U.S. patent application number 12/766967 was filed with the patent office on 2010-08-19 for medical instrument to place a pursestring suture, open a hole and pass a guidewire.
This patent application is currently assigned to LSI Solutions, Inc.. Invention is credited to Jude S. Sauer.
Application Number | 20100211082 12/766967 |
Document ID | / |
Family ID | 38649269 |
Filed Date | 2010-08-19 |
United States Patent
Application |
20100211082 |
Kind Code |
A1 |
Sauer; Jude S. |
August 19, 2010 |
MEDICAL INSTRUMENT TO PLACE A PURSESTRING SUTURE, OPEN A HOLE AND
PASS A GUIDEWIRE
Abstract
A therapeutic instrument for the ergonomic, effective and safe
opening and closing of targeted remote tissue sites; includes a
pistol grip style handle with a hand activated lever for needle
deployment and, optionally, with features to control tissue cutting
and guide wire installation; also incorporates a specialized
elongated rigid or flexible instrument shaft, which enables vacuum
assisted holding of tissue at a uniquely contoured distal tip,
where placement of a suture in a purse string configures occurs
along with, if desired, tissue cutting and guide wire passage.
Inventors: |
Sauer; Jude S.; (Pittsford,
NY) |
Correspondence
Address: |
Stephen B. Salai, Esq.;Harter Secrest & Emery LLP
1600 Bausch & Lomb Place
Rochester
NY
14604-2711
US
|
Assignee: |
LSI Solutions, Inc.
Victor
NY
|
Family ID: |
38649269 |
Appl. No.: |
12/766967 |
Filed: |
April 26, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11411626 |
Apr 26, 2006 |
7731727 |
|
|
12766967 |
|
|
|
|
Current U.S.
Class: |
606/144 |
Current CPC
Class: |
A61B 2017/1142 20130101;
A61B 17/0469 20130101; A61B 17/30 20130101; A61B 2017/22038
20130101; A61B 17/0057 20130101; A61B 17/320016 20130101; A61B
2017/2905 20130101; A61B 2017/306 20130101; A61B 2017/00862
20130101; A61B 2017/00278 20130101; A61B 2017/00663 20130101 |
Class at
Publication: |
606/144 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A tissue suturing instrument comprising: a handle having an
operating lever on the handle; an elongated body extending from the
handle to a distal end; a tip at a distal end of the elongated
body; a tissue receiving region in the tip; first and second
retractable needles coupled to the operating lever and selectively
extending across the tissue receiving region and retracting; a
cutter arranged generally parallel to the tissue receiving region;
and a suture having first and second ends disposed at the distal
end of the tissue receiving region, the first and second ends
engaging the first and second retractable needles when the needles
are extended across the tissue receiving region, and being carried
proximally across the regions by the needles when the needles are
retracted.
2. A method of gathering and placing a suture in tissue comprising:
attracting a section of tissue to a pleat forming surface; placing
a suture through the folds of a pleat of tissue while attracted to
the surface.
3. The method of claim 2 in which the attracting step comprises
attracting the tissue to the surface with suction.
4. The method of claim 3 in which the step of placing a suture
through the folds comprising advancing a needle through the folds,
capturing an end of a length of suture with the needle, and drawing
the suture back through the folds.
5. The method of claim 2 further comprising cutting an opening in
the section of tissue.
6. The method of claim 5 in which cutting the opening comprises
cutting the opening adjacent to the suture.
7. The method of claim 6 comprising passing a guide wire through
the opening.
8. The method of placing a suture in a section of tissue of claim 2
comprising: positioning the pleat forming surface adjacent to the
tissue; attracting the tissue to the surface to form a pleat in the
tissue; extending a pair of needles through the pleat; engaging
first and second ends of a length of suture distally of the pleat;
retracting the pair of needles proximally through the pleat;
carrying first and second ends of a length of suture proximally
through the pleat; and securing the suture proximally of the pleat
to form the pursestring suture.
9. The method of claim 8 in which the attracting step comprises
attracting the tissue to the surface with suction.
10. The method of claim 8 further comprising cutting an opening in
the section of tissue.
11. The method of claim 10 in which cutting the opening comprises
cutting an opening between the pair of needles.
12. The method of claim 11 in which the cutting step is performed
between the extending step and the retracting step.
13. The method of claim 10 comprising advancing a guide wire
through the opening.
14. A method of making an incision, guiding an instrument through
the incision withdrawing the instrument, and closing the incision
comprising: inserting a cutting and suturing instrument through an
organ structure naturally communicating with an existing external
orifice; substantially simultaneously placing a purse string suture
in a wall of the existing organ structure and cutting an opening in
the wall; placing a guide wire through the opening with the cutting
and suturing instrument; withdrawing the cutting and suturing
instrument leaving the guide wire in place; inserting a second
instrument through the organ structure and the opening and
performing a procedure outside the organ structure; withdrawing the
second instrument; and closing the opening with the previously
placed purse string suture
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 11/411,626, filed Apr. 26, 2006.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] None.
NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT
[0003] None.
REFERENCE TO A "SEQUENCE LISTING"
[0004] None.
BACKGROUND OF THE INVENTION
[0005] 1. Field of the Invention
[0006] This invention relates generally to a medical device for
placement of a purse string suture in tissue and more particularly
to such a device that can also cut tissue and enable placement of a
guide wire through the cut opening. More particularly, this
invention relates to a method and apparatus in which living tissue
is positioned using vacuum within a contoured opening located near
the end of the device, which also provides for the simultaneous
passage of two needles through multiple points in the held tissue.
After traversing the tissue, the needles engage and pick up both
ends of a segment of suture and subsequently pull the suture ends
back through the targeted tissue to facilitate a reliably
customized suture placement. A slidable mechanism is provided to
cut the held tissue and also, when desired, to enable the passage
of a guide wire through the cut opening. This invention is
particularly useful for the creation of closable openings in tissue
structures or for safely harvesting deeper samples from the walls
of tissue structures.
[0007] 2. Description of Related Art
[0008] Despite all of the advances of modern medicine, many
seemingly simple patient interventions still present significant
challenges regarding their safe and reliable implementation. For
many patients, substantial therapeutic advantage could be offered
by a technology facilitating rapid and reliable cutting open and
closing of a remote tissue sites.
[0009] Efforts to improve a physician's ability to do more than
just see the outer characteristics of a patient are essential to
modern health care. For centuries, health care practitioners have
used existing external anatomic features for gaining limited access
to a patient's internal structures for diagnostic or therapeutic
interventions. Without the right equipment, health care providers
can only use their direct vision to view their patient's body
surfaces, exposed orifices or anatomy exposed through open
incisions or wounds. The use of radiographic techniques (e.g.,
X-ray, CT and MRI), endoscopic techniques (e.g., colonoscopy,
gastroscopy, cystoscopy, bronchoscopy) and open or laparoscopic
surgery, along with combinations of these modalities, now routinely
provide clinically significant data and the opportunity for direct
therapeutic interventions.
[0010] An endoscopic technique for viewing internal patient body
cavities was first reported in 1805. Important advancements in less
invasive techniques (e.g., laparoscopic surgery in 1901, flexible
fiber optic endoscopes in 1957, endoscopic retrograde
cholangiopancreatography (E.R.C.P) in 1968, laparoscopic
cholecystectomy in 1988, etc.) helped usher in this era of modern
medicine. Improvements to endoscopic technology continue to yield
significant improvements in therapeutics.
[0011] Many patients could benefit from a physician's ability to
gain access to internal body locations through an organ structure
naturally communicating with an existing external orifice instead
of through a painful incision in the skin and its underlying muscle
and fascial structures. Interventions using this alternative
approach have come to be called "Natural Orifice Translumenal
Endoscopic Surgery" or its acronym, "NOTES," procedures.
[0012] Examples of excellent potential access points to facilitate
minimally invasive NOTES procedures include: safe entry to and exit
from the peritoneal cavity through a wall of the stomach (i.e.,
transgastric), via the mouth, through the rectum and sigmoid colon
(i.e., transcolonic), via the anus, or through the posterior formix
of the vagina (i.e., transvaginal) via the external vaginal
opening. Generally, access to other body parts or compartments
through the wall of a tissue structure is commonly referred to as
"transmural" (i.e., through the wall) access; more specifically,
gaining such access through the wall of a tubular tissue structure,
from the inside (i.e., the lumen) to the outside, is commonly
called an extralumenal (i.e., outside of the lumen) approach.
[0013] The proper utilization of naturally existing orifices to
provide initial entry for therapeutic interventions may minimize
many of the risks and morbidities of more traditional open
laparotomy or laparoscopic surgery. To support a paradigm shift
away from surgery requiring skin incisions, it would be helpful to
have a technology, like the present invention, that could
appropriately hold remote tissue, reliably provide a suture to
subsequently secure it closed, safely cut it and to enable the
placement of a temporary guide wire to facilitate easier instrument
passage.
[0014] In the American Journal of Surgery, April 1944, Drs. Decker
and Cherry published a manuscript describing a procedure they
"termed culdoscopy." They reported use of the "vaginal route" to
access the peritoneal cavity for viewing internal structures and
for instrument manipulations. They presented the "Decker
culdoscope" and a "trochar and cannula set" for "puncturing the
posterior vaginal wall." Examples of the transmural procedures they
reported include rupture of small cysts, biopsy of ovaries, testing
the fallopian tubes for patency and tubal ligation for
sterilization.
[0015] A recent resurgence of interest in the transmural NOTES
procedures has lead to several new reports regarding the use of
this approach in mostly animal experimental models. A gastroscopic
"pancreatic necrosectomy" procedure was presented the
internationally renowned "Digestive Disease Week" conference in
2003. This presentation reported the use of a gastroscopic
instrumentation to exit through the stomach and debride a pancreas
of necrotic tissue. At the "Digestive Disease Week" conference in
2004, investigators presented their "successful peroral
transgastric ligation of fallopian tubes . . . in a survivor
porcine model." Other investigators presented transgastric biliary
surgery, including the removal of a gallbladder from a pig. While
the use of an instrument called the Eagle Claw V (Olympus Medical
Systems Corporation, Tokyo, Japan) was reported for transgastric
suturing of intraperitoneal tissue structures like a splenic
artery; it was not used to close the transmural access site. Other
investigators suggested the use of computer-controlled robots to
aid in transgastric surgery. A conclusion stated, "clearly, there
is a need for better instrumentation."
[0016] Academic leaders in this area wrote an authoritative
publication entitled, "ASGE/SAGES Working Group on Natural Orifice
Translumenal Endoscopic Surgery--White Paper--October 2005." They
reviewed recent porcine research and noted a report of a human
transgastric appendectomy. While the paper mostly highlighted the
per oral transgastric approach, they also mentioned the promise of
the transcolonic and transvaginal access. These expert laparoscopic
surgeons and endoscopists "(A)II agreed that Translumenal
Endoscopic Surgery could offer significant benefits to patients
such as less pain, faster recovery, and better cosmesis than
current laparoscopic techniques." They stated, "(I)t seems feasible
that major intraperitoneal surgery may one day be performed without
skin incisions. The natural orifices may provide the entry point
for surgical interventions in the peritoneal cavity, thereby
avoiding abdominal wall incisions."
[0017] This Natural Orifice Translumenal Endoscopic Surgery--White
Paper identified "ten critical areas that will impact the safety of
NOTES." The first two areas listed by these authors are directly
addressed by the present invention. From "Table 2. Potential
Barriers to Clinical Practice," the first and second listed areas
are, respectively, "Access to peritoneal Cavity" and Gastric
(intestinal) closure." They state that while the "most important
areas of initial study are . . . safe peritoneal access and secure
gastric closure," the "optimal techniques to do so . . . are
unknown."
[0018] The long term results of recent efforts to endoscopically
suture the native lining of remote tissue sites to achieve tissue
thickening and/or tightening (i.e., in medical terms, a
"plication") have proved to be relatively disappointing. Clinical
investigations exploring such suture-mediated changes to tissue
have typically shown excellent short-term realization of the
desired symptom relief. However, without any other wound closure
site preparation, over time, the sutures alone tend to loose their
ability to hold tissue together for thickening or tightening.
Examples of encouraging short termed success, but later
disappointment, are included in most of the published clinical
study's of the use of the ESD.TM., Endoscopic Suturing Device
(manufactured by LSI SOLUTIONS.RTM., Victor, N.Y.) or the
EndoCinch.RTM. (manufactured by Bard.RTM., Bellarica, Mass.); the
encouraging early relief from endoscopically placed suture alone
(without site preparation) at the distal esophagus in patients with
gastroesophageal reflux disease or at the dilated surgically
created stomach to small bowel connections (i.e., gastrojejunal
anastomoses) in gastric bypass patients usually faded completely
within two years.
[0019] Thousands of patients suffering from gastroesophageal reflux
disease (GERD) have undergone endoscopic suturing using
commercially available products in conjunction with gastroscopy.
Despite highly encouraging initial symptom relief, most patients
progressively returned to their baseline state of "heart burn" or
other discomfort over weeks or months following their procedure.
Without proper healing, living tissue tends to return to its
prevailing state. Sutures or surgical staples alone typically can
only provide a temporary mechanical arrangement to promote tissue
healing. In most cases, the body has to respond and take over the
functional process. Almost all patients receiving suture thickening
and tightening of their esophagus adjacent to the stomach only had
a few stitches placed to bulk up and narrow the native lining
(called the mucosa) of the esophagus against itself. Over time, the
bodies of these patients overcame the presence of the foreign
material (i.e., the suture) and the walls of their distal esophagus
attenuated and loosened.
[0020] Laboratory research indicates that successful long-term
plication to thicken and tighten the distal esophagus is more
achievable by stimulating the tissue to actually heal into the
desired configuration, instead of relying solely on sutures to hold
the tissue in position. Research in our porcine laboratory
indicated that methods using tissue cutting or burning to promote
healing at distal esophageal wound closure sites were worthy of
further study. A study, entitled, "Mucosal Apposition in Endoscopic
Suturing," published by colleagues at the Cleveland Clinic,
Cleveland, Ohio, reported promising results through the use of
cauterizing the esophageal mucosa prior to suturing. Excellent
clinical results were also reported in pediatric GERD patients who
received cautery mediated wound site preparation to take away the
protective mucosal lining of the esophagus and expose the inner
healing tissues in preparation prior to ESD suturing.
[0021] For some bariatric patients with failed gastric bypass
procedures, the endoscopic use of suturing to narrow the opening
between the reduced stomach and its outflow into the by-passed
small bowel has only produced acceptable, durable improvements in
patients who have also received suturing site preparation to remove
some mucosa and stimulate the underlying tissue to realize long
term healing. Dr. Christopher Thompson's pioneering team in Boston
report the largest series of patient amelioration by using suture
to reduce the diameter of the connection between the functional
stomach and small bowel. Their satisfactory results only came after
improving their anastomotic tightening technique to also include
suture site preparation.
[0022] To achieve long-term tissue thickening and tightening,
tissue closure site preparation is required in addition to suture
fixation. A device that facilitates remote tissue site preparation
for healing and reliable suture mediated site closure could offer a
substantial improvement to the therapeutic options for many
patients.
[0023] Another example of the need for better technology for remote
tissue cutting and closing is evident from the fact that currently
many patients still often require more extensive and dangerous
surgery to remove certain intestinal lesions (e.g., abnormal
growths, like polyps) that extend deeper than the superficial layer
lining the intestine. Many superficial intestinal lesions reached
using standard intestinal endoscopy equipment and techniques can be
routinely completely removed endoscopically from the intestinal
wall using a wire snare. Because of the lack of effective
technology and techniques, typical deeper lesions cannot yet be
safely removed using this non-surgical approach.
[0024] Patients who present with larger or deeper potentially
intramural intestinal lesions usually would benefit from having
part of the intestinal wall immediately adjacent to the base of the
lesion also removed with the lesion. While removing some of the
surrounding normal intestinal tissue can ensure that the lesion is
more adequately removed, the risk of harvest site leakage or
impaired wound healing substantially increases if the wound is not
adequately closed. Currently available technology fails to provide
a safe and reliable option for the completely endoscopic removal of
deep-seated internal pathologic lesions. This second preferred
embodiment holds promise for eliminating the need for some patients
to have to go to the surgical operating room instead of just
finishing the endoscopy in the endoscopy suite with the safe and
complete removal of these deeper lesions.
[0025] To provide better patient outcomes, improved technologies
are needed to continue to reduce the invasiveness and potential
morbidity of opening and closing holes remotely made inside of
patients. While the ability to remotely cut or open and close the
walls of tubular tissue structures along with the use of
translumenal therapeutic interventions offer exciting potential
improvements to patient care, excellent technology is needed to
make this promising opportunity into clinical reality. This
innovation represents a significantly means to help a broader
population of patients.
BRIEF SUMMARY OF THE INVENTION
[0026] Briefly stated and in accordance with both presently
preferred embodiments of the invention: a therapeutic instrument
for the ergonomic, effective and safe opening and closing of
targeted remote tissue sites; includes a pistol grip style handle
with a hand activated lever for needle deployment and, optionally,
with features to control tissue cutting and guide wire
installation; also incorporates a specialized elongated rigid or
flexible instrument shaft, which enables vacuum assisted holding of
tissue at a uniquely contoured distal tip, where placement of a
suture in a purse string configures occurs along with, if desired,
tissue cutting and guide wire passage.
[0027] In accordance with first preferred embodiment of this
invention used for providing safe and reliable transmural access,
this instrument enables creation of closeable transmural access
sites by utilizing the special features disclosed herein: This
innovation provides for vacuum mediated tissue manipulation and
holding across multiple specially contoured gaps, which also
support the simultaneous traverse of two needles that pick-up and
retract back both ends of a single strand of suture configured to
create a purse string suture arrangement in that tissue. The tissue
is cut with a blade oriented perpendicular to the tissue held in
the jaw and pulled toward the handle along the long axis of the
distal tip. This incision is located appropriately between the
purse string stitches. A guide wire can be passed through this
incised tissue opening within the purse string suture to enable
subsequent instrument passage over the guide wire through the
transmural access point and into the extralumenal location. Upon
completion of the intervention, after the device, guide wire and
any other instruments are removed form the patient, the suture is
drawn tight and secured to close the hole.
[0028] In accordance with another aspect, this invention provides a
novel approach to stimulate wound healing by cutting and closing
the wall of the tubular tissue structure (without necessarily
removing any tissue or using the site for access) has potential for
therapeutic interventions, called "plications," in which increasing
tissue thickness or tissue tightening is advantageous. For example,
a durable esophageal plication thickening and tighten tissue at the
distal esophagus may reduce the risk of stomach contents from
refluxing up from the stomach into the esophagus. Symptoms of
gastric reflux range from mild heart burn to obstruction from
esophageal cancer. Just placing stitches in the distal esophagus
leads to temporary amelioration of reflux while the stitches remain
in place to tip the balance towards supporting an effective
anti-reflux mechanism. Without healing the stitches typically fall
out within weeks or months. With healing at the site, the bulked up
region of the esophagus can act as a permanent pressure valve
against reflux.
[0029] A second embodiment of this invention can be used to safely
and efficiently remove part of the wall of a hollow tissue
structure along with an abnormal tissue growth attached to that
part of the wall. Limitations in currently available intestinal
endoscopy equipment force the need to have deep-seated lesions,
which may extend into the adjacent wall (i.e., intramural), removed
by a subsequent surgical procedure in the operating room instead of
at the time of their evaluation in the endoscopy suite.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING
[0030] The foregoing objects, features and advantages of the
invention will become more apparent from a reading of the following
description in connection with the accompanying drawings, in
which:
[0031] FIG. 1 is a perspective view of the tissue suturing
instrument in accordance with the first embodiment of the present
invention;
[0032] FIG. 2 is a perspective view of the tissue suturing
instrument of FIG. 1 in which the right cover of the housing of the
instrument is removed and sections of the shaft are removed to
illustrate internal components;
[0033] FIG. 3 is a partially exploded perspective view of the
tissue suturing instrument of FIG. 1 in which the handle halves are
separated highlighting the functional components for vacuum
augmented tissue manipulation, purse string suture placement,
tissue cutting and guide wire installation;
[0034] FIG. 4 is an exploded perspective view of the tissue
suturing instrument of FIG. 1;
[0035] FIG. 5 is a perspective view of the tissue suturing
instrument of FIG. 1 showing a curved or flexible shaft;
[0036] FIGS. 6A and 6B are perspective views of the vacuum assisted
tissue manipulation components of FIG. 3;
[0037] FIGS. 7A and 7B show an end view and a cross sectional view,
respectively, of the distal vacuum tip of FIG. 3;
[0038] FIG. 8A is an perspective view highlighting the needle drive
components of FIG. 3;
[0039] FIGS. 8B and 8C are perspective views of the proximal and
distal ends, respectively, of the needle of FIG. 3;
[0040] FIG. 9A is an perspective view showing the suture storage
features of FIG. 3;
[0041] FIG. 9B shows the ferrules at each end of a single strand of
suture of FIG. 3;
[0042] FIGS. 9C and 9D show a perspective views of a needle next to
a cross sectional view of a ferrule and another perspective view of
a needle engaged within a cross sectional view of a ferrule,
respectively;
[0043] FIG. 10A is a perspective view of the tell-tale suture loops
held in the suture storage indicator and of the relative of the
location of the ferrules held in the ferrule compartments at the
distal side of the distal tip of FIG. 1;
[0044] FIG. 10B is a perspective view of the tell-tale suture loops
now partially straightened out in the suture storage indicator and
of the relative location of the ferrules now brought back to the
proximal side of the distal tip of FIG. 1;
[0045] FIG. 11A is a perspective view of the tissue cutting
components instrument of FIG. 1 showing the tissue cutter knob
fully forward;
[0046] FIG. 11B is a perspective view of the tissue cutting blade
and shuttle components on the blade tube of the instrument of FIG.
11A;
[0047] FIG. 11C is a perspective view of the tissue cutting
components instrument of FIG. 1 showing the tissue cutter knob
about half way pulled back and the cutting blade near the middle of
the tissue manifold;
[0048] FIG. 11D is a perspective view of the tissue cutting blade
and shuttle components on the blade tube of the instrument of FIG.
11A highlighting the shuttle's location relative to the distal end
of the device;
[0049] FIG. 11E is a perspective view of the tissue cutting and
guide wire placement components instrument of FIG. 1 showing the
tissue cutter knob fully back and a guide wire partially inserted
through the shuttle tube;
[0050] FIG. 11F is a perspective view of the tissue cutting blade
and shuttle components on the blade tube of the instrument of FIG.
11A showing the blade shuttle fully retracted and the guide wire
protruding through the curved distal portion of the shuttle
tube;
[0051] FIG. 12A-12E show end views and cross section views of
various blade shuttle components of the instrument of FIG. 3;
[0052] FIG. 13A is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
to show the lever fully forward and the needle tips not extending
into the jaw;
[0053] FIG. 13B is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
to show the lever partially rotated back and the needle tips now
extending into the jaws;
[0054] FIG. 13C is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
to show the lever fully rotated back and the needles fully forward
through the jaw;
[0055] FIG. 13D is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
to show the lever partially released and the needles along with the
attached suture ends traversing back through the jaw;
[0056] FIG. 13E is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
to show the lever fully forward back into its initial position and
the needles and suture ends fully back to the proximal side of the
jaw;
[0057] FIG. 13F is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
highlighting the blade knob and blade partially pulled back;
[0058] FIG. 13G is a perspective view of the instrument of FIG. 1
with the right handle housing removed and the distal tip magnified
highlighting the blade knob and blade fully pulled back and a guide
wire partially in place;
[0059] FIG. 14 is a schematic perspective view of the tissue
suturing instrument of FIG. 1 shown in a transanal application;
[0060] FIG. 15A is a perspective view of the distal end of the
instrument of FIG. 1 and a schematic representation of a tubular
tissue;
[0061] FIG. 15B is a perspective view of the distal end of the
instrument of FIG. 1 shown inserted into the lumen of the tubular
tissue structure;
[0062] FIG. 15C is a perspective view of the distal end of the
instrument of FIG. 1 with a segment of the tissue sucked into the
jaws of the distal tip;
[0063] FIG. 15D is a perspective view of the distal end of the
instrument of FIG. 1 with a segment of the tissue sucked into the
jaws of the distal tip and the needles partially advanced through
the tissue over the proximal manifold;
[0064] FIG. 15E is a perspective view of the distal end of the
instrument of FIG. 1 with the needles fully advanced above the
tissue proximal and distal jaws, but under the tissue between the
jaws;
[0065] FIG. 15F is a perspective view of the distal end of the
instrument of FIG. 1 showing the suture coming back over the tissue
in the proximal and distal jaws but under the tissue in area
between the jaws;
[0066] FIG. 15G is a perspective view of the distal end of the
instrument of FIG. 1 showing a purse string suture placed around a
segment of the tissue sucked into the jaws and the tissue cutting
blade pulled back partially cutting the tissue held against the
manifold;
[0067] FIG. 15H is a perspective view of the distal end of the
instrument of FIG. 1 showing a purse string suture placed around a
segment of the tissue sucked into the jaws and the tissue cutting
blade pulled fully back into the instrument shaft to provide an
incision in the tissue held in the manifold;
[0068] FIG. 15J is a perspective view of the distal end of the
instrument of FIG. 1 inside of a tubular tissue structure showing a
guide wire advancing through the incision in the tissue held in the
manifold;
[0069] FIG. 15K is a perspective view of the distal end of the
instrument of FIG. 1 pulled out of the tubular tissue structure
leaving a purse string suture in place around an incision with a
guide wire passed through it;
[0070] FIG. 15L is a perspective view of the tubular tissue
structure with an incision circumscribed with a purse string suture
and containing a guide wire over which a endoscope is passed;
[0071] FIG. 15M is a perspective view of the tubular tissue
structure with an incision circumscribed with a purse string suture
after the guide wire and instruments are removed;
[0072] FIG. 15N is a perspective view of the tubular tissue
structure with an incision now drawn closed by placing tension on
the ends of the purse string suture;
[0073] FIG. 15P is a perspective view of the tubular tissue
structure with an incision now drawn closed by the tightened purse
string suture over which a suture fastener and cutting device is
passed;
[0074] FIG. 15R is a close-up perspective view of the tubular
tissue structure with an incision now secured closed by purse
string suture held in place with a mechanical fastener and the
extra suture material trimmed away after the suture fastener
instrument and trimmed suture ends are removed;
[0075] FIG. 16 is a perspective view of the second preferred
embodiment of this invention;
[0076] FIG. 17A is a partial section view of the distal end of the
instrument of FIG. 16 showing the needle and ferrule with suture
along with the horizontal cutting blade. FIG. 17B is a section view
through A-A of FIG. 17A.
[0077] FIG. 17C is a section view through B-B of FIG. 17A showing
the horizontal cutting blade along with its attached pulling
members from the instrument of FIG. 16.
[0078] FIGS. 18A, 18B and 18C show the distal end of the instrument
of FIG. 16 with the needles partially advanced, the needles fully
advanced with the horizontal blade partially pulled back and the
needles fully advanced with the horizontal blade almost entering
under the proximal vertical perforated wall, respectively.
[0079] FIG. 19 shows perspective view of the distal end of the
instrument of FIG. 16 with a partial cut-away to illustrate how
this instrument engages a lesion attached to the wall of a tubular
tissue structure;
[0080] FIG. 20A shows the distal end of the instrument of FIG. 16
inside of a tubular tissue structure containing a lesion;
[0081] FIG. 20B shows the distal end of the instrument of FIG. 16
inside of a tubular tissue structure now engaging the lesion within
the opening in the distal end of the instrument;
[0082] FIG. 20C shows the distal end of the instrument of FIG. 16
inside of a tubular tissue structure, engaging the polyp with the
needles fully advanced;
[0083] FIG. 20D shows the distal end of the instrument of FIG. 16
inside of a tubular tissue structure, engaging the polyp and the
needles and ferrules with suture fully retracted;
[0084] FIG. 20E shows the distal end of the instrument of FIG. 16
inside of a tubular tissue structure, engaging the lesion with the
needles fully retracted and the purse string suture in place around
the base of the polyp and the horizontal blade fully excising the
lesion's base from the wall of the tubular tissue structure;
[0085] FIG. 20F shows the distal end of the instrument of FIG. 16
now released from the inside of a tubular tissue structure with the
purse string suture in place and the lesion secured within the
distal opening.
DETAILED DESCRIPTION OF THE INVENTION
[0086] In accordance with the presently preferred embodiments of
the invention, medical therapeutic instruments are provided for the
ergonomic, effective and safe creation of transmural access sites,
effective tissue plication and harvesting deep-seated remote tissue
samples. Each instrument includes a pistol grip style handle with a
hand activated lever, a specialized vacuum tissue manipulation
feature at the end of the instrument shaft and a double needle
mechanism for engaging ferrules attached to the ends of a single
strand of suture to stitch a purse string suture configuration.
These embodiments vary regarding the availability of specific
customized features for tissue incisions and guide wire passage.
First, the first preferred embodiment is covered in this detailed
description for use in providing transmural access. Next, the use
of this first preferred embodiment for creating tissue plication is
addressed. Last, the second preferred embodiment is presented for
use in harvesting deep-seated remote lesions. For clarity, these
novel design features will be presented here in the sequence that
they are typically encountered in these example procedures.
[0087] FIG. 1 is a perspective view of a tissue suturing instrument
in accordance with the first embodiment of the present invention
instrument 10. A handle assembly is constructed from a right handle
portion 22 and a left handle portion 24 which are constructed of an
injection molded plastic or the like and to which subsequent
components are attached. An elongated body 34 extends from the
handle to a distal end at which a tip 32 is located. A suction
fitting 36 is disposed on the proximal end of body 34 and is
preferably rotatable with respect to the body. A removable cap 42
is attached to a neck of the suction fitting 36.
[0088] Preferably the handle 24 has a window 62 described in more
detail below. A cutter control knob 74 is attached to a cutter
shaft tube 72 extending rearwardly from the handle.
[0089] The first preferred embodiment of this invention, suturing
instrument 10, is represented in FIGS. 1-15P. Now referring to
FIGS. 1-4, the illustrated suturing technique using needles and
suture attached to ferrules of instrument 10 may be similar to that
shown in U.S. Pat. Nos. 5,431,666, 5,766,183, 6,997,931 B2,
European Patent No. EP 0669101, filed Feb. 23, 1995 and granted
Oct. 14, 1998, which are incorporated by reference in the
SEW-RIGHT.RTM. SR 5.RTM. and Running Device.RTM. and ESD.TM.
products manufactured by LSI SOLUTIONS, Inc. (formerly LaserSurge,
Inc.) of Victor, N.Y.
[0090] The innovation of the present invention is the unique
combination of simultaneously firing two needles through a tissue
gap in a pleat formed in the tissue by the instrument incorporating
customized contours in the distal tip 32 to enable the needles to
create a purse string suture configuration by parallel needles
entering and exiting the tissue multiple times in a single
traverse. This surgical purse string suture configuration resembles
the purse string or draw string at the top of a soft sided purse
and offers a similar function. It is a single suture sewn into and
out of the tissue circumscribing the selected site. The final
stitch exits the tissue near the entry point of the first stitch so
that the surrounded site is drawn closed when tension is placed on
both ends of the suture. This technology further utilizes vacuum
conveyed through a housing 36 to hold the tissue and a specialized
blade shuttle connected to a funnel knob 74 to reliably cut the
tissue and, when desired, permit the installation of a guide wire.
As used herein, pleat is intended to refer to any configuration of
tissue that permits the above described stitch to be placed.
[0091] FIG. 2 is a perspective view of the tissue suturing
instrument of FIG. 1 in which the right cover of the housing of the
instrument and sections of the shaft are removed to illustrate
internal components.
[0092] FIG. 3 is a partially exploded perspective view of the
tissue suturing instrument of FIG. 1 in which the handle halves are
separated highlighting the functional components for vacuum
augmented tissue manipulation, pleat formation, purse string suture
placement, tissue cutting, and guide wire installation. FIG. 4 is
an exploded perspective view of the tissue suturing instrument of
FIG. 1.
[0093] A lever 64 configured to be operated by the fingers of a
user while grasping handle 20 provides for the extension and
retraction of needles 56 of the instrument 10. Distally, a tube
shaft 34, shown here as rigid, but which may also be flexible,
protrudes from the handle assembly 20. The housing of the handle
assembly 20 has a body shaped like a pistol having a handle portion
made of a two-piece construction of molded plastic components 22
and 24. A pair of elongated needles 56 extends from housing 20
through the shaft 34 into the tissue-engaging tip 32. Each needle
56 has a non-tissue engaging end in the housing having a spherical
member 58, such as a ball or bearing, attached thereto. Both
needles 56 and spherical members 58 may be a made of metal, such as
surgical stainless steel. The spherical member 58 may have a bore
58B into which the non-tissue engaging ends of the needles 56
extend and are joined thereto, such as by welding or brazing.
[0094] The suturing instrument 10 includes an actuator member 64
preferably in the form of a lever 64 having two pins 64A extending
into holes 22A and 24A in the sides of housing 22 and 24
respectively, upon which pins the actuator member is pivotally
mounted in the housing. Actuator member 64 extends through an
opening 22D and 24D (FIGS. 3 and 4) in housing 20 to enable pivotal
movement about pins 64A. An extension spring 66 is provided which
hooks at one end in a notch 64E of actuator member 64 and is
connected at the other end around a handle spring post 24E, which
extends into a handle post receiving pocket located in the side of
housings 24 and 22, respectively, such that the actuator member 64
is spring biased to retain actuator member 64 normally in a forward
position, as shown for example in FIG. 1.
[0095] Ball sockets 64B are provided in the actuator member 64
which is shaped to received both of the non-engaging ends of
needles 56, i.e., spherical members 58, to be driven forward by an
operator pulling actuator member 64 to pivot actuator member 64
within lever openings 22D and 24D. Two slots 64C (FIG. 3) are
provided for needle shafts 56D near the spherical members 58. An
additional central slot 64D is also provided to allow free passage
of suture tube 54 and cutter tube 72.
[0096] With its right handle half 22 shown removed and its left
handle half 24 shown in place, FIG. 2 best illustrates the
relationship between the handle housing 20 and the tube shaft 34.
Note the slotted capture feature 24C in handle 24 engages the
annular protruding capture feature 34C of tube shaft 34. The
partially exploded view of FIG. 3. further reveals the
anti-rotation feature 34D of tube shaft 34 which is constrained by
the corresponding pocket 24K of handle 24. At its interface with
handle assembly 20, tube shaft 34 exits through hole 22B and
24B.
[0097] The partially exploded perspective view of FIG. 3 highlights
the major functional elements of the tissue suturing instrument 10,
which include the handle assembly 20, a vacuum assembly 30, a
needle drive and suture storage assembly 40, and a tissue cutting
shuttle assembly 50, which enable tissue incision and guide wire
installation. A clear plastic suture-viewing window 62 is shown in
position relative to lever 64 and to suture tube 54.
[0098] FIG. 4 is a fully exploded perspective view of the tissue
suturing instrument 10 showing its right handle portion 22, left
handle portion 24, needle actuating lever 64, and its spring 66.
The disassembled tube shaft assembly 30 is comprised, from distal
to proximal, of a distal tip 32, tube shaft 34, a needle guide 40,
a vacuum housing 36, a vacuum seal 38. Also contained therein, as
shown in the breakaway in FIG. 2, are the needles 56, suture tube
54 with its suture 52, along with cutter tube 72 attached at its
distal end to blade shuttle or follower 70 and its integrated blade
68 and, at its proximal end 72D, to funnel knob 74 capped by guide
wire seal 76.
[0099] FIG. 5 is a perspective view of the instrument 10 now shown
having a tube shaft 35 that is bent, flexible, malleable or steer
able as indicated at the curved section 35A near the middle of the
shaft. A non-straight or non-rigid shaft enables access to many
potentially clinically relevant sites that are not reachable by
straight or rigid instruments.
[0100] FIGS. 6A, 6B, 7A and 7B present the vacuum mediated tissue
positioning function of this first preferred embodiment. FIG. 6A is
a sectioned partially exploded view of the vacuum features of tube
shaft 34. FIG. 6B is a slightly enlarged (relative to FIG. 6A)
perspective view of distal tip 32. Vacuum is applied through
attaching a tube connected to a negative pressure source at the
hose connector 36D of rotational housing 36 (previously first
described in U.S. Pat. No. 6,997,931 B2). This housing has an
additional port 36C, which is closed by cap 42. Communicating hole
36B in vacuum housing 36 facilitates transmission of vacuum between
the vacuum source and the tube shaft 34 through the hole 34B. The
lip seals 36A on either side of housing 36 prevents vacuum leakage
even during rotation of the vacuum housing 36 about tube shaft 34.
Communicating hole 40G of needle guide 40 transmits vacuum to the
vacuum channel 40A of needle guide 40. Vacuum seal 38 has a
compressible rim 38A which seals against the inside surface of
capture feature 34C. This seal also prevents vacuum leakage around
the needles 56 (not shown) at 38D and the shuttle tube 72 (not
shown) at 38C and the suture tube 54 (not shown) at 38B.
[0101] The end view drawing on the left side of FIG. 7A shows
features of distal tip 32 with a the continuous path for vacuum
through channels 32N, which communicate with slots 32L located in
the manifold bed 32C to ultimately draw tissue into contoured gaps
32D separated by septum 32E and down against manifold bed 32C to
form a pleat in the tissue to enable purse string suture placement.
Note the cut away shown beneath distal tissue gap 32D. Also note
cut location features 32H, which controls cut length in tissue by
setting the start and stop points of the cut. Tissue stop features
32K prevent tissue from being sucked into the proximal and distal
ends of tissue gaps 32D. FIG. 7B also illustrates needle passages
32A, blade track 32B, shuttle track 32M and ferrule compartment 32F
with ferrule stop 32G.
[0102] FIG. 6B is an isometric view of the features described above
in FIG. 7. In addition, FIG. 6B well illustrates the guide wire
exit hole 32P and the rounded end 32J of distal tip 32.
[0103] FIGS. 8A, 8B and 8C show the needle drive components. Many
of the features in FIG. 8A. have already been individually
described. This illustration shows the relationship between the
pivoting lever 64 with its two ball sockets 64B and needle slots
64C and the needles 56 as well as the needle track features 41D of
the needle guide 41. FIG. 8B shows an enlarged view of a needle
ball 58 with bearing surface 58A and a needle receiving opening
58B, which attaches to the proximal needle end 56E. FIG. 8C shows
the distal needle end 56D, which connects to the distal tip of the
needle where ferrule engagement occurs. Needle ferrule stop
shoulder 56C is proximal to asymmetric ferrule snap feature 56B,
which includes opposing relief sections 56F for engaging and
releasing ferrules 52A (shown in FIGS. 9B and 9C) at the
symmetrical annular ferrule snap 52B. As can be seen, the needle
and section 56D has a larger diameter than the needle tip section.
The ferrule snap feature 506B located proximate to the distal end
of the needle has a dimension in one direction that is larger than
a diameter of the adjacent needle section and a dimension in
another direction, in this case orthogonal to the first direction
smaller than the needle dimension. Preferably, the surface in the
enlarged dimension is the rounded surface as indicated at 56B,
while the surface in the other direction is a flat surface as
indicated at 56F. A sharp pointed tip 56A, shown here in a conical
shape, is located at the most distal end of needle 56.
[0104] FIG. 9C shows the asymmetric needle snap feature 56B
engaging the symmetrical annular ferrule snap 52B to temporarily
attach the needle 56 to the ferrule 52A. The opposing relief
sections 56F of needle snap feature 56B permit release of ferrules
52A off of needle snap feature 56B by providing clearance for the
tubular ferrule to temporarily deform into an oval shape and pass
over the larger diameter needle snap feature 56B. It will be
appreciated that the ferrule is at least somewhat resilient to
permit to be deformed when the needle passes through the
constricted portion defined by interior circumferential rib 52B. As
can be seen, the rib 52B may be formed by deforming the sleeve
inwardly at the location of the rib.
[0105] FIGS. 9A, 9Ba and 9C highlight the suture and suture storage
of this embodiment. A complete suture set 52 is comprised of a
single strand of suture 52C attached to two ferrules 52A, one at
each end. Each ferrule 52A is held in its individual ferrule
compartment 32F (see FIGS. 7A, 7B,10A and 10B) with the attached
suture 52C fed through the distal tip 32 within the suture tube 54
underneath blade shuttle 70. The suture 52C continues back within
the suture tube 54 through the opening 41B in the needle guide 41.
The suture tube 54 passes through the vacuum seal 38, enters the
cavity within handle halves 22 and 24, traverses the lever slot 64D
in lever 64 and the suture tube distal end 54B terminates into the
opening described by the recesses 22G and 24G in handle halves 22
and 24, respectively.
[0106] The mid section of suture set 52 is arranged to indicate
suture 52C payout achieved by successful pick-up of both ferrules
52A; this tell-tale safety feature demonstrates the pulling of both
ferrules was described in U.S. Pat. No. 6,641,592 B1. Tell-tale
suture loops 52D are arranged immediately to the ferrule side of
the mid point of the suture strand. When the suture 52C connected
to each ferrule 52A is pulled toward the handle by the needles 56,
these tell-tale loops 52D straighten out as an indicator of
successful ferrule 52A pick-up.
[0107] FIG. 10A shows the arrangement and location through the
clear window 62 of both tell-tale suture loops 52D separated by a
septum composed of handle features 22J and 24J with both ferrules
52A remain held in their ferrule pockets 32F in the distal tip 32.
FIG. 10B shows the appearance of the now straightened out tell-tale
loops (pulled through handle channel composed of openings 22G and
24G) evident of needle 56 retraction of both ferrules 52A with
their attached suture 52C. As used herein, and in the claims, clear
and are transparent or exemplary and are meant to describe a window
through which the suture portions 52D can be seen, and not to
suggest that the window is clear or transparent in an optical
sense.
[0108] FIGS. 11A-11F are perspective views of the tissue cutting
and guide wire passage components 50 of instrument 10 of FIG. 1 as
shown assembled in FIG. 3. Note the reference lines located at the
proximal and distal ends of these drawings to help indicate the
relative travel of the funnel knob 74 disposed on the proximal and
of longitudinal blade actuator 72 and the blade shuttle 70 located
on the distal end thereof, respectively. FIG. 11A shows the funnel
knob fully forward. FIG. 11B shows the position of the blade
shuttle 70 relative to the distal tip 32 of FIG. 11A.
[0109] FIG. 11C shows the cutter control funnel knob 74 back about
half way and the cutting blade 68 near the middle of the tissue
manifold bed 32C. FIG. 11D shows the blade shuttle 70 relative to
the distal tip 32 of FIG. 11C. FIG. 11E shows funnel knob 74 in the
fully back position with the guide 80 passing through guide wire
seal 76 and through shuttle tube 72. The distal end 80A of guide
wire 80 exits in an upward orientation out of an upturned portion
72B of the shuttle tube 72 and a guide wire exit hole 32P at the
proximal side of distal tip 32. FIG. 11F shows blade shuttle
relative to the distal tip 32 of FIG. 11E and well illustrates the
curved guide wire director 72B located at the distal end of the
shuttle tube 72, where the guide wire 80 is diverted in the upward
directed.
[0110] FIG. 12A-12E show end views and cross section views of the
blade shuttle components of the instrument of FIG. 3. FIGS. 12A and
12 B show a guide wire seal having a slit 76A acts as closed valve
until it receives and seals around a guide wire 80 (not shown).
Guide wire seal 76 includes a recessed pocket 76B to engage and
seal on raised seal lip 74E at the proximal end of funnel knob 74,
FIG. 12C. A tapered guide wire receiving aperture 74A communicates
with a stepped longitudinal bore having a distal shoulder 74D for
engaging the proximal end 72D of shuttle tube 72 and an enlarged
shuttle tube receiving opening 74C within funnel knob 74, which is
gripped and pulled by grasping surface 74B. FIG. 12D shows the
proximal end 72D of shuttle tube 72, which can be attached to
funnel tube opening 74C by means such as gluing or welding.
[0111] FIG. 12E shows that the distal end of shuttle tube 72 is
received in opening 70B of blade shuttle 70, which also holds blade
68 in slot 70A thereof. Blade 68 can be attached to blade shuttle
70 by means such pinning, gluing or welding. The blade 68
incorporates a sharpened tip 68A and a sharpened curved cutting
surface 68B. Blade shuttle 70 includes bearing surfaces 70C, which
ride within corresponding features 32M of distal tip 32 as shown in
the end of FIG. 7.
[0112] FIGS. 13A-13G are perspective views of the instrument of
FIG. 1 with the right handle housing 22 removed and the distal tip
32 magnified relative to the rest of the drawing. These drawings
highlight the needle-suture function along with the tissue cutting
and guide wire passage features. FIG. 13A shows the lever 64 fully
forward with the needles 56 (not visible) fully retracted and not
extending into the tissue jaw 32R. FIG. 13B shows the lever 64
partially rotated back and the needles 56 now extending into the
distal tissue receiving region 32D of tissue jaw 32R. FIG. 13C
shows the lever 64 fully rotated back and the needles 56 fully
forward through the tissue jaw 32R to fully engage both suture
ferrules 52A (not visible).
[0113] FIG. 13D shows the lever 64 partially released and the
needles 56 along with the engaged or picked-up ferrules 52A with
their attached suture 52C traversing back through the tissue jaw
32R. FIG. 13E shows the lever 64 fully released in its forward
position, and the needles 56 and suture 52C fully extending across
tissue jaw 32R. FIG. 13F shows the blade knob 74 with its attached
shuttle tube 72 and blade 68 partially pulled back into tissue
receiving region of the jaw 32R. FIG. 13G shows the blade knob 74
with its attached shuttle tube 72 and blade 68 (not visible) now
fully pulled back. The proximal end 80B of guide wire 80 is
inserted into the guide wire opening 76A (not shown) through the
guide wire seal 76 on the shuttle pull knob 74 attached to shuttle
tube 72, through which tube the guide wire 80 passes until it exits
the upturned, curved guide wire opening 32P in the distal tip 32.
The distal tip 80A of guide wire 80 advances in an upward direction
because of the curved feature 72D in the distal end of the shuttle
tube 72, which are not visible in this drawing because they are
internal features.
[0114] FIG. 14 is a schematic illustration of a sagittal cross
section of a human female pelvis providing a perspective view of
the surgical suturing instrument 10 shown in a transanal 160
application. The placement of the shaft 34 of the instrument 10
determines the location of the distal tip 32. The right leg 150 and
anterior abdominal wall 140 are labeled at the top of the drawing.
The bladder 120 and uterus 110 are in the peritoneal cavity 130
above the rectum 100. Tissue receiving gaps 32D and projection 32E
in the tissue jaw 32R of distal tip 32 hold the rectal wall tissue
in a pleated configuration in preparation for purse string
suturing, tissue incision and guide wire passage. Use of this
innovation is also beneficial in other tubular tissue structures,
such as the vagina, esophagus, stomach, small intestine, cecum, the
entire colon and even the urinary bladder.
[0115] FIGS. 15A-15R show a method in accordance with this
invention for opening and closing a transmural access site. FIG.
15A is a perspective view of the distal end 32 of the instrument 10
and a schematic representation of a tubular tissue segment such as
rectal tubular tissue 100. The arrow indicates the direction in
which the rounded distal end 32J of the distal tip 32 will enter
the inner space or lumen of rectal tissue structure 100. FIG. 15B
is a perspective view of the rounded most distal end 32J now
inserted into the lumen of the tubular tissue structure 100 and a
hidden line representation of the remainder of the distal tip
32.
[0116] FIG. 15C shows a segment of the wall tissue sucked into the
tissue receiving region of the jaw 32R of the distal tip 32 and
contoured to form a pleat corresponding to the shape of the tissue
gaps 32D and projecting tissue septum 32E. FIG. 15D shows both
needles 56 partially advanced through the tissue over the manifold
into the proximal tissue gap 32D; the arrow indicates the direction
and length of the traverse of the needles 56. FIG. 15E shows the
needles 56 fully advanced above the tissue held in the proximal and
distal tissue gaps 32D, but through and under the tissue at the
tissue septum 32E; the arrow indicates the direction and full
length of the traverse of the needles 56. FIG. 15F shows ferrules
52A at each end of the attached suture 52C coming back over the
tissue in the proximal and distal tissue gaps 32D but under the
tissue at tissue septum 32E; this suture placement creates a purse
string configuration. The operator can now see through window 62
that the tell-tale suture loops have straightened out (FIGS.
10A-10B) to ensure effective suture pick-up. If either tell-tale
suture loop remains looped, satisfactory suture pick-up may not
have occurred. Prior to cutting any tissue, the operator can remove
the device and suture from the patient, view the targeted site
again and determine if another transmural attempt should be
made.
[0117] FIG. 15G shows the tissue cutting blade 68 pulled back
partially cutting the tissue 100 held against the manifold bed
between the a purse string suture 52 placed within the segment of
the tissue sucked against the manifold bed 32C of the jaw 32R. FIG.
15H shows a completed incision 101 in the tissue held against the
manifold bed 32C in the tissue jaw 32R; note the vertical incision
seen at the proximal cut location feature 32H. FIG. 15J shows a
guide wire 80 advancing through the incision 101 in the tissue held
in the tissue jaw 32R. FIG. 15K shows the instrument 10 pulled out
of the rectal tubular tissue structure 100 leaving a purse string
suture 52 in place around an incision 101 with a guide wire 80 also
left in place through the incision 101. FIG. 15L shows the incision
101 circumscribed with a purse string suture 52 and containing the
guide wire 80 over which an endoscope 85 is passed to complete the
desired procedure.
[0118] FIG. 15M shows the rectal tubular tissue structure 100 with
its incision 101 circumscribed with a purse string suture 52 after
the guide wire 80 and all other instruments are removed. FIG. 15N
shows the tubular tissue structure 100 with its incision 101 now
drawn closed by placing tension on the ends of the purse string
suture 52. FIG. 15P shows a suture fastener 91 installed in the tip
of the suture fastening and cutting device 90 being passed along
this suture toward the purse string closure site. FIG. 15R is a
close-up perspective view from the inside of the tubular tissue
structure 100 with the incision 101 now secured closed by purse
string suture 52C held in place with a mechanical fastener 91 and
the extra suture material trimmed away. The suture fastener
instrument 90 and trimmed suture ends are already removed.
[0119] The creation of durable tissue plications, an additional
example application of this first preferred embodiment, can also be
explained using FIGS. 15A-15R. Similar to using this first
preferred embodiment (just reviewed) for opening and closing a
transmural access site, the construction of a long-lasting
thickening and tightening plication can be achieved with the same
instrument 10 minus utilization of the guide wire passage features.
Referring now to FIGS. 13A-13B of instrument 10 of FIG. 1, the
instrument distal tip 32 is passed through a natural orifice and
positioned at an appropriate location in a tubular tissue
structure. Instead of the tubular tissue structure 100 representing
the rectum as in the above example, for this example, assume the
same tubular tissue structure 100 now represents the distal
esophagus. The instrument 10 is now proportionally smaller than the
previously described instrument 10 since the esophagus is usually
smaller than the rectum.
[0120] FIG. 15C now represents the wall of the distal esophagus of
tubular tissue 100 as it is drawn by vacuum into the tissue jaw
32R. FIGS. 13D-13F show the simultaneous traverse and retraction of
both needles 56 through the contoured tissue for placement of
sutures 52C in the purse string configuration. As described for
transmural access, the vertical tissue cutting blade 68 is guided
through the held tissue to create a tissue incision 101. This
incision, which can be cut either fully or partially through the
wall of the esophageal tissue, opens the protective mucosal lining
and exposes the submucosal tissue containing the tissue healing
elements that can promote actual healing at the wound site.
[0121] Passage of a guide wire 80 and utilization of the opening
for manipulating other instruments (e.g., an endoscope 85) as
illustrated in FIGS. 15J-15L are not required for this plication
application. Note, however, that instrument 10 without guide wire
80 must still be removed as shown in FIG. 15K prior to closing the
prepared wound with the incision 101 circumscribed by the purse
string sutures 52C as shown in FIGS. 15M-15R. Rather, after making
a successful incision 101 of FIG. 15H, the instrument is removed
and the wound closure steps of FIGS. 15M-15R are promptly
initiated. To bulk up and tighten the distal esophagus thereby
enhancing the effect of the anti-reflux valve naturally located
there, the suture 52 is drawn tight to close the wound. A surgical
knot or mechanical fastener 91 (FIG. 15P-15R) is applied to secure
the suture 52C, which is trimmed of its redundant suture tails.
Further wound site manipulation should be avoided to optimize the
potential of successful plication healing.
[0122] FIG. 16 is a perspective view of an instrument 12 in
accordance with a second preferred embodiment of this invention.
This embodiment has the same features and functions as the
instrument 10 of the first preferred embodiment of FIG. 1, except
its distal tip 44 is shown with a different tissue engaging jaw 44R
and it incorporates a horizontal cutting blade instead of a
vertical cutting blade.
[0123] FIG. 17A is a partial section view of the distal tissue
engaging tip 44 of the instrument 12 of FIG. 16 showing a needle 56
in a needle track 44A and ferrule 52A with suture 52C both located
in a ferrule pocket 44F abutting against a ferrule stop 44G. The
angled horizontal cutting blade 46 is guided by a blade track 44B
when it is pulled by blade wires 48. The longer tissue jaw 44R of
this embodiment consists of three distal gaps (proximal, middle and
distal) 44D and two projecting tissue septums (proximal and distal)
44E to provide for two more tissue engagement bites to form a
double pleat in the tissue with both needles in this purse string
suture configuration. A vertical perforated wall 44H defines the
proximal boundary of tissue jaw 44R. Note arrows indicating views
through A-A and through B-B.
[0124] FIG. 17B is a section view through A-A of FIG. 17A. This
view highlights tissue chamber 44K, which is separated from the
upper opening in the tissue jaw 44R by the path of the horizontal
blade 46. Vacuum channels 44N communicate through vacuum slots 44L
with tissue chamber 44K. The vacuum is also transferred through the
vacuum perforations 44M in vertical perforated wall 44H.
[0125] FIG. 17C is a section view through B-B of FIG. 17A showing
the horizontal cutting blade 46 with its angled sharp edge 46A
along with its attached wire pulling members 48 from instrument 12
of FIG. 16. Separated wire blade pulling members 48 can be attached
to themselves 48B or to the horizontal blade 46 at location 48A by
means such as welding, brazing or gluing. The bottom tissue contact
surface 44C of tissue chamber 44K represents the deepest tissue
engagement surface. Vacuum openings 44M provide vacuum to the
bottom of each tissue gap 44D.
[0126] FIGS. 18A, 18B and 18C show the distal tip of the instrument
12. These perspective views illustrate the horizontal blade 46
passage over tissue receiving chamber 44K. FIG. 18A shows the
needles 56 exiting the vertical perforated wall 44H and partially
advanced into the middle tissue gap 44D. FIG. 18B shows the needles
56 fully advanced into ferrules 52A (not shown) with the horizontal
blade 46 partially pulled back towards the vertical perforated wall
44H. FIG. 18C again shows the needles 56 fully advanced, but now
the horizontal blade is shown entering under the vertical
perforated wall 44H to create a shearing edge.
[0127] FIG. 19 is a perspective section view of the left half of
the distal tip 44 of instrument 12 of FIG. 16. This partial
cut-away illustrates how this instrument engages a lesion 104
attached to the wall of a tubular tissue structure 102 within its
tissue receiving chamber 44K in jaw 44R. Note how the lesion 104 is
positioned between the horizontal blade 46, the wire blade pulling
members 48 and the vertical perforated wall 44H.
[0128] FIG. 20A is a partial section view of the distal tip 44 of
the instrument 12 inside of a tubular tissue structure 102
containing a lesion 104. Tissue receiving jaw 44R is positioned to
receive lesion 104 and its adjacent wall tissue and to form a pleat
in the tissue proximate the lesion. FIG. 20B shows the effects of
the vacuum causing the distal tip 44 inside of a tubular tissue
structure 102 to now draw the lesion 104 into the jaw 44R. The
adjacent wall tissue is shown drawn over the tissue gaps 44D and
tissue projection septums 44E and into tissue chamber 44K. Needles
56 and ferrules 52A attached to suture 52C remain in their original
positions. FIG. 20C appears similar to FIG. 20B, except here the
needles 56 are shown fully advanced through the contoured tissue
and into the ferrules 52A.
[0129] FIG. 20D represents the next step after FIG. 20C. The
needles 56 are now retracted back to their original position along
with the ferrules 52A and attached suture 52C to create a purse
string configuration. Note the horizontal cutting blade 46 is in
its distal starting position. FIG. 20E shows the horizontal cutting
blade 46 now in its most proximal position having amputated off the
lesion 104 along with surrounding wall tissue, which is now
contained within tissue chamber 44K. FIG. 20F shows the distal tip
44 of the instrument 12 of FIG. 16 now released from the inside of
a tubular tissue structure 102 with the purse string suture 52C in
place through its undulating course within the surrounding
tissue.
[0130] Recently, at a Harvard/Brigham and Woman's Hospital research
facility in Boston, we conducted a series of laboratory studies of
this first embodiment of this invention for use in transmural
access. The new technology enabled the remote placement of a single
suture in a purse string configuration (i.e., a series of bites
into and out of the wall in a plane of tissue) around a transmural
incision. The abstract form our first ex vivo entitled, "EVALUATING
AN OPTIMAL GASTRIC CLOSURE METHOD FOR TRANS-GASTRIC SURGERY," was
selected for presentation at the SAGES conference in Dallas on Apr.
29, 2006.
[0131] This presentation will compare "the effectiveness of various
techniques for gastrotomy closure by assessing leak pressures in an
ex vivo porcine stomach model." This abstract includes: "Results:
The unclosed controls demonstrated air leakage at a mean pressure
of 15 mm Hg (95% CI: 14-16), representing baseline system
resistance. The QuickClip closures leaked air at a mean pressure of
34.2 mm Hg (95% CI: 20.7-47.6). The prototype gastrotomy device
yielded a mean air leak pressures of 98 mm Hg (95% CI: 23.9-172.0),
while dramatically diminishing time for incision and hole closure
to approx. 5 minutes. The hand-sewn closures leaked air at a mean
pressure of 52.2 mm Hg (95% CI: 21.2-83.2) . . . . Conclusions: The
prototype gastrotomy device decreases procedure time and yields
leak-resistant gastrotomy closures that are superior to clips and
rival hand-sewn interrupted stitches."
[0132] Results from the survivor studies from this research were
accepted for presentation at the next Digestive Disease Week
conference in May 2006. This abstract from the in vivo study,
"Transcolonic Access to the Peritoneal Cavity Using a Novel
Incision and Closure Device," notes "Closure of transluminal
incisions can be performed using a variety of techniques, however
these are technically demanding and inconsistent. Here we report
the use of a novel combined incision and closure device from LSI
Solutions . . . . Results. The colonic incision was easily
performed and peritoneal cavity accessed without difficulty using
the LSI device. Following endosope withdrawal into the lumen,
complete closure was achieved in under one minute using the device.
All animals survived 14 days without apparent sequelae before
elective sacrifice. At necropsy, limited pelvic adhesions were
identified and the incision sites were completely closed and well
healed. Conclusion. Use of this novel incision and closure device
allows transcolonic access to the peritoneal cavity in addition to
the rapid, complete, and reproducible closure of the colonic
incision. This will likely improve the efficiency and safety of
translumenal procedures."
[0133] While the invention has been described in connection with a
number of presently preferred embodiments thereof, those skilled in
the art will recognize that many modifications and changes may be
made therein without departing from the true spirit and scope of
the invention which accordingly is intended to be defined solely by
the appended claims.
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