Methods and products for enhancing blood flow to an anatomical region

Abstract

Methods and systems for enhancing blood flow to an anatomical region are disclosed. An applicator can include a stimulation portion for defining a protrusion extending from the applicator. Positioning the applicator relative to the anatomical region can position the protrusion at a predetermined area of the anatomical region, thereby applying a stimulation to the predetermined area. A blood flow enhancement device can be used with the applicator to apply suction, heating, and / or vibration effects to the anatomical region through the blood flow enhancement device having a vacuum portion, an ultrasonic transducer, and / or a vibrator. An inner surface of the protrusion of the applicator can receive a portion of the blood flow enhancement device, thereby allowing a user to apply these effects to the predetermined area associated with the protrusion. Combining the stimulation, heating, vibration, and / or suction applied to the anatomical region in this manner can allow a user to administer treatments such as therapy, diagnosis, and soothing relaxation.

Description

[0001] Cross-references to related applications

[0002] not applicable

[0003] Statement regarding federally funded research / development

[0004] not applicable Technical Field

[0005] This application relates to treatments for enhancing blood flow to a patient's anatomical area. More specifically, this application relates to applying stimulation, vibration, heating, and / or suction effects to a patient's anatomical area using an applicator and a blood flow enhancement device for treatment, diagnosis, and / or relaxation procedures. Background Technology

[0006] Vascular diseases can reduce blood flow to anatomical areas of the body, leading to dysfunction of related organs due to insufficient water / nutrient supply. Sexual dysfunction is a common example, as abnormal vascular circulation can cause pain, discomfort, erectile dysfunction, delayed vaginal engorgement, and other symptoms. These conditions can stem from advanced age, high blood pressure, arterial plaque buildup, smoking, physical trauma, and other factors.

[0007] Various vasodilatory therapies have emerged for identifying and treating these problems, primarily through drug development. Typically, these drugs bind to vascular endothelial cells and stimulate calcium release, increasing blood flow by relaxing vascular smooth muscle. However, many of these drugs can cause adverse side effects in users, including palpitations, edema, nausea, headache, chest pain, and fatigue. Devices capable of diagnosing these vascular diseases and / or administering therapeutic treatments for them are not widely used or proven effective alternatives. Therefore, it is evident that there is a need in the art for novel and improved methods and products capable of stimulating blood flow to specific anatomical areas of a patient to treat vascular diseases. Summary of the Invention

[0008] To address these and other issues, methods and systems capable of enhancing blood flow to a patient's anatomical region have been disclosed. An applicator and a blood flow enhancement device can be used in the anatomical region to stimulate, heat, vibrate, and / or apply suction to that region. Specifically, the applicator can be used to form a protrusion extending therefrom; when the applicator is correctly positioned, this protrusion can be placed on the anatomical region to apply stimulation. Depending on the precise positioning of the applicator and the construction of the protrusion, a specific predetermined area of ​​the anatomical region can be targeted. The blood flow enhancement device can be received and housed within the inner surface of the protrusion on the top surface of the applicator, thereby allowing the vacuum portion and / or ultrasound transducer of the device to target the same predetermined area associated with the protrusion. Thus, targeted treatments such as therapy, diagnosis, and relaxation can be provided using these tools.

[0009] A method for enhancing blood flow to a patient's anatomical region may include the steps of: positioning an applicator relative to the anatomical region; and actuating a vacuum portion of the blood flow enhancement device to apply suction to the anatomical region. The applicator may include at least: a stimulation portion that may define protrusions having an outer surface and an inner surface; and a membrane portion comprising an impermeable material. The blood flow enhancement device may include a distal end, a proximal end, and a tube defining a fluid passage within the device, wherein the passage fluidly connects the vacuum portion and an opening defined by the distal end to facilitate the application of suction.

[0010] In other anatomical areas, the male glans penis or the female clitoral glans, clitoris, and anterior vaginal wall can also be treated in this manner. The size of the applicator's protrusion can be adjusted during treatment. Positioning the applicator allows the protrusion of the stimulating part to be placed in a predetermined area of ​​the anatomical region, so that the protrusion is used to stimulate that predetermined area. In another step of positioning the flow-enhancing device, a portion of the device can be accommodated in the inner surface of the protrusion, thereby allowing suction to be applied to the same predetermined area. The stimulating part may include a receiving structure that receives and engages a distal portion of the flow-enhancing device to ensure proper positioning of that portion. This engagement of the distal portion with the receiving structure can form an airtight seal, thereby contributing to a stronger suction effect.

[0011] The blood flow enhancement device may also include a vibrator, in which case an additional step of actuating the vibrator to apply vibration to the anatomical area can be performed. The blood flow enhancement device may also include an ultrasound transducer that can be actuated to apply heat to the anatomical area. The blood flow enhancement device may be positioned such that the ultrasound waves emitted by the ultrasound transducer can be transmitted through the stimulation area of ​​the applicator, which can be achieved by means of a stimulation area made of a material with a low attenuation coefficient.

[0012] Products capable of performing these treatments may include at least one applicator and a flow enhancement device. Each applicator may include at least: a stimulating portion for defining a protrusion extending from the applicator, the protrusion defining an outer surface and an inner surface; and a membrane portion comprising an impermeable material. The flow enhancement device may have a distal end, a proximal end, and a tube defining a fluid passage within the device, wherein the passage fluidly connects a vacuum portion and an opening defined by the distal end.

[0013] The stimulation portion of the applicator may include a receiving structure that can be connected to the distal end of the blood flow enhancement device. This connection between the distal portion and the receiving structure can form an airtight seal. The protrusion of the applicator can be adjusted. The shape of the applicator can be designed according to the target anatomical region (such as the glans penis in men, the glans clitoris in women, the labia majora, the labia minora, the clitoris, or the anterior vaginal wall).

[0014] The vacuum section of the flow enhancement device can be adjusted to change the applied suction level. The flow enhancement device may also include a vibrator for applying vibration to the anatomical area. An ultrasound transducer may be included in the flow enhancement device; in this case, the stimulation section of the applicator is manufactured using a material with a low attenuation coefficient, allowing ultrasound waves to pass through.

[0015] All of these embodiments are considered to be within the scope of this disclosure. These and other embodiments will become apparent to those skilled in the art from the following detailed description of preferred embodiments with reference to the accompanying drawings, and this disclosure is not limited to any particular preferred embodiment. Attached Figure Description

[0016] These and other features and advantages of the various embodiments disclosed herein can be better understood with reference to the following description and accompanying drawings, in which the same reference numerals always denote the same parts, and wherein:

[0017] Figure 1 This is a top view of an exemplary embodiment of the applicator;

[0018] Figure 2 yes Figure 1 The side view of the cross section taken along line 2-2 of the applicator shown;

[0019] Figure 3 yes Figure 1 A top view of an exemplary embodiment of the applicator shown, the applicator also including a receiving structure;

[0020] Figure 4 yes Figure 3 The image shows a cross-sectional side view of the applicator taken along line 4-4, and the blood flow enhancement device; and

[0021] Figure 5 This is an example of a treatment procedure using an applicator and a blood flow enhancement device.

[0022] In all the accompanying drawings and detailed descriptions, common reference numerals are used to indicate the same elements. Detailed Implementation

[0023] The following description includes various embodiments of methods and systems capable of increasing blood flow to a patient's anatomical area. An applicator having at least a stimulation portion and a membrane portion can be positioned relative to the anatomical area. The stimulation portion can be configured to define an adjustable protrusion extending from the applicator, which can be used to stimulate the anatomical area or a specific predetermined region thereof; the degree of stimulation and the stimulated area can depend on the size of the protrusion and the positioning of the applicator. A blood flow enhancement device can be used with the applicator to apply heating, vibration, and / or suction effects to the anatomical area. The applicator can be configured to allow it to receive the blood flow enhancement device, for example by means of an inner surface of the protrusion for receiving the device, thereby allowing these effects to be applied to the same area of ​​the anatomical area associated with the protrusion. Combining stimulation, heating, vibration, and / or suction applied to the anatomical area or a predetermined region in this way allows for the effective and efficient application of treatments such as vasodilatory therapy, diagnostic, or relaxation techniques to precise parts of the patient's body.

[0024] Heating effects can be provided by incorporating an ultrasonic transducer capable of using high-intensity focused ultrasound (HIFU) technology into the flow enhancement device. Because the stimulation section of the applicator is made of a low-attenuation material, the stimulation section allows these ultrasonic waves to pass through with low attenuation. Similarly, the device can include a vibrator and / or a vacuum section to provide vibration and suction effects, respectively. A tube can be provided at the distal end of the flow enhancement device, providing a fluid path connecting the vacuum section to an opening defined at the distal end to facilitate the suction activity.

[0025] To aid in positioning the flow enhancement device, the stimulation section may include a receiving structure, such as a ring structure, which can be connected to the flow enhancement device (i.e., the distal end of the device may be cylindrical to fit within the ring receiving structure). Depending on the construction of the receiving structure and the device, this connection can create a substantially airtight seal, thereby allowing for a more effective suction effect to be applied to the anatomical area or its predetermined region.

[0026] First go to Figure 1 and Figure 2 The figures show a top view of an exemplary embodiment of the applicator and a cross-sectional side view of the applicator taken along line 2-2. The applicator 100 may include a stimulation portion 102 and a membrane portion 104, both of which may be at least partially exposed on the top surface 128 of the applicator 100. The dimensions and configuration of these regions 102, 104 may be designed such that, at least on the top surface 128, the membrane portion 104 surrounds the stimulation portion 102, and / or the stimulation portion 102 is located substantially at the center of the applicator 100. Ideally, the membrane portion 104 comprises an impermeable material to capture bodily fluids that might otherwise spill in response to the application of treatment.

[0027] The stimulating portion 102 may also be at least partially exposed on the bottom surface 130 of the applicator 100. Preferably, at least the exposed portion of the stimulating portion 102 corresponding to the bottom surface 130 of the applicator 100 comprises a skin-friendly material (e.g., foam, medical textiles, other materials well known to those skilled in the art) to avoid irritating the anatomical area where the applicator 100 will be placed. Similarly, the contact portion 112 exposed on the bottom surface 130 of the applicator 100 may comprise a skin-friendly material, which may be the same as or different from the material used for the stimulating portion 102. These portions 102, 112 may also, or optionally, comprise a plastic material. To help ensure that the applicator 100 remains in proper position on the anatomical area, an adhesive portion 140 may be at least partially exposed on the bottom surface 130 of the applicator 100. Preferably, the adhesive portion 140 is shaped according to the anatomical area to adhere to areas of the anatomical area where the adhesive can be comfortably received and removed (e.g., areas of skin with low hair density and fine texture). Guide lines 138 may be provided on the top surface 128 of the applicator 100, corresponding to the presence of adhesive portions 140 on the bottom surface 130, to aid in the positioning and adhesion of the applicator 100. Conventional adhesives may be used in the adhesive portions 140, particularly those that will not substantially irritate the patient's skin or cause pain upon removal. The contact portion 112 and / or adhesive portion 140 may be arranged in layers with the membrane portion 104 such that fluid flowing through the contact portion 112 / adhesive portion 140 cannot easily spill through the membrane portion 104.

[0028] The geometry of the applicator 100 (including the thickness, shape, and size of its various portions 102, 104, 112, and 140) can be varied and configured for specific applications. For example, the shape of the applicator can be designed according to the anatomical region where the applicator 100 is intended to be positioned (such as the male glans penis, female clitoral glans, or clitoris). The anatomical region can also be an internal area of ​​the patient, such as the interior of an organ (i.e., the vagina) or its anterior wall. The applicator 100 is preferably flexible, thereby allowing for bending and stretching of the applicator 100 to a certain extent, thus making it suitable for various anatomical structures.

[0029] The applicator 100 can be used to define a protrusion 106 extending therefrom. The protrusion 106 can define: an inner surface 108 associated with a top surface 128 of the applicator 100; and an outer surface 110 associated with a bottom surface 130 of the applicator 100 and corresponding to the side of the protrusion 106 extending away from the applicator 100. The protrusion 106 can be positioned on an anatomical region by means of the applicator 100 to stimulate the anatomical region via the protrusion 106; the stimulation resulting from this positioning can allow increased blood flow to the anatomical region. By constructing the applicator 100 and the protrusion 106, and by means of the positioning of the applicator 100 relative to the anatomical region, specific predetermined areas of the anatomical region can be targeted for stimulation, thereby allowing targeted treatment and diagnosis of these body parts. If the anatomical region is an internal region within a patient's body, the protrusion 106 of the applicator 100 can apply stimulation to that internal region; this result can be achieved simply by positioning the applicator 100 on the patient in a specific manner. Preferably, when placed on the anatomical area, the protrusion 106 will remain sufficiently rigid so that stimulation can continue to be applied to the anatomical area while the applicator 100 is in the correct position.

[0030] The stimulation area 102 of the applicator 100 can be used to define the protrusion 106. This can be manifested in the stimulation area 102 being rigid and formed into the shape of the protrusion 106, thus naturally forming the protrusion 106. If the stimulation area 102 comprises a plastic material, the protrusion 106 can be formed in a conical shape, thereby allowing for the application of high stimulation to a predetermined area of ​​the anatomical region. Alternatively, the stimulation area 102 can exhibit a degree of flexibility, thereby allowing the protrusion 106 to be formed and / or adjusted. For example, the stimulation area 102 can be generally flat and coplanar with the applicator 100 (it can be in the form of the applicator 100 when packaged / stored), and when the applicator 100 is ready for use, the protrusion 106 can be formed by pressing the stimulation area 102 downward from the top surface 128; pushing the side of the applicator 100 inward toward the center of the applicator 100; and / or pulling a cord or similar element attached to the stimulation area 102. The height of the protrusion 106 (which can be measured from the bottom surface 130 of the applicator 100) can be adjusted using similar / the same techniques. The stimulation zone 102 can be configured with a preset structure corresponding to the protrusion 106 set to a specific size and / or shape. Structures can be incorporated into the applicator 100 and / or embedded in the stimulation zone 102 to improve the adjustability and configurability of the protrusion 106. Larger protrusions can increase the stimulation applied to the patient's anatomical area compared to smaller protrusions. Smaller protrusions are useful in cases where the patient / anatomical area responds poorly to larger protrusions.

[0031] Preferably, the stimulation portion 102 may be used to define a protrusion 106 extending from the bottom surface 130 of the applicator 100, although the stimulation portion 102 may also or optionally be used to define a protrusion extending from the top surface 128 of the applicator 100, such that the inner surface 108 of the protrusion is associated with the bottom surface 130 of the applicator 100, and the outer surface of the protrusion 106 is associated with the top surface 128 of the applicator 100. Depending on the construction of the applicator 100 and / or the stimulation area 102, a plurality of protrusions 106 extending from the stimulation portion 102 and spaced apart from each other may be formed. The applicator 100 may also or optionally have a plurality of stimulation portions 102, each stimulation portion defining a protrusion 106 corresponding to a different region of the anatomical area. Preferably, the protrusion 106 has a smooth, finger-like projection shape, although it may or optionally be formed with different shapes and sharper edges.

[0032] See now Figure 3 The figure shows Figure 1 A top view of an exemplary applicator includes a receiving structure. The receiving structure 114 may be built into the applicator 100 or a separate component that can be positioned in and removed from the applicator 100. Thus, the receiving structure 114 may be embedded within the stimulation portion 102 or used for coupling with the stimulation portion 102 (e.g., the receiving structure 114 is adapted to fit within a recess defined by the stimulation portion 102). The receiving structure 114 may be used to receive and couple a blood flow enhancement device 116, as will be discussed later in this disclosure.

[0033] See also Figure 4 The figure shows Figure 3 The applicator is shown in a cross-sectional side view taken along line 4-4, along with a blood flow enhancement device. The blood flow enhancement device 116, having a proximal end 132 and a distal end 134, can be used to apply effects such as heating, vibration, and / or suction to the anatomical area to further enhance blood flow to that area. During treatment, the blood flow enhancement device 116 can be positioned relative to the applicator 100 such that one or more effects are applied to the anatomical area when one or more functions of the blood flow enhancement device 116 are activated. If the stimulation portion 102 defines a protrusion 106, this positioning can include receiving a portion of the blood flow enhancement device 116 within an inner surface 108 defined by the protrusion 106, which can be achieved by coupling the blood flow enhancement device 116 to a receiving structure 114 (i.e., adapting the distal end 134 of the device 116 within the receiving structure 114 embedded in the stimulation portion 102). In this configuration, the effects applied by the blood flow enhancement device 116 can be targeted at a predetermined area of ​​the anatomical area associated with the protrusion 106. When connected to the receiving structure 114, the device 116 can still move relative to the receiving structure 114 (e.g., axially), which can be done during treatment to improve the effect applied by the device 116.

[0034] The heating effect can be applied via a blood flow enhancement device 116 having an ultrasound transducer that emits ultrasound waves that pass through the applicator 100. Preferably, the ultrasound waves can be transmitted through a stimulation zone 102, which can be achieved by means of a stimulation zone 102 made of a material with a low attenuation coefficient to allow ultrasound waves to pass through. High-intensity focused ultrasound (HIFU) can be applied to heat the anatomical area using such a method; the frequency of the ultrasound transducer can be adjustable to allow the user to change the degree of heating applied.

[0035] The flow enhancement device 116 may have a vibrator 122 to apply vibration to the anatomical area. When a portion of the flow enhancement device 116 is housed in the inner surface 108 of the protrusion 106, activating the vibrator 122 can apply vibration to the anatomical area, although holding the flow enhancement device 116 on other portions of the applicator 100 may also allow similar vibration to be applied to the anatomical area.

[0036] To apply a suction effect to the anatomical area, the blood flow enhancement device 116 may include a tube 120 defining a fluid path between an opening defined by the distal end 134 of the device 116 and a vacuum section 118, which may be present at the proximal end 132 of the device 116. Suction can be applied via an applicator 100 (preferably via a stimulation section 102) to further increase blood flow to the anatomical area. Positioning a portion of the blood flow enhancement device 116 to be received within the inner surface 108 of the protrusion 106 allows suction to be applied to a predetermined area of ​​the anatomical area associated with the protrusion 106. The connection of the blood flow enhancement device 116 to the receiving structure 114 allows an airtight seal to be formed within the inner surface 108 of the protrusion, thereby allowing a stronger suction effect to be applied to the predetermined area of ​​the anatomical area. It can be seen that any combination of stimulation, heating, vibration, and suction effects can be applied to the anatomical area, thereby providing various ways to perform treatments such as therapy, diagnosis, and relaxation by inducing changes in blood flow.

[0037] The flow enhancement device 116 and its components can be powered by a battery 126 adapted within the proximal end 132 of the flow enhancement device 116, thereby allowing for comfortable holding and positioning of the device 116, and replacement of the battery 126 as needed. Other devices may also be inserted into a wall socket or as part of a larger machine. In this respect, the flow enhancement device 116 may be packaged and sold as a product, for example, with a stacked applicator 100, or as a sub-component of a medical device in a hospital, while the applicator 100 is obtained separately. The flow enhancement device 116 or the associated machine may include one or more actuators 124 for turning on the device 116 and / or activating its components (vibrator 122, vacuum unit 118).

[0038] See now Figure 5The figure illustrates an example of a treatment procedure using an applicator and a flow enhancement device. It can be seen that by positioning the applicator 100 on a sub-region 144 of the anatomical area 142, a protrusion 106 can be positioned against a predetermined area of ​​the anatomical area 142. By positioning the flow enhancement device 116 (by accommodating it within the inner surface 108 of the protrusion 106), in addition to the stimulation effect applied by the protrusion 106, heating, vibration, and / or suction effects can be applied to the predetermined area. This type of treatment procedure can be performed by the patient themselves or by an operator / physician. Those skilled in the art will understand the extent and duration of the stimulation, heating, suction, and / or vibration effects applied to the anatomical area to implement the intended treatment. In this respect, the treatment procedure can be improved (e.g., increasing / decreasing treatment intensity) in response to the patient's / anatomical area's response to treatment (e.g., whether the response is poor or weak). After treatment, the applicator 100 can be removed from the anatomical area 142 and disposed of appropriately.

[0039] The above description is given by way of example and not limitation. Based on the above disclosure, those skilled in the art can devise variations within the scope and spirit of this disclosure. Furthermore, various features of the embodiments disclosed herein can be used individually or in different combinations thereof, and are not intended to be limited to the specific combinations described herein. Therefore, the scope of the claims is not limited to the illustrated embodiments. Other modifications and improvements to this disclosure may also be apparent to those skilled in the art. Therefore, the specific combinations of components and steps described and illustrated herein are intended only to illustrate certain embodiments of the subject matter of this disclosure and are not intended to be used to limit alternative apparatuses and methods within the scope and spirit of this disclosure.

Claims

1. A method for enhancing blood flow to a patient's anatomical region, the method comprising the steps of: The applicator, relative to the anatomical region localization applicator, comprises: A stimulation portion, the stimulation portion defining a protrusion extending from the applicator, the protrusion defining an outer surface and an inner surface; and The membrane portion comprises a substantially impermeable material; Positioning the blood flow enhancement device in association with the applicator; and The blood flow enhancement device is actuated to apply negative pressure to the anatomical area. The blood flow enhancement device has a distal end and a proximal end. The blood flow enhancement device includes a tube that defines a fluid passage fluidly connected to a vacuum section and an opening defined by the distal end.

2. The method according to claim 1, wherein, The applicator is positioned such that the stimulation portion is placed in a predetermined area of ​​the anatomical region, and the protrusion is used to stimulate the predetermined area.

3. The method according to claim 1, wherein, The step of positioning the blood flow enhancement device in association with the applicator includes positioning a portion of the blood flow enhancement device in the inner surface of the protrusion.

4. The method according to claim 1, wherein, The stimulation portion includes a receiving structure; and the step of positioning the flow enhancement device in association with the applicator includes: connecting a portion of the distal end of the flow enhancement device to the receiving structure.

5. The method according to claim 4, wherein, The distal portion forms a substantially airtight seal with the connection of the receiving structure.

6. The method according to claim 1, wherein, The blood flow enhancement device further includes a vibrator; and the method further includes the step of actuating the vibrator to apply vibration to the anatomical area.

7. The method according to claim 1, wherein, The blood flow enhancement device further includes an ultrasonic transducer; and the method further includes the step of actuating the ultrasonic transducer to apply heat to the anatomical area.

8. The method according to claim 7, wherein, The ultrasonic waves emitted by the ultrasonic transducer are transmitted through the stimulation area.

9. The method according to claim 1, wherein, The method further includes the following step: adjusting the size of the protrusion.

10. The method according to claim 1, wherein, The applicator is sized and constructed to engage with one or more anatomical regions of the patient.

11. The method according to claim 10, wherein, The one or more anatomical regions are selected from the group consisting of: male glans penis, female glans clitoris, labia majora, labia minora, clitoris, and anterior vaginal wall.

12. A system for enhancing blood flow to a patient's anatomical region, the device comprising: At least one applicator, said at least one applicator comprising: A stimulation portion, the stimulation portion being used to define a protrusion extending from the pad, the protrusion defining an outer surface and an inner surface; and The membrane portion, said membrane portion comprising a substantially impermeable material; and A blood flow enhancement device having a distal end and a proximal end, the blood flow enhancement device including a tube defining a fluid passage for applying negative pressure to an opening defined by the distal end, the blood flow enhancement device being positioned in association with an applicator to apply negative pressure to the anatomical area.

13. The system according to claim 12, wherein, The stimulation portion further includes a receiving structure, and the blood flow enhancement device further includes a coupling portion located at its distal end, wherein the blood flow enhancement device is positioned in association with the applicator to apply negative pressure to the anatomical area through the coupling portion for coupling with the receiving structure.

14. The system according to claim 13, wherein, The connection between the distal end and the receiving structure is used to form a substantially airtight seal.

15. The system according to claim 12, wherein, The blood flow enhancement device also includes a vibrator.

16. The system according to claim 12, wherein, The blood flow enhancement device further includes an ultrasonic transducer; and wherein the stimulation portion is used to allow ultrasonic waves to be transmitted through it.

17. The system according to claim 12, wherein, The blood flow enhancement device is used to adjust the applied vacuum suction level.

18. The system according to claim 12, wherein, The size of the protrusion is adjustable.

19. The system according to claim 12, wherein, Each of the one or more applicators is sized and constructed to engage with one or more anatomical regions of the patient.

20. The system according to claim 19, wherein, The one or more anatomical regions are selected from the group consisting of: male glans penis, female glans clitoris, labia majora, labia minora, clitoris, and anterior vaginal wall.

Images