INFLATABLE ACCESS DEVICE
BACKGROUND [0001] i. Field of the Invention
[0002] The present invention generally relates to surgical devices and, more particularly, to surgical devices for manipulating tissue within a patient's body. [0003] ii. Description of the Related Art [0004] Traditional, or open, surgical techniques may require a surgeon to make large incisions in a patient's body in order to access a tissue treatment region, or surgical site. In some instances, these large incisions may prolong the recovery time of and/or increase the scarring to the patient. As a result, minimally invasive surgical techniques are becoming more preferred among surgeons and patients owing to the reduced size of the incisions required for various procedures. In some circumstances, minimally invasive surgical techniques may reduce the possibility that the patient will suffer undesirable post-surgical conditions, such as scarring and/or infections, for example. Further, such minimally invasive techniques can allow the patient to recover more rapidly as compared to traditional surgical procedures. [0005] Endoscopy is one minimally invasive surgical technique which allows a surgeon to view and evaluate a surgical site by inserting at least one cannula, or trocar, into the patient's body through a natural opening in the body and/or through a relatively small incision. In use, an endoscope can be inserted into, or through, the trocar so that the surgeon can observe the surgical site. In various embodiments, the endoscope may include a flexible or rigid shaft, a camera and/or other suitable optical device, and a handle portion. In at least one embodiment, the optical device can be located on a first, or distal, end of the shaft and the handle portion can be located on a second, or proximal, end of the shaft. In various embodiments, the endoscope may also be configured to assist a surgeon in taking biopsies, retrieving foreign objects, and introducing surgical instruments into the surgical site. [0006] Laparoscopic surgery is another minimally invasive surgical technique where procedures in the abdominal or pelvic cavities can be performed through small incisions in the patient's body. A key element of laparoscopic surgery is the use of a laparoscope which typically includes a telescopic lens system that can be connected to a video camera. In various embodiments, a laparoscope can further include a fiber optic system connected to a halogen or xenon light source, for example, in order to illuminate the surgical site. In various laparoscopic, and/or endoscopic, surgical procedures, a body cavity of a patient, such as the abdominal cavity, for example, can be insufflated with carbon dioxide gas, for example, in order to create a temporary working space for the surgeon. In such procedures, a cavity wall can be elevated above the organs within the cavity by the carbon dioxide gas. Carbon dioxide gas is usually used for insufflation because it can be easily absorbed and removed by the body. [0007] In at least one minimally invasive surgical procedure, an endoscope and/or laparoscope can be inserted through a natural opening of a patient to allow a surgeon to access a surgical site. Such procedures are generally referred to as Nature Orifice Transluminal Endoscopic Surgery or (NOTES)TM and can be utilized to treat tissue while reducing the number of incisions, and external scars, to a patient's body. In various NOTES procedures, for example, an endoscope can include at least one working channel defined
therein which can be used to allow the surgeon to insert a surgical instrument therethrough in order to access the surgical site.
SUMMARY
[0008] According to at least one aspect of the invention, surgical instruments including a frangible sleeve can be utilized to facilitate the entry of a deflated balloon into a surgical site. In various embodiments, as described herein, the frangible sleeve can allow a surgeon to easily introduce a deflated balloon into a surgical site.
[0009] In at least one aspect, the invention relates to a surgical instrument for use in manipulating tissue within the body of a patient. In various embodiments, the surgical instrument can include a balloon, and a sleeve, wherein the balloon can be configured to be transitioned, for example, from a collapsed position to an expanded position, wherein the sleeve can include at least one frangible portion, for example, and wherein the sleeve can be configured to at least partially surround the balloon when the balloon is in a collapsed position and to at least partially separate along the at least one frangible portion when the balloon is in an expanded position, for example.
[0010] In various embodiments, the at least one frangible portion on the sleeve of the surgical instrument can be configured to extend in various configurations relative to a longitudinal axis of the sleeve. In at least one embodiment, the frangible portion can be configured to extend in at least one line which is parallel, or at least substantially parallel, to the longitudinal axis of the sleeve. In a further embodiment, the frangible portion can be configured to extend in two, three, four or more lines, wherein each line is parallel, or at least substantially parallel, to the longitudinal axis of the sleeve. In another embodiment, the frangible portion can be configured to extend in at least one substantially helical pattern relative to the longitudinal axis of the sleeve. In a further embodiment, the frangible portion can be configured to extend along at least two congruent, or at least substantially congruent, helical patterns relative to the longitudinal axis of the sleeve. In a further embodiment, the at least two congruent, or at least substantially congruent, helical patterns do not intersect along a central portion of the sleeve, for example. In another embodiment, the frangible portion on the sleeve of the surgical instrument can be configured to extend in a pattern, wherein the pattern is substantially parallel to the longitudinal axis of the sleeve along a first portion of the sleeve and substantially helical relative to the longitudinal axis of the sleeve along a second portion of the sleeve. In at least one embodiment, the frangible portion comprises a perforation. In a further embodiment, the frangible portion comprises a score.
[0011] In at least one form of the invention, the surgical instrument can further include a catheter configured to be attached to a proximal portion of the balloon, for example, and optionally further configured to be attached to a distal portion of the balloon, for example. In various embodiments, the sleeve can further include an anchor portion at at least one end of the sleeve. In a further embodiment, the anchor portion of the sleeve can be located at a proximal portion of the sleeve and can be configured to be attached to a portion of the catheter adjacent to a proximal portion of the balloon. In an additional embodiment, the sleeve can further include a tapered transition portion at a distal portion of the sleeve configured to be located adjacent to a distal portion of the
balloon. In another further embodiment, the anchor portion of the sleeve can be located at a distal portion of the sleeve and can be configured to be attached to a portion of the catheter adjacent to a distal portion of the balloon. [0012] In at least one form of the invention, the surgical instrument can further include an endoscope, for example, including an endoscope lumen extending along a longitudinal axis of the endoscope. According to this embodiment, the balloon and the sleeve can be slidably received within the endoscope lumen. In a further form of the invention, the surgical instrument can further include a trocar, for example, including a trocar lumen extending along the longitudinal axis of the trocar. According to this embodiment, the balloon and the sleeve, and optionally an endoscope, can be slidably received within the trocar lumen.
[0013] In another aspect, the invention relates to a surgical kit for use in manipulating tissue within the body of a patient. In at least one form of the invention, the kit can include a balloon, a sleeve, a catheter, and an endoscope, wherein the balloon can be configured to be transitioned from a collapsed position to an expanded position, wherein the sleeve can include at least one frangible portion and wherein the sleeve can be configured to at least partially surround the balloon when the balloon is in the collapsed position and to at least partially release along the at least one frangible portion when the balloon is in the expanded position, wherein the catheter can be configured to be attached to at least a portion of the balloon, and wherein the endoscope further includes an endoscope lumen and wherein the catheter, balloon and sleeve can be slidably received within the endoscope lumen. In a further embodiment, the surgical kit can further include a trocar, wherein the trocar can include a trocar lumen extending along the longitudinal axis of the trocar and wherein the endoscope can be slidably received within the trocar lumen.
BRIEF DESCRIPTION OF THE FIGURES
[0014] The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
[0015] FIG. 1 is a diagram of a surgical instrument including a catheter, a balloon, a frangible sleeve and a needle in accordance with one non-limiting embodiment of the present invention;
[0016] FIG. 2 is a diagram of a sleeve including linear frangible portions in accordance with one non-limiting embodiment of the present invention; [0017] FIG. 3 is a diagram of a sleeve including a helical frangible portion in accordance with one non-limiting embodiment of the present invention; [0018] FIG. 4 is a diagram of a sleeve including two congruent helical frangible portions in accordance with one nonlimiting embodiment of the present invention; [0019] FIG. 5 is a diagram of a sleeve including frangible portions that are linearly arranged along a first portion and helically arranged along a second portion in accordance with one non-limiting embodiment of the present invention; [0020] FIG. 6 is a diagram of a surgical instrument including an endoscopic trocar, an endoscope, a catheter, a balloon, a sleeve and a needle after the needle has been inserted through a tissue wall in accordance with one non-limiting embodiment of the present invention;
[0021] FIG. 7 is a diagram of the surgical instrument of FIG. 6 after the balloon and sleeve have been inserted into the tissue wall in accordance with one non-limiting embodiment of the present invention;
[0022] FIG. 8 is a diagram of the surgical instrument of FIG. 6 after the balloon has been expanded in the tissue wall cavity and the sleeve has torn along its frangible portion in accordance with one non-limiting embodiment of the present invention;
[0023] FIG. 9 is a diagram of the surgical instrument of FIG. 6 after the endoscope, balloon and sleeve have been inserted through the tissue wall and the balloon has been deflated in accordance with one non-limiting embodiment of the present invention;
[0024] FIG. 10 is a diagram of the surgical instrument of FIG. 6 after the endoscope, balloon and sleeve have been inserted through the tissue wall, the balloon has been deflated and the balloon and sleeve are being retracted into the endoscope lumen in accordance with one non-limiting embodiment of the present invention;
[0025] FIG. 11 is a diagram of a surgical instrument including a catheter, a balloon, a frangible sleeve and a needle in accordance with one alternative non-limiting embodiment of the present invention;
[0026] FIG. 12 is a diagram of the surgical instrument of FIG. 11 after the balloon has been expanded in the tissue wall cavity and the sleeve has torn along its frangible portion in accordance with one non-limiting embodiment of the present invention;
[0027] FIG. 13 is a diagram of the surgical instrument of FIG. 11 after the endoscope, balloon and sleeve have been inserted through the tissue wall and the balloon has been deflated in accordance with one non-limiting embodiment of the present invention;
[0028] FIG. 14 is a diagram of the surgical instrument of FIG. 11 after the endoscope, balloon and sleeve have been inserted through the tissue wall, the balloon has been deflated and the balloon and sleeve are being retracted into the endoscope lumen in accordance with one non-limiting embodiment of the present invention;
[0029] FIG. 15 is a diagram of the surgical instrument of FIG. 11 as the balloon and sleeve are being retracted into the endoscope lumen in accordance with one non-limiting embodiment of the present invention; [0030] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate preferred embodiments of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
DETAILED DESCRIPTION
[0031] During the course of various surgical procedures, especially in intraluminal and transluminal procedures, there often exists a need to create a surgical space for advancing surgical instruments or for allowing a surgeon to access a surgical site, for example. Various surgical instruments include expandable balloons to create a surgical space in advance of the surgical instrument. For example, a surgical instrument may include a small needle or guidewire that can be first introduced through an organ wall, for example. A deflated balloon can then be introduced into the hole created by the advancing needle or guidewire. As the balloon is transitioned from a deflated or collapsed position to an inflated or
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