阅读说明：本技术 压力衰减装置 (Pressure attenuation device ) 是由 凯文·G·康纳斯 阿尔伯特·俊智·钱 罗伊·H·沙利文三世 马修·J·威特尼 威廉·H·格鲁 于 2020-02-06 设计创作，主要内容包括：用于身体中的压力衰减装置可以包括球囊,所述球囊包括外壁并在其中限定内部腔室,所述球囊被配置为弹性变形高达至至少90cmH-(2)O的内部压力。在37℃下具有155cm-185cm H-(2)O的蒸汽压的高蒸汽压介质可以定位在内部腔室内。所述球囊可以具有0.001英寸-0.00175英寸的最小壁厚。(A pressure attenuating device for use in a body may include a balloon including an outer wall and defining an interior chamber therein, the balloon configured to elastically deform up to at least 90cmH 2 The internal pressure of O. Has a pH of 155cm-185cm H at 37 DEG C 2 A high vapor pressure medium of the vapor pressure of O may be positioned within the internal chamber. The balloon may have a minimum wall thickness of 0.001 inch to 0.00175 inch.)

1. A pressure attenuating device for use in a body, the pressure attenuating device comprising:

a balloon comprising an outer wall and defining an interior chamber therein, the balloon having a minimum wall thickness of 0.001 inches to 0.00175 inches, the balloon configured to elastically deform up to at least 90cm H₂The internal pressure of O.

2. The pressure attenuating device of claim 1, further comprising a pressure of 155cm H at 37 ℃₂O-185cm H₂O, and a high vapor pressure medium.

3. The pressure attenuating device of claim 1, further comprising a pressure of 155cm H at 37 ℃₂O-165cm H₂O, and a high vapor pressure medium.

4. The pressure attenuating device of any one of the preceding claims, wherein the high vapor pressure medium is positioned within the internal chamber.

5. The pressure attenuating device of any one of the preceding claims, wherein the high vapor pressure medium includes a PFC.

6. The pressure attenuating device of any one of the preceding claims, wherein when the internal pressure within the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon elastically deforms and increases in volume by at least 10% but less than 90%.

7. The pressure attenuating device of any one of the preceding claims, wherein when the internal pressure within the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon elastically deforms and increases in volume by at least 75% but less than 90%.

8. The pressure attenuating device of any one of the preceding claims, wherein the balloon is elastically deformed to at least 120cm H₂Interior of OAnd (4) pressure.

9. The pressure attenuating device of any one of the preceding claims, wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml.

10. The pressure attenuating device of any one of the preceding claims, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O is elastically deformed for at least 15 cycles.

11. The pressure attenuating device of any one of the preceding claims, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O is elastically deformed for at least 25 cycles.

12. The pressure attenuating device of any one of the preceding claims, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O is elastically deformed for at least 50 cycles.

13. The pressure attenuating device of any one of the preceding claims, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O elastically deforms for at least 100 cycles.

14. A pressure attenuating device for use in a body, the pressure attenuating device comprising:

a balloon comprising an outer wall and defining an interior chamber therein, the balloon configured to elastically deform up to at least 90cm H₂The internal pressure of O;

has a pH of 155cm-185cm H at 37 DEG C₂O, and a high vapor pressure medium.

15. The pressure attenuating device of claim 14, wherein the high vapor pressure medium has a H of 155cm at 37 ℃₂O-165cm H₂The vapor pressure of O.

16. The pressure attenuating device of any one of claims 14-15, wherein the high vapor pressure medium is positioned within the internal chamber.

17. The pressure attenuating device of any one of claims 14-16, wherein the high vapor pressure medium comprises a PFC.

18. The pressure attenuating device of any one of claims 14-17, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles.

19. The pressure attenuating device of any one of claims 14-18, wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml.

20. A pressure attenuating device for use in a body, the pressure attenuating device comprising:

a balloon comprising an outer wall and defining an internal chamber therein when an internal pressure within the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 50% but less than 190%.

21. The pressure attenuating device of claim 20, wherein when the pressure within the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 65% but less than 100%.

22. The pressure attenuating device of any one of claims 20-21, wherein when the pressure within the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 75% but less than 90%.

23The pressure attenuating device of any one of claims 20-22, wherein when the pressure within the balloon is from 2.5cm H₂O increased to 70cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 20% but less than 150%.

24. The pressure attenuating device of any one of claims 20-23, wherein when the pressure within the balloon is from 2.5cm H₂O increased to 70cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 30% but less than 100%.

25. The pressure attenuating device of any one of claims 20-24, wherein when the pressure within the balloon is from 2.5cm H₂O increased to 70cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 45% but less than 60%.

26. The pressure attenuating device of any one of claims 20-25, wherein when the pressure within the balloon is from 2.5cm H₂O is increased to 40cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 10% but less than 45%.

27. The pressure attenuating device of any one of claims 20-26, wherein when the pressure within the balloon is from 2.5cm H₂O is increased to 40cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 18% but less than 30%.

28. The pressure attenuating device of any one of claims 20-27, wherein when the pressure within the balloon is from 2.5cm H₂O is increased to 40cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 19% but less than 27%.

29. The pressure attenuating device of any one of claims 20-28, comprising a pressure of 155cm H at 37 ℃₂O-185cm H₂O, and a high vapor pressure medium.

30. The pressure attenuating device of any one of claims 20-29, comprising a pressure of 155cm H at 37 ℃₂O-165cm H₂O, and a high vapor pressure medium.

31. The pressure attenuating device of claims 29 and 30, wherein the high vapor pressure medium is positioned within the internal chamber.

32. The pressure attenuating device of any one of claims 29-31, wherein the high vapor pressure medium comprises a PFC.

33. The pressure attenuating device of any one of claims 20-32, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles.

34. The pressure attenuating device of any one of claims 20-33, wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml.

35. The pressure attenuating device of any one of claims 20-34, wherein the balloon has a minimum wall thickness of 0.001 inches to 0.00175 inches.

36. A pressure attenuating device for use in a body, the pressure attenuating device comprising:

a balloon comprising an outer wall and defining an interior chamber therein; and

a high vapor pressure medium;

the balloon is configured to elastically deform at least up to 90cm H₂O, internal pressure within the chamber.

37. Pressure according to claim 36An attenuation device, wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles.

38. The pressure attenuating device of claim 37, wherein the balloon is configured to elastically deform at least up to 100cm H₂O, internal pressure within the chamber.

39. The pressure attenuating device of claim 38, wherein the balloon is at 2.5cm H₂O to 100cm H₂The internal pressure of the O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles.

40. The pressure attenuating device of claim 39, wherein the balloon is configured to elastically deform at least up to 120cm H₂O, internal pressure within the chamber.

41. The pressure attenuating device of claim 40, wherein the balloon is at 2.5cm H₂O to 120cm H₂The internal pressure of the O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles.

42. The pressure attenuating device of any one of claims 36-41, wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml.

43. The pressure attenuating device of any one of claims 36-42, wherein the balloon has a minimum wall thickness of 0.001 inches to 0.00175 inches.

44. The pressure attenuating device of any one of claims 36-43, wherein the high vapor pressure medium has a Hx of 155cm at 37 ℃₂O-185cm H₂The vapor pressure of O.

45.The pressure attenuating device of any one of claims 36-44, wherein the high vapor pressure medium has a Hx of 155cm at 37 ℃₂O-165cm H₂The vapor pressure of O.

46. The pressure attenuating device of any one of claims 36-45, wherein the high vapor pressure medium is positioned within the internal chamber.

47. The pressure attenuating device of any one of claims 36-46, wherein the high vapor pressure medium comprises a PFC.

48. The pressure attenuating device of any one of claims 36-46, wherein the high vapor pressure medium comprises a liquid at 37 ℃.

49. A method of treating urinary incontinence in a human or animal body, comprising implanting a pressure attenuating device according to any one of the preceding claims into the bladder of the human or animal body, and inflating the pressure attenuating device while in the bladder.

50. The method of treating urinary incontinence in the human or animal body of claim 49, further comprising removing said device from said bladder.

51. A pressure attenuating device comprising one or more of the features described above.

52. The pressure attenuating device of any one of the preceding claims, configured to be implanted within a human bladder.

53. The pressure attenuating device of any one of the preceding claims, configured to be implanted in an uninflated state within a human bladder and then inflated within the bladder.

54. A method of treating urinary incontinence in a human or animal body comprising implanting a pressure attenuating device as described herein within a bladder, and inflating the pressure attenuating device while in the bladder.

55. The pressure attenuating device of any one of the preceding claims, wherein the balloon includes a ball portion and a tail portion.

56. The pressure attenuating device of any one of the preceding claims, wherein the balloon is seamless.

FIELD

The present disclosure relates to methods and systems for performing medical procedures on anatomical structures of a body. Such medical procedures may include, for example, attenuating transient pressure waves in the anatomy of the body, for example, by implanting a pressure attenuating device in the anatomy of the body subject to such pressure waves.

Description of the related Art

Pressure waves are known to propagate through incompressible fluids in various anatomical structures of the body. These pressure waves may be caused by events that normally occur in the body, such as the beating of the heart, breathing in the lungs, peristaltic action in the gastrointestinal tract, and movement of body muscles. Alternatively, these pressure waves may be caused by sudden events, such as coughing, laughing, external trauma to the body, and movement of the body relative to gravity. The propagation of these pressure waves increases as the elasticity (sometimes called compliance) of the surrounding tissues and organs decreases. These pressure waves have many undesirable effects, from discomfort of pressure on organs and tissues, to fluid leakage, to renal failure, to stroke, to heart attack, to blindness.

Urinary tract disorders, such as urinary frequency, urgency, incontinence and cystitis, are a common problem in the united states and even worldwide, affecting people of all ages both physiologically and psychologically. Urine is composed primarily of water and is an incompressible fluid in nature in the typical pressure ranges found in the human bladder. The maximum urethral pressure for normal bladder urination is clearly related to the intravesical pressure. During normal urination, urethral relaxation occurs before detrusor contraction causes intravesical pressure to exceed urethral pressure.

The peak intravesical pressure is typically caused by volumetric tissue displacement in response to gravity, muscle activity, or rapid acceleration. The lack of compliance of the bladder and the urine contained therein with respect to high frequency, high intensity and short wavelength events results in minimal fluid pressure attenuation of the high frequency pressure waves and results in high intravesical pressures being transmitted directly to the bladder neck and urethra, which may or may not cause detrusor contraction. In these cases, the urethra may act as a volume pressure relief mechanism, allowing a proportional volume of fluid to escape (escape) the bladder, thereby reducing the intravesical pressure to a tolerable level. The urethra has a maximum urethral pressure value and when the intravesical pressure exceeds the maximum urethral pressure, fluid will overflow the bladder. In these cases, neuroreceptors in the bladder and/or bladder neck and/or trigone trigger detrusor contractions, which can result in voiding (urinary frequency) or can resolve without voiding (urgency) or can result in intravesical pressure exceeding the maximum urethral pressure, resulting in fluid overflow of the bladder (stress incontinence).

For most patients with problems with urinary tract disorders (e.g., frequency, urgency, stress and urge incontinence and cystitis), the cause and/or contributor to bladder dysfunction is a decrease in overall dynamic bladder compliance as opposed to a decrease in steady-state bladder compliance. These patients may typically have a bladder that is compliant under steady state conditions, but becomes non-dynamically compliant when subjected to an external pressure event having a short duration, e.g., less than 5 seconds, or in some cases less than 0.5 seconds. The decrease in dynamic compliance of the bladder is often caused by aging, use, distension, childbirth, and trauma. In addition, the anatomy of the bladder relative to the diaphragm, stomach, and uterus (for women) causes external pressure to be exerted on the bladder during athletic activities such as speaking, walking, laughing, sitting, moving, rolling, and rolling. For patients with stress incontinence due to lack of dynamic compliance in the bladder, leakage occurs when intravesical pressure exceeds the maximum urethral pressure.

In view of the above, many attempts have been made to combat urinary tract disorders. One such attempt has been to implant a compressible pressure attenuating device in the bladder to reduce the intravesical pressure. This method is disclosed, for example, in the following documents, all of which are incorporated herein by reference: U.S. patent No. 6,682,473, Matsuura et al, published 2004, 1/27; U.S. patent No. 7,074,178, Connors et al, published 2006, 7/11; and U.S. patent application publication No. 2010/0222802; gillespie, jr. et al, published 9/2/2010. In accordance with one aspect of the foregoing method, a compressible device is inserted in a compressed state through a patient's urethra into a patient's bladder, and then, once in the bladder, the compressible device is expanded, for example, by inflating with atmospheric air. The delivery system may be used to deliver the compressible device through the urethra and into the bladder, and may also be used to expand the compressible device from its compressed state to its expanded state and deploy the compressible device from the delivery system once expanded. If removal or replacement of the compressible device is desired, the compressible device can be removed from the bladder through the urethra using a removal system.

Background

SUMMARY

The systems, methods, and devices of the present disclosure each have several innovative aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.

In one aspect, the present disclosure improves upon existing pressure attenuating devices used in the bladder. It is therefore an object of certain embodiments of the present disclosure to provide methods and systems for performing medical procedures on anatomical structures of the body (e.g., the bladder). Medical procedures may be performed, for example, to attenuate transient pressure waves in an anatomical structure, and may include, for example, implanting a pressure attenuating device in an anatomical structure (e.g., a bladder) that is subject to such pressure waves. Such methods and systems may be used to treat, but are not limited to use in treating, urinary tract disorders.

Certain embodiments include methods of treating conditions affecting the bladder. The method may comprise the step of implanting the pressure attenuating device in a human or animal body. Conditions affecting the bladder may include: urinary incontinence, urinary tract cancer, infections affecting the bladder, or inflammatory conditions affecting the bladder.

In certain embodiments, a pressure attenuating device for use in a body may include a balloon including an outer wall and defining an interior chamber therein. The outer wall of the balloon may have a minimum wall thickness of 0.001 inches to 0.00175 inches. The balloon may be configured to elastically deform up to at least 90cm H₂The internal pressure of O. In some embodiments, the pressure attenuating device may further include one or more of the following features in any combination: (a) 155cm H at 37 DEG C₂O-185cm H₂A high vapor pressure medium having a vapor pressure of O; (b) 155cm H at 37 DEG C₂O-165cm H₂A high vapor pressure medium having a vapor pressure of O; (c) wherein the high vapor pressure medium is positioned within the internal chamber; (d) wherein the high vapor pressure medium comprises a PFC; (e) wherein when the internal pressure in the balloon is from 2.5cm H₂O increases to 90cm H₂At O, the balloon elastically deforms and increases in volume by at least 10% but less than 90%; (f) wherein when the internal pressure in the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon elastically deforms and increases in volume by at least 75% but less than 90%; (g) wherein the balloon is elastically deformed to at least 120cm H₂The internal pressure of O; (h) wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml; (i) wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of O elastically deforms for at least 15 cycles; (j) wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of O elastically deforms for at least 25 cycles; (k) wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of O elastically deforms for at least 50 cycles; and/or (1) wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of the O elastically deforms for at least 100 cycles.

In certain embodiments, a pressure attenuating device for use in a body mayTo include a balloon including an outer wall and defining an interior chamber therein. The device may include a high vapor pressure medium. The balloon may be configured to elastically deform at least up to 90cm H₂The internal pressure in the chamber of O.

In certain embodiments, a pressure attenuating device may include a balloon including an outer wall and defining an interior chamber therein. The balloon may be configured to elastically deform up to at least 90cm H₂The internal pressure of O. Has a pH of 155cm-185cm H at 37 DEG C₂A high vapor pressure medium, which is the vapor pressure of O, may be within the balloon. In some embodiments, the pressure attenuating device may further include one or more of the following features in any combination: (a) wherein the high vapor pressure medium has a vapor pressure of 155cm H at 37 deg.C₂O-165cm H₂The vapor pressure of O; (b) wherein the high vapor pressure medium is positioned within the internal chamber, (c) wherein the high vapor pressure medium comprises a PFC; (d) wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles; and/or (e) wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml.

In certain embodiments, a pressure attenuating device for use in a body includes a balloon including an outer wall and defining an interior chamber therein. When the internal pressure in the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon may be configured to elastically deform and increase in volume by at least 50% but less than 190%. In some embodiments, the pressure attenuating device may further include one or more of the following features in any combination: (a) wherein when the pressure in the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 65% but less than 100%; (b) wherein when the pressure in the balloon is from 2.5cm H₂O increases to 90cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 75% but less than 90%; (c) wherein when the pressure in the balloon is from 2.5cm H₂O increased to 70cm H₂O, the balloon is configured to elastically deform anda volume increase of at least 20% but less than 150%; (d) wherein when the pressure in the balloon is from 2.5cm H₂O increased to 70cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 30% but less than 100%; (e) wherein when the pressure in the balloon is from 2.5cm H₂O increased to 70cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 45% but less than 60%; (f) wherein when the pressure in the balloon is from 2.5cm H₂O is increased to 40cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 10% but less than 45%; (g) wherein when the pressure in the balloon is from 2.5cm H₂O is increased to 40cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 18% but less than 30%; (h) wherein when the pressure in the balloon is from 2.5cm H₂O is increased to 40cm H₂O, the balloon is configured to elastically deform and increase in volume by at least 19% but less than 27%; (i) comprising a molecular weight of 155cm H at 37 DEG C₂O-185cm H₂A high vapor pressure medium having a vapor pressure of O; (j) comprises a molecular weight distribution at 155cm H at 37 ℃₂O-165cm H₂A high vapor pressure medium having a vapor pressure of O; (k) wherein the high vapor pressure medium is positioned within the internal chamber; (1) wherein the high vapor pressure medium comprises a PFC; (m) wherein the balloon is at 2.5cm H₂O to 90cm H₂The internal pressure of O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles; (n) wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml; and/or (o) wherein the balloon has a minimum wall thickness of 0.001 inch to 0.00175 inch.

In several embodiments, a pressure attenuating device for use in a body includes a balloon including an outer wall and defining an interior chamber therein; and high vapor pressure media. The balloon is configured to elastically deform at least up to 90cm H₂The internal pressure in the chamber of O. In some embodiments, the pressure attenuating device may further include one or more of the following features in any combination: (a) wherein the balloon is at 2.5cm H₂O to 90cm H₂Elastic deformation of O by internal pressure of at least 15 cycles, 25 cycles, 50 cycles or100 cycles; (b) wherein the balloon is configured to elastically deform at least up to 100cm H₂Internal pressure within the chamber of O; (c) wherein the balloon is at 2.5cm H₂O to 100cm H₂The internal pressure of O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles; (d) wherein the balloon is configured to elastically deform at least up to 120cm H₂Internal pressure within the chamber of O; (e) wherein the balloon is at 2.5cm H₂O to 120cm H₂The internal pressure of O elastically deforms for at least 15 cycles, 25 cycles, 50 cycles, or 100 cycles; (f) wherein the balloon has a natural volume of 1 to 180cc, 10 to 60cc, 24ml to 40ml, or 25ml to 29 ml; (g) wherein the balloon has a minimum wall thickness of 0.001 inches to 0.00175 inches; (h) wherein the high vapor pressure medium has a vapor pressure of 155cm H at 37 ℃₂O-185cm H₂The vapor pressure of O; (i) wherein the high vapor pressure medium has a vapor pressure of 155cm H at 37 ℃₂O-165cm H₂The vapor pressure of O; (j) wherein the high vapor pressure medium is positioned within the internal chamber; (k) wherein the high vapor pressure medium comprises a PFC; and/or (1) wherein the high vapor pressure medium comprises a liquid at 37 ℃.

In certain embodiments, the pressure attenuating device includes one or more of the features described above. In certain embodiments, the pressure attenuating device includes one or more of the features described above and is configured to be placed within a human bladder.

Certain embodiments include a method of treating urinary incontinence in a human or animal body comprising implanting a pressure attenuating device comprising one or more of the features described above into the bladder of the human or animal body, and inflating the pressure attenuating device while in the bladder. In certain embodiments, the method further comprises removing the device from the bladder.

Certain embodiments include a pressure attenuating device configured to be implanted within a human bladder, including one or more of the features described above.

Certain embodiments include a pressure attenuating device including one or more of the features described above, configured to be implanted in an uninflated state within a human bladder and then inflated within the bladder.

Certain embodiments include a pressure attenuating device including one or more of the features described above, wherein the balloon includes a ball portion and a tail portion.

Certain embodiments include a pressure attenuating device including one or more of the features described above, wherein the balloon is seamless.

Other features and advantages will become apparent to those skilled in the art in view of the following detailed description of the preferred embodiments, when considered in conjunction with the accompanying drawings and claims.