System and method for implanting a cardiac wrap

• US 6,572,534 B1
• Filed: 09/14/2000
• Issued: 06/03/2003
• Est. Priority Date: 09/14/2000
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Buck, Robert L., Milbocker, Michael T.
• Primary Examiner(s): GILBERT, SAMUEL G
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US09/661,624
• Time in Patent Office: 992 Days
• Field of Search: 600/16-18, 600/37, 601/151-153, 623/3.1
• US Class Current: 600/37
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: A61B 42/10 Surgical gloves
• CPC Class Codes: A61B 42/20 Finger-stalls specially adapted for surgery
• 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
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A system and method for implanting a wrap on a patient'"'"'s heart or other organ provides a wrap having finger-engagement members typically defining loops that encompass all or a substantial portion of the fingers of a surgeon'"'"'s treatment hand. The loops retain the fingers to the wrap during implant, and enable the fingers to be detached after the procedure is complete. The loops can be detachable from the wrap after the procedure is completed or can be formed to remain with the wrap.

Claims

1. A system for treating an affected organ of a patient comprising:

an engagement member adapted to removably engage a clinician'"'"'s hand until a predetermined disengagement time, the engagement member being operatively connected to an implantable wrap to provide tactile control of wrap placement during implantation.

2. The system as set forth in claim 1 wherein the engagement member comprises a loop member adapted to extend substantially around a portion of the finger of the hand to removably restrain the finger with respect to the wrap.

3. The system set forth in claim 2 wherein the loop member comprises a fabric loop attached to a surface of the wrap.

4. The system as set forth in claim 2 wherein the loop member includes a proximal end adapted to receive the finger therein and a distal end remote from the proximal end, the proximal end being wider than the distal end to thereby define a taper for restraining the finger against forward movement beyond a predetermined position within the loop.

5. The system as set forth in claim 2 further comprising a plurality of loop members located at predetermined positions about a circumference of the wrap for engaging each of a plurality of fingers of the hand.

6. The system as set forth in claim 2 wherein the loop member comprises a material capable of being absorbed by a human body.

7. A system for treating an affected organ of a patient comprising:

an implantable wrap;

an engagement member adapted to removably engage a clinician'"'"'s hand until a predetermined disengagement time, the engagement member being operatively connected to the implantable wrap;

the engagement member comprising a loop member adapted to extend substantially around a portion of a finger of the hand to removably restrain the finger with respect to the wrap;

wherein the loop includes a proximal end for receiving the finger and a distal end remote from the proximal end, the distal end being enclosed to prevent movement of the finger therethrough.

8. A system for treating an affected organ of a patient comprising:

an implantable wrap;

an engagement member adapted to removably engage a clinician'"'"'s hand until a predetermined disengagement time, the engagement member being operatively connected to the implantable wrap;

the engagement member comprising a loop member adapted to extend substantially around a portion of a finger of the hand to removably restrain the finger with respect to the wrap;

wherein the wrap includes at least two plies of material overlaid atop each other and wherein the loop is defined by a slit in an outer ply of the two plies of material constructed and arranged to receive the finger there into.

9. The system as set forth in claim 8 wherein the slit is located on a pocket for holding an inflatable balloon.

10. A system for treating an affected organ of a patient comprising:

an implantable wrap;

an engagement member adapted to removably engage a clinician'"'"'s hand until a predetermined disengagement time, the engagement member being operatively connected to implantable wrap;

the engagement member comprising a loop member adapted to extend substantially around a portion of a finger of the hand to removably restrain the finger with respect to the wrap; and

a removable base attached to the loop, the base being constructed and arranged so that the loop is removable from the wrap upon application of a predetermined motion thereto in a predetermined direction.

11. The system as set forth in claim 10 wherein the base comprises a pin adapted for insertion into a portion of the wrap.

12. The system as set forth in claim 10 wherein the loop comprises a finger of a glove and the base is attached thereto.

13. A system for treating an affected organ of a patient comprising:

an implantable wrap;

an engagement member adapted to removably engage a clinician'"'"'s hand until a predetermined disengagement time, the engagement member being operatively connected to the implantable wrap;

the engagement member comprising a plurality of loop members located at predetermined positions about a circumference of the wrap for engaging each of a plurality of fingers of the hand;

each loop member adapted to extend substantially around a portion of a finger to removably restrain the finger with respect to the wrap;

wherein the wrap includes a pair of free ends and wherein each of the loops are positioned so that a thumb of the hand can be placed over the ends when the free ends are joined together with the wrap in a wrapped orientation around a heart.

14. A method for implanting a cardiac wrap on a heart comprising:

mounting selected fingers of a clinician'"'"'s hand to engagement members interconnected with the wrap so as to maintain the fingers in tactile control of wrap placement during implantation until a predetermined time;

moving the wrap into a geometry adapted for implanting the wrap with respect to the heart through a chest incision proximate to the heart;

locating the wrap at an implanted position with respect to the heart;

affixing the wrap in the implanted position on the heart; and

at the predetermined time performing a detachment motion so as to detach the selected fingers from engagement with the wrap.

15. A method for implanting a cardiac wrap on a heart comprising:

mounting selected fingers of a clinician'"'"'s hand to engagement members interconnected with the wrap so as to engage the fingers with the wrap until a predetermined time;

moving the wrap into a geometry adapted for implanting the wrap with respect to the heart through a chest incision proximate to the heart;

locating the wrap at an implanted position with respect to the heart;

affixing the wrap in the implanted position on the heart; and

at the predetermined time performing a detachment motion so as to disengage the selected fingers from the wrap;

wherein the step of mounting comprises inserting the selected fingers into loop members attached to a surface of the wrap at predetermined locations about a circumference thereof.

16. A method for implanting a cardiac wrap on a heart comprising:

mounting selected fingers of a clinician'"'"'s hand to engagement members interconnected with the wrap so as to engage the fingers with the wrap until a predetermined time;

moving the wrap into a geometry adapted for implanting the wrap with respect to the heart through a chest incision proximate to the heart;

locating the wrap at an implanted position with respect to the heart;

affixing the wrap in the implanted position on the heart; and

at the predetermined time performing a detachment motion so as to disengage the selected fingers from the wrap;

wherein the step of detaching comprises removing the selected fingers from the loop members.

17. A method for implanting a cardiac wrap on a heart comprising:

mounting selected fingers of a clinician'"'"'s hand to engagement members interconnected

with the wrap so as to engage the fingers with the wrap until a predetermined time;

moving the wrap into a geometry adapted for implanting the wrap with respect to the heart through a chest incision proximate to the heart;

locating the wrap at an implanted position with respect to the heart;

affixing the wrap in the implanted position on the heart; and

at the predetermined time performing a detachment motion so as to disengage the selected fingers from the wrap;

wherein the step of detaching comprises removing the loop members from the wrap based upon a predetermined detachment motion.

18. A method for implanting a cardiac wrap on a heart comprising:

mounting selected fingers of a clinician'"'"'s hand to engagement members interconnected with the wrap so as to engage the fingers with the wrap until a predetermined time;

moving the wrap into a geometry adapted for implanting the wrap with respect to the heart through a chest incision proximate to the heart;

locating the wrap at an implanted position with respect to the heart;

affixing the wrap in the implanted position on the heart; and

at the predetermined time performing a detachment motion so as to disengage the selected fingers from the wrap;

wherein the step of affixing includes moving the selected fingers so as to place opposing free ends of the wrap in an overlapping relationship and applying securing members to maintain the free ends in the overlapping relationship.

19. The method is set forth in claim 18 wherein the step of affixing includes holding the free ends together in the overlapping relationship while the securing members are applied to the free ends.

20. An apparatus for treating a heart comprising:

a cardiac wrap constructed and arranged to apply pressure about a portion of a circumference of the heart; and

a plurality of finger-engaging loops located at predetermined positions on a surface of the wrap so that a hand has tactile control of wrap placement during implantation on the heart, the loops adapted to apply friction to respective fingers inserted thereinto to maintain engagement therebetween.

21. A cardiac wrap adapted to apply pressure about a portion of a circumference of a heart when the wrap is in engagement with the heart comprising:

a wrap body having an inner surface adapted to engage the heart and an opposing outer surface; and

a plurality of material loops each attached to at least two locations along the outer surface so as to define openings that receive fingers of a hand, wherein the hand is movable to place the wrap into an enclosing relationship around the heart.

22. The cardiac wrap as set forth in claim 21 wherein the wrap body includes a plurality of inflatable elements between the inner surface and the outer surface for applying variable pressure to the heart based upon an amount of fluid present in the balloons.

23. The cardiac wrap as set forth in claim 21 wherein the wrap body defines an upper edge and a lower edge opposite the upper edge, the lower edge adapted to be more remote from major blood vessels of the heart than the upper edge when the wrap is in engagement with the heart, and each of the material loops being located adjacent the upper edge of the wrap.

24. The cardiac wrap as set forth in claim 23 wherein each of the material loops defines a first loop edge adjacent the upper edge of the wrap body and a second loop edge remote from the upper edge of the wrap body and wherein the first loop edge defines a first loop opening and the second loop edge defines a second loop opening.

25. The cardiac wrap as set forth in claim 24 wherein the first loop opening is smaller than the second loop opening so as to resist passage of a finger from the second loop opening through the first loop opening.

26. The cardiac wrap as set forth in claim 23 wherein each of the material loops defines a first loop edge adjacent the upper edge of the wrap body and a second loop edge remote from the upper edge of the wrap body wherein the second loop edge defines a loop opening sized to allow a finger to pass therethrough and wherein the first loop edge is sealed against the wrap body.

27. The cardiac wrap as set forth in claim 21 wherein each of the material loops is joined to the wrap body at two-spaced apart locations by seams that include securing thread.

28. A method for implanting a cardiac wrap having a wrap body adapted to enclose a portion of a circumference of a heart comprising:

engaging the wrap body with a hand, including placing fingers of the hand within each of a plurality of material loops attached along an outer surface of the wrap body and forming a cup-shape with the wrap;

passing the wrap body over a ventricular region of the heart and positioning the wrap body at a desired location around the circumference of the heart;

securing free ends of the wrap body together so that the wrap body defines a predetermined circumference; and

removing the fingers from the material loops.

29. The method as set forth in claim 28 further comprising detaching the material loops after the fingers are removed therefrom.

30. The method as set forth in claim 28 wherein the step of detaching includes cutting the material loops at locations on the loops adjacent the outer surface of the wrap body.

31. The method as set forth in claim 28 wherein the step of placing the fingers within each of the material loops includes passing fingers into respective openings in the material loops until each of the fingers is resisted by an increasing taper defined in each of the material loops.

32. A cardiac wrap adapted to apply pressure about a portion of a circumference of a heart when the wrap is in engagement with the heart comprising:

a wrap body having an inner surface adapted to engage the heart and an opposing outer surface; and

a plurality of pockets defined on the outer surface, the pockets being sized and arranged so that respective fingers can pass thereinto, each of the pockets including a first end defining an opening for receiving each of the fingers, respectively, and a second end that is closed against the wrap body to resist movement of each of the fingers, respectively.

33. The cardiac wrap as set forth in claim 32 wherein the outer surface comprises an outer surface material layer and wherein each of the pockets are defined by a portion of the outer surface material layer, the first end of each of the pockets being a separation of the portion of the outer surface material layer for a surrounding region of the outer surface material.

34. The cardiac wrap as set forth in claim 33 wherein the first edge is constructed an arranged to be sealed against the wrap body so as to close the opening at a predetermined time.

35. The cardiac wrap as set forth in claim 32 further comprising a plurality of inflation elements that expand and contract in response to a level of fluid therein, each of the plurality of inflation elements including a balloon disposed between the inner surface and the outer surface.

36. The cardiac wrap as forth in claim 35 wherein each of the pockets is located between a respective pair of the plurality of inflation elements.

37. A cardiac wrap adapted to apply pressure about a portion of a circumference of a heart when the wrap is in engagement with the heart comprising:

a wrap body having an inner surface adapted to engage the heart and an opposing outer surface; and

a plurality of removable loop members adapted to engage fingers of a hand, the loop members being attached to the outer surface so that the loop members remain engaged to the outer surface to provide tactile control of wrap placement as an implanting force is applied in a first direction that can move the wrap over a ventricular region of the heart, toward major blood vessels of the heart, onto a predetermined location thereon.

38. The cardiac wrap as set forth in claim 37 wherein the plurality of removable loop members include hook elements that selectively engage the outer surface when force is applied to the plurality of removable loop members in the first direction and that, alternatively disengage in the outer surface when force is applied in an opposing second direction.

39. The cardiac wrap as set forth in claim 38 wherein the plurality of removable loop members comprise semi-rigid ring elements adapted to frictionally engage tips of the fingers.

40. The cardiac wrap as set forth in claim 38 wherein the semi-rigid ring elements define a split adapted to enable the rigid members to flex about the fingers.

41. The cardiac wrap as set forth in claim 38 wherein the plurality of removable loop members comprise enclosed structures having an opening at one end for receiving fingers thereinto and an enclosed tip at an opposing end for resisting passage of fingers therethrough.

42. A cardiac wrap as set forth in claim 38 wherein the hooks are mounted on each of the plurality of removable loop members, respectively, and the hooks are adapted to be removed, respectively, from the outer surface of the wrap body in conjunction with each of the plurality of removable loop members.

43. The cardiac wrap as set forth in claim 38 wherein the hooks are fixedly mounted to predetermined locations on the outer surface of the wrap body and the plurality of removable loop members are each adapted to disengage from the hooks when force is applied in the second direction to each of the loop members.

44. A system for implanting a cardiac wrap adapted to apply pressure about a portion of a circumference of a heart when the wrap is in engagement with the heart comprising:

a wrap body having an inner surface adapted to engage the heart and an opposing outer surface; and

a glove having fingers, each finger of the glove including one of a hook and a spike for engaging the outer surface so as to grip the outer surface when pressure is applied in a first direction to pass the wrap over a ventricular region of the heart, toward major blood vessels.

45. The system as set forth in claim 44 wherein the wrap body includes a pair of free ends adapted to be joined when the wrap body is in engagement with the heart so as to define a predetermined circumference of the wrap body in engagement with the heart.

46. The system as set forth in claim 44 wherein the wrap body includes a plurality of inflation elements that expand and contract in response to an amount of fluid therein.

47. A method for implanting a cardiac wrap that applies pressure about a portion of a circumference of a heart comprising:

engaging, with fingers of a hand, a plurality of finger engaging members;

applying a plurality of finger-engaging members to a wrap body so that the finger engaging members remain removably attached to the wrap body while a force is applied by the hand in a first direction toward major blood vessels to implant the wrap over a ventricular region of the heart; and

disengaging the hand from the wrap body so that the plurality of finger-engaging members remain attached the fingers when a force is applied is a second opposing direction from the first direction by the hand.

48. The method as set forth in claim 47 wherein the step of applying includes passing the plurality of finger-engaging members over hooks fixedly attached to the wrap.

49. The method as set forth in claim 47 wherein the step of applying includes directing respective pointed members on each of the plurality of finger-engaging members into the wrap body in the first direction so as to engage the wrap body.