U.S. patent application number 10/657357 was filed with the patent office on 2004-03-11 for surgical procedures and instruments.
This patent application is currently assigned to Smith & Nephew, a Massachusetts corporation. Invention is credited to Harvie, Fraser, Huckle, James William, James, Adam, Richardson, Peter.
Application Number | 20040049194 10/657357 |
Document ID | / |
Family ID | 24419402 |
Filed Date | 2004-03-11 |
United States Patent
Application |
20040049194 |
Kind Code |
A1 |
Harvie, Fraser ; et
al. |
March 11, 2004 |
Surgical procedures and instruments
Abstract
Surgical instruments and methods are provided. In one aspect, a
method of securing a fixation device within an opening in a tissue
is provided, including delivering a material in a flowable state to
said opening, and changing the state of the material so that the
material forms an interference fit that secures the fixation device
in the opening.
Inventors: |
Harvie, Fraser; (St.
Leonards, GB) ; James, Adam; (Talbot Green, GB)
; Richardson, Peter; (Arlington, MA) ; Huckle,
James William; (Northallerton, GB) |
Correspondence
Address: |
FISH & RICHARDSON PC
225 FRANKLIN ST
BOSTON
MA
02110
US
|
Assignee: |
Smith & Nephew, a Massachusetts
corporation
|
Family ID: |
24419402 |
Appl. No.: |
10/657357 |
Filed: |
September 8, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10657357 |
Sep 8, 2003 |
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09604387 |
Jun 27, 2000 |
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6620185 |
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Current U.S.
Class: |
606/232 ;
128/898; 523/114; 606/139; 606/213; 606/86R; 606/910; 606/92 |
Current CPC
Class: |
A61B 17/0401 20130101;
A61B 17/068 20130101; A61B 17/8836 20130101; A61B 2017/0437
20130101; A61B 17/0467 20130101; A61B 2017/0404 20130101; A61B
17/0487 20130101; A61B 17/0642 20130101; A61B 2017/0462 20130101;
A61B 17/0644 20130101; A61B 2017/0412 20130101; A61B 2017/005
20130101; A61B 2017/0647 20130101; A61B 2017/0427 20130101; A61B
17/1684 20130101; A61B 2017/0414 20130101; A61B 17/00491 20130101;
A61B 2017/0446 20130101; A61B 2017/0417 20130101; A61B 2017/0409
20130101; A61B 17/1637 20130101 |
Class at
Publication: |
606/072 |
International
Class: |
A61B 017/58 |
Claims
What is claimed is:
1. A method of securing a fixation device within an opening in a
tissue, comprising: delivering a material in a flowable state to
said opening, and changing the state of the material so that the
material forms an interference fit that secures the fixation device
in the opening.
2. The method of claim 1 wherein said tissue comprises bone.
3. The method of claim 1 wherein said tissue comprises soft
tissue.
4. The method of claim 1 wherein said fixation device is selected
from the group consisting of suture, anchors, and screws.
5. The method of claim 1 wherein the changing step comprises
allowing the material to at least partially harden.
6. The method of claim 1 wherein the changing step comprises at
least partially cross-linking the material.
7. The method of claim 1 wherein said material comprises a
polymer.
8. The method of claim 7 wherein said polymer comprises a
thermoplastic polymer.
9. The method of claim 1 wherein said material comprises a
hydrogel.
10. The method of claim 1 further comprising using the fixation
device to secure a second tissue to the tissue having the
opening.
11. The method of claim 10 wherein the tissue having the opening
comprises bone and the second tissue comprises soft tissue.
12. The method of claim 11 further comprising, prior to delivery of
the material: piercing the soft tissue; forming the opening in an
underlying area of the bone; and delivering the fixation device
through the pierced tissue; wherein the fixation device is
constructed to hold the soft tissue in place against the bone.
13. The method of claim 12 wherein the fixation device comprises a
suture.
14. The method of claim 13 wherein the suture includes a region of
increased surface area to enhance anchoring.
15. The method of claim 14 wherein said region is selected from the
group consisting of knots, barbs, braided areas, balls and shaped
elements.
16. The method of claim 12 wherein all of the steps are performed
endoscopically.
17. The method of claim 12 further comprising incorporating bone
fragments generated during the forming step into the material
during or prior to the delivering step.
18. The method of claim 12 further comprising causing the material
to infiltrate the trabecular network
19. The method of claim 1 further comprising incorporating bone
fragments into the flowable material during or prior to the
delivering step.
20. The method of claim 1 wherein the flowable material includes an
osteoconductive filler.
21. The method of claim 1 further comprising causing the flowable
material to infiltrate the trabecular network
22. The method of claim 1 further comprising forming said
opening.
23. The method of claim 22 wherein the forming step is performed
using micro-tooling.
24. The method of claim 1 wherein the opening has a diameter of
less than about 3 mM.
25. The method of claim 12 or 22 wherein the forming step comprises
forming the opening using a consumable cutting tool, and the
delivering step comprises causing the cutting tool to melt in
response to frictional heat generated during the forming step.
26. The method of claim 12 or 22 wherein all of the steps are
performed using a single endoscopic surgical tool having a
plurality of attachments, and the tool is not removed from the
patient until after the steps are completed.
27. The method of claim 22 wherein said forming step comprises
forming the opening with a cutting tool having a detachable
portion, and the method further comprises detaching the detachable
portion in the opening after the forming step is completed, to
serve as the fixation device.
28. A method of anchoring soft tissue to bone comprising: piercing
the soft tissue; forming an opening in an underlying area of the
bone; delivering a material, in a flowable state, to the opening;
and molding a portion of the material that is not in the opening to
form a fixation device constructed to hold the soft tissue in place
against the bone after the material changes state to a relatively
less flowable state.
29. The method of claim 28 wherein the molding step includes
forming a portion of the material into a shape that extends
radially over a portion of the soft tissue surrounding the
opening.
30. The method of claim 28 wherein the forming step includes
drilling or abrading.
31. The method of claim 28 wherein all of the steps are performed
endoscopically.
32. The method of claim 28 further comprising incorporating bone
fragments generated during the forming step into the material
during or prior to the delivering step.
33. The method of claim 28 wherein the material comprises an
osteoconductive filler.
34. The method of claim 28 further comprising causing the material
to infiltrate the trabecular network
35. The method of claim 28 wherein the opening has a diameter of
less than about 3 mm.
36. The method of claim 28 wherein the opening has a diameter of
from about 0.1 to 6.0 mm.
37. The method of claim 28 wherein the forming step is performed
using micro-tooling.
38. The method of claim 28 wherein the material comprises a
polymer.
39. The method of claim 29 wherein the formed portion extending
radially over the soft tissue is coextensive with the material in
the opening, defining a bolt-like anchor.
40. A method of fixing soft tissue to bone comprising: (a) at a
first location, piercing through the soft tissue; (b) forming an
opening in the bone underlying the soft tissue; (c) delivering a
fixation device through the pierced tissue to the opening; (d)
delivering a material, in a flowable state, to the opening; and (e)
causing the material to change state, to a relatively less flowable
state, to anchor at least a portion of the fixation device in the
opening.
41. The method of claim 40, wherein said fixation device is
selected from the group consisting of suture, anchors and
screws.
42. The method of claim 41 wherein said fixation device is a
suture.
43. The method of claim 42, further comprising: (f) drawing the
suture across the soft tissue to a second location, and (g)
repeating steps (a)-(e) at the second location to form a stitch
with said suture between the first and second locations, the stitch
securing the soft tissue to the bone.
44. The method of claim 40 further comprising gripping the soft
tissue to hold it in place against the bone.
45. The method of claim 43 further comprising, after step (g), (h)
cutting the suture.
46. The method of claim 45 comprising performing steps (a) and (h)
with a single tool.
47. The method of claim 40 further comprising performing steps
(a)-(d) endoscopically.
48. The method of claim 43 further comprising repeating steps
(f)-(g) at subsequent locations to form a line of connected
stitches.
49. The method of claim 40 comprising performing steps (c) and (d)
substantially simultaneously.
50. The method of claim 40 comprising performing step (c) prior to
step (d).
51. The method of claim 42 comprising delivering the suture as a
continuous length from a supply of suture material.
52. The method of claim 40 comprising providing said material in
the form of a pellet, powder, chips, flakes or rod, and further
comprising melting the material prior to delivery.
53. The method of claim 40 further comprising incorporating bone
fragments generated during the forming step into the material
during or prior to the delivering step.
54. The method of claim 40 further comprising incorporating an
osteoconductive filler into said material.
55. The method of claim 40 further comprising causing the material,
in its flowable state, to infiltrate the trabecular network
56. The method of claim 40 wherein the forming step comprises
forming a opening having a diameter of less than about 3 mm.
57. The method of claim 54 wherein the opening has a diameter of
from about 0.1 to 6.0 mm.
58. The method of claim 40 wherein the forming step comprises
drilling or abrading.
59. The method of claim 40 further comprising performing the
forming step using micro-tooling.
60. The method of claim 40 wherein the method comprises performing
the forming step in the bone of a human shoulder.
61. The method of claim 60 wherein the method comprises a rotator
cuff repair.
62. A surgical instrument for tissue fixation comprising: a
handpiece constructed to be held by a surgeon during a fixation
procedure; and a fixation instrument, mounted on the handpiece and
comprising a piercing element constructed to pierce through the
tissue and form an opening therein; and a lumen for delivery of a
material, in a flowable state, and a fixation device to the
opening.
63. The surgical instrument of claim 62 wherein the fixation device
comprises a suture.
64. The surgical instrument of claim 63 further comprising a suture
feed mechanism constructed to deliver the suture through the lumen
to the opening.
65. The surgical instrument of claim 62 wherein the surgical
instrument is constructed for endoscopic use.
66. The surgical instrument of claim 62 further comprising a
heating element for heating said material to a molten state.
67. The surgical instrument of claim 66 wherein said heating
element is mounted on said fixation instrument.
68. The surgical instrument of claim 64 wherein said suture feed
mechanism comprises a movable needle.
69. The surgical instrument of claim 63 further comprising a probe
constructed to tighten a stitch formed with the suture.
70. The surgical instrument of claim 69 wherein said probe is
mounted on an external surface of said fixation instrument.
71. The surgical instrument of claim 70 wherein said probe is
constructed to be manually actuated by a surgeon during an
endoscopic procedure.
72. The surgical instrument of claim 62 wherein said handpiece
comprises a reservoir for receiving the material in solid form.
73. The surgical instrument of claim 72 wherein said reservoir is
constructed to receive a supply of pellets of the material and said
handpiece further comprises a mechanism for delivering said pellets
from said reservoir to said lumen.
74. The surgical instrument of claim 72 wherein said reservoir is
constructed to receive a supply of powdered material and said
handpiece further comprises a mechanism for delivering a
predetermined dose of powdered material from said reservoir to said
lumen.
75. The surgical instrument of claim 62, wherein said fixation
instrument is detachable from said handpiece.
76. The surgical instrument of claim 62 further comprising a mixing
device constructed to mix bone fragments and debris generated
during opening forming into the material prior to delivery to the
opening.
77. The surgical instrument of claim 62 further comprising a drive
mechanism constructed to drive the piercing element.
78. The surgical instrument of claim 64 further comprising a drive
mechanism constructed to drive the piercing element and the suture
feed mechanism.
79. The surgical instrument of claim 77 or 78 wherein the drive
mechanism is disposed in said handpiece.
80. The surgical instrument of claim 78 further comprising a clutch
mechanism constructed to allow a surgeon to selectively engage and
disengage the drive of the piercing element and the drive of the
suture feed mechanism.
81. The surgical instrument of claim 62 further comprising a
reservoir for receiving a supply of the material.
82. The surgical instrument of claim 62 wherein said handpiece is
constructed to receive attachments other than said fixation
instrument.
83. The surgical instrument of claim 63 wherein said piercing
element is constructed to cut said suture.
84. The surgical instrument of claim 62 wherein said fixation
instrument is constructed to perform a complete fixation procedure
without removing the fixation instrument from the surgical
site.
85. A surgical instrument constructed to perform the steps of the
method of claim 1 endoscopically.
86. A surgical method comprising: (a) forming an opening in bone of
a patient; (b) incorporating bone fragments generated during the
forming step into a polymer as an autologous filler to form a
bone/polymer blend; and (c) delivering the bone/polymer blend, in a
flowable state, to the patient; wherein steps (a)-(c) are performed
endoscopically.
87. The surgical method of claim 86 wherein the bone/polymer blend
is delivered to the opening.
88. A method of securing a first layer of soft tissue to a second
layer of soft tissue comprising: forming an opening extending
through both layers of soft tissue; delivering a material, in a
flowable state, through the opening so that the flowable material
extends beyond the soft tissue at each end of the opening; and
causing the material to change state, to a relatively less flowable
state, forming an anchor to secure the two layers of soft tissue
together.
89. A method of securing a first layer of soft tissue to a second
layer of soft tissue comprising: forming an opening extending
through both layers of soft tissue; delivering a thermoplastic
member to the opening, so that a portion of the member extends
beyond the soft tissue at each end of the opening; softening the
extending portions of the member; and forming each of the softened
extending portions so that each extends radially over a portion of
the soft tissue to secure the two layers of soft tissue
together.
90. The method of claim 89 wherein said member comprises a hollow
tube.
91. The method of claim 90 wherein the forming step results in a
rivet-like anchor.
92. A method of securing two tissues together comprising: forming
an opening extending through the two tissues, delivering a
material, in a flowable state, to the opening, and causing the
material to change state, to a relatively less flowable state;
wherein the material forms an anchor that secures the two tissues
together.
93. The method of claim 92 wherein said anchor comprises a
bolt-like anchor.
94. An endoscopic instrument for securing two tissues together
comprising: a piercing device constructed to form an opening
extending through the two tissues; and a delivery device
constructed to deliver a material, in a flowable state, and a
fixation device, to the opening.
Description
TECHNICAL FIELD
[0001] This invention relates to surgical procedures and
instruments.
BACKGROUND
[0002] Many surgical procedures involve fixing soft tissue to bone,
particularly in the area of shoulder surgery, for example rotator
cuff repairs and instability repair. Generally, in these
procedures, the surgeon forms an incision to access the surgical
site and then uses one of the following techniques to reattach the
soft tissue.
[0003] In one technique, the surgeon drills bone tunnels through
which a suture is passed. The suture is tied through the soft
tissue, which is then reapproximated back to the bone.
[0004] In an alternative technique, the surgeon drills a cavity in
the bone and inserts a bone anchor. Typically, the bone anchor is
formed of metal, plastic or a resorbable material, and is held in
place by wings or barbs that deploy outward, by threads or by
radial expansion. The anchor includes an eyelet through which a
suture is threaded. After placing the anchor, the surgeon ties the
suture through the soft tissue, connecting it to the eyelet of the
bone anchor and thus reapproximating the soft tissue to the
bone.
[0005] If multiple sutures are needed to attach the soft tissue,
either technique is repeated multiple times at different locations
in the bone, with a separate knot tied at each location. It is
generally not possible to connect a series of anchors formed using
the techniques described above, due to the difficulty of tightening
stitches between the anchors.
SUMMARY
[0006] According to one aspect of the invention, fixation of soft
tissue to bone or to other soft tissue is performed using a
flowable material, e.g., a polymer, in place of, or in addition to,
a conventional bone anchor. Because the flowable material generally
infiltrates the porous cancelous bone (also known as the
"trabecular network"), the flowable material effectively forms an
anchor that extends under the stronger cortical bone. As a result,
an anchor formed in this manner typically exhibits a high pull-out
strength. In preferred implementations, bone fragments are
incorporated into the flowable material as an autologous filler, to
enhance regrowth of bone into the material during natural
healing.
[0007] Using preferred surgical procedures and instruments of the
invention, fixation can be performed endoscopically, rather than in
an open surgical procedure, resulting in less invasive treatment
with minimal trauma to the patient. In preferred implementations
piercing of soft tissue, drilling of a cavity, delivery of a suture
and/or bone anchor (if used), and injection of the flowable
material into the cavity are performed using a single endoscopic
surgical instrument. In some preferred implementations knot-tying,
which tends to require considerable skill and dexterity and is
generally time-consuming, is not necessary. Thus, the surgical
procedures of the invention are generally relatively quick,
reducing trauma, and relatively easy to perform. In some
implementations, the methods of the invention allow a series of
connected, tensioned stitches to be made to fix a region of soft
tissue to bone.
[0008] In implementations in which a conventional bone anchor is
not used with the flowable material, certain risks that may be
associated with such bone anchors are eliminated. For example, if a
suture is used the suture does not run through an eyelet, and thus
will not be microscopically damaged by friction between the suture
and eyelet. Also, anchors formed using a flowable material do not
rely heavily on the quality and density of the bone in which the
anchor is placed, and thus a placement in compromised, low density
bone may still exhibit good holding power.
[0009] The invention also features surgical procedures involving
endoscopic application of polymers for other purposes, e.g., to
repair a bone defect, to fill holes that are left when bone plugs
are harvested, to repair osteochondritis dessicans injuries, for
repair or revision of ACL grafts that exhibit micromovement, for
spine fusion, for meniscal repair, and to repair bone fractures.
The use of endoscopic devices and techniques significantly reduces
invasiveness, generally resulting in less trauma and quicker
recovery.
[0010] In one aspect, the invention features a method of securing a
fixation device within an opening in a tissue, including (a)
delivering a material in a flowable state to the opening, and (b)
changing the state of the material so that the material forms an
interference fit that secures the fixation device in the opening.
The fixation device may also be secured in the opening by other,
supplemental means, e.g., threaded engagement, but at least a
portion of the securing is provided by the interference fit.
[0011] Implementations of this aspect of the invention may include
one or more of the following features. The tissue includes bone
and/or soft tissue. The fixation device is selected from the group
consisting of suture, anchors, and screws. The changing step
includes allowing the material to at least partially harden. The
changing step includes at least partially cross-linking the
material. The material includes a polymer, e.g., a thermoplastic
polymer. The material includes a hydrogel. The method further
includes using the fixation device to secure a second tissue to the
tissue having the opening. The tissue having the opening includes
bone and the second tissue includes soft tissue. The method further
includes, prior to delivery of the material, piercing the soft
tissue; forming the opening in an underlying area of the bone; and
delivering the fixation device through the pierced tissue; wherein
the fixation device is constructed to hold the soft tissue in place
against the bone. The fixation device includes a suture. The suture
includes a region of increased surface area to enhance anchoring,
e.g., a knot, barb, braided area, ball or shaped element. All of
the steps of the method are performed endoscopically, for example
the steps are performed using a single endoscopic surgical tool
having a plurality of attachments, and the tool is not removed from
the patient until after the steps are completed. The method further
includes incorporating bone fragments, e.g., fragments generated
during the forming step, into the material during or prior to the
delivering step. The method further includes causing the material
to infiltrate the trabecular network. The material includes an
osteoconductive filler. The opening is formed using micro-tooling.
The opening has a diameter of less than about 3 mm. The forming
step includes forming the opening using a consumable cutting tool,
and the delivering step includes causing the cutting tool to melt
in response to frictional heat generated during the forming step.
The forming step includes forming the opening with a cutting tool
having a detachable portion, and the method further includes
detaching the detachable portion in the opening after the forming
step is completed, to serve as the fixation device.
[0012] In another aspect, the invention features a method of
anchoring soft tissue to bone including (a) piercing the soft
tissue; (b) forming an opening in an underlying area of the bone;
(c) delivering a material, in a flowable state, to the opening; and
(d) molding a portion of the material that is not in the opening to
form a fixation device constructed to hold the soft tissue in place
against the bone after the material changes state to a relatively
less flowable state.
[0013] Implementations of this aspect of the invention may include
one or more of the following features. The molding step includes
forming a portion of the material into a shape that extends
radially over a portion of the soft tissue surrounding the opening.
The forming step includes drilling or abrading. All of the steps
are performed endoscopically. The method further includes
incorporating bone fragments generated during the forming step into
the material during or prior to the delivering step. The material
includes an osteoconductive filler. The method further includes
causing the material to infiltrate the trabecular network The
opening has a diameter of less than about 3 mm, more preferably
from about 0.1 to 6.0 mm. The forming step is performed using
micro-tooling. The material includes a polymer. The formed portion
extending radially over the soft tissue is coextensive with the
material in the opening, defining a bolt-like anchor.
[0014] In a further aspect, the invention features a method of
fixing soft tissue to bone including (a) at a first location,
piercing through the soft tissue; (b) forming an opening in the
bone underlying the soft tissue; (c) delivering a fixation device
through the pierced tissue to the opening; (d) delivering a
material, in a flowable state, to the opening; and (e) causing the
material to change state, to a relatively less flowable state, to
anchor at least a portion of the fixation device in the opening.
The fixation device is selected from the group consisting of
suture, anchors and screws. The method further includes (f) drawing
the suture across the soft tissue to a second location, and (g)
repeating steps (a)-(e) at the second location to form a stitch
with the suture between the first and second locations, the stitch
securing the soft tissue to the bone. The method further includes
gripping the soft tissue to hold it in place against the bone. The
method further includes (h) cutting the suture. Steps (a) and (h)
are performed with a single tool. Steps (a)-(d) are performed
endoscopically. The method further includes repeating steps (f)-(g)
at subsequent locations to form a line of connected stitches. Steps
(c) and (d) are performed substantially simultaneously, or,
alternatively, step (c) is performed prior to step (d). The method
further includes delivering the suture as a continuous length from
a supply of suture material. The material is provided in the form
of a pellet, powder, chips, flakes or rod, and the method further
includes melting the material prior to delivery. The method further
includes incorporating bone fragments generated during the forming
step into the material during or prior to the delivering step. The
method further includes incorporating an osteoconductive filler
into the material. The method further includes causing the
material, in its flowable state, to infiltrate the trabecular
network The forming step includes forming a opening having a
diameter of less than about 3 mm. The opening has a diameter of
from about 0.1 to 6.0 mm. The forming step includes drilling or
abrading. The forming step is performed using micro-tooling. The
forming step is performed in the bone of a human shoulder.
[0015] In yet another aspect, the invention features a surgical
instrument for tissue fixation including (a) a handpiece
constructed to be held by a surgeon during a fixation procedure;
and (b) a fixation instrument, mounted on the handpiece and
including (i) a piercing element constructed to pierce through the
tissue and form an opening therein; and (ii) a lumen for delivery
of a material, in a flowable state, and a fixation device to the
opening.
[0016] Implementations of this aspect of the invention may include
one or more of the following features. The fixation device includes
a suture. The surgical instrument further includes a suture feed
mechanism constructed to deliver the suture through the lumen to
the opening. The surgical instrument is constructed for endoscopic
use. The surgical instrument further includes a heating element for
heating the material to a molten state. The heating element is
mounted on the fixation instrument. The suture feed mechanism
includes a movable needle. The surgical instrument further includes
a probe constructed to tighten a stitch formed with the suture,
e.g., mounted on an external surface of the fixation instrument.
The probe is constructed to be manually actuated by a surgeon
during an endoscopic procedure. The handpiece includes a reservoir
for receiving the material in solid form. The reservoir is
constructed to receive a supply of pellets of the material and the
handpiece further comprises a mechanism for delivering the pellets
from the reservoir to the lumen. Alternatively, the reservoir is
constructed to receive a supply of powdered material and the
handpiece further comprises a mechanism for delivering a
predetermined dose of powdered material from the reservoir to the
lumen. The fixation instrument is detachable from the handpiece.
The surgical instrument further includes a mixing device
constructed to mix bone fragments and debris generated during
opening forming into the material prior to delivery to the opening.
The surgical element further includes a drive mechanism constructed
to drive the piercing element and, if it is included, the suture
feed mechanism. The drive mechanism is disposed in the handpiece.
The surgical instrument further includes a clutch mechanism
constructed to allow a surgeon to selectively engage and disengage
the drive of the piercing element and the drive of the suture feed
mechanism. The handpiece is constructed to receive attachments
other than the fixation instrument. The piercing element is
constructed to cut the suture. The fixation instrument is
constructed to perform a complete fixation procedure without
removing the fixation instrument from the surgical site.
[0017] In another aspect, the invention features a surgical method
including (a) forming an opening in bone of a patient; (b)
incorporating bone fragments generated during the forming step into
a polymer as an autologous filler to form a bone/polymer blend; and
(c) delivering the bone/polymer blend, in a flowable state, to the
patient; wherein steps (a)-(c) are performed endoscopically. In
some implementations, the bone/polymer blend is delivered to the
opening.
[0018] In yet another aspect, the invention features a method of
securing a first layer of soft tissue to a second layer of soft
tissue including (a) forming an opening extending through both
layers of soft tissue; (b) delivering a material, in a flowable
state, through the opening so that the flowable material extends
beyond the soft tissue at each end of the opening; and (c) causing
the material to change state, to a relatively less flowable state,
forming an anchor to secure the two layers of soft tissue
together.
[0019] In a further aspect, the invention features a method of
securing a first layer of soft tissue to a second layer of soft
tissue including (a) forming an opening extending through both
layers of soft tissue; (b) delivering a thermoplastic member to the
opening, so that a portion of the member extends beyond the soft
tissue at each end of the opening; (c) softening the extending
portions of the member; and (d) forming each of the softened
extending portions so that each extends radially over a portion of
the soft tissue to secure the two layers of soft tissue
together.
[0020] In some implementations, the member includes a hollow tube
and the forming step results in a rivet-like anchor.
[0021] In another aspect, the invention features a method of
securing two tissues together including (a) forming an opening
extending through the two tissues, (b) delivering a material, in a
flowable state, to the opening, and (c) causing the material to
change state, to a relatively less flowable state; wherein the
material forms an anchor that secures the two tissues together. In
some implementations, the anchor is a bolt-like anchor.
[0022] In a further aspect, the invention features an endoscopic
instrument for securing two tissues together including (a) a
piercing device constructed to form an opening extending through
the two tissues; and (b) a delivery device constructed to deliver a
material, in a flowable state, and a fixation device, to the
opening.
[0023] In another aspect, the invention features surgical
instruments constructed to perform the steps of the methods
described above. Preferred instruments are constructed to perform
all steps of the methods endoscopically.
[0024] Other features and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
DESCRIPTION OF DRAWINGS
[0025] FIG. 1 is a diagrammatic perspective view of the surgical
environment of an endoscopic procedure according to one embodiment
of the invention.
[0026] FIGS. 2-2K are diagrammatic views of a procedure for forming
a series of polymeric anchors connected by stitching.
[0027] FIGS. 3-3E are views of a surgical instrument suitable for
performing the method shown in FIGS. 2-2K. FIG. 3 is a side view of
the surgical instrument. FIG. 3A is a highly enlarged detail
perspective view of area A of FIG. 3. FIG. 3B is a cross-sectional
view of the surgical instrument of FIG. 3. FIG. 3C is an exploded
cross-sectional view of the surgical instrument of FIG. 3. FIG. 3D
is an exploded view of area D of FIG. 3C. FIG. 3E is an exploded
view showing an enlarged cross-sectional view of the polymer
cartridge of the instrument.
[0028] FIGS. 4-4J are diagrammatic views of an alternative
procedure for forming a series of polymeric anchors connected by
stitching.
[0029] FIGS. 5-5F are diagrammatic views of a procedure for forming
a sutureless polymeric anchor to fix soft tissue to bone.
[0030] FIG. 6 is an exploded cross-sectional view of a surgical
instrument attachment suitable for use in the procedure of FIGS.
5-5F. FIG. 6A is a cross-sectional view of the surgical instrument
attachment of FIG. 6 assembled.
[0031] FIG. 7 is a diagrammatic cross-sectional view showing a
handpiece and a number of interchangeable attachments that are
mountable on the handpiece.
[0032] FIGS. 8-8F are diagrammatic views of a procedure for fixing
soft tissue to soft tissue with a polymeric anchor. FIG. 8G is a
partial perspective view of the finished anchor.
[0033] FIG. 9 is a cross-sectional view of a surgical instrument
attachment suitable for use in the procedure of FIGS. 8-8F.
[0034] FIGS. 10-10H are diagrammatic views of an alternative
procedure for fixing soft tissue to soft tissue with a polymeric
anchor.
[0035] FIG. 11 is a cross-sectional view of a surgical instrument
attachment suitable for use in the procedure of FIGS. 10-10H.
[0036] FIGS. 12-12I are diagrammatic views of another alternative
procedure for fixing soft tissue to bone.
[0037] FIGS. 13-13J are diagrammatic views of yet another
alternative procedure for fixing soft tissue to bone.
[0038] FIGS. 14-14D are diagrammatic views showing a cavity being
drilled with a consumable drill bit.
[0039] FIGS. 15 and 15A are perspective and side views,
respectively, of an alternative cutting tool.
[0040] FIGS. 16 and 16A are perspective and side views,
respectively, of an alternative cutting tool.
[0041] FIGS. 17 and 17A are perspective views of an alternative
cutting tool in closed and open positions, respectively.
[0042] FIGS. 18 and 18A are perspective and front views,
respectively, of an alternative cutting tool.
[0043] FIG. 19 is a perspective view of an alternative cutting
tool.
[0044] FIGS. 20 and 20A are perspective and cross-sectional views,
respectively, of an alternative cutting tool. FIG. 20B is a
diagrammatic cross-sectional view showing the cutting tool of FIGS.
20-20A in use.
[0045] FIGS. 21-21G are diagrammatic views of various types of
augmented sutures.
DETAILED DESCRIPTION
[0046] Referring to FIG. 1, a surgical site 10 includes a number of
portals 12, through which endoscopic devices can be inserted. The
surgeon can view the surgical site using an arthroscope 14, while
placing a polymeric anchor, as will be discussed in detail below,
using a surgical instrument 16. Surgical instrument 16 generally
depicts an instrument for placing a polymeric anchor. Examples of
particular instruments that are suitable for use in the various
methods of the invention will be discussed in further detail below.
In the initial step shown in FIG. 1, the surgeon is using a shaver
18 to remove a portion of soft tissue 20, expose the surface 24 of
bone 22 and create a bleeding bone bed, in preparation for the
surgical procedures described below. While shaver 18 is shown as a
separate instrument in FIG. 1, it may instead be integrated with
surgical instrument 16.
[0047] A procedure for fixing soft tissue to bone is shown in FIGS.
2-2K. In this procedure, one or more stitches are formed to fix the
soft tissue to the bone over an area. The steps shown in FIGS. 2-2K
are performed endoscopically, in the environment shown in FIG. 1.
However, for the sake of clarity, only the surgical instrument 16,
the bone and the soft tissue are shown in FIGS. 2-2K.
[0048] The steps shown in FIGS. 2-2K are performed using an
endoscopic surgical instrument 16 that is constructed to perform a
stitching operation. Generally, surgical instrument 16 includes a
cannulated tube, a cutting tool within the cannulated tube, and a
drive mechanism constructed to power the cutting tool to pierce
soft tissue and form a cavity in the underlying bone. The drive
mechanism is programmable, to allow the cutting tool to be either
rotated or reciprocally oscillated (i.e., rotated back and forth
through successive cycles, each rotation cycle being less than 360
degrees), as desired, for reasons that will be discussed below. The
surgical instrument also includes a supply of suture material,
e.g., on a spool, a mechanism for advancing the suture material
through the cannulated tube, a chamber containing a supply of
polymer in solid form (e.g., powder or pellets), and a heating
element for melting the polymer for delivery in molten form. When
the cutting tool is retracted, the suture and polymer are delivered
through the cannulated tube, as will be described below, to anchor
a portion of the suture in the cavity. Optionally, the surgical
device may include a cannulated needle for positioning the suture
in the cavity.
[0049] Using surgical instrument 16, a stitching procedure is
performed as follows. First, the soft tissue 20 is held in place by
the proximal end 19 of surgical instrument 16, and pierced by a
cutting tool 26 (FIG. 2A). Cutting tool 26 also forms a cavity in
bone 22 (FIG. 2A). Next, the cutting tool is retracted and a suture
70 is fed through the cannula 17 of the surgical instrument 16,
e.g., from a reel of suture material (not shown) in the surgical
instrument. The suture 70 may be positioned in the cavity by
advancing a cannulated needle 72, through the cannula of which the
suture is fed, into the cavity, as shown in FIG. 2B. Alternatively,
the suture may be positioned by gravity or in any suitable
manner.
[0050] After the suture is positioned, needle 72 is retracted and
molten polymer 28 is injected into the cavity around suture 70
(FIG. 2C). The polymer 28 penetrates through the side walls and
bottom of the cavity into the trabecular network (cancelous bone)
in region 30.
[0051] Once polymer 28 has at least partially solidified, anchoring
the suture in the cavity, the surgical instrument 16 is retracted
(FIG. 2D), and suture 70 is fed from the surgical instrument as the
surgical instrument is moved to a second location (FIG. 2E). As
shown in FIG. 3A, and discussed in further detail below, as the
suture 70 is fed from the instrument it exits the instrument
through an inverted-L-shaped channel 69 extending up the side 74 of
the surgical instrument, so that the suture is not cut during the
piercing of the soft tissue.
[0052] When the surgical instrument is positioned at the second
location, the surgical instrument again holds the soft tissue 20 in
place, and cutting tool 26 again pierces the soft tissue 20 (FIG.
2E). The cutting tool 26 is then reciprocally oscillated to form a
second cavity, as shown in FIG. 2F. (At this stage, the cutting
tool cannot be rotated 360 degrees, as this would cut or break the
suture, or cause the suture to wind around the cutting tool. Thus,
the surgeon sets the programmable drive mechanism to an oscillating
mode. The surgeon can use either a rotating or an oscillating
motion to form the first cavity (FIG. 2A), depending on the
surgeon's preference.) The suture 70 is fed from the supply reel
into the new cavity, and positioned by advancing needle 72 into the
cavity, as shown in FIG. 2G (as discussed above, the suture could
instead be positioned by gravity).
[0053] A probe 71 is used to press the suture through the soft
tissue, compressing the soft tissue against the surface of the bone
in the vicinity of the second cavity and tensioning the suture
material as it passes between the cavities, tightening the "stitch"
that will be formed between the cavities. Needle 72 is retracted,
leaving a loop of suture material (not shown) in the cavity, and
molten polymer 28 is injected into the second cavity around the
suture 70 (FIG. 2H).
[0054] Once the polymer in the second cavity has at least partially
solidified, the surgical instrument 16 is again retracted (FIG.
21). At this point, a "stitch" 76 of suture extends between the
first and second cavities, holding region 20A of the soft tissue 20
securely against bone 22. The stitching procedure can then be
terminated, as shown in FIG. 2J, by cutting the suture, or
stitching can be continued, by repeating the above steps, to form a
line of stitches as shown in FIG. 2K. The stitches can be of
uniform lengths, or of different lengths (i.e., d1 may or may not
be equal to d2). The suture can be cut, at the end of the
procedure, using the surgical instrument 16 or a separate tool,
e.g., a scalpel that is inserted through the cannula of an
endoscope.
[0055] The polymer used in the procedure described above is
preferably provided in the form of a plurality of pellets or a
powder, and is preloaded into the surgical instrument prior to
surgery, as will be described in further detail below. One pellet
or shot of powder is used to fill each cavity. The pellets or
powder are melted, to form the molten polymer, immediately prior to
injection.
[0056] Many types of instruments may be suitable for use as
surgical instrument 16 in the procedure described above with
reference to FIGS. 2-2K. An example of a suitable surgical
instrument, stitching instrument 50, is shown in FIGS. 3-3E.
[0057] Instrument 50 includes a handpiece 52, and a removable
attachment device 54. As indicated in FIG. 7, and discussed further
below, attachment device 54 is one of many modular attachment
devices that may be interchangeably mounted on handpiece 52. The
attachment devices may be disposable. The handpiece 52 is
sterilizable and is designed for repeated use, e.g., 100 uses or
more. The attachment devices are clipped into the handpiece, on a
bearing, as is well known for endoscopic surgical instruments with
interchangeable attachments, such as those commercially available
from Smith & Nephew, Andover, Mass., under the tradename
DYONICS.TM..
[0058] Referring to FIG. 3, handpiece 52 is constructed to be held
by a surgeon during a surgical procedure, and includes switches
56a, 56b and 56c that are positioned to be easily actuated by the
surgeon to control the functions of the surgical instrument, as
will be discussed below. Handpiece 52 is connected to a power
supply by an adapter cord 39 (e.g., a Dyonics EP1 power supply
cord, available from Smith & Nephew). The handpiece 52 may be
fitted with interchangeable molded grips, e.g., two-piece housings
that snap on over the handpiece 52 and include recesses through
which switches 56 extend, thus providing the surgeon with a more
customized grip.
[0059] Referring now to FIGS. 3B and 3C, the handpiece 52 includes
a removable polymer cartridge 40 that is preloaded with a supply of
polymer pellets 45 (FIG. 3E) prior to surgery, and a chamber 41
(FIG. 3C) for receiving the polymer cartridge. The polymer
cartridge 40 includes aligned slots 42a, 42b, through which a
pellet can be pushed out for delivery to a cavity.
[0060] To push a pellet out of the cartridge for delivery, the
surgeon pulls back on switch 56a. This causes toothed cam 57 to
push rod 58 against inclined surface 59 of block 60, causing block
60 to move downward through slot 42a, thereby displacing the pellet
through slot 42b into chamber 43 through an cavity that is not
shown in the cross-section of FIG. 3B. The pellet then passes into
the lumen of the attachment 54 through an cavity 44 (FIG. 3D).
After the pellet has been dispensed, block 60 is returned to, and
biased in, its previous position by spring 61. This reverses the
movement of the rod 58 and toothed cam 57, returning the switch 56a
to its normal position. The pellets are advanced toward the
proximal end of the cartridge, to move a new pellet into place for
delivery through slot 42b, by spring 47 (FIG. 3E).
[0061] The polymer pellet is moved to the delivery end 61 (FIG. 3B)
of the instrument 50 by compressed gas delivered from pre-filled
reservoirs 62a and 62b. To deliver air to move the pellet, the
surgeon pushes switch 56b forward, which moves a hydraulic fluid in
chamber 63 against spring 64, cavity a valve (not shown) to release
the compressed gas from the reservoirs into the lumen of the
attachment 54.
[0062] The cutting tool (cutting device 176, discussed below) and
the suture delivery mechanism are both driven by a single motor,
and a clutch mechanism and switch are provided to allow the surgeon
to selectively activate the piercing/cavity forming function of the
cutting device and the suture delivery function (performed by the
suture delivery mechanism), as will be discussed below. The motor
is normally off, and is activated by the surgeon pressing switch
56c upward (arrow A, FIG. 3B), moving contact 65 into engagement
with contact 66 of motor 68. The switch is held in the engaged
position by a catch (not shown), so that to deactivate the motor
the surgeon needs to press the switch upward again, as which point
spring 67 will return the switch to its normal position.
[0063] The surgeon can select between the piercing/cavity forming
function and the suture delivery function by moving switch 56c back
and forth axially (arrow B, FIG. 3B). This causes member 76 to move
axially, engaging a set of gears that drives one of these functions
and disengaging a set of gears that drives the other function, as
will be discussed further below.
[0064] When the suture delivery function is selected, i.e., when
switch 56c is in the position shown in FIG. 3B (its left-hand
position), bevel gear 166, mounted on drive shaft 154 of the motor,
is engaged with bevel gear 168, which drives a suture feed cog
170a, through which a suture 172 (FIG. 3B) is fed from a reel 173.
A series of bearings 174 drive suture feed cogs 170b-170d, which
advance the suture towards the delivery end 61 of the surgical
instrument.
[0065] When the piercing/cavity forming function is selected, i.e.,
when switch 56c is moved to the right in FIG. 3B, a spline (not
shown) in the center of cog 150 engages end 152 of drive shaft 154
of the motor. Simultaneously, the teeth of cog 150 engage the teeth
of cog 156, causing shaft 158 to rotate, driving bevel gear 160
which engages bevel gear 162 on the cutting tube 164 of attachment
54. Engagement of bevel gears 160 and 162 rotates the cutting
device 176 (or oscillates the cutting device, depending on the
setting of the programmable drive). The motor is programmed to stop
rotation, when the piercing/cavity forming function is deselected,
in a position in which cavity 44 is aligned with the
polymer-delivery cavity in the handpiece that is in turn aligned
with cavity 42b of the polymer cartridge.
[0066] Referring to FIG. 3D, the attachment 54 includes an inner
cutting device 176 that slides into an outer guide/heating device
178 when the surgical instrument is assembled for use. When the
instrument is assembled, as shown in FIG. 3C, the guide/heating
device 178 snaps into the handpiece 52, and the cutting device 176
is trapped between the handpiece 52 and the guide/heating device
174.
[0067] Cutting device 176 includes a cannulated cutting tube 164
having a cutting tip 180, a member 182 that defines chamber 43 and
a gas inlet 184, and bevel gear 162. End 181 of the cutting tube
includes a flap valve 183 to prevent the compressed gas from
escaping through end 181. When the suture delivery function is
selected, the pressure of the end of the advancing suture opens
valve 183, and the suture is guided through the cavity at end 181
by a conical portion 185.
[0068] Guide/heating device 174 includes a cannulated guide tube
186 and, within the guide tube, a heating element 188 for melting
the polymer pellets. The guide tube 186 includes a movable probe
portion 71, which can be moved axially (arrows C, FIGS. 3 and 3A)
by the surgeon, using grip 190, to push the suture 172 against the
soft tissue as discussed above. The probe portion is in its upper
position in FIG. 3A, allowing clearance for the suture as it feeds
from the tip. It is lowered prior to dispensing the polymer (to
keep the polymer from escaping through channel 69), and to tighten
the suture when a stitch is formed. The guide tube 186 is spring
loaded so that it will retract under pressure when pressed against
the soft tissue, allowing the cutting tip to penetrate the bone to
a desired depth which is determined by the degree of spring
loading. When pressure is released, the guide tube is biased by the
spring load back to its normal, extended position. The
guide/heating device also includes an attachment portion 200 that
releasably snap fits into the handpiece.
[0069] Thus, to use the stitching instrument 50 in the procedure
shown in FIGS. 2-2K and described above, a surgeon would first
preload a supply of polymer into the instrument 50, by installing
polymer cartridge 40, preprogram the programmable drive mechanism
as desired, and move probe portion 71 to its lowered position. The
surgeon would then press the delivery end 61 of the device against
the soft tissue, and select the piercing/cavity forming function by
moving switch 56c to the appropriate position, to pierce the soft
tissue and form a cavity. Next, the surgeon would move switch 56c
to select the suture delivery function, and deliver a desired
amount of suture material to the cavity. After delivery of the
suture, the surgeon would move switch 56c to deactivate the drive
motor (turning off both the piercing/cavity forming and suture
delivery functions), and pull back on switch 56a and push forward
on switch 56b to deliver polymer to the cavity. Once the polymer
had at least partially solidified, the surgeon would raise probe
portion 71, move switch 56c to select the suture delivery function,
and feed out suture while moving the instrument 50 to a second
location. At the second location, the surgeon would move switch 56c
to select the piercing/cavity forming function, and form a second
cavity. The surgeon would then move switch 56c to select the suture
delivery function, deliver a desired amount of suture to the
cavity, move switch 56c to deactivate the drive motor, lower probe
portion 71 to tighten the "stitch" between the cavities, and move
switches 56a and 56b to deliver polymer to the cavity. These steps
would be repeated to form as many stitches as desired.
[0070] If desired, the surgical instrument may be used to deliver
polymer without performing any cutting procedure.
[0071] An alternative procedure for forming a row of stitches is
shown in FIGS. 4-4G. In this procedure, the bone fragments and
debris generated during cavity forming are incorporated into the
polymer as a filler. It is noted that bone fragments and debris can
be incorporated into the polymer in a similar manner in any of the
procedures described herein. The procedure shown in FIGS. 4-4G is
performed using a surgical device 116 that is similar to surgical
device 16, except that it also includes a suction device for
extracting bone fragments and debris from the cavity, and a mixing
chamber and a mixing device, for incorporating the bone fragments
and debris into the polymer.
[0072] Referring to FIGS. 4 and 4A, using surgical instrument 116
the soft tissue 20 is pierced and a cavity is drilled in the bone
22, as discussed above. In this embodiment, the cutting tool is a
perforated drill 80 (similar to a grater), having a serrated tip
82. Because the drill tip is serrated, it is preferred that the
surgical instrument 116 be held at an angle, rather than
perpendicular to the surface of the soft tissue 20, as indicated by
angle A in FIG. 4, until the soft tissue 20 has been pierced.
During drilling, the resulting bone fragments and debris 84 are
suctioned out of the cavity and up through the cannula of the
drill, as indicated schematically in FIG. 4B. The bone
fragments/debris are then retained in a temporary chamber 86,
defined by the cylindrical cutting tool barrel and a balloon
diaphragm 88, suspended on a needle 90, that is inflated at this
point in the procedure (arrows A, FIG. 4C). As shown in FIG. 4D,
the surgeon then delivers suture 70 through needle 90, while
simultaneously adding polymer to chamber 86 and mixing the polymer
with the bone fragments/debris 84 (arrow A). Using the air supply,
the polymer is fed to chamber 86, in powder form, from a reservoir
that is preloaded prior to surgery. Mixing can be performed using
any desired mixing device, e.g., a mobius band 89 mounted on needle
90. The polymer is heated during or after mixing. Once the polymer
has melted, the polymer/bone fragment mixture 92 is delivered from
the temporary chamber 86 to the cavity by collapsing the diaphragm
88 so that the polymer mixture will flow into the cavity due to the
force of gravity (FIG. 4E). The surgeon collapses the diaphragm by
operating a switch on the surgical device which inflates and
deflates the diaphragm, in the same manner that balloon catheters
are conventionally actuated. The remaining steps of the procedure,
shown in FIGS. 4F-4J, are conducted in the same manner as the steps
shown in FIGS. 2E-2J and discussed above, except that bone
fragments and debris are collected and mixed into the polymer each
time a cavity is drilled.
[0073] An alternate surgical procedure, used to form a single,
bolt-like polymeric anchor, is shown in FIGS. 5-5F. This procedure
utilizes a surgical instrument 216, which includes a cutting tool
to pierce soft tissue and form a cavity in bone, a supply of
polymer and a heating element to melt the polymer, a cannulated
tube to guide the cutting tool and deliver the polymer to the
cavity, and a compounder that is constructed to form a molding
cavity for shaping the "head" of the bolt-like anchor.
[0074] Referring to FIGS. 5-5F, a surgical instrument 216 is
pressed against the soft tissue 20, which is in turn pressed
against the bone surface 24 (FIG. 5), and a cutting tool, e.g., a
drill bit 26, is used to pierce soft tissue 20 and form a cavity in
bone 22 (FIG. 5A). The cutting tool is then retracted (arrow A,
FIG. 5B), and a molten polymer 28 (e.g., melted as described above)
is injected into the cavity (arrow B, FIG. 5B) through a cannula of
the surgical instrument 216.
[0075] Next, a compounder 34 (a part of surgical instrument 16 that
has been retracted in previous steps) is extended (arrow A, FIG.
5C) so that the tip 36 of the compounder presses against soft
tissue 20 to hold it against bone surface 24. Meanwhile, the
cannulated head 32 of the surgical instrument 16, through which the
polymer is delivered, is retracted a short distance so that, with
the cylindrical wall of the compounder, it defines a small molding
chamber. Polymer continues to be delivered through the cannula of
the surgical instrument and this polymer fills the molding chamber
to form a polymeric "bolt head" 38 (FIG. 5D). The bolt head 38 is
integral with the polymer in the cavity, which extends through the
soft tissue 20. Thus, the polymer forms a bolt-like anchor that
secures the soft tissue to the bone (FIGS. 5E and 5F).
[0076] As shown in FIGS. 5E and 5F, the procedure is completed by
removing the surgical instrument 16 (arrow A, FIG. 5E) and snipping
any excess polymer off at the top of the bolt head. The manner in
which the polymer is snipped off is not shown; if this step is
necessary, it can be performed using a clipper attachment to the
surgical instrument 16, or using a separate device such as a
scalpel.
[0077] The procedure shown in FIGS. 5-5F can be performed using an
attachment 225, shown in FIG. 6, mounted on the handpiece 52 that
is shown in FIGS. 3-3D and discussed above. The handpiece 52 can be
used with a wide variety of interchangeable attachments, suitable
for use in various procedures of the invention. For example, as
shown in FIG. 7, the handpiece can be used with attachment 54 to
perform a stitching procedure, with attachment 225 to form a
bolt-like polymeric anchor using the procedure shown in FIGS. 5-5F,
and with attachments 250 and 300 to perform soft tissue to soft
tissue fixation procedures that will be described below.
[0078] Attachment 225 is similar to attachment 54, discussed above,
except that it does not include a chamber or cavity for receiving a
polymer pellet. Instead, a polymer rod 226 (FIG. 6A) is advanced
through the handpiece using the suture delivery function. The
polymer rod 226 includes a grommet (not shown) at its distal end
228, to prevent gas from escaping through end 181'. Also, the
guide/heating device 178' includes a compounder 227 which defines a
molding chamber 229, as discussed above. The compounder 227 is
moved axially by the surgeon as discussed above with reference to
FIGS. 5C-5E.
[0079] In another embodiment, fixation methods are provided for
attaching soft tissue to soft tissue. These fixation methods are
suitable for use, for example, in laparoscopic surgery. Procedures
and devices for soft tissue to soft tissue fixation are shown in
FIGS. 8-11 and described below.
[0080] A first procedure, which forms a polymeric "rivet", is shown
in FIGS. 8-8F. This procedure uses a surgical instrument 316, which
generally includes an inner, axially movable tube having a sharp
tip for piercing through soft tissue, and a cannulation in
communication with a number of openings for delivery of hot and
cold air from the inner tube. The surgical device also includes an
outer tube, on which is mounted a polymeric sheath that will be
softened and shaped by the delivered air to form the rivet, and a
compounder, surrounding the outer tube, that includes a flange for
directing the air and shaping the polymeric sheath into a rivet
shape.
[0081] Referring to FIG. 8, two portions of soft tissue 20a, 20b,
are compressed together (arrows A, FIG. 8), using known surgical
techniques. Next, the tip 251 of an inner, axially movable tube 253
(FIG. 9) of surgical device 316 is punched through the soft tissue
(FIG. 8A). A polymeric sheath 252 is mounted on outer tube 257, and
a portion 252a of the polymeric sheath is carried through the soft
tissue and out the other side. The polymeric sheath is held in
place by ridges 255 on outer tube 257. Outer tube 257 is surrounded
by compounder 259, the function of which will be described
below.
[0082] Hot air (arrows H, FIG. 8B) is then directed out of side
openings 254 of tip 251, and cold air (arrows C, FIG. 8B) is
directed out of tip openings 256. The hot air melts the polymeric
sheath, and the cold air forces it downward (arrows D, FIG. 8B)
against the soft tissue (FIG. 8D). The hot air is generated at the
tip due to the relationship between the air pressure being forced
out of the tip and the size of side openings 254.
[0083] The inner tube 253 of instrument 250 is then withdrawn
through the polymeric sheath until the side openings 254 are
aligned with portion 252b of the polymeric sheath (FIG. 8C). Hot
air is directed out through the side openings 254 (arrows H, FIG.
8D) to melt portion 252b. Flange 260 of compounder 259 is then
pressed against portion 252b, while cold air is directed out
through tip openings 256 (FIG. 8E), solidifying portion 252b in
place against the soft tissue (FIG. 8F). The air is directed by
flange 260, which also serves to press portion 252B against the
soft tissue. The surgical instrument 316 is then withdrawn (FIG.
8F), leaving a rivet-like anchor 262 (FIG. 8G) to hold the soft
tissue firmly together.
[0084] A surgical instrument attachment 250, for use with handpiece
52 to form a surgical instrument 316 suitable for performing the
procedure shown in FIGS. 8-8F and described above, is shown in FIG.
9. Attachment 250 includes the components described above with
reference to FIGS. 8-8F, and can be mounted on handpiece 52 in the
same manner as attachment 54, discussed above.
[0085] An alternative procedure for fixing soft tissue to soft
tissue is shown in FIGS. 10-10H. This procedure is performed using
a surgical instrument 416, which generally includes an inner tube
having a sharp tip for piercing soft tissue and a cannulation for
delivery of polymer. The surgical instrument 416 also includes a
device for releasably mounting a porous sheath over the inner
tube.
[0086] First, the soft tissue is compressed and is pierced by the
sharp tip of surgical device 416 (FIGS. 10, 10A), as described
above with reference to FIGS. 8 and 8A. The distal end 306 of a
porous sheath 302, e.g, a braid or mesh, is gripped by a releasable
chuck 304. A small polymer weld (not shown) near distal end 306 of
the sheath keeps the sheath from being forced backwards during the
piercing step.
[0087] The inner tube 308 is then withdrawn slightly (FIG. 10B),
breaking the polymer weld and leaving the sheath 302 in position,
and molten polymer 28 is delivered down the central cannulation of
inner tube 308 and out of tip openings 310 (FIGS. 10C, 10D). The
polymer bleeds out of the open end of sheath 302, and also out
through the open structure of the mesh or braid, forming a "blob"
312a of polymer on top of the soft tissue and adhering the side
walls of the sheath to the side walls of the opening in the soft
tissue (FIG. 10D). The inner tube 308 is then withdrawn further,
while continuing to deliver polymer through openings 310, filling
the sheath with polymer and forming a "blob" 312b of polymer on the
side of the soft tissue opposite blob 312a. Thus, the polymer
defines a bolt-like anchor extending through the soft tissue.
[0088] To complete the procedure, the sheath is released from chuck
304 (FIG. 10G), the attachment 300 is removed, and any excess
sheath material is snipped off (FIG. 10H).
[0089] An attachment 300, suitable for use with handpiece 52 to
form a surgical instrument 416, is shown in FIG. 11. Attachment 300
includes the components described above with reference to FIGS.
10-10H, and can be mounted on handpiece 52 in the same manner as
attachment 54, discussed above.
[0090] An alternative soft tissue to bone fixation procedure is
shown in FIGS. 12-121. In this procedure, a bone core is used to
provide an osteoconductive medium within the polymeric anchor. This
procedure is performed using a surgical instrument 516 that
includes a cutting tool that is capable of forming in bone while
leaving a bone core extending upward from the base of the opening.
The surgical instrument 516 is constructed to deploy a tubular
suture over the core, and deliver a polymer to the opening.
[0091] First, soft tissue is pierced, and a cavity is drilled
(FIGS. 12-12B). The cavity is drilled using a cannulated cutting
tool 331 that is constructed to leave a bone core 330 in the cavity
(FIG. 12C). A flexible sleeve 332, e.g., a braided hollow suture,
is deployed over the core 330, as shown in FIG. 12C. Polymer 28 is
then delivered to the cavity (FIGS. 12D, 12E) around the sleeve 332
and core 330, and impregnates the sleeve 332. More polymer is
delivered, while retracting the surgical instrument (FIGS. 12F,
12G), to form a blob 334 on the surface of the soft tissue,
anchoring the soft tissue against the bone (FIG. 12H). Any excess
sleeve material is then snipped off (FIG. 121). The presence of the
bone core in the anchor will tend to increase bone remodeling, and
thus the suture may become embedded in bone more rapidly than would
occur if the bone core were not present.
[0092] Another alternative soft tissue to bone fixation procedure
is shown in FIGS. 13-13J. In this procedure, a suture is anchored
in a cavity, using polymer, and a fixation device 340 is deployed
around, and adhered to, the suture above the soft tissue to
mechanically clamp the soft tissue in place. This procedure
provides a low-profile anchor that may be useful in low clearance
areas to prevent impingement. This procedure is performed using a
surgical instrument 616 that includes a cutting tool to pierce soft
tissue and form a cavity in underlying bone, a cannulated tube for
delivery of a suture and polymer to the cavity and deployment of a
fixation device around the suture, and a compounder to press the
soft tissue against the bone and the fixation device against the
soft tissue.
[0093] As shown in FIGS. 13-13C, soft tissue is pierced, a cavity
is formed, and suture and polymer are delivered as discussed above,
e.g., with regard to the procedures shown in FIGS. 2-2K. Next,
while holding down the soft tissue with a compounder 335 (FIG.
13D), an expandable fixation device 340 is deployed around the
suture to clamp the soft tissue in place (FIGS. 13E-13G). The
expandable fixation device 340 includes a central region 341,
having a bore 346, and a plurality of wings 354 extending radially
from the central region. Wings 354 are joined to central region 341
by a plastic hinge having a memory that biases the wings toward an
open position (FIG. 13F), while allowing the wings to be moved to a
compressed position (FIG. 13E) so that the device can be deployed
through a cannula. Thus, fixation device 340 is compressed and
placed in delivery tube 339, with a suture 347 threaded through
central bore 346, and is deployed by pressing down on the fixation
device 340 with a cannulated probe 343 (FIGS. 13E-G). As the
fixation device exits the compounder 335, the wings 354 expand
outward to their normal position (FIG. 13F), and the compounder 335
presses the fixation device 340 down to flatten it against the soft
tissue (FIG. 13G). Barbs 342 on wings 354 hold the fixation device
340 in place against the soft tissue, in its flattened position.
The suture 347 is then snipped (FIG. 13H), and a blob of polymer
344 is delivered on top of the fixation device to cover bore 346
and adhere to the suture, anchoring the fixation device in place
(FIGS. 13I and 13J). Preferably, fixation device 340 is formed of a
resorbable plastic.
[0094] Many different types of cutting tools may be used in the
procedures of the invention. Generally, it is preferred that the
cutting tool not compact the bone fragments and debris into the
side wall of the cavity, as this may impede infiltration of the
polymer into the trabecular network surrounding the cavity. Thus,
for example, a twist drill is generally preferred to a compacting
drill. Some of the types of cutting tools that may be used are
discussed below.
[0095] Referring to FIGS. 14-14D, the cutting tool may be a drill
bit 94 that is consumable, i.e., the drill bit is formed of a
polymer that melts during drilling (FIGS. 14B-14C), as a result of
the heat generated by friction, to fill the cavity with molten
polymer. A suture 95 is attached to the drill bit 94, so that the
suture is delivered with the polymer and left behind when the
surgical instrument is retracted (FIG. 14D). In this case, it is
generally preferred that the drill bit be coated with a very thin
layer of porous ceramic, just thick enough to provide the drill
with sufficient hardness to penetrate the cortical bone and
sufficiently thin so that the polymer will be able to melt during
drilling. The ceramic can be applied by firing, plasma coating,
deposition, or other suitable methods. Alternatively, a thin,
hollow ceramic preform can be formed and then filled with polymer.
Preferred polymers have a sufficiently low melting point to melt
under drilling friction, and sufficient strength to contribute
mechanical strength to the drill bit. The suture 95 may be
conductive, to allow it to serve as a heating element to assist in
melting the polymer if drilling does not generate sufficient
heat.
[0096] FIGS. 15-20 show various suitable cutting tool
geometries.
[0097] FIGS. 15 and 15A show a perforated drill 100, including
openings 96 and sheath 98. Perforated drill 100 is useful when bone
fragments/debris are to be collected for incorporation into the
polymer (as discussed above with reference to FIGS. 4-4J), and when
it is necessary that the cutting tool oscillate, rather than
rotating (e.g., to avoid cutting or breaking a suture between
stitches).
[0098] FIGS. 16-16A show a configured head 102, having a blade 103
that includes an opening 104 through which a suture can be threaded
for delivery, and a barrel 105 defining a lumen 106 for suture and
polymer delivery. Lumen 106 is generally substantially coaxial with
opening 104.
[0099] FIGS. 17-17A show an awl 110. Awl 110 includes a plurality
of retractable "petals" 112, which when closed (as shown in FIG.
17) define a drill tip. When open (as shown in FIG. 17A), the
petals 112 allow polymer and suture to be delivered through lumen
114. The petals may be opened and closed using a spring mechanism
(not shown) or other suitable actuator.
[0100] FIGS. 18-18A show a cutting head 120 having blades 122
radially extending crosswise across an open lumen 124. An open area
between the blade tips defines an eyelet 126, to allow delivery of
a knotted suture.
[0101] FIG. 19 shows a borer 126, including a plurality of serrated
cutting/abrading tubes 128, a central lumen 130 through which
polymer and suture can be delivered, and an extraction tube 132 for
drawing bone fragments/debris away from the cutting site by
suction. If desired, the contents of the extraction tube can be fed
into the barrel of the borer, or elsewhere into the surgical
instrument, at a location where the bone fragments/debris can be
blended into the polymer prior to delivery of the polymer.
[0102] FIGS. 20-20B show a twist drill bit 134 having a delivery
channel 136 for delivery of polymer and suture. The inner wall 138
of the delivery channel, in the vicinity of the tip 140 of the
drill bit, may be abrasive, so as to break up the bone "core" 142
(FIG. 20B) if a bone core is not desired.
[0103] Cutting can also be accomplished using other techniques,
such as laser, ultrasonic or water jet cutting. For example, water
jet cutting could be performed using the saline supply that is
present in the operating room. In this embodiment, a dynamo
generator would be included in the surgical instrument, to power
the water jet, and the surgical instrument would include an adaptor
to allow the saline supply to be plugged in to the surgical
instrument. Other suitable techniques include crush indentation,
hot needle drilling, thermally degrading the bone, e.g., with RF
ablation, and cryogenic freeze fracturing. In some implementations,
it is preferred that the cutting method be capable of forming a
very small diameter cavity, e.g., less than 2 mm and preferably
less than 1.5 mm. To form such a small diameter cavity, cutting may
be performed using microtooling. Because a conventional bone anchor
is not needed in many of the procedures of the invention, the
cavity can be made smaller than the diameter of such anchors,
thereby preserving more cortical bone, limiting trauma, and
potentially improving the pull-out strength of the anchor. When a
very small diameter cavity is used, e.g., less than 3 mm, the
cortical bone will tend to grow back over the cavity, further
increasing the strength of the anchor.
[0104] While in the embodiments discussed above the polymer is
generally provided in the form of a powder or pellets, the polymer
may be provided in any desired form. For example, the polymer may
be contained in a cartridge that can be heated using equipment that
is available in the operating room, e.g., an autoclave or heated
bath. Thus, the cartridge can be preheated prior to surgery, and
then inserted into a surgical instrument (not shown) that is
adapted to puncture the cartridge for delivery of the polymer. The
polymer may also be provided as a rod, or in the form of fibers or
strands to increase its surface area and thereby decrease melting
time.
[0105] The polymer can be heated using any suitable method.
Preferred methods will heat the polymer in a controlled manner, to
a temperature just above its melting temperature, to avoid
overheating and possible thermal trauma to the tissue and bone at
the delivery site. To expedite the surgical procedure, it is
preferred that heating occur within 2 minutes or less, unless the
polymer is provided in a cartridge and is pre-heated, e.g., in an
autoclave. One suitable method is to provide a heating element in
the surgical instrument, as discussed above. Preferably the heating
element is thermostatically controlled to prevent overheating of
the polymer. Other suitable heating methods include ultrasound
(which may also be used to form the cavity), use of the drive
mechanism of the surgical instrument to heat the polymer, use of a
conductive suture embedded in the polymer as a heating filament,
laser (e.g., by including an indicator dye in the polymer and using
a laser frequency that would not burn the tissue at the delivery
site but would melt the polymer), and radio frequency and induction
heating.
[0106] The suture material, if a suture is used, may be resorbable
or non-resorbable. It is generally preferred that the suture
material be braided, rather than monofilamentary, for greater
surface area and surface roughness, to enhance pull-out strength.
However, monofilament may be used if desired. A loose braid is
generally preferred, as the spaces in the braid enhance polymer
infiltration. A "bird's nest" arrangement of suture can also be
formed by feeding suture out into the cavity and allowing it to
pile up loosely in the cavity. Preferably, the suture does not
include a polymeric coating. Suitable suture materials include
polyesters, polyamides, e.g. Nylon, polybutester, polyglycolic
acid, polyglyconate, poly-L-lactic acid and polydioxanone. It is
generally preferred that the suture have a high tensile strength,
i.e., sufficient strength so that the mode of failure during
pull-out testing is not premature suture failure.
[0107] The suture may also include any desired feature or
augmentation. For example, the suture may include one or more of
the suture augmentations shown in FIGS. 21-21G, i.e., a knot 400 or
knot bundle 402 (FIGS. 21 and 21D), a sphere 404 (FIGS. 21C and
21E), a shaped element 406, e.g., a larger diameter portion (FIG.
21A), a flexible 4-way connector 408 (FIG. 21B) or a t-bar 412
(FIG. 21G), or a plurality of barbs 410 (FIG. 21F). If positioned
on top of the soft tissue after the suture is anchored in place,
the suture augmentations shown in FIGS. 21-21G may secure the soft
tissue in place against the bone. If positioned in the cavity and
surrounded by polymer, these features may increase the resistance
of the suture to pull-out. Other features that will provide these
or other functions may also be used.
[0108] Suitable polymers are thermoplastics that are acceptable for
use in the body and can be delivered to a surgical site in a molten
state. Preferably, the polymer will have a relatively low melting
temperature to prevent thermal damage to tissue and bone during
injection. For optimal deliverability, it is generally preferred
that the polymer have an inherent viscosity of greater than about
0.6 dl/g, preferably about 0.6 to 0.7 dl/g, and an average
molecular weight of greater than about 60,000 Mw, preferably about
60,000-70,000 Mw. The inherent viscosity is measured in chloroform,
using the test described at col. 4, lines 33-36 of U.S. Pat. No.
5,679,723, which is incorporated herein by reference.
[0109] Preferably, the polymer used includes a resorbable polymer,
e.g., polycaprolactone (PCL), which will slowly resorb during the
natural healing process. The polymer may also include a
non-resorbable polymer, e.g., polypropylene, polyacetal,
polyethylene or polyurethane. The polymer may also include a blend
of different resorbable polymers that resorb at different rates,
e.g., blends of two or more of the following polymers:
polycaprolactone (PCL), poly-1-lactic acid, poly-DL-lactic acid,
polyglycolic acid, polydioxanone, polyglyconate, polytrimethylene
carbonate, and copolymers of poly-L-lactic acid, poly-DL-lactic
acid, polyglycolic acid, polydioxanone, polyglyconate,
polytrimethylene carbonate, poly(hydroxyalkonates) (PHB, PHO, PHV),
polyorthoesters, polyanhydrides, poly(pseudo-amino acids),
poly(cyanoacrylates), poly(ester-anhydrides), polyoxalates, and
polysaccharides. Other suitable polymers include
poly-4-hydroxybutyrate (4PHB) and poly(alkylene oxalates).
[0110] As the polymer resorbs, the remaining, porous polymer
resembles the trabecular network and thus encourages infiltration
of osteoclasts, which cause breakdown of the polymer, and
osteoblasts, which generate new bone. To encourage bone growth into
the polymer, it is preferred that the polymer include an
osteoconductive filler, e.g., hydroxyapatites (HA), calcium
sulfates, tricalcium phosphates, bioactive glasses, aragonite,
calcite, and mixtures of these fillers. A suitable level of
osteoconductive filler will encourage bone growth without an
unacceptable reduction in the deliverability of the polymer.
Preferred levels are generally from about 0 to 40% by volume, most
preferably about 30 to 40% by volume. Instead of or in addition to
a conventional osteoconductive filler, the polymer may include bone
fragments and debris, as discussed above. If bone fragments are
used without another filler, it is generally preferred that the
polymer include from about 0 to 60% bone fragments by weight, more
preferably about 20 to 50% by weight.
[0111] The procedures discussed above may be used in many types of
soft tissue fixation, including rotator cuff repair; instability
repairs of the shoulder (e.g., SLAP, Bankart lesions, labral
reattachment); repair or supplementation of anchors, screws and
interference screws for attaching ACL autografts and allografts
(e.g., bone-patella tendon-bone, Semigracilis, tendinosis,
quadriceps autograft); and ACL repairs or revisions (e.g., where
there is micromovement due to loosening of the fixation means and
subsequent movement of the graft, or as a sealant to eliminate
synovium fluid flow into bone hole cavities in ACL repair).
[0112] Endoscopic delivery of polymer may also be used in other
applications, such as chondral repair, filling of harvest site
defects in mosaicplasty, as an autograft diluent, refixation of
small bony fragments, repair of osteochondritis dessicans (OCD)
(i.e., by using injectable polymer to endoscopically reattach a
loose flake of bone or cartilage, rather than pinning the flake in
place), for spinal fusions, meniscal repair, fracture repair of
non-load bearing bones, supplementation or augmentation of
cancellous/cortical screws for long bone fractures especially in
compromised or deficient bone, supplementation or augmentation of
suture anchoring devices, in laparoscopic procedures to re-attach
soft tissue to soft tissue or soft tissue to bone, and plastic
surgery to aid in facial reconstruction.
[0113] Anchors of the invention generally provide good pull-out
strengths. Pull-out strength will vary depending upon the suture,
suture augmentation, number of sutures, and polymer used. For
example, reduced pull-out strengths will be observed if a
relatively weak suture material is used and the mode of failure is
breakage of the suture. However, preferred anchors of the invention
generally provide pull-out strengths of at least 150 Newtons, with
some anchors providing strengths in excess of 300 Newtons, when
tested in accordance with either of the test procedures (Test
Procedures 1 and 2) described below. Pull-out strength is measured
on cadaveric samples (shoulders) and on sawbone blocks (artificial
bone), using the following test procedures.
[0114] Pull-Out Test Procedures
[0115] Test Procedure 1: Cadaveric Samples
[0116] All of the shoulders used would be harvested from fresh
specimens, i.e., unpreserved, and stored at approximately -10
degrees Celsius until necessary for testing. Before testing, the
specimens would be allowed to thaw to room temperature before
dissecting and sample preparation.
[0117] The humerus would be prepared for the repair of a rotator
cuff tear at the bony site. A cavity would be drilled to a depth of
about 10 mm using a twist drill bit having a diameter of 3.3 mm. A
suture, e.g., Spectra thread or similar suture material, would be
delivered to the cavity, and the cavity would be filled with
polymer. The polymer would be allowed to harden/set, after which
the sample would be placed in an Instron servo-hydraulic testing
machine, with the suture orientated parallel in relationship to the
force applied by the testing machine.
[0118] The samples would be held in an appropriate vice/clamp which
is itself attached to a 3-axis vice to permit the precise
orientation of the samples being tested, using an appropriate
Instron servo-hydraulic testing machine and associated Instron Max
software, at a displacement rate of 8.5 mm/sec.
[0119] Test Procedure 2: Sawbone Block Samples
[0120] Samples would be prepared and tested as described above in
Test Procedure 1, except that instead of a cadaveric humerus, the
anchor would be formed in a sawbone block. A suitable sawbone block
material is commercially available from Pacific Research, under the
tradename "Sawbones".
[0121] Other embodiments are within the claims.
[0122] For example, although in most of the embodiments discussed
above polymer is used as a substitute for a conventional bone
anchor, in some cases it may be desirable to use the polymer to
supplement the anchoring provided by a conventional anchor, e.g.,
by applying the polymer on top of or around the anchor when the
anchor is placed. This option could be useful, for example, in
cases in which the surgeon chooses to use a conventional anchor and
the patient will be on an aggressive rehabilitation schedule.
[0123] Also, in some applications bone fragments harvested at one
site may be mixed with polymer and injected at a second site in the
same patient. This procedure may be used, for example, in cases in
which the bone at the injection site is diseased or compromised,
and fresh bone is desired as an autologous filler. In addition,
bone fragments can be mixed into polymer within the cavity that is
being formed, rather than extracting the bone fragments first as
described above. This will occur, for example, when the drill bit
is consumable.
[0124] Additionally, in certain circumstances multiple "bolt-like"
polymer anchors could be used to attach a region of soft tissue to
bone, rather than using a row of connected stitches.
[0125] Moreover, while the endoscopic procedures described above
are generally preferred over open procedures because the endoscopic
procedures are less invasive, similar techniques can be used in an
open surgery environment if desired.
[0126] Further, while thermoplastic polymers have been discussed
above, the polymer may be delivered in liquid, non-molten form and
cured or dried in situ. For example, the polymer may be a thermoset
polymer, e.g., a UV or laser curable material, may be electrolytic
gelling, or may be in the form of a hydrogel (e.g., pH sensitive or
ionic sensitive), a pluronic, or a sol-gel system, e.g. a polxamer
polyol.
[0127] Moreover, non-polymeric flowable materials may be used in
place of the polymer, e.g., injectable bone cements such as
polyacrylic acid/divalent metal ion cements.
* * * * *