CARDIAC HARNESS DELIVERY DEVICE

• US 20090048480A1
• Filed: 08/13/2007
• Published: 02/19/2009
• Est. Priority Date: 08/13/2007
• Status: Abandoned Application

• Current Assignee: Paracor Surgical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: KLENK, ALAN R., Wallin, Joshua
• Application Number:
  US11/837,619
• Publication Number:
  US 20090048480A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor

Abstract

An apparatus for delivering a cardiac harness onto a heart includes an elongate body and a plurality of elongate push rods longitudinally movable with respect to the elongate body. The elongate body has a tubular housing that is sized to contain the cardiac harness which is removably attached to the push rods. The cardiac harness is releasably attached to the push rods such that advancement of the push rods in a distal direction moves the cardiac hearness from a compacted configuration in the housing to an expanded configuration outside the housing. A deflector is attached to the elongate body and is configured to flare radially outwardly. As the push rods advance out of the housing, the push rods slide over the deflector to more easily and safely advance over the enlarged heart and position the cardiac harness over the heart.

Claims

1. A medical device, comprising:

a deflector having a plurality of petals having a distal end and a proximal end;

a ring, the proximal end of the petals being attached to the ring;

the petals tapering from a relatively narrower proximal end to a relatively wider distal end; and

the petals being flexible so that the petals can be collapsed into a delivery configuration and flared radially outwardly into a deployed configuration.

2. The medical device of claim 1, wherein the plurality of petals number in the range from four to twenty petals.

3. The medical device of claim 1, wherein the petals are formed from a polymer material.

4. The medical device of claim 3, wherein the polymer material is taken from the group of polymers including polyamides, polyamide copolymers such as PEBAX, silicone rubber, polyurethanes, and nylons.

5. The medical device of claim 1, wherein at least a portion of the petals are formed from a metallic material.

6. The medical device of claim 1, wherein at least some of the petals are loaded with a radiopaque material to enhance visualization of the device under fluoroscopy.

7. The medical device of claim 6, wherein the radiopaque material is barium sulfate.

8. The medical device of claim 1, wherein a radiopaque material is attached to at least some of the petals to enhance visualization of the device under fluoroscopy.

9. The medical device of claim 1, wherein the distal ends of the petals are biased radially outwardly to form a flared configuration.

10. The medical device of claim 1, wherein at least a portion of each petal overlaps with adjacent petals.

11. The medical device of claim 1, wherein adjacent petals slide over each other when the deflector is compressed into the delivery configuration and expanded to the deployed configuration.

12. A medical device, comprising:

a deflector having a first ring with a plurality of first petals attached to the first ring, the plurality of first petals being spaced apart forming first gaps between adjacent first petals;

the deflector also having a second ring with a plurality of second petals attached to the second ring, the plurality of second petals being spaced apart forming second gaps between adjacent second petals; and

the first ring and the second ring being configured to interlock so that the first petals and second petals overlap.

13. The medical device of claim 12, wherein the first petals interleave with the second petals by filling the second gaps and the second petals interleave with the first petals by filling the first gaps.

14. The medical device of claim 12, wherein the first petals and the second petals are formed from a polymer material.

15. The medical device of claim 14, wherein the polymer material is taken from the group of polymers including polyamides, polyamide copolymers such as PEBAX, silicone rubber, polyurethanes, and nylons.

16. The medical device of claim 12, wherein at least a portion of the first petals and the second petals are formed from a metallic material.

17. The medical device of claim 12, wherein at least some of the first petals and second petals are loaded with a radiopaque material to enhance visualization of the device under fluoroscopy.

18. The medical device of claim 17, wherein the radiopaque material is barium sulfate.

19. The medical device of claim 12, wherein a radiopaque material is attached to at least some of the petals to enhance visualization of the device under fluoroscopy.

20. The medical device of claim 12, wherein the first petals and the second petals have a distal end and a proximal end, the first petals and the second petals tapering from a relatively narrower proximal end to a relatively wider distal end.

21. The medical device of claim 20, wherein the distal ends of the first petals and the second petals are biased radially outwardly to form a flared configuration.

22. The medical device of claim 12, wherein the first petals and the second petals are flexible so that the petals can be collapsed into a delivery configuration and flared radially outwardly into a deployed configuration.

23. The medical device of claim 12, wherein the deflector has a distal end having a first diameter in the delivery configuration and a second diameter in the deployed configuration.

24. The medical device of claim 23, wherein the deflector distal end first diameter is smaller than the second diameter.

25. An apparatus for delivering a cardiac harness onto a heart, comprising:

an elongate body having a proximal portion and a distal portion, the distal portion having a tubular housing sized to contain the cardiac harness in a compacted configuration, the tubular housing having a proximal end, an open distal end, an inner surface, and an outer surface;

a plurality of elongate push rods longitudinally movable with respect to the elongate body, the cardiac harness releasably connected to each of the push rods such that advancement of the push rods in a distal direction moves the cardiac harness from the compacted configuration in the housing to an expanded configuration outside the housing;

a deflector sheath slidably mounted over the outer surface of the tubular housing for retaining the petals; and

the petals being configured to be collapsed into the deflector sheath in a delivery configuration and flared radially outwardly in a deployed configuration so that the push rods and cardiac harness slide over the deflector as the harness slides over the heart.

26. The apparatus of claim 25, wherein the plurality of petals number in the range from four to twenty petals.

27. The apparatus of claim 25, wherein the petals are formed from a polymer material.

28. The apparatus of claim 25, wherein the polymer material is taken from the group of polymers including polyamides, polyamide copolymers such as PEBAX, silicone rubber, polyurethanes, and nylons.

29. The apparatus of claim 25, wherein the proximal ends of the petals are biased radially outwardly to form a flared configuration.

30. The apparatus of claim 25, wherein the housing has a substantially circular cross-sectional shape having a diameter, and wherein at least a portion of the housing is compressible to a substantially elliptical cross-sectional shape having a minor axis that is less than the diameter.

31. The apparatus of claim 25, wherein the housing has a cross-sectional shape having a first perimeter, and wherein at least a portion of the housing is compressible to a reduced cross-sectional shape having a second perimeter that is less than the first perimeter.

32. The apparatus of claim 25, wherein the cross-sectional shape is adapted for advancing through a minimally invasive surgical entry path.

33. The apparatus of claim 25, wherein the housing tapers from a first cross-sectional shape having a first perimeter at the proximal end of the housing to a second cross-sectional shape having a second perimeter at the distal end of the housing, the second perimeter being smaller in size than the first perimeter.

34. A method of delivering and mounting a cardiac harness on a heart, comprising:

providing a minimally invasive access site;

advancing an elongated delivery device through the access site;

extending a deflector out of the delivery device;

advancing a cardiac harness out of the delivery device and over the deflector;

the cardiac harness flaring outwardly as the harness advances over the deflector and onto the heart; and

withdrawing the delivery device and deflector through the access site.

35. The method of claim 34, wherein a suction cup extends from a distal end of the delivery device and engages the heart wherein a vacuum is drawn within the suction cup to firmly attach the cup onto the heart.

36. The method of claim 35, wherein the deflector extends over the suction cup.