Suturing method and apparatus
A suturing apparatus comprises an elongated body, at least one arms movable relative to the elongated body and at least one needle movable relative to the elongated body. The arm releasably holds an end portion of a length of suture. The arm has a sharp end portion adapted to pierce an inner surface of a wall of a biological structure and pass an end portion of the suture through the inner surface. The needle is adapted to pierce the inner surface of such biological structure at a location proximal to the location where the end portion of the suture was inserted. The needle captures an end portion of the suture from the arm and draws the end portion of the suture back through the inner surface. The end of the suture is then drawn out of the biological structure by removing the elongated body.
This application is a divisional of U.S. application Ser. No. 09/882,821, filed Jun. 14, 2001, which claims the benefit of U.S. Provisional Application No. 60/211,763, filed Jun. 14, 2000, the entirety of both which are hereby incorporated by reference.
BACKGROUND OF THE INVENTION1. Field of the Invention
The present invention relates generally to medical devices, and more specifically to suturing devices and methods for applying suture to internal biological structures. The suturing devices and methods are well-suited for passing suture through the wall of a tubular biological structure from a location within the lumen or around the ostium for the purpose of closing the tubular biological structure. The suturing devices and methods are particularly well-suited for tubal sterilization.
2. Description of the Related Art
Each year, many thousands of women undergo some form of tubal sterilization in the United States and around the world. Tubal sterilization involves the blocking or removal of a segment from each of the fallopian tubes to prevent the fertilization of ovulated eggs. The various surgical methods used to accomplish tubal sterilization include: the laparoscopy method, the abdominal method, and the vaginal method.
In the laparoscopy method, one or two tiny incisions are made in the abdomen, in or near the navel. The laparoscope, a slim, lighted viewing tube, is inserted and a cauterizing instrument is passed through the laparoscope or through a second incision. The tubes are visualized so the surgeon can cauterize and seal each tube in turn.
In the abdominal method, a 3 to 4 inch incision is made just above the pubic hairline. The fallopian tubes are cut, sealed, and a section of each tube is removed. The ends of the tubes may be sealed or tied into the surrounding tissue.
In the vaginal method, the procedure is similar to the abdominal method. However, in this method the incision is made at the top of the vagina to avoid leaving a visible scar.
Unfortunately, these tubal sterilization procedures are quite invasive and involve the formation of one or more incisions. Because the incisions leave scars and can be damaging to the surrounding tissue, a need exists for an improved method for accomplishing tubal sterilization in a less invasive manner.
Hysterectomy is a common medical procedure in which the uterus is surgically removed from the body. Surgical removal of the uterus is widely accepted both by medical professionals and the public as an appropriate treatment for uterine cancer, and for various common non-cancerous uterine conditions that can produce often disabling levels of pain, discomfort, uterine bleeding, emotional distress, and related symptoms. A hysterectomy first requires cutting and tying the fallopian tubes to detach the uterus from the fallopian tubes. Accessing the fallopian tubes typically involves the formation of one or more incisions in the patient's skin as described above with respect to tubal sterilization procedures.
There are two traditional methods for removing the uterus from the body. The first method involves removing the uterus through a cut in the lower abdomen. The second method involves removing the uterus through a cut in the top of the vagina. The top of vagina is then sutured shut. Because these traditional hysterectomy methods involve the formation of one or more large incisions in the patient's abdomen or vagina in order to remove the uterus, a less invasive method is desired.
One less invasive method of hysterectomy has recently been developed and is known as laparoscopically-assisted vaginal hysterectomy (LAVH). In this procedure, a few small abdominal incisions are made which allow for the insertion of a laparoscope and specially designed instruments designed for detaching and removing the uterus. The procedure is referred to as “vaginal” because the uterus is then removed through the vagina. While this procedure has become quite popular with patients because of the shortened recovery time and reduced scarring, this method has been shown to have a higher complication rate than traditional vaginal or abdominal techniques. Therefore, an improved method for performing a hysterectomy is needed.
Vasectomy is a medical procedure in which the vas deferentia are surgically interrupted so that the sperm can no longer enter the ejaculatory ducts and fertilization cannot take place. In a conventional vasectomy, the surgeon makes one or two small incisions in the scrotum to gain access to the vas deferens. One vas deferens is isolated, drawn through the incision, and clamped at two sites close to each other. The segment between the clamps is then removed. The surgeon seals either one or two of the cut ends with sutures, clips, or cauterization using an electric needle. The vas deferens is gently placed back into the scrotum and the procedure is then repeated on the other vas deferens.
No-scalpel vasectomy (NSV) is a less invasive procedure in which the vas deferens are accessed without making any incisions in the scrotum. In this procedure, the surgeon makes only one tiny puncture in the scrotum using a special instrument. The instrument is then used to gently stretch the opening until the vas deferens can be pulled through it. The vas is then blocked using any of the same methods as conventional vasectomy.
A wide variety of other surgical procedures may involve the application of suture to biological structures, such as, for example, soft tissue approximation and the treatment of bladder or uterine prolapse. These procedures typically require the formation of one or more large incisions through the patient's skin in order to access the target site. Once the target site is accessed, the application of suture to the biological structure is often cumbersome and time consuming due to the anatomy of the biological structure or the consistency of the tissue.
Thus, there has been a long-felt need for new and improved devices and methods for applying suture to internal biological structures that are difficult to treat with existing suturing devices.
SUMMARY OF THE INVENTIONThe preferred embodiments of the present invention describe devices and methods for applying suture to internal biological structures. The suturing devices provide means for quickly and easily applying suture to areas of the body that are often difficult to access with existing suturing devices and methods. The suturing mechanism of these devices can be operated remotely from outside the body, thereby making it possible to perform a wide variety of surgical procedures in a minimally invasive or non-invasive manner.
One aspect of the invention relates to a suturing device for closing an opening in a tubular biological structure having an inner surface, such as, for example, a fallopian tube, a common bile duct, or an arterial-venous fistula. One embodiment comprises a suturing device for applying a suture, comprising an elongated body, at least one arm having a suture mounting portion, and at least one needle having a distal end. The suture mounting portion of the arm releasably holds a portion of the suture. The arm is mounted to cause an end portion of the arm to move (i) away from the elongated body from a first position to a second position and (ii) towards the elongated body from the second position to the first position. The end portion of the arm is adapted to penetrate tissue as the arm moves away from the elongated body to the second portion while holding the portion of the suture during such movement. The needle is mounted to move relative to the elongated body, the distal end of the needle movable from a first position adjacent to the elongated body to a second position adjacent the suture mounting portion of the arm when the arm is in the second position. The distal end of the needle is adapted to capture the portion of the suture from the suture mounting portion of the arm and draws the portion of the suture toward the elongated body.
The suturing device in one preferred embodiment is particularly adapted for closing a conical or funnel-shaped biological structure such as, for example, an ostium or an infundibulum where the uterine cavity narrows into the fallopian tube. However, this embodiment is not limited to such applications, and can be used for other biological structures as well. This embodiment is formed with one or more arms that extend distally and radially at an angle ideally positioned for insertion into the tissue of the funnel-shaped biological structure. This embodiment is also well suited for soft-tissue approximation procedures and can be used to facilitate various steps in a hysterectomy procedure, as described below.
In another embodiment, the arms of the suturing device can be operated independently, thereby allowing each end portion of the suture length to be applied separately. This modification is ideally suited for closing a gap between a first body structure and a second body structure or for attaching tissue to an adjacent body structure, such as, in the treatment of bladder or uterine prolapse. This modification is also ideally suited for use in achieving male sterilization wherein the suturing device is used to loop suture around a vas deferens.
In another embodiment, the suturing device is adapted for closing wounds or surgical incisions from the surface of the skin or other biological structure. This modification includes arms that extend beyond the distal end of the elongated body for insertion into the surface from an external location. The distal end of the elongated body is placed against the surface and the arms are extended distally to penetrate the tissue on both sides of the wound. The needles are deployed to capture and withdraw the suture ends from the tissue. After the suture ends have been withdrawn, they are tied together to close the wound.
Another aspect of the present invention relates to a method of placing a suture. The method comprises positioning a distal portion of an elongated member adjacent a location to be sutured. At least one arm is deployed which releasably holds a portion of a suture. A sharp end portion of the arm penetrates tissue. A needle also penetrates tissue and is driven toward the suture portion. The suture portion is captured from the arm with the needle and drawn through the tissue and toward the elongated body.
BRIEF DESCRIPTION OF THE DRAWINGS
The application of suture to an internal biological structure can often be difficult due to the location of the target site in the body. Therefore, a suturing procedure often requires the formation of one or more large incisions through the patient's skin simply to access the target site. Because of the highly invasive nature of such procedures and other difficulties associated with suturing internal biological structures, there is an urgent need for improved suturing devices and methods that can be used in a less invasive manner. Various forms of improved suturing devices are disclosed in U.S. Pat. No. 5,860,990 to Nobles et al., and U.S. Pat. No. 6,117,144 to Nobles et al., both of which are incorporated herein by reference in their entirety.
Before operation, the arms 204, 204′ are pre-loaded with the ends of a suture, such as a polypropylene suture. Specifically, each end of a suture has a capture portion comprised of a loop, a sphere or a ferrule. In one embodiment, the loop, sphere or ferrule may be formed (e.g., by heat molding) with the same suture material as the length of suture. In another embodiment, the loop, sphere or ferrule may be a separate piece attached (e.g., molded, glued, etc.) onto each end of the length of suture. The loop, sphere or ferrule is loaded in each suture end support 206 (
When the lever actuator is moved upwardly, the actuating rod 226 translates proximally. As the actuating rod 226 translates proximally, the ends 208, 208′ of the arms 204, 204′ come in contact with the curved, upper arm guides 282, 282′ and cause the arms 204, 204′ to deploy radially. In one embodiment, the arms 204, 204′ continue to deploy radially until the arms 204, 204′ are substantially parallel to each other and perpendicular to the axis of the main body, as shown in
The needles 216, 216′ move distally at an angle or along a curved path until the tips of the needles 216, 216′ engage the capture portion of the suture ends (e.g., loop, sphere or ferrule) lying within the suture end supports 206, 206′. Such engagement causes the suture capture portions to become attached to the ends of the needles 216, 216′, respectively. The physician then returns the trigger actuator to its original position to cause the needles 216, 216′, with the ends of the suture attached to the ends of the needle 216, 216′, to retract proximally back into the introducer head 202 and the shaft 102. The physician then moves the lever actuator such that the actuating rod 226 translates distally. As the actuating rod 226 translates distally, the arms 204, 204′ come in contact with the lower arm guides 280, 280′, which causes the arms 204, 204′ to return to their retracted position as shown in
The suturing device 100 of
In one application, shown in
Referring to
As shown in
In one variation, the arms 204, 204′ are deployed until the arms 204, 204′ are parallel to each other as shown in
As shown in
When the needles 216, 216′ are withdrawn back into the introducer head 202, the ends of the suture are also drawn into the distal portion 200, as shown in
Although the above-discussed procedure passed the suture through walls of the fallopian tube without penetrating the exterior surface of the fallopian tube, it will be understood that the suturing device 200 may also be configured to pass the suture completely through the walls so as to penetrate the exterior surface of the fallopian tube.
As illustrated in
During insertion of the shaft 260 into the tubular biological structure, the cutter 264 retracted. Once the shaft 260 and cutter 264 are positioned at a desired location near the first suture knot 270, the physician deploys the cutter 264. In one embodiment, the cutter 264 may be attached to an actuating rod or a spring that is attached to a lever or actuating rod at the proximal end of the shaft 260 outside of the tubular structure. The physician deploys the cutter 264 by pushing or pulling the lever or actuating rod outside of the tubular biological structure.
When the cutter 264 is deployed, the cutter 264 pierces the walls of the tubular biological structure. The physician rotates the cutter 264 to completely sever the tubular structure and thereby create a distal end 266 and a proximal end 268. The physician then retracts the cutter 264 and removes the shaft 260.
As shown in
After the suture 274 has been passed through the tissue at the end 268, the physician removes the introducer head 202 from the tubular structure, pulls the second suture ends taut, and secures the second suture 274 with a second knot 272 or clip, as illustrated in
The order of the acts described above with reference to
It will also be appreciated that the suturing device described in
Still referring to
A method of using the device of
Once the physician places the distal portion 400 of the suturing device at the desired location within the body structure 420, the plunger 306 (shown in
After the arms are fully deployed, the physician pushes the plunger distally relative to the main body to advance the needles 416, 416′ through the needle apertures and out toward the needle receiving portion of each arm as shown in
After the suture has been applied through the tissue of the biological structure, the arms are retracted by rotation of the plunger in the other direction. The arms are retracted so that the suturing device can be removed from the biological structure without damaging the surrounding tissue. The physician removes the suturing device from the biological structure 420 with the capture portions of the suture ends still held by the needles as shown in
The second preferred embodiment described above in
A method of using the device of
It will be appreciated that for each of the embodiments described above, the arms and/or needles can be deployed simultaneously or sequentially.
The use of independently deployable arms allows for suturing across large gaps in tissue by first placing a first end of a suture in one area of tissue and then moving the device and placing a second end of the suture in a different area or tissue. In operation, one end of the suture is passed through tissue on one side of a cavity using the first needle arm pair 1004, 1016. The other end of the suture is passed through tissue using the second needle/arm pair 1004′, 1016′ on the other side of the cavity. This feature may also be advantageous for moving a body structure and attaching it to a new location such as in the treatment of bladder or uterine prolapse.
Independent actuation of the arms can also be advantageously used to attach or suspend a first body structure to a second body structure. The body structures used in this method can be any implantable or biological structures, including bones, ligaments, muscle tissue and body organs. In operation, one end of a suture is looped around a first body structure 1050 for use as an anchor as illustrated in
The other end portion of the suture can then be threaded through a second body structure or tissue 1020 that is adjacent to, or distanced from, the first body structure. A penetrating arm 1004 penetrates the tissue 1020, and a deploying needle 1016 is moved relative to the arm 1004 to retrieve the suture end held in the arm 1004. Alternatively, the second arm and needle can be used to loop a suture around a second body structure, as with the first arm and needle. The ends of the suture 1022 are then pulled tight to bring the body structure 1050 and the tissue 1020 together as illustrated in
It will be appreciated that the arms 1004 and 1004′ can be deployed in any preferred sequence, and thus, arm 1004 can be used to penetrate tissue before arm 1004′ is used to loop a body structure. It will also be appreciated that the arms 1004 and 1004′ can be deployed simultaneously. In one embodiment of the device of
The embodiment of
The ability of the suturing device to loop suture around a body structure may also be advantageously applied to an improved method for performing male sterilization. The vas deferens are first accessed using either a conventional approach (through scrotal incisions) or through a tiny puncture (similar to the no-scalpel vasectomy approach). After accessing the vas deferens, one arm of the suturing device is then deployed on one side of the vas deferens and one needle is deployed on the other side. The needle picks up the suture to loop suture around the vas deferens. The suture is then pulled tight and tied off to block the lumen in the vas deferens thereby blocking the flow of sperm into the ejaculatory ducts.
Other devices, including those described above, may also be used for looping suture around a body structure or for suspending a first body structure to a second body structure. For example, suturing devices may be used in which the arms are not moveable from within the elongated body to outside the elongated body. Rather, in these embodiments, the arm or arms may be fixed relative to the elongated body, and may simply be placed around the body structure to be suspended before the needles are deployed. Furthermore, once a first body structure is suspended to a second body structure, it will be appreciated that the distance between the two structures can be adjustable using an adjustment feature, such as a turnbuckle, that can be utilized to draw up an organ, or draw to an organ.
It will also be appreciated that a suturing device with one or more fixed arms extending from the elongated body can be used in other applications as well. For example, this device can be used to place suture into tissue simply by manipulating the device such that the arm or arms punctures the desired tissue location. The needles then deploy in the manner described above to grab the suture ends mounted on the arms of the device.
In variations of the preferred embodiments described above, each of the suturing devices described above may be formed with a guidewire lumen extending lengthwise through the elongated body for slidably receiving a guidewire. Such a lumen preferably terminates at an opening located on the distal portion of the device. Such an opening may be similar to the opening 428 shown in
In another aspect of the present invention, various devices and methods are provided for performing a hysterectomy. In a first preferred method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, the uterus is inverted through the cervix. The uterus is cut away from the cervix and is removed from the body. A suturing device as described above can then be used to apply suture to the cervix to close the distal portion of the vagina. For closure of the cervix, it may be preferable to use a suturing device with multiple arms and needles, for example, 6 or 8.
In a second method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, the uterus is cut away from the cervix and is removed from the body. A suturing device as described above is then used to apply suture to the cervix to close the distal portion of the vagina.
In a third preferred method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, a suturing device such as described is inserted into the cervical opening, and suture ends are placed loosely applied around the opening of the cervix in a purse-string arrangement. The uterus is cut around the cervix at a location distal to the placed sutures and is removed from the body. The ends of the sutures are then pulled together and tied to close the distal portion of the vagina.
In a fourth preferred method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, suture is loosely applied around the cervical opening as described in the third method above. After the suture has been applied, the uterus is inverted through the cervix. The uterus is then cut at a location distal of the placed sutures and the uterus is removed from the body. The ends of the sutures are then pulled together and tied to close the distal portion of the vagina.
While embodiments and applications of this invention have been shown and described, it will be apparent to those skilled in the art that various modifications are possible without departing from the scope of the invention. It is, therefore, to be understood that within the scope of the appended claims, this invention may be practiced otherwise than as specifically described.
Claims
1. A method of placing a suture, comprising:
- positioning a distal portion of an elongated member adjacent a location to be sutured;
- deploying at least one arm which releasably holds a portion of a suture;
- penetrating tissue with a sharp end portion of the arm;
- penetrating tissue with a needle and driving the needle toward said suture portion; and
- capturing the suture portion from the arm with the needle and drawing the suture portion through the tissue and toward the elongated body.
2. The method of claim 1, wherein penetrating tissue with a sharp end portion of the arm comprises penetrating an inner wall of a tubular biological structure.
3. The method of claim 2, wherein the tubular biological structure is a fallopian tube.
4. The method of claim 2, wherein the tubular biological structure is a common bile duct.
5. The method of claim 2, wherein the tubular biological structure is an arterial-venous fistula.
6. The method of claim 2, wherein penetrating tissue with a sharp end portion of the arm further comprises positioning the sharp end portion beyond an outer surface of the biological structure.
7. The method of claim 1, comprising deploying two arms which releasably hold end portions of a suture.
8. The method of claim 7, further comprising penetrating tissue with the two arms on opposite sides of an opening.
9. The method of claim 8, wherein the two arms penetrate tissue simultaneously.
10. The method of claim 8, wherein the two arms penetrate tissue sequentially.
11. The method of claim 8, comprising penetrating tissue with two needles and driving each needle toward the end portions of the suture held by each of the arms.
12. The method of claim 7, further comprising penetrating tissue with only one of the two arms.
13. The method of claim 12, comprising penetrating tissue with a first needle and driving the first needle toward the end portion of the suture held by the first arm, and driving a second needle toward the end portion of the suture held by the second arm without driving the second needle through tissue.
14. The method of claim 1, wherein deploying the at least one arm comprises moving the arm from within the elongated member to outside the elongated member.
15. The method of claim 11, wherein deploying the at least one arm comprises moving the end portion of the arm to a location distal to the elongated member.
16. A method of closing a tubular biological structure from within the tubular biological structure, the method comprising:
- inserting a distal portion of an elongated member into the tubular biological structure;
- deploying a pair of arms, each arm releasably holding an end portion of a suture;
- penetrating an inner surface of the tubular biological structure with sharp end portions of the arms such that the arms position the suture portions beyond the inner surface of the tubular biological structure;
- penetrating the inner surface of the tubular biological surface with a pair of needles;
- capturing the suture portions from the arms with the needles and drawing the suture portions through the tissue and toward the elongated body; and
- tying the suture to close the tubular biological structure.
17. The method of claim 16, wherein deploying the pair of arms comprises moving the arms from within the elongated member to outside the elongated member.
18. The method of claim 16, wherein the pair of arms when deployed are parallel to one another.
19. The method of claim 16, wherein the pair of arms when deployed form an acute angle relative to one another.
20. A method of suspending a biological structure, comprising:
- positioning a distal portion of an elongated member adjacent the biological structure to be suspended;
- positioning a first arm connected to the elongated member on one side of the biological structure, the first arm releasably holding an end portion of a suture;
- penetrating tissue of an adjacent biological structure with a sharp end portion of a second arm, the second arm releasably holding an end portion of the suture;
- driving a first needle toward the end portion of the suture in the first arm, the first needle moving on an opposite side of the biological structure such that when the first needle engages the first arm, the biological structure is surrounded by the first arm, the first needle and the elongated member;
- driving a second needle toward the end portion of the suture in the second arm, wherein the second needle penetrates tissue to engage the second arm;
- capturing the suture portions from the arms with the needles and drawing the suture portions with the needles toward the elongated member; and
- tying the ends of the suture together to suspend the biological structure to the adjacent biological structure.
21. The method of claim 20, wherein the first arm and the second arm are moveable from a first position within the elongated member to a second position extended from the elongated member.
22. The method of claim 20, wherein positioning the first arm and driving the first needle occurs prior to penetrating tissue with the second arm.
23. The method of claim 20, wherein penetrating tissue with the second arm and driving the second needle occurs prior to positioning the first arm.
24. A method of blocking the vas deferens to achieve male sterilization, comprising:
- accessing the vas deferens through the scrotum;
- positioning a distal portion of an elongated member adjacent a vas deferens to be blocked;
- deploying an arm connected to the elongated member on one side of the vas deferens, the first arm releasably holding an end portion of a suture;
- deploying a needle toward the end portion of the suture in the first arm, the needle moving on an opposite side of the vas deferens such that when the needle engages the arm, the vas deferens is surrounded by the arm, the first needle and the elongated member;
- capturing the suture portion from the arm with the needle and drawing the suture portion with the needle toward the elongated member;
- tying the ends of the suture together to block the vas deferens; and
- repeating the procedure on the other vas deferens.
Type: Application
Filed: Jun 1, 2005
Publication Date: Oct 13, 2005
Inventors: Anthony Nobles (Fountain Valley, CA), Steven Decker (Anaheim, CA), Rod Peterson (Anaheim, CA), Chad Trembath (Eden Prairie, MN)
Application Number: 11/142,102