Medical Device Delivery System Having Integrated Introducer

• US 20100081867A1
• Filed: 09/23/2009
• Published: 04/01/2010
• Est. Priority Date: 08/13/2007
• Status: Active Grant

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: Martin, Peter M., Wallin, Joshua, Fishler, Matthew G., Klenk, Alan R.
• Granted Patent: US 8,192,351 B2
• 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 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 medical device onto a heart includes a housing within which is releasably disposed the medical device. The housing in one embodiment comprises inner and outer deflectors between which is delivered the medical device. Both deflectors are self-expanding. A deflector compression sheath is slidable longitudinally over the housing to a delivery position at which it moves the deflectors to a collapsed configuration. The compression sheath is retracted to a deployment position to permit the deflectors to deploy by self-expanding to their larger diameters. The outer deflector has an expanded diameter sufficient to engage the inner surface of the pericardium to hold it away from the delivery site while the second deflector guides the medical device into position over the heart while protecting the heart. In another embodiment, the housing includes only an outer deflector. The apparatus also functions as an introducer when the compression sheath is moved to the delivery or “introducer” position at which configuration, the apparatus functions as an introducer.

Claims

1. A delivery system for deploying a medical device, the delivery system comprising:

a housing having a longitudinal axis, a proximal end, a distal end, and a medical device location adapted to releasably contain the medical device;

an outer deflector that deploys to a first diameter at a distal end, the outer deflector also having a proximal end mounted at the distal end of the housing;

an inner deflector disposed within the outer deflector, the inner deflector deploying to a second diameter, and having a proximal end and a distal end; and

a compression device disposed over the housing, movable in relation to the housing, and adapted for moving over the outer and inner deflectors to a delivery position to thereby collapse both the outer and inner deflectors into a delivery configuration, and for sliding to a retracted position to permit the outer and inner deflectors to expand to a deployed configuration;

wherein the medical device location in the housing is located so that the medical device is deployed between the outer and inner deflectors.

2. The delivery system of claim 1, wherein the outer deflector is configured to be self expanding.

3. The delivery system of claim 1, wherein the inner deflector is configured to be self expanding.

4. The delivery system of claim 1, wherein the outer deflector comprises a plurality of petals, each petal having a proximal end and a distal end, the petals flaring outwardly in the deployed configuration at the distal end;

and

the inner deflector comprises a plurality of petals, each petal having a proximal end and a distal end, the petals flaring outwardly in the deployed configuration at the distal end.

5. The delivery system of claim 4, wherein the petals of the inner deflector are formed such that they taper from a relatively narrower proximal end to a relatively wider distal end.

6. The delivery system of claim 4, wherein the petals of the outer deflector are formed such that they are not tapered from one end to the other.

7. The delivery system of claim 4, wherein at least a portion of each petal of the inner deflector overlaps an adjacent petal.

8. The delivery system of claim 4, wherein adjacent petals of the inner deflector are configured in relation to one another so that they slide over each other when the inner deflector is collapsed to the delivery configuration and expanded to the deployed configuration.

9. The delivery system of claim 4, wherein the petals of the outer deflector are separate from one another such that they do not overlap one another in either the delivery or deployed configurations.

10. The delivery system of claim 4, wherein the inner deflector comprises:

a first set of petals having a first set of gaps between them; and

a second set of petals having a second set of gaps between them;

wherein the first set of petals interleaves with the second set of petals by filling the second gaps and the second set of petals interleaves with the first set of petals by filling the first gaps.

11. The delivery system of claim 4, wherein the outer deflector comprises:

a third set of petals having a third set of gaps between them; and

a fourth set of petals having a fourth set of gaps between them;

wherein the third set of petals interleaves with the fourth set of petals by filling the fourth gaps and the fourth set of petals interleaves with the third set of petals by filling the third gaps.

12. The delivery system of claim 1, wherein:

the housing comprises an outer tubular wall having a distal end and an outer surface with the outer deflector comprising a plurality of petals that are formed at the distal end of the tubular wall of the housing and extending distally therefrom;

wherein the compression device comprises a compression sheath adapted to be slidable over the outer surface of the tubular wall of the housing to the delivery position to cover and collapse the outer deflector petals into the delivery configuration.

13. The delivery system of claim 12, wherein the outer deflector petals are formed as part of an outer deflector ring that is aligned with and attached to the distal end of the tubular wall of the housing.

14. The delivery system of claim 13, wherein the outer deflector ring and the distal end of the tubular wall of the housing comprise complementary threads wherein the outer deflector ring and the tubular wall of the housing are attached together by engagement of these threads.

15. The delivery system of claim 4, wherein a plurality of the deflector petals comprise distal tips having varying radii at the distal tips.

16. The delivery system of claim 4, wherein a plurality of the deflector petals comprise varying thicknesses between the proximal ends and the distal ends.

17. The delivery system of claim 4, wherein the outer deflector is formed to the distal end of the tubular wall by a mechanical connection selected from the group consisting of:

threaded fit, snap fit, overmolded, adhesively bonded, chemically bonded, and molded directly as part of the tubular wall.

18. The delivery system of claim 4, wherein a radiopaque material is attached to at least some of the petals to enhance visualization of the system under fluoroscopy.

19. The delivery system of claim 18, wherein the radiopaque material comprises barium sulfate.

20. The delivery system of claim 4, wherein a radiopaque material is embedded within at least some of the petals to enhance visualization of the system under fluoroscopy.

21. The delivery system of claim 1, wherein:

the housing comprises an outer tubular wall having a distal end and an outer surface with the outer deflector comprising a plurality of petals that are formed at the distal end of the tubular wall of the housing and extending distally therefrom;

the outer and inner deflectors are self expanding;

the outer deflector comprises a plurality of petals, each petal having a distal end at which the petal flares outwardly in the deployed configuration;

the inner deflector comprises a plurality of petals, each petal having a distal end at which the petal flares outwardly in the deployed configuration; and

the compression device comprises a compression sheath adapted to be slidable over the outer surface of the tubular wall of the housing to the delivery position to cover and collapse the outer deflector petals and the inner deflector petals into the delivery configuration.

22. The delivery system of claim 1, 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.

23. The delivery system of claim 22, wherein the cross-sectional shape is adapted for advancing through a minimally invasive surgical entry path.

24. A method of delivering a medical device, comprising:

advancing an elongated delivery housing through an access site;

deploying an outer deflector from the delivery housing;

expanding the outer deflector to engage first tissue;

deploying an inner deflector from the delivery housing;

expanding the inner deflector to engage second tissue;

advancing the medical device out of the delivery housing under the expanded outer deflector and over the expanded inner deflector into a desired position;

collapsing the inner and outer deflectors; and

withdrawing the delivery housing with the inner and outer deflectors from the access site.

25. The method of claim 24, wherein the step of expanding the outer deflector comprises self expanding the outer deflector.

26. The method of claim 24, wherein the step of expanding the inner deflector comprises self expanding the inner deflector.

27. The method of claim 24, wherein the step of expanding the inner deflector to engage the second tissue further comprises guiding delivery of the medical device into the desired position with the second deflector.

28. The method of claim 24, wherein the step of expanding the inner deflector to engage the second tissue further comprises protecting the second tissue with the second deflector during delivery of the medical device.

29. The method of claim 24, wherein the step of expanding the outer deflector further comprises engaging the first tissue to move it away from the second tissue thereby opening a space between the first and second tissues for delivery of the medical device.

30. The method of claim 24, wherein:

the step of expanding the inner deflector to engage the second tissue further comprises protecting the second tissue during delivery of the medical device with the inner deflector; and

the step of expanding the outer deflector out of the delivery housing further comprises engaging the first tissue to move it away from the second tissue thereby opening a space between the first and second tissues for delivery of the medical device.

31. A delivery system with integrated introducer for introducing and deploying a medical device, the delivery system comprising:

a tubular housing comprising an outer tubular wall, the wall having an outer surface, a longitudinal axis, and a distal end, the tubular housing also comprising a medical device location adapted to releasably contain the medical device within the tubular wall;

an outer deflector that deploys outwardly to a first diameter at a distal end, the outer deflector having a proximal end mounted at the distal end of the tubular housing wall;

a compression sheath disposed over the outer surface of the tubular wall and longitudinally movable in relation thereto, the sheath adapted for moving over the outer deflector to an introducer position to thereby collapse the outer deflector into a delivery configuration, and for moving to a retracted position to permit the outer deflector to expand to a deployed configuration;

wherein the medical device location in the housing is located so that the medical device is deployed through the outer deflector.

32. The delivery system of claim 31, wherein the outer deflector is configured to self-expand.

33. The delivery system of claim 31, wherein the outer deflector comprises a plurality of petals, each petal having a proximal end and a distal end.

34. The delivery system of claim 33, wherein the petals of the outer deflector are formed such that they are not tapered from one end to the other.

35. The delivery system of claim 33, wherein the petals of the outer deflector are formed such that they taper from a relatively narrower proximal end to a relatively wider distal end.

36. The delivery system of claim 33, wherein at least a portion of each petal of the outer deflector overlaps an adjacent petal.

37. The delivery system of claim 36, wherein adjacent petals of the outer deflector are configured in relation to one another so that they slide over each other when the outer deflector is compressed into the delivery configuration and expanded to the deployed configuration.

38. The delivery system of claim 33, wherein the petals of the outer deflector are separate from one another and do not overlap one another.

39. The delivery system of claim 31, wherein the outer deflector comprises:

a first set of petals having a first set of gaps between them; and

a second set of petals having a second set of gaps between them;

wherein the first set of petals interleaves with the second set of petals by filling the second gaps and the second set of petals interleave with the first set of petals by filling the first gaps.

40. The delivery system of claim 33, wherein the petals comprise distal tips having varying radii at the distal tips.

41. The delivery system of claim 33, wherein the petals comprise varying thicknesses between the proximal ends and the distal ends.

42. The delivery system of claim 33, wherein the outer deflector petals are formed as part of an outer deflector ring that is aligned with and formed to the distal end of the tubular wall.

43. The delivery system of claim 42, wherein the outer deflector ring and the distal end of the housing comprise complementary threads wherein the outer deflector ring and the housing are attached together by interaction of these threads.

44. The delivery system of claim 31, wherein the outer deflector is formed to the distal end of the tubular wall by a mechanical connection selected from the group consisting of:

threaded fit, snap fit, overmolded, adhesively bonded, chemically bonded, and molded directly as part of the tubular wall.

45. The delivery system of claim 31, 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.

46. The delivery system of claim 45, wherein the cross-sectional shape is adapted for advancing through a minimally invasive surgical entry path.

47. A method of introducing and delivering a medical device with a single system, the system comprising a housing with outwardly expanding deflector fixedly mounted to a distal end of the housing, and a compression sheath movably mounted over the housing, the method comprising:

moving the compression sheath over the housing and the deflector to an introducer configuration thereby collapsing the deflector within the compression sheath;

advancing the compression sheath and collapsed deflector that are in the introducer configuration through an access site;

moving the compression sheath over the housing away from the deflector to a delivery position thereby deploying the deflector;

expanding the deflector outwardly to engage first tissue to move it away from second tissue;

advancing the medical device out of the delivery housing under the expanded deflector into a desired position;

moving the compression sheath over the housing to the introducer position to collapse the deflector thereby attaining the introducer configuration; and

withdrawing the delivery housing, the compression sheath, and the deflector from the access site.

48. The method of claim 47, wherein the step of expanding the outer deflector comprises self expanding the outer deflector.

49. The method of claim 47, wherein the step of advancing the medical device comprises advancing the medical device into a desired position in relation to the second tissue.

50. 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;

an outer deflector having a distal end and a proximal end, the outer deflector being flexible and configured so that it can be collapsed into a delivery configuration, and can be flared radially outwardly to a deployed configuration at which it has a first diameter at its distal end;

an inner deflector having a distal end and a proximal end, the inner deflector being flexible and configured so that it can be collapsed into a delivery configuration, and can be flared radially outwardly to a deployed configuration at which it has a second diameter at its distal end;

a deflector sheath slidably mounted over the outer surface of the tubular housing and having a delivery position at which the sheath retains the outer and inner deflectors in a collapsed, delivery configuration; and

the deflector sheath being further slidably mounted over the outer surface of the tubular housing to a deployment position at which the outer and inner deflectors flare radially outwardly in deployed configurations so that the outer deflector engages the pericardium and the push rods and cardiac harness slide under the outer deflector and over the inner deflector as the harness slides over the heart.

51. The apparatus for delivering a cardiac harness of claim 50, wherein the inner deflector comprises a plurality of petals, the plurality of petals being configured to be collapsed into the deflector sheath in a delivery configuration and flared radially outwardly in a deployed configuration at which the petals have a second diameter at a distal end, the second diameter being smaller than the first diameter of the outer deflector;

52. The apparatus of claim 51, wherein the plurality of petals number in the range from four to twenty petals.

53. The apparatus of claim 51, wherein the petals are formed from a polymer material.

54. The apparatus of claim 53, wherein the polymer material is taken from the group of polymers including polyamides, polyamide copolymers such as PEBAX, silicone rubber, polyurethanes, and nylons.

55. The apparatus of claim 51, wherein the proximal ends of the petals are biased radially outwardly to form a flared configuration.

56. The apparatus of claim 50, 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.

57. The apparatus of claim 50, 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.

58. The apparatus of claim 50, wherein the cross-sectional shape is adapted for advancing through a minimally invasive surgical entry path.

59. The apparatus of claim 50, 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.

60. A method of delivering a cardiac harness onto a heart, comprising:

advancing an elongated delivery device through a minimally invasive access site;

deploying an outer deflector from the delivery device to engage the pericardium and open a space between the pericardium and the heart;

deploying an inner deflector from the delivery device to engage the heart;

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

flaring the cardiac harness outwardly over the inner deflector and onto the heart; and

withdrawing the delivery device with the inner and outer deflectors through the access site.

61. The method of claim 60, further comprising:

extending a suction cup from a distal end of the delivery device;

engaging the heart with the extended suction cup; and

applying a vacuum to the suction cup to firmly attach the cup onto the heart.

62. The method of claim 61, wherein the inner deflector extends over the suction cup.

63. The method of claim 60, wherein the step of expanding the inner deflector to engage the heart further comprises guiding delivery of the harness onto the heart with the second deflector.

64. The method of claim 60, wherein the step of expanding the inner deflector out of the delivery housing to engage the heart further comprises protecting the heart with the second deflector during delivery of the medical device.