Systems and methods for treating female incontinence and pelvic nerve dysfunction
AssigneeParaPatch, Inc.
InventorsCora St. Anne, Joseph St. Anne, Cindy Santa Cruz, Theodore V. Benderev, Eric Willis, Kevin Wasserstein
Life of this patent
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Abstract
Systems and methods for neuromodulation of a female patient suffering from a pelvic condition, such as incontinence, are disclosed. A mechanical stimulus such as pressure, tension, traction, friction, or vibration for example can be applied to one, two, or more clitoral structures sufficient to cause a physiologic stimulus or inhibition, such as neuromodulation to treat or prevent the pelvic condition.
Claims21
-58. (canceled)
A device for treating a pelvic condition of a female patient, comprising:
- a support structure comprising an adhesive layer sized and configured for application between opposing folds of the labia majora,
- wherein the support structure when applied has a contact surface that is configured to directly contact and adhere to a skin of one or more clitoral structures selected from the group consisting of one or more of the following:
- a clitoral shaft, a clitoral hood, and a clitoral glans,
- wherein the support structure when applied is configured to apply a mechanical force to the one or more clitoral structures sufficient to stimulate one or more clitoral nerves while not causing sexual arousal,
- wherein the support structure is between 0.5 inches and 3 inches long at its longest, between 0.5 inches and 2 inches wide at its widest, and has a thickness of between 0.0001 inches and 0.1 inches at its thickest point;
- and
- wherein the support structure further comprises one or more of the following features selected from the group consisting of:
- (a) a contoured portion;
- (b) a raised portion;
- a
- (c) a tab;
- and
- (d) a malleable portion,
- wherein the contoured portion, raised portion, and/or malleable portion are configured to facilitate maintenance of the mechanical force on the one or more clitoral structures while the patient is at rest and/or during activity.
A device for treating a pelvic condition of a female patient, comprising:
- a support structure comprising an adhesive layer sized and configured for application between opposing folds of the labia majora,
- wherein the support structure when applied has a contact surface that is configured to directly contact and adhere to the skin of one or more clitoral structures selected from the group consisting of one or more of the following:
- the clitoral shaft, clitoral hood, and the clitoral glans,
- wherein the support structure when applied is configured to apply a mechanical force to the one or more clitoral structures sufficient to stimulate one or more clitoral nerves while not causing sexual arousal,
- wherein the adhesive layer comprises an adhesive configured such that when removed from the clitoral structures less than about 50% of the adhesive surface area is covered by detached skin cells of the patient,
- wherein the weight of the adhesive layer per surface area of the patch is in the range of about 7 g/m2 to about 100 g/m2,
- wherein the support structure is between about 0.5 inches and about 3 inches long at its longest, between about 0.5 inches and about 2 inches wide at its widest, and has a thickness of between about 0.0001 inches and about 0.1 inches at its thickest point;
- and
- wherein the support structure further comprises one or more of the following features selected from the group consisting of:
- (e) a contoured portion;
- (f) a raised portion;
- a
- (g) a tab;
- and
- (h) a malleable portion,
- wherein the contoured portion, raised portion, and/or malleable portion are configured to facilitate maintenance of the mechanical force on the one or more clitoral structures while the patient is at rest and/or during activity.
A device for treating a pelvic condition of a female patient, comprising:
- a support structure comprising an adhesive layer sized and configured for application between opposing folds of the labia majora,
- wherein the support structure when applied has a contact surface that is configured to directly contact and adhere to the skin of one or more clitoral structures selected from the group consisting of one or more of the following:
- the clitoral shaft, clitoral hood, and the clitoral glans,
- wherein the support structure when applied is configured to apply a mechanical force to the one or more clitoral structures sufficient to stimulate one or more clitoral nerves while not causing sexual arousal,
- wherein the adhesive layer comprises an adhesive configured such that when removed from the clitoral structures less than about 50% of the adhesive surface area is covered by detached skin cells of the patient,
- wherein the support structure is between about 0.5 inches and about 3 inches long at its longest, between about 0.5 inches and about 2 inches wide at its widest, and has a thickness of between about 0.0001 inches and about 0.1 inches at its thickest point;
- and
- wherein the support structure further comprises one or more of the following features selected from the group consisting of:
- (i) a contoured portion;
- (j) a raised portion;
- a
- (k) a tab;
- and
- (l) a malleable portion,
- wherein the contoured portion, raised portion, and/or malleable portion are configured to facilitate maintenance of the mechanical force on the one or more clitoral structures while the patient is at rest and/or during activity.
Dependencies are inferred from the claim text.