Puncture needle and medical procedure using puncture needle that is performed via natural orifice

A puncture needle includes: a needle part that has a first needle part and a second needle part that are hollow, adjacent, and have resiliency; and a sheath that retractably accommodates the needle part; in which a bend part that separates distal end sides of the first needle part and the second needle part to be further apart than proximal end sides thereof is provided in at least one of the first needle part and the second needle part.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a puncture needle and medical procedure using the puncture needle that is performed via a natural orifice.

DESCRIPTION OF RELATED ART

Laparoscopic operations are known in which, in performing a medical procedure of observing, treating, etc. an organ of the human body, instead of incising the abdominal wall widely, a plurality of orifices are opened in the abdominal wall and procedures are performed upon inserting a laparoscope, forceps, and other treatment instruments into the orifices. Such procedure provides the benefit of lessening the burden placed on the patient because only small orifices need to be opened in the abdominal wall.

In recent years, methods of performing procedures upon inserting a flexible endoscope via the mouth, nose, anus, or other natural orifice of the patient have been proposed as methods of further reducing the burden on the patient. An example of such procedures is disclosed in U.S. Pat. No. 5,458,131.

With this method, a flexible endoscope is inserted from the mouth of a patient, an opening is formed in the stomach wall, and a distal end part of the endoscope is fed into the abdominal cavity from the opening. Then while using the endoscope as a device for observing the interior of the abdominal cavity, desired procedures are performed inside the abdominal cavity using a treatment instrument inserted through the endoscope or a treatment instrument inserted from another opening.

SUMMARY OF THE INVENTION

An object of this invention is to provide a puncture needle that can more readily suture incised tissue in performing a medical procedure using an endoscope, and a medical procedure using the puncture needle that is performed via a natural orifice.

A puncture needle according to a first aspect of this invention includes: a needle part that has a first needle part and a second needle part that are hollow, adjacent, and have resiliency; and a sheath that accommodates the needle part to freely protrude and retreat; in which a bend part that separates distal end sides of the first needle part and the second needle part to be further apart than proximal end sides thereof is provided in at least one of the first needle part and the second needle part.

A medical procedure through a natural orifice according to a second aspect of this invention includes: inserting a device that extends in an axial direction into a lumen disposed in an insertion part of an overtube and inserting the insertion part into a hollow organ through a natural orifice of a subject; guiding the insertion part to an incision target site while using an observation device to observe the incision target site; inserting the puncture needle according to the first aspect of this invention via the device insertion part up to the incision target site and simultaneously placing placing members disposed on the puncture needle at a plurality of locations; forming an opening at the incision target site; introducing at least one of an operative device and the overtube into an abdominal cavity via the opening; and suturing the opening using the placing member.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments according to the present invention will now be described in detail below. In the following description, components that are the same shall be provided with the same numeric symbol and redundant description shall be omitted.

As shown inFIG. 1andFIG. 2, a puncture needle1according to the present embodiment includes: a needle part2that has a first needle part2A and a second needle part2B that are hollow, adjacent, and have resiliency; and a sheath3that accommodates the first needle part2A and the second needle part2B to freely protrude and retreat; and a needle manipulating part5that extends and retracts the needle parts2A and2B with respect to the sheath3.

The first needle part2A and the second needle part2B are each provided with a bend part2athat separates a distal end side of the first needle part2A and the second needle part2B to be further apart than a proximal end side thereof. Further to the distal end side than the bend part2aof the first needle part2A and the second needle part2B is also provided an alignment part2bthat disposes the distal end sides of the first needle part2A and the second needle part2B to be mutually parallel. A slit2cthrough which a suture6C described below passes is formed at the distal end of the first needle part2A and the second needle part2B. The bend part2aand the alignment part2bresiliently deform to be accommodated in the sheath3when accommodating the needle parts2A and2B in the sheath3.

Two anchors6A of double T-bars (placing members)6, shown inFIG. 3, are respectively held inside the respective needle parts2A and2B as shown inFIG. 4. The double T-bars6have two sutures (wires)6C, one end side of each being passed through a substantially triangular stopper6B. At one end, the sutures6C are bound together to form a large diameter part6Ca. Each of the other ends of the sutures6C is fixed to the anchors6A. Each anchor6A has a cylindrical shape with a slit formed at an end, and the suture6C is inserted in the longitudinal direction of the interior of anchor6A through the slit. The large diameter part6Ca that has greater diameter than that of the anchor6A is formed at the other end of the suture6C. The stopper6B has a hole, through which the sutures6C are passed, at a center in the longitudinal direction of an elongated, thin plate member. The respective ends in the longitudinal direction of the stopper6B are folded obliquely and sandwich the sutures6C. The respective ends in the longitudinal direction of the stopper6B are cut to notches of triangular shape. With the stopper6B, the respective ends are folded back obliquely so that the notches intersect and thereby sandwich the sutures6C. The sutures6C thus do not fall off from between the ends. When the large diameter part6Ca of the sutures6C is pulled in a direction away from the stopper6B, the respective end parts of the stopper6B spread apart slightly. The stopper6B thus allows movement of the sutures6C in this direction. Meanwhile, when a large diameter part6Ca at the anchor6A side of a suture6C is pulled, a tendency for the suture6C to move in the direction indicated by the arrow inFIG. 3arises. However, since the respective ends of the stopper6B close and grasp the sutures6C in this process, the suture6C does not move. As shown inFIG. 4, a pusher7is movably disposed in advancing and retracting directions in the interior of the respective needle parts2A and2B. A rigid, pushing member7A is disposed at a distal end of the pusher7.

The sheath3is provided with a first sheath3A that accommodates the first needle part2A to freely protrude and retreat and a second sheath3B that accommodates the second needle part2B to freely protrude and retreat. The first sheath3A and the second sheath3B are disposed to be parallel, with the distal end sides thereof connected so as to be integrated. Here, the sheath3is of a material and size that, when housing the needle part2therein, the first needle part2A and the second needle part2B extend and deform to be accommodated in the sheath3by the resilient deformation of the bend parts2aand the alignment parts2b.

The needle manipulating part5includes a sheath holding part8connected to the proximal ends of the first sheath3A and the second sheath3B; a needle manipulating handle10connected to proximal ends of the two needle parts2A and2B that have been passed in a manner enabling advancing and retracting through through-holes8aformed in the sheath holding part8; and a pusher connection part12that connects end portions of rod-like, rigid parts11, which are passed in a manner enabling advancing and retracting through through-holes10aformed in the needle manipulating handle10and are connected to proximal ends of the two pushers7, to each other. The needle manipulating handle10is provided with finger rings10A. Each of the needle manipulating handle10and the pusher connection part12may be divided into two parts so as to enable the first needle part2A and the second needle part2B and the two pushers7to be manipulated independently of each other.

The puncture needle1is used for example with a flexible endoscope13shown inFIG. 5. This endoscope13consists of an endoscope inserting part16, which is elongated and has flexibility to be inserted into a patient's body, that extends outward from an endoscope manipulating part15manipulated by an operator. An endoscope distal end part17of the endoscope inserting part16can be bended by manipulating an angle knob18disposed at the endoscope manipulating part15. At the endoscope distal end part17are disposed an objective lens20, a distal end face of an optical fiber22that guides light from a light source device21disposed outside the body, and distal end openings of treatment instrument insertion channels23and25. The treatment instrument insertion channels23and25are ducts for inserting and removing a treatment instrument. Moreover, the treatment instrument insertion channel23is connected via a universal cable26to an air/water feeding device27or a suction device28disposed outside the body. The treatment instrument insertion channel25is disposed at a position of six o'clock to eight o'clock of the endoscope inserting part16.

An observation image inputted into the objective lens20is displayed on a monitor31via a control unit30.

Moreover, an overtube32such as shown inFIG. 6is used as a guide tube when inserting the endocope13into a body. The overtube32includes an insertion part36that is inserted into a stomach or other hollow organ or abdominal cavity, etc., of a patient (subject) and has a lumen33, through which the endoscope inserting part16is removably inserted, and a bending part35that bends the distal end side of the lumen33.

The bending part35is disposed on the distal end side of the insertion part36and consists of a plurality of ring-shaped joint rings38that are mutually connected via connection shafts37along the lumen33to freely move.

A proximal handle44having a larger diameter than the insertion part5, is disposed at the proximal end of the insertion part36of the overtube32. The proximal handle44includes a bending lever45, a bending lock lever46, and an endoscope lock button47. The bending lever45is connected to the proximal ends of the bending wires that connect the joint rings38for performing bending manipulation of the bending part35. The bending lock lever46is used for fixing the position of the bending lever45at an arbitrary position. The endoscope lock button47is used for fixing the endoscope13with respect to the lumen33upon insertion of the endoscope13through the lumen33.

When the endoscope13must be fixed to the insertion part5upon being inserted through the interior, pressing the endoscope lock button47inward in the radial direction presses and fixes the endoscope13in a relative manner by a frictional force. The endoscope lock button47may be arranged so as to oppositely release the frictional force when pressed.

Actions of the present embodiment shall now be described in line with a medical procedure performed via a natural orifice as shown by the flow chart ofFIG. 7. In the following description, it shall be deemed that an incision target site is located on an anterior wall of a stomach, and a surgical procedure of inserting the endoscope13into the stomach from a mouth (natural orifice) of a patient (subject) and performing treatment upon forming an opening in the stomach wall and inserting the endoscope inserting part16into an abdominal cavity shall be described. Also, though in the embodiment described below, the endoscope13is introduced into the body from the mouth of the patient and made to approach the abdominal cavity upon forming the opening in the anterior wall of the stomach, the natural orifice from which the endoscope13is introduced is not restricted to the mouth and may be another natural orifice, such as the anus, nose, etc. Furthermore, though the forming of the opening in the anterior wall of the stomach is desirable, this invention is not restricted thereto, and an opening may be formed on the wall of another hollow organ (hollow organ) into which a device is introduced via a natural orifice, such as another area of the stomach, the esophagus, small intestine, or large intestine.

The medical procedure performed via a natural orifice according to the present embodiment consists of an inserting step (S10) of inserting the endoscope inserting part16through the lumen33that is disposed in the insertion part36of the overtube32and inserting the insertion part36of the overtube32into the stomach (hollow organ) from the mouth of the patient; a distending step (S20) in which air is supplied to inflate the stomach; a guiding step (S30) of guiding the insertion part to the incision target site while checking the incision target site using the endoscope13; a needle moving step (S40) of inserting the puncture needle1to the incision target site via the endoscope inserting part16and placing the double T-bars6disposed on the puncture needle1at two locations simultaneously; an incising step (S50) of providing an opening in the incision target site; an introducing step (S60) of introducing at least one of the endoscope inserting part16and the insertion part36of the overtube32into the abdominal cavity through the opening; a treating step (S70) of performing a predetermined treatment in the abdominal cavity; and a suturing step (S80) of suturing the opening using the double T-bars6. Contents of each of the steps are explained below.

First, as shown inFIG. 8, with the patient PT being made to lie in a supine position, the inserting step (S10) of inserting the endoscope inserting part16through the lumen33in the insertion part36of the overtube32and inserting the insertion part36of the overtube32and the endoscope inserting part16into the stomach ST from the mouth M of the patient PT while observing the interior of the body cavity by means of an endoscopic image is performed. A mouthpiece48is fitted onto the mouth of the patient PT and the overtube32and the endoscope13are inserted, with the endoscope inserting part16being inserted through the interior of the lumen33, into the esophagus ES from the mouthpiece48.

Next, in the distending step (S20), air is supplied from the air/water feeding device27via the treatment instrument insertion channel23of the endoscope inserting part16to inflate the stomach ST.

The guiding step (S30) of guiding the insertion part36of the overtube32to the incision target site T while checking the incision target site T using the endoscope13, which is also an observation device, is then performed. First, after inserting the endoscope inserting part16of the endoscope13into the stomach ST, the angle knob18is manipulated to bring the distal end of the endoscope inserting part16close to the incision target site T while observing the interior of the stomach ST via the objective lens20, disposed at the endoscope inserting part16. Then with the incision target site T being specified, the endoscope inserting part16is used as a guide to push the insertion part36of the overtube32and bring the distal end close to the incision target site T.

The needle moving step (S40) of making the needle part2of the puncture needle1puncture the stomach wall SW and placing the double T-bars6is then performed.

First, in a grasping step (S41), as shown inFIG. 9, the endoscope inserting part16is protruded from the distal end of the insertion part36of the overtube32, and grasping forceps50inserted in the treatment instrument insertion channel25are further protruded near the incision target site T to grasp the stomach wall SW including the incision target site T. Then, by pulling the grasping forceps50into the treatment instrument insertion channel25, a sufficient space is thereby secured in the abdominal cavity AC on the outer side of the stomach wall SW by making the stomach wall SW concave.

An abdominal cavity insufflating step (S42) is then performed. First, an injection needle51connected to the air/water feeding device not shown is inserted through the treatment instrument insertion channel23of the endoscope13. A distal end of the injection needle51is then protruded from the distal end, and as shown inFIG. 10, pierced through the stomach wall SW pulled by the grasping forceps50and inserted up to the abdominal cavity AC. Because the injection needle51pierces with the stomach SW wall being pulled in and a space being secured with the abdominal wall not shown, just the stomach wall SW can be punctured reliably. Air is then fed into the abdominal cavity AC via the injection needle51so that the stomach ST and the abdominal wall separate.

The injection needle51preferably has a needle length of approximately 12 mm and more preferably has a bendable distal end to enable piercing of the center of the pulled stomach wall. In this case, a bended injection needle has a bending tendency at a distal end and has a bending wire (not shown) that passes from the distal end toward a proximal side in an inward radial direction of the bending tendency. Here, since the treatment instrument insertion channel23of the endoscope13is disposed at a position of six o'clock to eight o'clock of the endoscope inserting part16, the incision site is approached from an upward angle in incising the anterior stomach wall SW of the stomach ST that is preferable as the incision site. Accordingly, since the bending tendency faces the center of the bending wire following the bended state of the insertion part36of the overtube32, the center of the stomach wall can be punctured reliably by pulling the bending wire toward the proximal side. In the process of feeding air, the interior of the abdominal cavity AC may be maintained at an appropriate pressure by monitoring and automatic control of the feed air pressure.

A placing step (S43) is then performed.

First, the needle manipulating handle10is advanced in the direction of the sheath holding part8while holding the sheath holding part8to make at least the bend part2aof the first needle part2A and the second needle part2B protrude from the distal end of the first sheath3A and the second sheath3B until an exposed position. Then, the anchors6A of the double T-bars6are inserted in the first needle part2A and the second needle part2B.

Next, the needle manipulating handle10is again retracted toward the proximal side, and as shown inFIG. 11, the first needle part2A and the second needle part2B are respectively plunged into the first sheath3A and the second sheath3B. At this time, the stopper6B side of the double T-bars6is also in a state of insertion in the sheath3. The puncture needle1in this state is inserted in the treatment instrument insertion channel23instead of the injection needle51.

As shown inFIG. 12, the distal end of the sheath3is protruded from the treatment instrument insertion channel23to be disposed near the stomach wall SW. Moreover, the needle manipulating handle10is advanced in the direction of the sheath holding part8, and as shown inFIG. 13, the distal end sides further than at least the bend parts2aof the first needle part2A and the second needle part2B are protruded from the distal end of the sheath3. At this time, the distal end sides further than the alignment parts2bare extended in parallel separated by a predetermined distance. At this time, the distal end sides of the first needle part2A and the second needle part2B are disposed in a stable state on one plane P by the needle manipulating handle10and the sheath holding part8.

By thus advancing the needle manipulating handle10, as shown inFIG. 14, two different locations of the stomach wall SW are simultaneously pierced.

The pusher connection part12is advanced from this state with respect to the needle manipulating handle10, and the pusher7moves in the distal end direction of the first needle part2A and the second needle part2B. At this time, the anchors6A of the double T-bars6are pushed by the pushers7to be sent out from within the first needle part2A and the second needle part2B to the abdominal cavity AC.

After the anchors6A of the double T-bars6are released, the pusher connection part12retracts with respect to the needle manipulating handle10, and moreover, the needle manipulating handle10retracts with respect to the sheath holding part8, and the first needle part2A and the second needle part2B reenter the sheath3. At this time, the two anchors6A of the double T-bars6open in a T shape due to the bending disposition of the sutures6C. Thereafter, the entire puncture needle1is pulled back to the proximal side, to be withdrawn from the treatment instrument insertion channel23.

The process then proceeds to the incising step (S50). First, a high-frequency knife52is inserted through the treatment instrument insertion channel25instead of the grasping forceps50. At this time, it is confirmed that the connection terminal of the power cord is connected to the connection terminal of the electrode manipulating part not shown. Then, high-frequency power is supplied from a high-frequency power source not illustrated in the state of the distal end of the high-frequency knife52abutting the stomach wall SW as shown inFIG. 15. As shown inFIG. 16, the high-frequency knife52is inserted through the treatment instrument insertion channel23in the state of the grasping forceps50inserted through the treatment instrument insertion channel25. While pulling on the stomach wall SW with the grasping forceps50, the distal end of the high-frequency knife52may be made to abut the stomach wall SW with the placement position of the double T-bars6and the incision position in an optimal state.

At this time, as shown inFIG. 17andFIG. 18, the stomach wall SW is incised by the high-frequency knife52, and an opening SO is formed in the stomach wall SW.

Next, the process proceeds to the introducing step (S60). That is, as shown inFIG. 19, after removing the high-frequency knife52, the endoscope inserting part16of the endoscope13, which is also an operative device, is introduced into the abdominal cavity AC through the opening SO. If, in this process, relative movement of the insertion part36and the endoscope inserting part16must be restricted, the endoscope lock button47is pressed and contacted against the endoscope inserting part16to fix the movement of the endoscope inserting part16by the frictional force. Since the endoscope lock button47is provided, the endoscope lock button47can be manipulated to restrain relative movement of the endoscope13with respect to the overtube32, and the overtube32and the endoscope inserting part16can thus be inserted into the body simultaneously. Also, since the task of inserting the endoscope13can be performed while holding the proximal handle44of the overtube32, an operation, in which the insertion part36of the overtube32is supported by one hand of the operator and the proximal handle44is held by the other hand, is enabled, and the operability is thus more improved.

After positioning, a treating step (S70) of performing observation, incision, cell sampling, suturing, or any of other various treatments (medical procedures) is carried out. After performing the treatment, the overtube32and the endoscope13are removed from the opening SO of the stomach wall SW.

In a suturing step (S80), when removing the endoscope13from the opening SO, as shown inFIG. 20, the grasping forceps50, inserted to freely advance and retract in an outer sheath53, are protruded with the outer sheath53from the treatment instrument insertion channel25. Then, as shown inFIG. 21, the large diameter part6Ca of the sutures6C is held and pulled by the grasping forceps50while making the distal end of the outer sheath53abut the stopper6B of the double T-bars6, which had been placed in advance. Thus, as shown inFIG. 22, by moving the stopper6B to clinch the stomach wall SW, the opening SO is thereby sutured. Additional double T-bars6, etc., are provided to perform further suturing if necessary. In this process, since the insufflation is performed in the process of placing the double T-bars6at the stomach wall SW, suturing by means of additional double T-bars6can be readily performed.

After suturing, the endoscope13and the overtube32are drawn out of the patient, the pressure applied to the abdominal cavity AC is released, and the surgical procedure is ended.

According to this puncture needle1and the medical procedure through a natural orifice using the puncture needle1, since bend parts2aare provided in both the first needle part2A and the second needle part2B, when protruding the distal end side from the bend parts2aof the first needle part2A and the second needle part2B from the sheath3, the gap at the distal end side of the first needle part2A and the second needle part2B can be made greater than the gap at the proximal end side. Accordingly, by protruding the needle part2from the sheath3, the needle part2A and the second needle part2B can be made to simultaneously pierce living body tissue in a predetermined direction.

At this time, since an alignment part2bis also provided in addition to the bend part2a, when the bend part2aand the alignment part2bare protruded from the sheath3, the distal ends of the first needle part2A and the second needle part2B can be aligned to be mutually parallel. Then, when simultaneously piercing with the first needle part2A and the second needle part2B, it is possible to pierce in the state of maintaining the piercing gap constant.

Also, since the sheath3of the puncture needle1is provided with the first sheath3A and the second sheath3B, it is possible to smoothly protrude and retract the first needle part2A and the second needle part2B while restricting contact between them.

The scope of the art of this invention is not restricted to the embodiments described above, and various changes can be added within a range that does not fall outside the spirit of this invention.

For example, through in the above embodiment a flexible endoscope is used as an observation device, this invention is not limited thereto and, for example, a so-called capsule endoscope may be placed inside the body, and, while observing the interior of the body using the endoscope, an insertion part of a treatment device that does not have an observation device may be inserted through the overtube to perform the desired surgical procedure.

Also, although the first needle part2A is accommodated in the first sheath3A and the second needle part2B is accommodated in the second sheath3B to freely protrude and retreat, the invention is not limited thereto. As shown inFIG. 23andFIG. 24, it may be a puncture needle56in which the first needle part2A and the second needle part2B are accommodated in a single sheath55. In this case, since the first needle part2A and the second needle part2B are accommodated in the one sheath55, the outer diameter of the sheath55can be made even smaller.

Moreover, as shown inFIG. 25, the puncture needle may be a puncture needle58in which a first needle part57A and a second needle part57B are provided extending toward the distal end with only the bend parts2aprovided and the alignment parts2bnot provided. In this case, the slits2care provided in facing side surfaces of the first needle part57A and the second needle part57B at the distal ends of the first needle part57A and the second needle part57B. Also, the distal end sides of the first needle part57A and the second needle part57B can be made to protrude and retreat with respect to the sheath55, and the outer diameter of the sheath can be made still smaller.