Tissue lockable connecting structures

• US 20030236575A1
• Filed: 07/09/2003
• Published: 12/25/2003
• Est. Priority Date: 10/31/2000
• Status: Active Grant

• Current Assignee: East Carolina University
• Original Assignee: East Carolina University
• Inventors: Yu, Chang, Harris, Glenn
• Granted Patent: US 7,083,648 B2
• Time in Patent Office: Days
• US Class Current: 623/32
• CPC Class Codes: A61C 8/0009 Consolidating prostheses or implants, e.g. by means of stabilising pins A61C8/0031 takes precedence
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/60 Artificial legs or feet or parts thereof
• CPC Class Codes: A61F 2/72 Bioelectric control, e.g. myoelectric
• CPC Class Codes: A61F 2/78 Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/30467 using hook and loop-type fasteners
• CPC Class Codes: A61F 2002/30914 Details of the mesh structure, e.g. disposition of the woven warp and weft wires
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/704 computer-controlled, e.g. robotic control
• CPC Class Codes: A61F 2002/705 Electromagnetic data transfer for implantable prostheses A61F2250/0002
• CPC Class Codes: A61F 2002/7615 Measuring means for implanting artificial joints A61F2/4657
• CPC Class Codes: A61F 2002/7881 using hook and loop-type fasteners for connecting prosthetic parts A61F2002/30467
• CPC Class Codes: A61F 2002/7887 for connecting limb exoprostheses to the stump bone
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Percutaneous skin access devices include a plurality of locked connecting units mounted to the exterior surface of an implantable medical object which, in position, is configured to penetrate the skin of a subject. The locked connecting units may be mounted directly onto the desired surface of the exterior of the device or may be held on a substrate sheet, which is mounted to the exterior surface of the device. In position, the locked connecting units engage with soft tissue which can include the skin to form a bio-junction layer which includes mechanical and bio-sealing connection between the device body and the soft tissue. The configuration at the bio-junction layer secures the medical object in location in the subject even for long-term indwelling applications in a manner, which inhibits soft tissue infection.

The locked connecting units may be rigid or semi-rigid for longer-term indwelling applications, and semi-rigid and/or resilient for shorter term indwelling applications. The locked connecting units may take on the form of rings, hooks, or loops having aperture or gap width/length sizes of from about 0.2-4 mm. The rings, loops, or hooks may connect with any soft tissue including skin as well subcutaneous tissue. The rings, hooks, or loops may be released from the skin/tissue without requiring surgical cutting procedures.

The locked connecting units may be configured as a semi-rigid mesh collar arranged about the primary body providing access to the subject such that it resides in the subject and engages with the skin (epidermal/dermal layer). The mesh collar can be described as a particular type of ring or loop structure as the mesh defines the gap provided in individual loop configurations. The mesh collar may be used alone, or in combination with the loops, rings, or hooks. A skin stop collar having increased rigidity may be disposed under the mesh collar.

Claims

1. A percutaneous access device configured for implantation into a subject to provide subcutaneous access therethrough, comprising:

a primary body having opposing top and bottom portions, each with a respective outer surface, and at least one sidewall extending therebetween, wherein in position in a subject, said primary body bottom portion resides within the subject and said bottom portion outer surface faces into the subject; and

an outwardly extending mesh collar attached to said primary body such that said mesh collar is positioned intermediate said top and bottom portions and extends outwardly from said at least one sidewall a first distance, and wherein, in position in the subject, said mesh collar is configured to engage with the skin of a subject.

2. A percutaneous access device according to claim 1, wherein said mesh collar has a plurality of apertures formed therein, said apertures having an associated gap area of between about 0.1-10 mm².

3. A percutaneous access device according to claim 1, wherein said mesh collar is resiliently configured and able to substantially retain its shape in situ.

4. A percutaneous access device according to claim 3, wherein said mesh collar is formed of polymer screen.

5. A percutaneuos access device according to claim 2, wherein said apertures are sized with an area of between about 0.5 mm-5 mm.

6. A percutaneuos access device according to claim 1, wherein said mesh collar is configured with between about 10-500 apertures/cm².

7. A percutaneuos access device according to claim 1, wherein said mesh collar comprises polymer screen defining about 50-200 apertures per cm².

8. A percutaneuos access device according to claim 1, wherein said mesh collar comprises polymer net including warp and weft fibers having a diameter of about 0.05-0.2 mm.

9. A percutaneuos access device according to claim 1, wherein said mesh collar comprises warp and weft yarns which are substantially fixed relative to each other and define a substantially fixed aperture size of about 1 mm².

10. A percutaneous access device according to claim 1, wherein said mesh collar has a thickness which is on the order of about 0.05-0.3 mm.

11. A percutaneous access device according to claim 1, wherein said mesh collar is substantially planar.

12. A percutaneous access device according to claim 1, wherein said primary body defines a sealable access port, and wherein said top portion of said primary body has a perimeter associated therewith, and wherein in position in the subject, skin engages with said perimeter of the device and said mesh collar to define a biosealing junction with the skin and to provide mechanical structural support for the device with the tissue.

13. A percutaneous access device according to claim 1, wherein said access device is configured as a long term indwelling device to provide access to a selected site in the subject.

14. A percutaneous access device according to claim 1, wherein said top portion of said primary body includes a plurality of tissue connectors which extend outwardly from the wall of the primary body, wherein in position, at least some of said tissue connectors reside above the natural level of the skin, and wherein said mesh collar is attached to said primary body beneath said plurality of tissue connectors.

15. A percutaneous access device according to claim 12, wherein said top portion of said primary body is configured, in position, to rise above the normal level of the skin of the subject, and wherein, in position, said primary body defines an access port therethrough.

16. A percutaneuos access device according to claim 1, wherein said primary body is cylindrical, and wherein said mesh collar is configured to circumferentially extend about said primary body.

17. A percutaneuos access device according to claim 1, wherein said mesh collar is located closer to said top portion than said bottom portion of said primary body.

18. A percutaneuos access device according to claim 1, further comprising a plurality of tissue connectors positioned about the perimeter of said primary body below said mesh collar.

19. A percutaneuos access device according to claim 18, wherein said plurality of tissue connectors are configured to extend outwardly a second distance from said at least one sidewall, said second distance being less than said first distance.

20. A percutaneous access device according to claim 19, wherein, in position, said tissue connectors are configured to engage with subcutaneous tissue.

21. A percutaneuos access device according to claim 20, wherein said tissue connectors are resiliently configured and sufficiently rigid so as to substantially retain its shape in situ.

22. A percutaneuos access device according to claim 21, wherein said tissue connectors are configured as one or more of hooks and rings.

23. A percutaneuos access device according to claim 1, further comprising a skin stop collar attached to said primary body below and proximate to said mesh collar, said stop collar being downwardly spaced apart from said mesh collar to define a space therebetween.

24. A percutaneuos access device according to claim 23, wherein said skin stop collar has an increased rigidity relative to said mesh collar.

25. A percutaneuos access device according to claim 24, wherein said skin stop collar extends outwardly from said primary body a lesser distance than said mesh collar.

26. A percutaneuos access device according to claim 25, wherein said skin stop collar has a width which is about 0.2-0.6 times less that of said mesh collar.

27. A percutaneuos access device according to claim 26, wherein said skin stop collar is formed of a metallic mesh.

31. A percutaneuos device according to claim 25, wherein said skin stop collar has a width which is about 0.2-0.6 times less the width of said mesh collar.

28. A percutaneous device configured for implantation into a subject to provide subcutaneous access therethrough, comprising:

a primary body having opposing top and bottom portions, each with a respective outer surface, and at least one sidewall extending therebetween, wherein in position in a subject, said primary body bottom portion resides within the subject and said bottom portion outer surface faces into the subject;

an outwardly extending mesh collar attached to said primary body such that said mesh collar is positioned intermediate said top and bottom portions and extends outwardly from said at least one sidewall a first distance, and wherein, in position on the subject, said mesh collar is configured to engage with the skin of a subject; and

a skin stop collar attached to said primary body such that said skin stop collar is proximate to and beneath said mesh collar.

29. A percutaneous device according to claim 28, wherein said mesh collar is semi-rigid, and wherein said skin stop collar has an increased rigidity relative to said mesh collar.

30. A percutaneuos device according to claim 29, wherein said skin stop collar extends outwardly from said primary body a lesser distance than said mesh collar.

32. A percutaneuos device according to claim 30, wherein said mesh collar is formed of polymer screen, and wherein said skin stop collar is formed of a metallic mesh.

33. A skeletal limb extension device for providing support for a prosthesis device, comprising:

an elongated extension member adapted to attach to the bone of a subject, wherein, in position, said elongated extension member resides inside the body of the subject;

a tissue connector member attached to said elongated extension member, said tissue connector member having opposing distal and proximal portions at a sidewall portion extending therebetween, the distal portion configured to reside inside the subject and at least the outer surface of said proximal portion configured to extend external of the subject above and proximate the normal level of the skin, said tissue connector member comprising a plurality of tissue connectors extending outwardly from said sidewall portion and configured to engage with subcutaneous tissue in the subject; and

a prosthesis attachment member attached to said tissue connector member in a direction opposing said elongated extension member such that said prosthesis attachment member extends outwardly from the subject, wherein the skin of the subject attaches to the upper portion of the perimeter of said sidewall portion to define a sealing junction about said device, and wherein said elongated extension member, said tissue connector, and said prosthesis attachment member define a load path in a manner which avoids contact with skin and subcutaneous tissue to reduce the discomfort to the subject.

34. A skeletal limb extension device for providing support for a prosthesis device according to claim 33, wherein said tissue connectors comprise a mat of polymer loops.

35. A method of attaching a prosthetic device to a subject using a tissue connector member and elongated extension member comprising the steps of:

inserting the elongated extension member into a selected bone of a subject;

attaching the tissue connector member to the elongated extension member; and

positioning the tissue connector member in the subject such that it resides below the bone and elongated member in a load path which is substantially devoid of subcutaneous tissue.

36. A method of implanting an access device having a semi-rigid mesh collar adapted to engage with the skin of a subject, comprising the steps of:

introducing an opening in the skin of a subject; and

positioning the device into the opening of the subject such that the semi-rigid mesh collar resides below but proximate the skin of the subject so that, over time, the skin engages with the mesh collar and defines a mechanical and biosealing connection proximate the perimeter of the device about the outer surface of the skin to close the opening of said introducing step.

37. A method according to claim 36, further comprising the step of temporarily securing the skin to the mesh collar during an initial healing period.

38. A method according to claim 36, wherein the opening of said introducing step is smaller than the width of the body of the device.

39. A method according to claim 38, wherein the opening is on the order of 60-75% of the width of the device.

40. A method according to claim 38, wherein a healing assist device is positioned on the external surface of the skin such that it is aligned over the mesh collar.

41. A method according to claim 40, wherein the healing assist device compresses the skin to facilitate contact between the lower surface of the skin and the mesh collar to promote tissue growth therebetween.

42. A pin for providing structural support for treatment of a bone condition, comprising:

an elongated member having a perimeter configured for positioning into a biological subject; and

a plurality of tissue connectors attached to and extending outwardly from a portion of the perimeter of said elongated member, said tissue connectors having a body shape with a discontinuous perimeter defining an opening thereabout and adapted to engage with biomaterial in situ, wherein when said tissue connectors are moved in a predetermined direction, the localized tissue is directed through the opening in the discontinuous perimeter to disengage therefrom.

43. A pin according to claim 42, wherein said elongated member is threaded.

44. A pin according to claim 42, wherein said tissue connectors are substantially rigid.

45. A pin according to claim 42, wherein said tissue connectors are semi-rigid.

46. A pin according to claim 42, wherein said pin is cylindrical, wherein said plurality of tissue connectors are arranged circumferentially spaced apart, and wherein said plurality of tissue connectors is from about 50-100 connectors.

47. A pin according to claim 46, wherein said tissue connectors are shaped as one of hooks, forks, discontinuous perimeter rings, and discontinuous perimeter loops.

48. A pin according to claim 42, wherein said tissue connectors are non-metallic.

49. A pin according to claim 42, wherein said tissue connectors open end portion has a width which is about 0.2-4 mm.

50. A percutaneous device configured for implantation into a subject to provide subcutaneous access therethrough, comprising:

a primary body having opposing top and bottom portions, each with a respective outer surface, and at least one sidewall extending therebetween and a perimeter associated therewith, wherein in position in a subject, said primary body bottom portion resides within the subject and said bottom portion outer surface faces into the subject;

a plurality of tissue connectors attached to said primary body and extending outwardly therefrom about a portion of the perimeter thereof, such that, in position, a plurality of tissue connectors are adapted to engage with subcutaneous tissue to provide structural attachment for the device, and a plurality of tissue connectors are adapted to engage with the skin of the subject to define a bioconnection about a sealing junction defined by the region where the skin meets the perimeter of the primary body.

51. A device according to claim 50, wherein said tissue connectors are rings with apertures, said apertures having a diameter of about 0.2-4 mm.

52. A device according to claim 51, wherein said tissue connectors are substantially rigid.

53. A device according to claim 51, wherein said tissue connectors are semi-rigid such that they are able to substantially retain their shape and position in situ.

54. A device according to claim 51, wherein, in position, a plurality of said tissue connectors reside above the external surface of the skin.

55. A device according to claim 51, wherein tissue connectors have a discontinuous perimeter, and wherein said tissue connectors are configured to be separated from localized tissue in a manner which inhibits tissue damage thereat after residing in situ in the biological subject between 6-12 months.

56. A percutaneous access device according to claim 51, wherein, in position, a portion of said tissue connectors are configured to engage with at least one of subcutaneous tissue, bone, and an internal organ.

57. A method of providing a structurally supported bioconnection for a device, comprising the steps of:

implanting a device having a perimeter with a plurality of outwardly extending tissue connectors mounted thereon through an opening in biological subject, each tissue connector defining an aperture sized in width at about 0.2-4 mm; and

growing proximately located tissue into proximately located tissue connectors such that the tissue connectors engage with the tissue to define a bioconnection which engages the device with localized tissue in a desired location in the subject.

58. A method according to claim 57, wherein the tissue connectors have a discontinuous perimeter, and wherein said further comprises the step of removing said device by moving the device in a direction which directs the localized tissue through an opening formed by the discontinuous perimeter in the tissue connectors thereby releasing the tissue from the tissue connectors.

59. A method according to claim 57, wherein said tissue connectors are hooks.

60. A method according to claim 57, further comprising the step of sealing the device to define a skin bioconnection defined by the attachment of the skin about the perimeter of the upper portion of the implanted device.

61. A method according to claim 60, wherein the device includes a semi-rigid mesh collar located above the tissue connectors, wherein, said method further comprises the step of positioning the mesh collar adjacent the lower internal surface of the skin such that the skin attaches to the perimeter of the device over the mesh collar and tissue grows through said mesh collar to close the opening of said implanting step to provide a skin biosealed junction, and wherein the device provides access through the skin to a subject.

62. A method according to claim 57, wherein said device includes both tissue connectors and a semi-rigid mesh collar, and said growing step includes growing subcutaneous tissue into the tissue connectors and tissue associated with the skin into the mesh collar.

63. A method of locking a foreign object into a biological subject, the foreign object comprising a plurality of outwardly extending tissue connectors connected to the outer perimeter thereof into a biological subject, each of the tissue connectors having an aperture formed therein, the method comprising the step of:

implanting the object into a biological subject such that localized tissue grows into the apertures in the tissue connectors to provide structural support for the object in the biological subject, wherein the apertures have an opening gap of between about 0.2 mm-5 mm, and wherein the object is adapted to reside in the biological subject for at least 6-12 months.

64. A method according to claim 63, wherein the tissue connectors are arranged on a portion of the perimeter of the object in a quantity of between about 50-100 per cm².

65. A method according to claim 64, wherein the tissue connectors are arranged to cover a major portion of the perimeter surface of the object.

66. A method according to claim 65, wherein the tissue connectors are configured as at least one of hooks, rings, and loops.

67. A method according to claim 63, wherein the object is a dental implant.

68. A method according to claim 63, wherein the object comprises an artificial cornea.

69. A method according to claim 63, wherein the object comprises a skeletal extension member.

70. A method according to claim 63, wherein the object comprises a percutaneous access device.

71. A method according to claim 63, wherein the object is adapted to deliver insulin subcutaneously.

72. A method according to claim 63, wherein said object provides connections for peritoneal dialysis.

73. A method according to claim 63, wherein the tissue connectors are substantially rigid.

74. A method according to claim 63, wherein the tissue connectors have sufficient rigidity to substantially retain their shape in situ.

75. A method according to claim 63, where the tissue connectors comprise polymer fibers.

76. A percutaneous access device configured for implantation into a subject to provide subcutaneous access therethrough, the device being characterized by a plurality of locked connecting structures located proximate to at least one selected external surface thereof, the locked connecting structures defining an air gap space sized from between about 0.2-4 mm.

77. A percutaneous skin access device according to claim 76, wherein the device comprises a primary body defining an access passage therein, and wherein the locked connecting structures are defined by a thin semi-rigid mesh collar having the gap spaces formed therein, the mesh collar being positioned on the devices such that it radially extends outwardly from the primary body of the device.

78. A percutaneous skin access device according to claim 76, wherein the device comprises a primary body with sidewalls defining an access passage therein, and wherein the locked connecting structures are a plurality of loops defining the gap spaces and extending outwardly from the sidewalls of the primary body of the device.

79. A percutaneous skin access device according to claim 76, wherein the device comprises a primary body with sidewalls defining an access passage therein, and wherein the locked connecting structures are a plurality of hooks defining the gap spaces and extending outwardly from the sidewalls of the primary body of the device.

80. A percutaneous skin access device according to claim 76, wherein the device comprises a primary body with sidewalls defining an access passage therein, and wherein the locked connecting structures are formed directly onto the exterior surface of the primary body.

81. A percutaneous skin access device according to claim 76, wherein the device comprises a primary body with sidewalls defining an access passage therein, and wherein the locked connecting structures are formed onto a substrate sheet which is attached to the external surface of the sidewall of the device.

82. A percutaneous skin access device according to claim 76, wherein the device is a dental implant.

83. A percutaneous skin access device according to claim 76, wherein the device comprises an artificial cornea.

84. A percutaneous skin access device according to claim 76, wherein the device comprises a skeletal extension member.

85. A percutaneous skin access device according to claim 76, wherein the device is adapted to deliver insulin subcutaneously.

86. A percutaneous skin access device according to claim 76, wherein the device provides connections for peritoneal dialysis.