Blood pressure monitoring pad assembly and method

• US 5,586,555 A
• Filed: 09/30/1994
• Issued: 12/24/1996
• Est. Priority Date: 09/30/1994
• Status: Expired due to Fees

• Current Assignee: Innerspace
• Original Assignee: Innerspace
• Inventors: Bobo, Donald E. Jr., Doupe, Thomas H.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/316,555
• Time in Patent Office: 816 Days
• Field of Search: 606/201-203, 128/672, 128/677, 128/680-687, 128/689-694
• US Class Current: 600/485
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132

Abstract

An improved blood pressure monitoring pad assembly and its method of use are disclosed herein. In accordance with a first feature of the pad assembly a release mechanism is used to prevent the pad assembly from detaching from the skin as the bladder is pressurized. In accordance with a second feature, the pad assembly includes a flexible cover movably connected with a flexible base assembly. In accordance with a third feature, the pad assembly incorporates a biflex member.

Claims

1. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder is supported on the skin of the person adjacent to and in cooperation with a particular target artery in combination with means for pressurizing the bladder in a controlled way, said pad assembly comprising:

a) said pressure transducing bladder; and

b) support means including adhesive tape for fixably supporting said bladder in place against the skin adjacent the target artery so that the bladder is in direct contact with the skin and said adhesive tape is directly attached to a portion of the skin adjacent the bladder, said support means further including movement means configured to move at least to a limited extent within a release zone in response to the pressurization of said bladder in a way which prevents said adhesive tape from detaching from the skin as the bladder is pressurized.

2. A pad assembly in accordance with claim 1 wherein said target artery is a supraorbital artery of said person and wherein said pad assembly is specifically configured for attachment adjacent said supraorbital artery.

3. A pad assembly in accordance with claim 1 wherein said support means includes a particular release surface within said release zone and said movement means includes separation means adhesively bonded to said release surface with a bonding strength which is weaker than the bond between the adhesive tape and the skin in order to cause said separation means to incrementally separate from the release surface at least to a limited extent sufficient to keep the adhesive tape attached to the skin in response to pressurization of the bladder.

4. A pad assembly in accordance with claim 1 wherein said movement means is designed so that as the bladder is pressurized to couple with the target artery it incrementally internally separates to at least a limited extent from the rest of the support means sufficient to prevent said adhesive tape from detaching from the skin.

5. A pad assembly in accordance with claim 4 wherein said movement means is further designed so as to reach a point of complete separation from the rest of the support means prior to any detachment of said adhesive tape from the skin without interfering with the proper communication of the bladder with the target artery after said point of separation is attained.

6. A pad assembly in accordance with claim 4 wherein said support means includes a particular release surface within said release zone and wherein said movement means includes means adhesively bonded to said release surface to a predetermined extent which is weaker than the bond of said adhesive tape to the person'"'"'s skin.

7. A pad assembly in accordance with claim 1 further including a base assembly which, itself, includes said support means, a cover assembly and means connecting said cover assembly to said base assembly for movement of said cover assembly between an opened position separated from said base assembly and a closed position in which the cover assembly is placed directly against the base assembly and serves as a backing for said bladder.

8. A pad assembly in accordance with claim 7 wherein said base assembly further includes an inner frame which is part of said support means and serves as said movement means which is disposed adjacent said bladder and which is adhesively bonded to the cover assembly when the cover assembly is placed in its closed position, said pad assembly further including a particular release surface within said release zone and forming part of said support means and means also forming part of said support means for adhesively bonding said inner frame to said release surface with a bonding strength which is weaker than the bond between the adhesive tape and the skin in order to cause said inner frame to incrementally separate from the release surface at least to a limited extent sufficient to keep the adhesive tape attached to the skin in response to pressurization of the bladder.

9. A pad assembly in accordance with claim 8 wherein said inner frame is designed so as to eventually attain a point of complete separation from said release surface in response to continuing pressurization of the bladder and wherein said cover assembly includes an outer frame adhesively bonded to said base assembly and surrounding the inner frame when the cover assembly is placed in the closed position, said outer frame being capable of supporting said bladder in its operating position coupled to the target artery in the event of complete separation of said inner frame.

10. A pad assembly according to claim 9 wherein said cover assembly includes an outermost cover fixedly supporting said outer frame throughout movement of the cover assembly and bonded to said inner frame at a predetermined lateral distance from the outer frame when the cover assembly is in its closed position such that the outer frame surrounds the inner frame at said predetermined lateral distance to define a stop gap therebetween whereby upon complete separation of the inner frame from said release surface, said outer frame and outermost cover hold the inner frame in place.

11. A pad assembly in accordance with claim 10 further including a plastic sheet member, said member including a cover portion serving as said outermost cover forming said backing in the cover assembly and a base portion interposed between and respectively bonded to at least a portion of the inner frame and at least a portion of the adhesive tape which is bonded to the skin in the base assembly, said sheet member including between the cover and base portions a narrow portion forming said connection means whereby to flexibly connect the cover assembly to the base assembly.

12. A pad assembly in accordance with claim 11 wherein said base portion of the plastic sheet member includes as one surface said release surface adhesively bonded to the inner frame and another surface adhesively bonded to the adhesive tape, the base portion defining an opening therethrough for accommodating the bladder.

13. A pad assembly in accordance with claim 12 wherein said plastic sheet member is rigid PVC.

14. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder is supported on the skin of the person adjacent to and in cooperation with a particular target artery in combination with means for pressurizing the bladder in a controlled way, said pad assembly comprising:

a) a base assembly including;

i) a plastic base defining an opening for receiving said bladder;

ii) said bladder positioned over said base and across the opening in the base;

iii) adhesive skin tape for adhesively attaching the base to said person'"'"'s skin in conformance to the shape of the skin at the target artery such that the bladder is in direct contact with the skin adjacent the target artery and the adhesive skin tape is attached to a portion of skin adjacent the bladder;

iv) an inner frame including a top surface and a bottom surface, the bottom surface of which is adhesively bonded to the base by means of an adhesive bond which is not as strong as the bond between the adhesive skin tape and the skin, whereby to establish a release zone between the inner frame and the base causing the inner frame and base to incrementally separate as the bladder is pressurized up to a point of complete separation prior to any separation of the adhesive skin tape from the skin; and

b) a cover assembly including;

i) a plastic backing flexibly attached to said plastic base such that said cover assembly is movable between an open position separated from the base assembly prior to attachment to the skin and a closed position directly against the base assembly following attachment of the base assembly to the skin so that said top surface of the inner frame adhesively bonds to the backing; and

ii) an outer frame affixedly attached to said plastic backing and adhesively bonded to a portion of said adhesive skin tape in the base assembly when the cover assembly is in its closed position so as to conform the cover assembly to the base assembly, said outer frame surrounding the inner frame at a predetermined lateral distance therefrom when said cover assembly is in its closed position and being capable of supporting said bladder in position against the target artery in the event of complete separation of the release zone, and further, said predetermined lateral distance serving as a stop gap whereby to provide an additional expanse of skin stretchable by the bladder in the event of complete separation of the release zone.

15. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder is supported on the skin of the person adjacent to and in cooperation with a particular target artery in combination with means for pressurizing the bladder in a controlled way, said pad assembly comprising:

a) said pressure transducing bladder;

b) a base assembly including adhesive tape for supporting said bladder in place against the skin adjacent the target artery;

c) a cover assembly;

d) means connecting said cover assembly to said base assembly for movement of the cover assembly between an open position separated from the base assembly and a closed position in which the cover assembly is placed directly against the base assembly and fixedly attachable thereto to provide a backing for the bladder; and

(e) means for adhesively attaching the cover assembly to the base assembly when the cover assembly is in its closed position.

16. A pad assembly in accordance with claim 15 wherein said base assembly, apart from said cover assembly, is sufficiently flexible so as to conform to the contour of the skin adjacent the target artery.

17. A pad assembly in accordance with claim 16 wherein said cover assembly is sufficiently flexible so as to conform to the contoured shape of the base assembly after the base assembly is attached to the person'"'"'s skin.

18. A pad assembly in accordance with claim 17 wherein said particular artery is a supraorbital artery of said person and wherein said pad assembly is specifically configured for attachment adjacent said supraorbital artery.

19. A pad assembly in accordance with claim 15 wherein said connecting means is integrally formed as part of particular components of said base and cover assemblies and flexibly connects the cover assembly to the base assembly.

20. A pad assembly in accordance with claim 15 wherein said base assembly further includes an inner frame disposed adjacent said bladder and surrounding at least a portion of said bladder and wherein said frame is adhesively bonded to the cover assembly when the cover assembly is in its closed position.

21. A pad assembly in accordance with claim 20 wherein said cover assembly includes an outer frame, said outer frame being adhesively bonded to said base assembly when the cover assembly is placed in the closed position whereby to surround at least a portion of the inner frame.

22. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by oscillometry in which a pressurizable pressure transducing bladder is supported on the skin of the person adjacent to and in cooperation with the supraorbital target artery in combination with means for pressurizing the bladder in a controlled way for producing a series of pressure pulses that are responsive to the actual blood pressure within the cooperating target artery and that, upon analysis thereof, provide said information, said pad assembly comprising:

a) said pressure transducing bladder;

b) a base assembly fixedly connected with said bladder and including a base having top and bottom opposing surfaces, said base defining an opening for accommodating the bladder, said base assembly further including adhesive tape bonded directly to the bottom surface of the base for adhesively attaching the base assembly to the skin on said person'"'"'s forehead with the bladder in position through said opening in direct contact with the skin adjacent the target artery, said base assembly being sufficiently flexible so as to conform to the contour of the person'"'"'s skin adjacent said target artery;

c) a cover assembly and means for flexibly connecting the cover assembly to the base assembly for movement between a separated open position away from the base assembly and a closed position in which the cover is placed directly against the base assembly, said cover assembly apart from said base assembly being sufficiently flexible so as to conform to the contoured shape of the base assembly after the base assembly is attached to the person'"'"'s forehead and the cover assembly is moved to its closed position, whereby the cover assembly in its closed position provides a backing for the overall bladder assembly; and

d) means for adhesively bonding the cover assembly to the base assembly when the cover assembly is in its closed position.

23. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by oscillometry in which a pressurizable pressure transducing bladder is supported on the forehead of the person adjacent to and in cooperation with a supraorbital target artery in combination with means for pressurizing the bladder in a controlled way for producing a series of pressure pulses that are responsive to the actual blood pressure within the cooperating target artery and that, upon analysis thereof, provide said information, said pad assembly including:

a) said pressure transducing bladder;

b) a biflex member including a sheet of plastic material having spaced apart end sections joined by an intermediate narrower section such that the sheet is more flexible in one direction than in a transverse direction, said biflex member also including two stiffening strips respectively attached to the end sections of said sheet member so as to provide further rigidity in said transverse direction;

c) means fixedly attaching said bladder to said biflex member;

d) a frame including top and bottom surfaces, the top surface being bonded to a portion of the biflex member adjacent and surrounding the bladder so as to define an opening therein for the bladder to contact the skin;

e) an adhesive skin tape including top and bottom surfaces wherein the top surface is bonded to portions of the bottom surface of the frame and the bottom surface is bondable to a portion of skin adjacent the bladder such that the bladder is in direct contact with the skin adjacent the target artery and the overall pad assembly is oriented so as to flexibly conform to the contour of the skin at the location of the target artery while providing a sufficiently rigid support for the bladder to keep the bladder in communication with the target artery;

f) release zone tape adhesively bonded between the bottom surface of the frame and the adhesive skin tape in certain predetermined areas such that the bond between the frame and the release zone tape comprises an adhesive bond which will incrementally separate as the bladder is pressurized to maintain the bond between the adhesive tape and the skin; and

g) an overall layer of adhesive tape attached to portions of the biflex member, portions of the frame and a portion of skin adjacent the adhesive skin tape, said overall layer of tape having an elastic characteristic whereby to elastically support the pad assembly and thereby the bladder against the target artery during subsequent pressurization of the bladder.

25. A method according to the method of claim 23 wherein the target artery is a supraorbital artery and wherein said base assembly is specifically configured for attachment adjacent said supraorbital artery.

24. In a method of obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder located adjacent and cooperating with a particular target artery of the person is used in combination with means for pressurizing the bladder in a controlled way, the improvement comprising the steps of:

a) providing a flexible base assembly including said bladder attached thereto and a cover assembly connected to the base assembly for movement between positions spaced from and directly adjacent said base assembly;

b) with the cover assembly in its spaced position, adhering said base assembly to said person'"'"'s skin so that it conforms to the contour thereof and so that the bladder directly contacts the skin adjacent to the target artery; and

c) thereafter moving said cover assembly to its adjacent position against said base assembly so as to conform with the contour of said base assembly and bond the two together.

26. In a method of obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder located adjacent and cooperating with a particular target artery of the person is used in combination with means for pressurizing the bladder in a controlled way, the improvement comprising the steps of:

a) adhesively placing a blood pressure monitoring assembly including said bladder and support means for supporting the bladder on the skin of said person to form an adhesive bond between the skin and the monitoring assembly such that said bladder is brought into direct contact with the skin adjacent said target artery;

b) pressurizing the bladder to bring the bladder into communication with the target artery; and

c) providing movement means within said support means configured to move within a release zone in a way which prevents said adhesive tape from detaching from the skin.

27. A method according to the method of claim 26 wherein the target artery is a supraorbital artery and wherein said pad assembly is specifically configured for attachment adjacent said supraorbital artery.

28. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder is supported on the skin of the person adjacent to and in cooperation with a particular target artery in combination with means for pressurizing the bladder in a controlled way, said pad assembly comprising:

a) said pressure transducing bladder;

b) a base assembly including adhesive tape for supporting said bladder in place against the skin adjacent the target artery;

c) a cover assembly;

d) means connecting said cover assembly to said base assembly for movement of the cover assembly between an open position separated from the base assembly and a closed position in which the cover assembly is placed directly against the base assembly and fixedly attachable thereto to provide a backing for the bladder; and

e) a plastic sheet member, said member including a backing portion serving as said backing for the bladder when the cover assembly is in its closed position and a base portion bonded directly to a portion of said adhesive tape in the base assembly, said sheet member including between the cover and base portions a flexible portion serving as said connecting means whereby to flexibly connect the cover assembly to the base assembly.

29. A pad assembly in accordance with claim 28 wherein said base portion of the plastic sheet member further defines an opening therethrough for accommodating the bladder.

30. A pad assembly in accordance with claim 29 wherein said plastic sheet member is comprised of rigid PVC.

31. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder is supported on the forehead of the person adjacent to and in cooperation with a particular target artery in combination with means for pressurizing the bladder in a controlled way, said pad assembly including:

a) said pressure transducing bladder; and

b) support means including adhesive tape for fixably supporting said bladder in place against the skin adjacent the target artery so that the bladder is in direct contact with the skin and said adhesive tape is directly attached to a portion of the skin adjacent the bladder, said support means including a biflex member which displays greater flexibility in one predetermined direction than in another predetermined transverse direction, said support means further including movement means configured to move at least to a limited extent within a release zone in response to the pressurization of said bladder in a way which prevents said adhesive tape from detaching from the skin as the bladder is pressurized.

32. A pad assembly in accordance with claim 31 wherein said movement means is designed so that as the bladder is pressurized to couple with the target artery it incrementally internally separates to at least a limited extent from the rest of the support means sufficient to prevent said adhesive tape from detaching from the skin.

33. A pad assembly in accordance with claim 32 wherein said movement means is designed so as to reach a point of complete separation from the rest of the support means prior to any detachment of said adhesive tape from the skin without interfering with the proper communication of the bladder with the target artery after said point of separation is attained.

34. A pad assembly in accordance with claim 33 wherein said support means includes a particular release surface within said release zone and wherein said movement means includes means adhesively bonded to said release surface to a predetermined extent which is weaker than the bond of said adhesive tape to the person'"'"'s skin.

35. A pad assembly for use in a system for obtaining certain information about the blood pressure of a given person by a particular blood pressure technique in which a pressurizable pressure transducing bladder is supported on the forehead of the person adjacent to and in cooperation with a particular target artery in combination with means for pressurizing the bladder in a controlled way, said pad assembly including:

a) said pressure transducing bladder;

b) support means including adhesive tape for fixably supporting said bladder in place against the skin adjacent the target artery so that the bladder is in direct contact with the skin and said adhesive tape is directly attached to a portion of the skin adjacent the bladder, said support means including a biflex member which displays greater flexibility in one predetermined direction than in another predetermined transverse direction;

c) a frame defining an opening therein accommodating said bladder, said frame being adhesively bonded to the biflex member and to a portion of the adhesive tape with the bladder contacting the skin through the opening to dispose the frame between the biflex member and the adhesive tape; and

d) release zone tape adhesively bonded to said frame and to the adhesive tape in certain predetermined areas, and the bond between the frame and the release zone tape being weaker than the bond between the adhesive tape and the skin so as to incrementally separate as the bladder is pressurized to maintain the bond between the adhesive tape and the skin.

36. A pad assembly according to claim 35 wherein the target artery is a supraorbital artery and wherein said pad assembly is specifically configured for attachment adjacent said supraorbital artery.