Aortic occlusion balloon apparatus, system and method of making

• US 10,433,852 B2
• Filed: 05/08/2017
• Issued: 10/08/2019
• Est. Priority Date: 05/08/2017
• Status: Active Grant

• Current Assignee: H'Doubler, William Z.
• Original Assignee: H'Doubler, William Z.
• Inventors: H'Doubler, William
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/588,698
• Publication Number:
  US 20180317932A1
• Time in Patent Office: 883 Days
• Field of Search: 604 9601, 604 9904, 604525, 604104, 604103, 60416405
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61M 2005/006 for gases, e.g. CO2
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/0478 Heparin
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

The disclosure sets forth various exemplary embodiments of systems, methods, and/or medical apparatuses including but not limited to: a sheath; and a balloon disposed at a working distal end of the sheath. According to one example embodiment the medical device can include where the sheath can include woven wire reinforcing axial and longitudinal strength, side holes, a one direction distal valve, and can include an inflator. According to one example embodiment the medical device can include where the sheath can include a narrow cross-section of, e.g., 7-8 Fr and balloon of length of, e.g., 12 cm.

Claims

1. A medical device comprising:

a stiffened sheath comprising;

a narrow cross-section,

wherein said narrow cross-section comprises;

an external cross-sectional outer diameter of 5-10 Fr (1.667 mm-3.333 mm) for use intraluminally in the vasculature of a patient; and

wherein said stiffened sheath comprises;

woven wire or metal reinforcing axial and longitudinal strength;

wherein said woven wire or metal comprises;

 

wherein said woven wire or metal comprises a plurality of wires, woven to form a wire mesh comprising at least one of;

 

wherein said wire mesh is circumferentially-embedded at least partially within a lumen of said stiffened sheath, or

 

wherein said wire mesh is adjacent to a lumen of said stiffened sheath; and

an elongated balloon occluder disposed at a working distal end of said stiffened sheath,

wherein said elongated balloon occluder comprises;

an elongated balloon comprising;

wherein said elongated balloon comprises;

 

a longitudinal length of at least one or more of;

 

9-15 cm (270-450 Fr, or 90 mm-150 mm), or 12 cm (360 Fr, or 120 mm).

2. The medical device according to claim 1, wherein said narrow cross-section sheath comprises an external cross-sectional diameter of at least one or more of:

6-9 Fr (2 mm-3 mm);

6-7 Fr (2 mm-2.333 mm);

or

5-8 Fr (1.667 mm-2.667 mm).

3. The medical device according to claim 1, wherein said sheath comprises:

at least one hole.

4. The medical device according to claim 3, wherein said at least one hole of said sheath comprises at least one or more of:

at least one side hole;

a one-way valve;

a one-way valve at a distal tip of said sheath;

or

a one-way valve on a distal end, distal to said balloon.

5. The medical device according to claim 4, wherein said sheath further comprises:

a lumen comprising at least one channel for use in dispensing via said at least one hole at least one or more of;

a radio opaque dye;

a radio opaque gas;

a CO₂ gas;

an anti-coagulant;

a heparin injection;

or

a drug.

6. The medical device according to claim 3, wherein said at least one hole of said sheath comprises:

a plurality of side holes; and

a one-way valve on a distal end, distal to said balloon.

7. The medical device according to claim 1, wherein said sheath further comprises:

a lumen comprising at least one internal channel for use in dispensing at least one or more of;

a radio opaque dye;

anti-coagulant;

or

a drug.

8. The medical device according to claim 1, wherein said balloon comprises:

wherein said balloon is recessed in a cavity in said sheath.

9. The medical device according to claim 1, wherein said balloon comprises:

wherein said balloon is integrated coaxially in a cavity in said sheath.

10. The medical device according to claim 1, wherein said balloon comprises:

wherein said balloon is coupled to an inflator.

11. The medical device according to claim 10, wherein said balloon and inflator are coupled together via at least one or more of:

lumen;

or

inflation port.

12. The medical device according to claim 10, wherein said inflator comprises at least one or more of:

a syringe;

a compressed gas source;

a fluid source;

a CO₂ cartridge;

a hypodermic syringe;

a pressurized air;

a pressurized gas;

or

a pressurized liquid.

13. The medical device according to claim 1, wherein said balloon comprises:

wherein said balloon has an inflation diameter at least of one or more of;

10 mm-60 mm (30-150 Fr);

15 mm-48 mm (45-144 Fr);

10 mm-48 mm;

15 mm-60 mm;

15 mm-44 mm;

44 mm-48 mm;

44 mm-60 mm;

48 mm-60 mm;

or

44 mm (132 Fr).

14. The medical device according to claim 1, further comprising:

a lumen coupled to said sheath wherein said lumen is configured to;

flush said sheath;

or

inject gas or fluid through said sheath.

15. The medical device according to claim 1, further comprising at least one or more of:

a wire for passing the medical device through the vasculature of a patient;

an introducer;

an atraumatically tipped introducer;

an rounded end introducer;

an introducer configured to introduce the medical device through the vasculature of a patient;

or

an introducer configured to pass over a wire the medical device.

16. The medical device according to claim 1, wherein said sheath comprises at least one polymer material comprising at least one or more of:

PS, ABS, SAN, PMMA, PPE, PP, PE, PA, PC, PET, PA, POM, PMP, PPP, PC-HT, PEI, PSU, PES, PPSU, PAI, PI, PVDF, ETFE, PCTFE, PTFE, ePTFE, PFA, LCP, PPS, PEEK, PEK, PEKEKK, FEP, PFA, nylon, fluoropolymer, LCP, or engineered plastic.

17. The medical device according to claim 1, wherein said combination of said stiffened sheath with said woven wire or metal, and said elongated balloon provides an increase in length of vascular wall apposition, and results in increased resistance to movement of the medical device, and decreases or eliminates balloon migration during treatment of trauma or abdominal aortic aneurysm (AAA).

18. A medical device comprising:

a stiffened sheath comprising;

a narrow cross-section,

wherein said narrow cross-section comprises;

an external cross-sectional outer diameter of 5-10 Fr (1.667 mm-3.333 mm) for use intraluminally in the vasculature of a patient; and

wherein said stiffened sheath comprises;

woven wire or metal reinforcing axial and longitudinal strength;

wherein said woven wire or metal comprises;

 

wherein said woven wire or metal comprises a plurality of wires, woven to form a wire or metal mesh comprising;

 

wherein said wire or metal mesh is circumferentially adjacent and externally wrapping a lumen of said stiffened sheath; and

an elongated balloon occluder disposed at a working distal end of said stiffened sheath,

wherein said elongated balloon occluder comprises;

an elongated balloon comprising;

wherein said elongated balloon comprises;

 

a longitudinal length of about 12 cm (360 Fr, or 120 mm).

19. A method of making a medical device comprising:

weaving a plurality of wires into a circular or oval cross-section tubular wire or metal mesh;

placing or wrapping said circular or oval cross-section tubular wire or metal mesh externally and circumferentially adjacent, or at least partially embedded, about a stiffened sheath lumen or inserting said stiffened sheath lumen into said circular or oval cross-section tubular wire or metal mesh,

wherein said stiffened sheath lumen comprises;

a narrow cross-section,

wherein said narrow cross-section comprises;

 

an external cross-sectional outer diameter of 5-10 Fr (1.667 mm-3.333 mm) for use intraluminally in the vasculature of a patient; and

coupling an elongated balloon at a distal end of said stiffened sheath lumen,

wherein said elongated balloon comprises;

a longitudinal length of at least one or more of;

9-15 cm (270-450 Fr, or 90 mm-150 mm);

or

12 cm (360 Fr, or 120 mm).