Blood pressure cuffs with resilient support sleeves

• US 6,988,992 B2
• Filed: 11/12/2002
• Issued: 01/24/2006
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: SunTech Medical, Inc. (Halma PLC)
• Original Assignee: SunTech Medical, Inc. (Halma PLC)
• Inventors: Just, Steven M., McBee, Dayn C., Gallick, David A.
• Primary Examiner(s): Marmor, Charles
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/292,174
• Publication Number:
  US 20040092833A1
• Time in Patent Office: 1,169 Days
• Field of Search: 600485-507
• US Class Current: 600/499
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence

Abstract

Inflatable blood pressure cuff assemblies include an inflatable elongate cuff member having opposing long edges and opposing short edge portions with a fluid chamber therein and a resilient support sleeve attached to a respective one of the opposing short edge portions of the inflatable elongate cuff member. The sleeve may be configured with a sensor chamber and a cable routing channel. Related systems and methods of fabricating cuff assemblies and resilient support sleeves are also described.

Claims

1. An inflatable blood pressure cuff assembly comprising:

an inflatable elongate cuff member having opposing long edges and opposing short edge portions with an inflatable fluid chamber therein; and

a resilient sleeve attached to a minor portion of the cuff member proximate a single one of the opposing short edge portions of the inflatable elongate cuff member, wherein the sleeve has a body with at least a major portion of the body sized and configured to elastically expand to snugly and generally conformably fit on a limb of a patient when in position on the patient prior to inflation of the cuff member, and wherein, in position, the sleeve is configured to define a first closed member before the cuff member is wrapped over the sleeve and the cuff member defines a second closed member after the cuff member is wrapped over the sleeve.

2. A blood pressure cuff assembly according to claim 1, wherein the sleeve is air permeable and comprises a fabric that includes stretch fibers, and wherein the sleeve is configured to generally radially elastically compress against the limb of the patient under the cuff member when the cuff member is inflated.

3. A blood pressure cuff assembly according to claim 1, wherein the sleeve has a closed perimeter configuration defining an aperture extending in the axial direction, wherein the sleeve aperture is sized and configured to stretch to receive a limb of a patient therein during use.

4. A blood pressure cuff assembly according to claim 3, wherein the sleeve aperture has a first configuration with a first width during periods of non-use and a second configuration with an expanded second width when in position on a patient, wherein, in the second configuration, the sleeve is substantially conformable to and resides securely against a desired portion of the limb of the patient with sufficient compressive force so that it is able to maintain its desired longitudinal position to thereby inhibit slippage during use.

5. A blood pressure cuff assembly according to claim 2, wherein the sleeve comprises nylon fibers.

6. A blood pressure cuff assembly according to claim 2, wherein the sleeve comprises spandex fibers.

7. A blood pressure cuff assembly according to claim 4, wherein the sleeve has opposing upper and lower edge portions, and wherein, in position on a patient, the sleeve is configured to have an elastic lateral stretch of at least about 15% at the lower edge portion to provide the second configuration width.

8. A blood pressure cuff assembly according to claim 7, wherein the sleeve is configured to accommodate patients having limbs that vary in width by up to at least about 150%.

9. A blood pressure cuff assembly according to claim 8, wherein the sleeve is sized and configured to accommodate patients having limbs that vary in width between about 100–

205%.

10. A blood pressure cuff assembly according to claim 1, wherein the sleeve has a frustoconical shape.

11. A blood pressure cuff assembly according to claim 1, wherein the cuff member is bladderless.

12. A blood pressure cuff assembly according to claim 1, wherein the cuff member comprises an inflatable bladder held in a receiving chamber.

13. A blood pressure cuff assembly according to claim 12, wherein the sleeve is formed of a fabric comprising nylon as a major constituent and spandex as a minor constituent.

14. A blood pressure cuff assembly according to claim 1, wherein the sleeve comprises a sensor chamber.

15. A blood pressure cuff assembly according to claim 14, wherein the sleeve comprises a sensor held in the sensor chamber.

16. A blood pressure cuff assembly according to claim 14, wherein the sleeve comprises upper and lower edge portions, and wherein the sensor chamber is located proximate the lower edge portion.

17. A blood pressure cuff assembly according to claim 1, wherein, in position on the patient, the sleeve defines a closed member that, away from the attachment portion, is generally independent of the cuff member with the cuff member overlying the sleeve when wrapped about the patient so that one short end portion of the cuff member releasably attaches to an outside primary surface of the cuff member whereby the sleeve helps hold the cuff member in position on the subject.

18. A blood pressure cuff assembly according to claim 1, wherein the sleeve comprises visual arterial alignment indicia.

19. A blood pressure cuff assembly according to claim 16, wherein the sleeve further comprises a cable channel in communication with the sensor chamber.

20. A blood pressure cuff assembly according to claim 19, wherein the sleeve cable channel is curvilinear.

21. A blood pressure cuff assembly according to claim 18, wherein the visual arterial alignment indicia includes an alignment arrow.

22. A blood pressure cuff assembly according to claim 1, wherein the assembly is configured for stress test blood pressure measurements.

23. A blood pressure cuff assembly according to claim 1, wherein the sleeve is formed from a unitary sheet of material.

24. A blood pressure cuff assembly according to claim 1, wherein the sleeve is formed of an anisotropic material.

25. A blood pressure cuff assembly according to claim 1, wherein the sleeve is attached to the cuff member in a releasably detachable manner.

26. A blood pressure cuff assembly according to claim 25, wherein the sleeve is configured as a single-use disposable member.

27. A blood pressure cuff assembly according to claim 1, wherein the sleeve is fixedly attached to the cuff member.

28. A blood pressure cuff assembly according to claim 1, wherein the sleeve has opposing first and second short end portions, and wherein the first end portion is configured to releaseably attach to the cuff member and/or the second short end portion of the sleeve.

29. A blood pressure cuff assembly according to claim 1, wherein the cuff member and sleeve are configured to accommodate both the left and right arms of patients.

30. A blood pressure cuff assembly according to claim 1, wherein the assembly is configured for ambulatory blood pressure measurements.

31. An inflatable blood pressure cuff assembly comprising:

an inflatable elongate cuff member having a body with opposing long edges and opposing short edge portions with a fluid chamber therein, in operation, the cuff member body being configured to wrap about a limb of a user and define a first closed member; and

a resilient sleeve configured to reside under the wrapped cuff member, wherein the sleeve has a primary body portion that is formed of an air-permeable stretch fabric that is sized and configured to stretch to accommodate the limb of the user whereby the sleeve is adapted to snugly and conformably fit about the limb of the user independent of the cuff member, the resilient sleeve configured to define a second closed member that is adapted to elastically expand about the body portion of the user in a generally form fitting manner before inflation of the cuff member and elastically compress against the body portion when the cuff member is inflated.

32. A blood pressure cuff assembly according to claim 31, wherein the sleeve comprises visual arterial alignment indicia.

33. A blood pressure cuff assembly according to claim 31, wherein the sleeve remains unattached to the cuff member during operation.

34. A blood pressure cuff assembly according to claim 31, wherein the sleeve is releasably attachable to a minor portion of the cuff at one of the short edge portions of the elongate cuff member.

35. A blood pressure cuff assembly according to claim 31, wherein the sleeve is fixedly attached to the elongate cuff member.

36. A blood pressure cuff assembly according to claim 31 wherein the sleeve includes opposing first and second short end portions, and wherein the first end portion is configured to releaseably attach to the cuff member and/or the sleeve second end portion.

37. A blood pressure cuff assembly according to claim 35, wherein, in position, the sleeve is sized and configured to be forced to stretch in a lateral direction by at least about 15% to accommodate the limb of the patient, and wherein the air permeable sleeve body stretch fabric comprises at least one of spandex and nylon.

38. A blood pressure cuff assembly according to claim 31, in combination with a plurality of different blood pressure cuff assemblies, each having a sleeve configured in a predetermined size to accommodate a range of different size patients and wherein the sleeves are configured to have a lateral stretch of at least about 500% to accommodate a range of different size limbs.

39. A blood pressure cuff assembly according to claim 32, wherein the visual arterial alignment indicia includes an alignment arrow.

40. An inflatable blood pressure cuff assembly comprising:

an inflatable elongate cuff member having a body with opposing long edge portions and opposing short edge portions; and

a resilient sleeve attached to a minor portion of the cuff member at an attachment portion that is proximate one of the short edge portions of the inflatable elongate cuff member so that the sleeve extends outward from the cuff member body, the sleeve having a body that is sized and configured to snugly and generally conformably elastically expand to receive a target region of a limb of a patient independent of the cuff member, wherein when positioned on a target patient, wherein, when positioned on the subject, the cuff member wraps one of the opposing short edge end portions over the body of the cuff member to close the cuff member and reside over the sleeve.

41. A blood pressure cuff assembly according to claim 40, wherein the sleeve comprises visual arterial alignment indicia.

42. A blood pressure cuff assembly according to claim 40, wherein the visual arterial alignment indicia includes an alignment arrow.

43. A blood pressure cuff assembly according to claim 40, wherein the sleeve is non-inflatable and does not expand as the cuff member is inflated.

44. A blood pressure cuff assembly according to claim 40, wherein the sleeve body is non-inflatable and fanned from an air permeable stretch fabric that is adapted to generally conform to the shape of the limb of the subject when the cuff member is deflated and when the cuff member is unwrapped, and wherein the sleeve is adapted to elastically compresses against the limb of the patient under the cuff in response to inflation of the cuff member.

45. An inflatable blood pressure cuff assembly comprising:

an inflatable elongate cuff member having opposing long edges and opposing short edge portions with an inflatable fluid chamber therein; and

a resilient sleeve attached to a respective one of the opposing short edge portions of the inflatable elongate cuff member,

wherein the sleeve comprises a sensor chamber, wherein the sleeve comprises upper and lower edge portions, wherein the sensor chamber is located proximate the lower edge portion, and wherein the sleeve sensor chamber has a lower edge portion that is seamless.

46. An inflatable blood pressure cuff assembly comprising:

an inflatable elongate cuff member having opposing long edges and opposing short edge portions with an inflatable fluid chamber therein; and

a resilient sleeve attached to a respective one of the opposing short edge portions of the inflatable elongate cuff member,

wherein the sleeve comprises a sensor chamber, wherein the sleeve comprises upper and lower edge portions, wherein the sensor chamber is located proximate the lower edge portion, and wherein the sleeve sensor chamber has a lower edge portion that is open.

47. An inflatable blood pressure cuff assembly comprising:

an inflatable elongate cuff member having opposing long edges and opposing short edge portions with an inflatable fluid chamber therein; and

a resilient sleeve attached to a respective one of the opposing short edge portions of the inflatable elongate cuff member,

wherein the sleeve comprises a sensor chamber, wherein the sleeve comprises upper and lower edge portions, wherein the sensor chamber is located proximate the lower edge portion, wherein the sleeve further comprises a curvilinear cable channel in communication with the sensor chamber, and wherein the sleeve cable channel includes an intermediate segment that is arcuate, a lower first segment that is substantially longitudinal, and an upper segment above the arcuate segment that includes lateral directional components.

48. A blood pressure cuff assembly according to claim 47, further comprising a sensor and a cable attached to the sensor, wherein the sensor is held proximate a lower portion of the sleeve and the cable is directed to travel through the channel and exit the cuff assembly proximate an upper portion of the sleeve.

49. A method of obtaining a blood pressure measurement, comprising:

stretching a resilient stretch fabric sleeve to fit on a limb of a patient so that at least a major portion of the sleeve body elastically expands to snugly and substantially conformably reside around the limb as a first closed member that stretches to compress the selected limb portion;

then

wrapping a blood pressure cuff over the sleeve and attaching the cuff theretogether so that the blood pressure cuff surrounds the sleeve and defines a second closed member over the sleeve;

inflating the blood pressure cuff to a pressure sufficient to restrict blood flow in a selected artery proximate the sleeve and blood pressure cuff while elastically compressing the sleeve under the blood pressure cuff during the inflating;

releasing the inflation pressure in the blood pressure cuff; and

detecting a blood pressure measurement.

50. A method according to claim 49, wherein the sleeve is configured to hold at least one sensor, the method further comprising aligning visible marking indicia on the sleeve with a target artery position on the patient.

51. A method of obtaining a blood pressure measurement, comprising:

slipping a resilient sleeve onto a patient so that it resides on a selected body portion and stretches to compress the selected body portion;

wrapping the blood pressure cuff over the sleeve and attaching the cuff theretogether;

inflating the blood pressure cuff to a pressure sufficient to restrict blood flow in a selected artery proximate the sleeve and blood pressure cuff;

releasing the inflation pressure in the blood pressure cuff; and

detecting a signal in the patient corresponding to blood pressure measurements,

wherein the selected body portion is the arm, and wherein the sleeve includes a sensor chamber that holds a sensor used to obtain the signal to determine blood pressure measurements in snug abutment to the arm of the patient during the inflating, releasing and detecting steps.

52. A method of obtaining a blood pressure measurement, comprising:

placing a resilient sleeve having a sleeve body onto a limb of a patient so that at least a major portion of the sleeve body elastically expands to snugly and substantially conformably reside on a selected limb portion as a first closed member that stretches to compress the selected limb portion;

wrapping a blood pressure cuff over the sleeve after the placing of the sleeve on the limb and attaching the cuff theretogether so that the blood pressure cuff surrounds the sleeve and defines a second closed member over the sleeve;

inflating the blood pressure cuff to a pressure sufficient to restrict blood flow in a selected artery proximate the sleeve and blood pressure cuff while elastically compressing the sleeve under the blood pressure cuff during the inflating;

releasing the inflation pressure in the blood pressure cuff; and

detecting a signal in the patient corresponding to blood pressure measurements.

53. A method according to claim 52, further comprising the step of attaching the sleeve to a minor region of the blood pressure cuff prior to the wrapping step, wherein the attaching is carried out so that the sleeve extends outwardly away from a body of the blood pressure cuff.

54. A method according to claim 53, further comprising detaching the sleeve after at least one detecting step.

55. A method according to claim 52, further comprising repeating the inflating, releasing and detecting steps a plurality of times over a desired monitoring period.

56. A method according to claim 55, wherein the sleeve is detachably engaged with the sleeve during the inflating, releasing, and detecting steps, and the method further comprises detaching the sleeve at the cessation of the monitoring period and disposing the sleeve after use on a single patient.

57. A method according to claim 52, wherein the sleeve is configured to hold a sensor securely against the patient, and the step of detecting is carried out in an automated manner at desired intervals by detecting a Korotkoff signal via the sensor.

58. A method according to claim 52, wherein the sleeve is attached to the blood pressure cuff at a generally longitudinally extending region of the blood pressure cuff at a single short end portion thereof prior to the placing step.

59. A method according to claim 52, wherein the step of detecting is carried out while the patient is undergoing a stress test.

60. An automated blood pressure monitoring system, comprising:

a plurality of inflatable blood pressure cuff assemblies, each sized and configured to accommodate a different patient size range, each cuff assembly comprising an elongate cuff member having opposing long edges and opposing short edge portions with an inflatable fluid chamber therein and a resilient sleeve having a predetermined patient size range that is attachable and/or attached to a respective one of the opposing short edge portions of the inflatable elongate cuff member to extend outwardly away from a respective cuff member body prior to wrapping the cuff member on the patient, and wherein the sleeve has a body, at least a major portion of which is sized and configured to generally conformably reside about a target portion of a limb of a subject independent of the cuff member, and wherein the sleeve is configured to substantially elastically compress against the target portion of the limb when the cuff member is inflated;

an inflation unit in fluid communication with a selected one of the blood pressure cuffs and configured to generate a pressure sufficient to restrict blood flow in a selected artery of a patient proximate the sleeve and the blood pressure cuff;

means for releasing the inflation pressure in the blood pressure cuff; and

means for detecting a signal corresponding to blood pressure measurements of the patient.

61. A system according to claim 60, wherein the sleeves are non-inflatable air permeable stretch fabric sleeves that are releasably attached to the cuff members, and wherein the sleeves are configured to elastically expand to cover the target portion of the limb of the patient in a generally form fitting manner.

62. A system according to claim 60, wherein one of the opposing sleeve short edge portions is configured to be releaseably attachable to the other sleeve short edge portion and/or the cuff member to define a closed sleeve that is generally separate from the cuff member about a major portion of the sleeve and has an axially extending aperture.

63. A system according to claim 62, wherein the sleeves are arranged in different predetermined sizes and are configured to be disposable single-use sleeves.

64. A system according to claim 60, further comprising a kit of replacement sleeves tat are configured to be individually selectably releaseably attachable to the blood pressure cuff members.

65. A system according to claim 60, wherein the system is an ambulatory blood pressure measurement system.

66. A system according to claim 60, wherein the system is a stress test blood pressure measurement system.

67. A system according to claim 60, wherein, the sleeves are non-inflatable air permeable stretch fabric sleeves that are fixedly attached to the corresponding cuff members, and wherein the sleeves are configured to elastically expand to cover the target portion of the limb of the patient in a generally form fitting manner.