APPARATUS, SYSTEMS, AND METHODS FOR AUGMENTING THE FLOW OF FLUID WITHIN BODY VESSELS

• US 20120089063A1
• Filed: 12/13/2010
• Published: 04/12/2012
• Est. Priority Date: 10/12/2010
• Status: Active Grant

• Current Assignee: Venous Health Systems, Inc.
• Original Assignee: Venous Health Systems, Inc.
• Inventors: Olson, Jonathan M., Mangano, Salvatore G., Donohoe, Brendan M., Johansson, Peter K., Lotti, Richard A., Fogarty, Thomas J.
• Granted Patent: US 8,858,475 B2
• Time in Patent Office: Days
• US Class Current: 601/152
• CPC Class Codes: A61H 2201/1238 with hydraulic or pneumatic drive
• CPC Class Codes: A61H 2201/164 Feet or leg, e.g. pedal
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/169 Physical characteristics of the surface, e.g. material, relief, texture or indicia
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/501 connected to external computer devices or networks
• CPC Class Codes: A61H 2201/5015 using specific interfaces or standards, e.g. USB, serial, parallel
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5071 Pressure sensors
• CPC Class Codes: A61H 2209/00 Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
• CPC Class Codes: A61H 9/0078 with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: A61H 9/0092 Cuffs therefor

Abstract

Apparatus, systems, and methods are sized and configured to effectively and efficiently augment the flow of fluid within body vessels, not only during conditions in which a patient is bedbound and immobile, but also in conditions when the individual is out of bed, and completely mobile and ambulatory.

Claims

1. A network sized and configured to be fitted to the musculature of a limb for distributing pneumatic fluid pressure to compress the musculature and augment blood flow velocity toward the heart, the network comprising

two or more zones of individual pneumatic cells comprising, for each zone, a core cell and a plurality of branch cells, distinct from the core cell, that communicate with the core cell and with each other, the plurality of branch cells extending laterally from the respective core cell along at least one of a lateral right and left branch axis from a most-medial branch cell to a most-lateral branch cell, the core cells of the two or more zones being generally mutually aligned along a common medial axis that, when the network is fitted to the musculature of the limb, is generally aligned with a longitudinal axis of the limb, the at least one of the lateral left and right branch axis diverging from the medial axis by a branch angle that is less than 90°

so that, when the network is fitted to the musculature of the limb, the at least one left and right branch axis is not substantially aligned with the longitudinal axis of the limb, each zone further including an intra-zone channel extending from at least one of the most-lateral branch cells of the respective zone to the core cell of the next proximal zone to convey pneumatic pressure between the zones, the network, when fitted to the musculature of the limb, distributing pneumatic pressure through the zones to provide compression to the musculature of the limb that progresses laterally within each zone as well as proximally between the zones from distal limb to proximal limb, to thereby augment blood flow velocity in the limb toward the heart.

2. A network according to claim 1

wherein the plurality of branch cells extends laterally from the respective core cell along both lateral right and left branch axes from a most-medial branch cell to a most-lateral branch cell, and

wherein each lateral left and right branch axis diverges from the medial axis by a branch angle that is less than 90°

.

3. A network according to claim 1

wherein the intra-zone channel includes a flow restriction to delay compression between the respective zones.

4. A network according to claim 1

wherein the branch angle is between about 15°

and about 85°

.

5. A network according to claim 1

wherein the individual pneumatic cells comprise shapes selected among generally curvilinear generally rectilinear, or combinations thereof.

6. A network according to claim 1

wherein at least one of the individual pneumatic cells comprises a generally circular shape.

7. A network according to claim 1

wherein the network comprises a total active fluid volume fitted to the musculature (AFV, expressed in ml) to apply an average compressive force to the musculature (ACF, expressed in mmHg), the network having a volume-to-compressive force ratio comprising AFV/ACF being equal to or less than 8 ml/mmHg.

8. A network according to claim 1

wherein the network is sized and configured to be fitted to a calf of a leg.

9. A network sized and configured to be fitted to the musculature of a limb for distributing pneumatic fluid pressure to compress the musculature and augment blood flow velocity toward the heart, the network comprising a total active fluid volume fitted to the musculature (AFV, expressed in ml) to apply an average compressive force to the musculature (ACF, expressed in mmHg), the network having a volume-to-compressive force ratio comprising AFV/ACF being equal to or less than 8 ml/mmHg.

10. A network according to claim 9

wherein the network is sized and configured to be fitted to a calf of a leg.

11. A method for distributing pneumatic fluid pressure to compress the musculature of a limb and augment blood flow velocity toward the heart, the method comprising

(i) fitting a fluid distribution network to the musculature of the limb, the fluid distribution network comprising a first, more distal zone and a second, more proximal zone, each first and second zones comprising a core cell and a plurality of branch cells, distinct from the core cell, that communicate with the core cell and with each other, the plurality of branch cells extending laterally from the respective core cell along at least one of a lateral right and left branch axis from a most-medial branch cell to a most-lateral branch cell, the core cells of the two or more zones being generally mutually aligned along a common medial axis that, when the network is fitted to the musculature of the limb, is generally aligned with a longitudinal axis of the limb, the at least one of the lateral left and right branch axis diverging from the medial axis by a branch angle that is less than 90°

so that, when the network is fitted to the musculature of the limb, the at least one left and right branch axis is not substantially aligned with the longitudinal axis of the limb, each zone further including an intra-zone channel extending from at least one of the most-lateral branch cells of the respective zone to the core cell of the next proximal zone to convey pneumatic pressure between the zones,

(ii) establishing communication between the fluid distribution network and a pneumatic fluid source, and

(iii) operating the pneumatic fluid source to convey pneumatic pressure into the first, more distal zone to provide compression to the musculature of the limb that progresses laterally within the first, more distal zone as well as proximally toward the heart,

(iv) operating the pneumatic fluid source to convey pneumatic pressure through the intra-zone channel from the first, more distal zone to the second, more proximal zone to provide compression to the musculature of the limb that progresses laterally within the second, more proximal zone as well as proximally toward the heart, and

(v) venting pneumatic pressure from the first and second zones.

12. A method according to claim 11

and further including repeating (iii), (iv), and (v) over a preselected time interval.

13. A pneumatic fluid distribution assembly for augmenting blood flow velocity in a limb of the body, the limb having a longitudinal axis extending from distal limb to proximal limb in the direction of the heart, the fluid distribution assembly comprising

a garment sized and configured to be fitted on the limb to overlie musculature of the limb, and

a pneumatic network formed in the garment for communication with a pneumatic fluid source, the pneumatic network including two or more zones of individual pneumatic cells comprising, for each zone, a core cell and a plurality of branch cells, distinct from the core cell, that communicate with the core cell and with each other, the plurality of branch cells extending laterally from the respective core cell along at least one of a lateral right and left branch axis from a most-medial branch cell to a most-lateral branch cell, the core cells of the two or more zones being generally mutually aligned along a common medial axis that, when the garment is fitted to the musculature of the limb, is generally aligned with a longitudinal axis of the limb, the at least one of the lateral left and right branch axis diverging from the medial axis by a branch angle that is less than 90°

so that, when the garment is fitted to the musculature of the limb, the at least one left and right branch axis is not substantially aligned with the longitudinal axis of the limb, each zone further including an intra-zone channel extending from at least one of the most-lateral branch cells of the respective zone to the core cell of the next proximal zone to convey pneumatic pressure between the zones,

whereby the pneumatic fluid distribution assembly is sized and configured, when the garment is fitted to the musculature of the limb, to distribute pneumatic pressure through the zones to provide compression to the musculature of the limb that progresses laterally within each zone as well as proximally between the zones from distal limb to proximal limb, to thereby augment blood flow velocity in the limb toward the heart.

14. A pneumatic fluid distribution assembly according to claim 13

wherein the plurality of branch cells extend laterally from the respective core cell along both lateral right and left branch axes from a most-medial branch cell to a most-lateral branch cell, and

wherein each lateral left and right branch axis diverges from the medial axis by a branch angle that is less than 90°

.

15. A pneumatic fluid distribution assembly according to claim 13

wherein the intra-zone channel includes a flow restriction to delay compression between the respective zones.

16. A pneumatic fluid distribution assembly according to claim 13

wherein the branch angle is between about 15°

and about 85°

.

17. A pneumatic fluid distribution assembly according to claim 13

wherein the individual pneumatic cells comprise shapes selected among generally curvilinear generally rectilinear, or combinations thereof.

18. A pneumatic fluid distribution assembly according to claim 13

wherein at least one of the individual pneumatic cells comprises a generally circular shape.

19. A pneumatic fluid distribution assembly according to claim 13

wherein the pneumatic network comprises a total active fluid volume fitted to the musculature (AFV, expressed in ml) to apply an average compressive force to the musculature (ACF, expressed in mmHg), the network having a volume-to-compressive force ratio comprising AFV/ACF being equal to or less than 8 ml/mmHg.

20. A pneumatic fluid distribution assembly according to claim 13

wherein the garment is sized and configured to be fitted to a calf of a leg.

21. A pneumatic fluid distribution assembly according to claim 13

wherein the garment comprises a flexible material.

22. A pneumatic fluid distribution assembly according to claim 13

and further including fasteners on the garments for adjusting fitment of the garment to the limb.

23. A pneumatic fluid distribution assembly according to claim 13

wherein the garment is sized and configured to be fitted on the limb such that only the pneumatic network overlies the musculature of the limb.

24. A pneumatic fluid distribution system for augmenting blood flow velocity in a limb of the body, the limb having a longitudinal axis extending from distal limb to proximal limb in the direction of the heart, the fluid distribution system comprising

a pneumatic fluid distribution assembly as defined in claim 13, the pneumatic fluid distributing assembly further including a first coupler on the garment communicating with the pneumatic network, and

a pneumatic fluid source including a second coupler sized and configured to mate with the first coupler to establish fluid communication between the pneumatic fluid source and the pneumatic fluid distribution assembly.

25. A pneumatic fluid distribution system according to claim 24

wherein the pneumatic fluid source is sized and configured, when the first and second couplers are mated, to be carried wholly by the garment.

26. A pneumatic fluid distribution system according to claim 24

and further including a controller coupled to the pneumatic fluid source, and

wherein the controller and the pneumatic fluid source are together sized and configured to be wholly carried by the garment when the first and second couplers are mated.

27. A pneumatic fluid distribution system according to claim 24

and further including a power supply coupled to the pneumatic fluid source, and

wherein the power supply and pneumatic fluid source are together sized and configured to be wholly carried by the garment when the first and second couplers are mated.

28. A pneumatic fluid distribution system according to claim 27

wherein the power supply comprises a battery.

29. A pneumatic fluid distribution system according to claim 27

wherein the power supply comprises a rechargeable battery.

31. A method for distributing pneumatic fluid pressure to compress the musculature of a limb and augment blood flow velocity toward the heart, the method comprising

(i) providing a pneumatic fluid distribution assembly as defined in claim 13 or 30,

(ii) fitting the garment to the musculature of the limb,

(iii) establishing communication between the pneumatic network and a pneumatic fluid source,

(iv) operating the pneumatic fluid source to convey pneumatic pressure through the pneumatic network to provide compression to the musculature of the limb, and

(v) venting pneumatic pressure from the pneumatic network.

32. A method according to claim 31

and further including repeating (iv) and (v) over a preselected time interval.

33. A method according to claim 31

performing (i) to (v) to achieve a therapeutic objective comprising at least one of the following:

treating deep vein thrombosis;

enhancing blood circulation in general;

diminishing post-operative pain and swelling;

reducing wound healing time;

treatment and assistance in healing stasis dermatitis, venous stasis ulcers, and arterial and diabetic leg ulcers;

treating chronic venous insufficiency;

or reducing edema.

34. A method according to claim 33

and further including repeating (iv) and (v) over a preselected time interval.

30. A pneumatic fluid distribution assembly to be fitted to the musculature of a limb for distributing pneumatic fluid pressure to compress the musculature and augment blood flow velocity toward the heart, the assembly comprising

a garment sized and configured to be fitted on the limb to overlie musculature of the limb, and

a pneumatic network formed in the garment for communication with a pneumatic fluid source, the pneumatic network including a total active fluid volume fitted to the musculature (AFV, expressed in ml) to apply an average compressive force to the musculature (ACF, expressed in mmHg), the network having a volume-to-compressive force ratio comprising AFV/ACF being equal to or less than 8 ml/mmHg.