IMPLANTABLE DEVICE FOR PULSATILE COMPRESSION

• US 20140336551A1
• Filed: 05/08/2013
• Published: 11/13/2014
• Est. Priority Date: 05/08/2013
• Status: Active Grant

• Current Assignee: Annamarie Mantese, Mantese, Lucymarie, Vito A. Mantese
• Original Assignee: Annamarie Mantese, Mantese, Lucymarie, Vito A. Mantese
• Inventors: Mantese, Lucymarie, Mantese, Vito A., Mantese, Annamarie
• Granted Patent: US 9,585,808 B2
• Time in Patent Office: Days
• US Class Current: 601/134
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61H 2201/0103 inflatable
• CPC Class Codes: A61H 2201/5058 Sensors or detectors
• CPC Class Codes: A61H 2201/5084 Acceleration sensors
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 9/00 Pneumatic or hydraulic massage
• CPC Class Codes: A61H 9/0007 Pulsating
• CPC Class Codes: A61H 9/005 Pneumatic massage
• 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

Abstract

A method of treating venous insufficiency and lymphedema in an individual by placing pulsatile, localized pressure or compression on deep veins and subcutaneous tissue by inflating and deflating volume-changing members implanted within the individual. A method of potentiating venous circulation, by placing pulsatile, localized pressure that compresses the deep veins by expanding and contracting volume-changing members located between the fascia and muscular compartment, such that the increase in volume from the volume-changing members is transferred to deep veins, and augmenting the effects of muscle contractions around the deep veins and improving blood circulation. A method of potentiating lymphatic circulation. A method of potentiating venous and lymphatic circulation. A pulsatile pressure implant including at least one volume-changing member in electronic connection with an electronic-controlled microprocessor.

Claims

1. A method of treating venous insufficiency and lymphedema in an individual, including the step of:

placing pulsatile, localized pressure that compresses the deep veins or subcutaneous tissue by expanding and contracting volume-changing members implanted within the individual.

2. The method of claim 1, further including prior to said placing step, an insertion step chosen from the group consisting of inserting at least one volume-changing member between the fascia and a muscular compartment of the leg;

inserting at least one volume-changing member between the fascia and a muscular compartment of the arm;

inserting at least one volume-changing member between the fascia and subcutaneous tissue of the leg;

inserting at least one volume-changing member between the fascia and subcutaneous tissue of the arm;

performing a fasciotomy and inserting at least one volume-changing member between the fascia and a muscular compartment in the leg and performing a fasciotomy and inserting at least one volume-changing member between the fascia and a muscular compartment in the arm; and

combinations thereof.

3. The method of claim 2, wherein the at least one volume-changing member is inserted in an extremity chosen from the group consisting of at least one arm, at least one leg, and combinations thereof.

4. The method of claim 1, wherein said at least one volume-changing member is chosen from the group consisting of a balloon and a volume-changing material.

5. The method of claim 2, further including the step of inserting microprocessor-controlled electronics and a pump in the individual remote from the at least one volume-changing member.

6. The method of claim 2, further including the step of inserting microprocessor-controlled electronics remote from the at least one volume-changing member and wirelessly controlling the at least one volume-changing member.

7. The method of claim 1, further including a step chosen from the group consisting of narrowing the diameter of the deep veins, compressing the subcutaneous tissue, augmenting the effects of muscle contractions around the deep veins and improving blood circulation and lymphatic flow, and combinations thereof.

8. The method of claim 1, further including the step of adjusting pressure amplitude and/or frequency according to feedback.

9. The method of claim 2, further including the step of wearing a lightweight non-stretchable, non-compressive outer garment on the outside of the body at the location of the at least one volume-changing member.

10. The method of claim 9, wherein the lightweight non-stretchable, non-compressive outer garment contains the pressure from the increase in volume from the at least one volume-changing member to the deep veins and subcutaneous tissue.

11. The method of claim 1, wherein said expanding step is further defined as the volume-changing member constricting the deep vein or subcutaneous tissue, and wherein said contracting step is further defined as the at least one volume-changing member releasing the deep vein or subcutaneous tissue.

12. The method of claim 1, further including the steps of applying a strip with a hydrophilic coating to subcutaneous tissue and absorbing excess lymphatic fluid.

13. A method of potentiating venous circulation, including the steps of:

placing pulsatile, localized pressure that compresses the deep veins by expanding and contracting volume-changing members located between the fascia and muscular compartment, such that the increase in volume from the volume-changing members is transferred to deep veins; and

augmenting the effects of muscle contractions around the deep veins and improving blood circulation.

14. A method of potentiating lymphatic circulation, including the steps of:

placing pulsatile, localized pressure that compresses the subcutaneous tissue by expanding and contracting volume-changing members positioned between the fascia and subcutaneous tissue, such that the increase in volume from the volume-changing members is transferred to the subcutaneous tissue; and

supplementing muscle contractions and improving lymphatic flow.

15. The method of claim 14, further including the step of using a lightweight non-stretchable, non-compressive outer garment to contain the pressure from the increase in volume from the volume-changing members to the subcutaneous tissue.

16. A method of potentiating venous and lymphatic circulation, including the steps of:

creating an incision in the fascia;

placing pulsatile, localized pressure that compresses the deep veins and subcutaneous tissue by expanding and contracting volume-changing members located between the fascia and muscular compartment, such that the increase in volume from the volume-changing members is transferred to deep veins and subcutaneous tissue; and

augmenting the effects of muscle contractions around the deep veins and improving blood circulation and lymphatic flow.

17. The method of claim 16, further including the step of using a lightweight non-stretchable, non-compressive outer garment to contain the pressure from the increase in volume from the volume-changing members to the deep veins and subcutaneous tissue.

18. A pulsatile pressure implant comprising:

at least one expandable means for placing pulsatile, localized pressure on deep veins and subcutaneous tissue in electronic connection with microprocessor-controlled electronics.

19. The pulsatile pressure implant of claim 18, wherein said at least one expandable means is further in fluid connection with a pumping means for pumping fluid through tubing to expand said expandable means.

20. The pulsatile pressure implant of claim 18, wherein said expandable means is a balloon made of a material chosen from the group consisting of plastic, silicone, and elastomers.

21. The pulsatile pressure implant of claim 18, wherein said expandable means is a volume-changing material activated by modulation of an external stimuli chosen from the group consisting of temperature, pH, magnetic field, and voltage.

22. The pulsatile pressure implant of claim 18, wherein said expandable means includes a fill port.

23. The pulsatile pressure implant of claim 18, wherein said expandable means is powered by a battery wirelessly charged.

24. The pulsatile pressure implant of claim 18, wherein said expandable means is coated with a drug chosen from the group consisting of non-steroidal anti-inflammatory drugs (NSAIDS), steroids, and immune selective anti-inflammatory derivatives (ImSAIDs).

25. The pulsatile pressure implant of claim 18, wherein said expandable means is coated with a hydrophilic material.

26. The pulsatile pressure implant of claim 18, wherein said expandable means includes a single chamber and provides pulsatile pressure.

27. The pulsatile pressure implant of claim 18, wherein said expandable means includes multiple chambers and provides a pressure chosen from the group consisting of gradient pressure and segmented pressure.

28. The pulsatile pressure implant of claim 18, wherein said expandable means includes radiopaque markers to aid in placement within an extremity.

29. The pulsatile pressure implant of claim 18, wherein said microprocessor-controlled electronics is controlled wirelessly and remotely.

30. The pulsatile pressure implant of claim 18, further including a pressure relief means for preventing over-inflation of said extremity by said volume-changing member.

31. The pulsatile pressure implant of claim 18, wherein said tubing includes a biocompatible fluid chosen from the group consisting of air and saline that expands said expandable means.

32. The pulsatile pressure implant of claim 18, further including a lightweight non-stretchable, non-compressive outer garment worn on the outside of the body at the area of said expandable means.