lumen by said first selected distance to return to a second shape that conforms to a curvature that is defined by an inverse tangent function and is different from the first shape, the cannula having had said curvature before being inserted in said cannula lumen, and to cause the cannula tip to be at a first selected radial distance from the cannula lumen; (f) moving the introducer distally and inserting the needle into the bladder, injecting a selected amount of onabotulinumtoxina into a bladder wall at an injection site using said syringe, withdrawing the needle from the bladder, rotating the cannula to thereby point the needle to another injection site, moving the introducer distally and injecting another selected amount of onabotulinumtoxina into the bladder wall, at a site circumferentially spaced from the site of the preceding injection, and repeating step (f) a selected number of times; and (g) moving the cannula along said cannula lumen to cause the cannula tip to extend distally away from the cannula lumen by a second selected distance, to thereby cause the cannula tip to be at a second radial distance that is different from the first radial distance, and repeating step (f); (h) thereby injecting a therapeutically effective amount of onabotulinumtoxina in a therapeutically effective pattern of injection sites in the bladder wall; and providing the cannula with a flexural modulus sufficient for inserting the needle into bladder tissue, including when the curvature thereof conforms to an inverse tangent function, and with sufficient flexibility to assume said first shape when in the cannula lumen.

23. The method of claim 22 in which said using of the syringe to inject comprises providing a syringe with detents along an axis in which a syringe plunger body moves in a syringe barrel and tabs interacting with said detents to provide a tactile indication of a predetermined motion of the plunger body relative to the syringe barrel corresponding to the injection of said predetermined amount of onabotulinumtoxina.

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