Medical device sheath apparatus and method of making and using same

• US 6,958,035 B2
• Filed: 12/30/2002
• Issued: 10/25/2005
• Est. Priority Date: 10/15/2002
• Status: Expired due to Fees

• Current Assignee: Dusa Pharmaceuticals (Sun Pharmaceutical Industries Limited)
• Original Assignee: Dusa Pharmaceuticals (Sun Pharmaceutical Industries Limited)
• Inventors: Smith, Anthony Mark, Moynihan, Shawn Timothy, Friedman, Marc David
• Primary Examiner(s): FLANAGAN, BEVERLY MEINDL
• Application Number:
  US10/331,561
• Publication Number:
  US 20040073088A1
• Time in Patent Office: 1,030 Days
• Field of Search: 600/121, 600123-125, 600114-116, 600/105, 604/27, 604/30, 604/43, 604/506
• US Class Current: 600/121
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• CPC Class Codes: A61B 1/2733 Oesophagoscopes
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body

Abstract

A medical device sheath apparatus including: a fitting being suitable for receiving the medical device in a self sealing manner; a first sheath for receiving the medical device as it passes through the fitting; a second sheath surrounding the first sheath; a dilator defining a treatment area, coupled to at least the second sheath, and being suitable for dilating a bodily cavity and passing therapeutic or diagnostic energy in such forms as electromagnetic radiation or acoustic energy there through; and, a window operatively positioned with respect to the first sheath so as to enable viewing of an area substantially adjacent the second sheath upon insertion of the medical device into the apparatus.

Claims

1. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device; and

further comprising at least one additional bore being suitable for receiving at least one tube for inflating or deflating said dilator.

2. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device; and

wherein said seal is mechanically or pneumatically actuatable.

3. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus; and

wherein said dilator further comprises at least one of a partially reflective coating and an absorptive coating.

4. The apparatus of claim 3, wherein said coating comprises at least one of gold, aluminum, silver, titanium oxide and carbon black.

5. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing, a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device, and at least one retainer securing said seal to said housing; and

wherein at least two of said housing, seal and retainer are keyed.

6. The apparatus of claim 5, wherein said keying comprises at least one notch.

7. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing, a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device, and at least one retainer securing said seal to said housing; and

wherein said seal comprises a plurality of fins suitable for mating with at least said housing or retainer.

8. A The apparatus of claim 7, wherein at least one of said housing and retainer comprise a plurality of grooves suitable for receiving said fins.

9. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus; and

further comprising means for inflating at least said dilator.

10. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing, a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device, and at least one retainer securing said seal to said housing; and

wherein said retainer comprises a plurality of channels.

11. The apparatus of claim 10, wherein said housing comprises a plurality of projections positioned to mate with said channels when said retainer and housing are coupled to one another.

12. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device in a self sealing manner;

a first sheath for receiving said medical device as it passes through said fitting;

a second sheath surrounding said first sheath;

a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and

, a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device; and

wherein said seal comprises;

a disc portion;

an o-ring peripherally positioned with respect to said disk portion; and

, a tubular portion extending from said disk portion;

wherein said disk portion and tubular portion define at least one bore suitable for receiving said medical device there through.

13. The apparatus of claim 12, wherein said tubular portion comprises a plurality of radially outwardly extending protrusions.

14. The apparatus of claim 13, further comprising at least one aperture passing through said disk portion, wherein said disk portion is adapted to be compressed between said housing and retainer.

15. The apparatus of clam 14, wherein said housing defines an internal bore corresponding to said bore of said seal, and said housing bore comprises a plurality of internal steps.

16. The apparatus of claim 15, wherein said housing further comprises a first bonding location for said first sheath and a second bonding location for said second sheath.

17. The apparatus of claim 16, wherein said housing further comprises at least two substantially concentric cone portions defining said first and second bonding locations.

18. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured in said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device;

further comprising at least one additional bore being suitable for receiving at least one tube for inflating or deflating said dilator.

19. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured in said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device;

wherein said seal is mechanically or pneumatically actuatable.

20. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus; and

wherein said dilator further comprises at least one of a reflective, partially reflective and absorptive coating.

21. The apparatus of claim 20, wherein said coating comprises at least one of gold, aluminum, silver, titanium oxide and carbon black.

22. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured in said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device;

further comprising at least one retainer securing said seal to said housing; and

wherein at least two of said housing, seal and retainer are keyed.

23. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus;

further comprising means for inflating at least said dilator.

24. The apparatus of claim 23, wherein said means for inflating further comprises means for inflating said sheath.

25. A medical device sheath apparatus comprising:

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured in said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device; and

wherein said seal comprises;

a disc portion;

an o-ring peripherally positioned with respect to said disk portion; and

, a tubular portion extending from said disk portion;

wherein said disk portion and tubular portion define at least one bore suitable for receiving said medical device there through.

26. The apparatus of claim 25, further comprising at least one aperture passing through said disk portion, wherein said disk portion is adapted to be compressed between said housing and retainer.

27. A medical device sheath apparatus comprising;

a fitting being suitable for receiving said medical device;

a seal being suitable for receiving said medical device through said fitting;

a sheath for receiving said medical device through said fitting and seal;

a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and

, a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus;

wherein said fitting comprises;

a seal housing; and

, a seal secured in said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device;

wherein said housing defines an internal bore corresponding to said bore of said seal, and said housing bore comprises a plurality of internal steps;

wherein said housing further comprises a first bonding location for said first sheath and a second bonding location for said second sheath; and

wherein said housing further comprises at least two substantially concentric cone portions defining said first and second bonding locations.