WO2006010596A1

WO2006010596A1 - Device for endoscopic cutting and clamping

Info

Publication number: WO2006010596A1
Application number: PCT/EP2005/008120
Authority: WO
Inventors: Knud Lykke Jensen; Peter Sølbeck
Original assignee: Price Invena Aps
Priority date: 2004-07-30
Filing date: 2005-07-26
Publication date: 2006-02-02
Also published as: GB0417104D0

Abstract

A device for endoscopic clamping and cutting of a tubular structure comprises: a housing (18) having a mouth; engaging means (30) for hooking the tubular structure, drawing the tubular structure into the housing (18) via the mouth and holding the tubular structure while it is clamped and cut; clamping means (46, 48) for clamping the tubular structure at two clamping locations; cutting means (44) for cutting the tubular structure between the two clamping locations; and control means (14, 16) operable to control the engaging means (30), the clamping means (46, 48) and the cutting means (44) to engage, clamp and cut the tubular structure.

Description

DEVICE FOR ENDOSCOPIC CUTTING AND CLAMPING

The present invention relates to a device for endoscopic clamping and cutting and to a method of using such a device.

Endoscopic surgery has become widely accepted in the medical community. There are a number of benefits associated with endoscopic surgery compared with conventional open surgery. Avenues for infection are greatly reduced and the patient typically has a shorter post-operative recovery period. It is not unusual for the post-operative recovery period to be shortened from weeks to several days. Outpatient endoscopic surgery is becoming increasingly common. In a typical endoscopic surgical procedure, a trocar is inserted into the abdominal cavity of a mammal through skin, tissue and muscle. Such trocars typically consist of a trocar cannula housing a trocar obturator with a piercing point. Once the trocar has been positioned in the abdominal cavity close to the target surgical site, the trocar obturator is removed to leave the trocar cannula as a pathway to the abdominal cavity. The trocar is fitted with a tube through which a flow of a sterile gas such as carbon dioxide is supplied. The gas is used to insufflate the abdominal cavity to provide increased manoeuvring room for endoscopic instruments within the body cavity.

Further trocars are then inserted into the patient's body. The surgeon introduces various endoscopic surgical instruments through the trocar to access the target surgical site. Endoscopic surgical instruments include tissue manipulators, tissue graspers, needle graspers, endoscopes, ligating clip appliers, electrosurgical instruments and cannulas.

The trocars are provided with valves to maintain the pressure within the abdominal cavity. Small amounts of gas will leak from the abdominal cavity during the operation, for example when changing instruments.

There are some problems with endoscopic surgery. In particular, when a surgeon carries out endoscopic surgery he typically views the surgical site via an endoscope positioned within the body cavity through a trocar. The endoscope is typically connected to a video camera with the output from the video camera displayed on a video monitor. The video monitor only provides the surgeon with a two- dimensional view and there is a consequent lack of depth perception. This may result in the endoscopic instruments being incorrectly positioned within the abdominal cavity. When ligating a blood vessel, the surgeon typically positions an endoscopic ligating clip applier around the blood vessel and applies clips to either side of an intended cut. Alternatively, O-rings may be applied.

During this procedure, the surgeon must position the jaws of the clip applier around the vessel. Because the surgeon only has a two-dimensional view from the video monitor, it can be difficult to judge whether the vessel is between the clip applier' s jaws when the clip is applied.

The view is further impaired by the rod of the clip applier, which may block the view of the vessel .

During the application of the clip, the surgeon must squeeze the handle of the applier whilst keeping the applier' s jaws accurately positioned around the vessel.

This combination of simultaneous coarse and fine movement is difficult to achieve. After applying the clips the surgeon removes the ligating clip applier from the patient's abdominal cavity and inserts a cutting device, for example endoscopic scissors. Manoeuvring the endoscopic scissors to the ligated blood vessel is potentially hazardous because of the surgeon's two-dimensional view. If appropriate care is not taken, it is possible for the surgeon accidentally to cut or puncture vessels or organs.

Staplers which staple the colon are also known, for example the Endo-Gia™ stapler. Such staplers may include a blade which can be manoeuvred to cut the colon. The stapler has jaws which are closed around the colon using a handle. The staples are then dispensed. The stapling and cutting operations are separate. The staples are very small and resemble ordinary office staples. Thus, the staplers are not suitable for ligating blood vessels or similar structures.

•In a first aspect, the present invention relates to a device for endoscopic clamping and cutting of a tubular structure, comprising: a housing having a mouth; engaging means for hooking the tubular structure, drawing the tubular structure into the housing via the mouth and holding the tubular structure while it is clamped and cut; clamping means for clamping the tubular structure at two clamping locations; cutting means for cutting the tubular structure between the two clamping locations; and control means operable to control the engaging means, the clamping means and the cutting means to engage, clamp and cut the tubular structure. In a preferred embodiment, the device is suitable for clamping and cutting vessels in the body. For example, the device may be used to clamp and cut blood vessels, bile ducts, appendices or similar vessels. Vessels of diameter 1 to 12 mm can be clamped and cut using the device.

Preferably, the device is sterile and individually packaged. For example, the device may be sterilised with ethylene oxide. The device is preferably a single-use product . Preferably, the control means is operable to clamp and then to cut the tubular structure in the same operation. This reduces the risk of cutting an undamped structure. More preferably, the control means is operable to draw the tubular structure into the housing in the same operation as clamping then cutting the tubular structure.

Preferably, the device comprises more than one clamping means such that more than one tubular structure can be clamped and cut. This allows the device to be used to excise a section of the tubular structure or an organ (for example the gall bladder) . In a preferred embodiment, the device further comprises means for advancing a second clamping means after a first tubular structure has been clamped and cut . Preferably, each clamping means is biodegradable. This means that no removal of the clamps is necessary. Suitably, the biodegradable material has a degradation time of 1 to 4 months. This allows time for the wound to heal before degradation, since healing typically takes a few days.

Examples of suitable biodegradable materials are given in "Synthetic Biodegradable Polymers as Medical Devices", John C. Middleton and Arthur J. Tipton, Medical Plastics and Biomaterials Magazine, March 1998. These include products based on lactic and glycolic acid and on other materials, including poly(dioxanone) , poly(trimethylene carbonate) copolymers, and poly (ε-caprolactone) homopolymers and copolymers.Preferably, the housing comprises a tube which can be inserted into a body via a trocar. Preferably, the mouth of the housing has opposed notches for accommodating the tubular structure when it is drawn into the housing. This may be achieved using a mouth with an open-jaw shape.

Preferably, the engaging means is moveable between an engaging position in which it extends from the mouth of the housing and a clamping and cutting position in which it lies within the housing. More preferably, the engaging means is also moveable to a clamp-applying position intermediate between the engaging position and the clamping and cutting position. Suitably, in the clamp-applying position the engaging means extends a short way from the mouth of the housing.

Suitably, the engaging means is a hook and is linked to the control means via a control rod. Preferably, each clamping means comprises a pair of clamps each comprising a pair of legs hinged together at one end and open at the other end, the other end being provided with locking means for locking the clamp.

Preferably, the housing is provided with a pair of clamp receiving channels in each of which one of the clamps is slideably mounted such that the clamps can be slid along the clamp receiving channels in a first direction to lock the clamps and thereby clamp the tubular structure.

Preferably, sliding of the clamps in the first direction retracts the clamps into the housing.

Preferably, each clamp is slideably mounted in the respective clamp receiving channel by a rail on one of the clamp and the clamp receiving channel received in a slot on the other of the clamp and the clamp receiving channel.

Suitably, the rail is a flanged rail.

Preferably, the housing is further provided with a pair of clamp distorting surfaces such that the clamps can be slid along the clamp receiving channels in a second direction opposite to the first direction without the clamps being locked.

Preferably, each clamp distorting surface pivots one leg of the clamp relative to the other leg when the clamps are slid along the clamp receiving channels in the second direction such that the non-aligned open ends of the legs are not locked, but does not pivot the leg when the clamps are slid along the clamp receiving channels in the first direction such that the aligned open ends of the legs are locked.

Preferably, one leg of each clamp is slideably mounted in the respective clamp receiving channel by a rail on one of the clamp and the clamp receiving channel received in a slot on the other of the clamp and the clamp receiving channel, and the other leg of each clamp is pivoted by the clamp distorting surface.

Preferably, the cutting means is positioned between the clamp receiving channels such that when the clamps are slid along the clamp receiving channels in the first direction to lock the clamps and thereby clamp the tubular structure, the structure is cut.

Preferably, the device is provided with means to prevent the tubular structure from interfering with the clamping means. In a second aspect, the present invention provides a method of clamping and cutting a tubular structure using a device as described above, comprising the steps of: hooking a tubular structure in the engaging means, drawing the tubular structure into the housing and holding the tubular structure; clamping the tubular structure at two clamping locations with the clamping means; and cutting the tubular structure using the cutting means between the two clamping locations.

The invention will be further described with reference to the illustrated preferred embodiment, as shown in the drawings, in which:

Fig. 1 shows a perspective view of the device of the preferred embodiment;

Fig. 2 shows a partial exploded view of the device of Fig. 1;

Fig. 3 shows a perspective view of the first guide part of the device of Fig. 1;

Fig. 4 shows a perspective view from below of the second guide part of the device of Fig. 1 in use;

Fig. 5 shows a perspective view of a clamp of the device of Fig. 1;

Fig. 6 shows a section through the shaft 18 of the device of Fig. 1 in use. Fig. 7 shows perspective views of part of the device of Fig. 1 at five stages during use.

The device 10 of the preferred embodiment (Fig. 1) comprises a handle 12, a trigger 14, an operating button 16 and a hollow shaft 18 of stainless steel extending from the handle 12. The distal end of the shaft 18 has the form of a pair of jaws 19.

A first guide part 20 (Fig. 2) extends through the shaft 18. The first guide part 20 has three longitudinal slots 22, 24, 26. The outer slots 22, 24 are undercut and each has a small ledge (not shown) . The central slot 26 is not undercut .

A rod 28 is connected to the trigger 14 and extends through the shaft 18 supported in the central slot 26. A hook 30 at the distal end of the rod 28 protrudes slightly from the shaft 18. A spring (not shown) is mounted to the hook 30 to bias it into this position. The hook 30 is provided with two lateral curved beams 34, 36. A second guide part 38 is mounted inside the distal part 32 of the shaft 18 opposite to the first guide part 20. The second guide part is tapered to form a narrow portion 39 (Fig. 4) at the distal end of the shaft 18. The second guide part 38 is provided with a surface 40 at an angle to the longitudinal direction and longitudinal slots 42. A longitudinally arranged blade 44 extends from the second guide part 38 towards the first guide part 20 such that it lies between the outer slots 22, 24.

Five pairs of clamps 46, 48 are mounted within the shaft 18. Each clamp 46, 48 of biodegradable plastics comprises two legs 50, 52 (Fig. 5) hinged to one another at the proximal end. The distal end 56 of each clamp is open, and is provided with locking means 58. One leg 50 of each clamp 46, 48 is provided with a rectangular cross-section flanged rail 54. The other leg 52 of each clamp 46, 48 is provided with a T cross-section flanged rail 56. The rectangular cross-section flanged rails 54 are engaged in the outer slots 22, 24 of the first guide part 20. The T cross-section flanged rails 56 are engaged in the slots 42 of the second guide part 38.

Two compressed springs 59 are mounted to the lower guide part 20 and two support blocks 60 within the proximal part of the shaft 18. The support blocks 60 are engaged in the outer slots 22, 24 of the first guide part 20.

A pair of flexible rods 61 is connected to the operating button 16 and extend through the shaft 18 along the sides of the clamps 46, 48. The flexible rods 61 have inwardly directed tips 66. The flexible rods 61 are mounted to the shaft 18 by a compressed spring (not shown) .

The device 10 is used on a patient who has been anaesthetised. The patient's abdominal cavity is insufflated using carbon dioxide. Three trocars (not shown) are inserted through the abdominal wall into the abdominal cavity. The trocars have elongated obturators with piercing tips concentrically housed in trocar cannulas. The obturators are removed to leave the trocar cannulas as pathways to the abdominal cavity. An endoscope (not shown) is inserted through one of the trocar cannulas. The output from the endoscope is displayed on a video monitor (not shown) .

The device 10 is inserted into the abdominal cavity through one of the trocar cannulas with the handle 12 remaining outside the body cavity. The trigger 14 is operated against the spring (not shown) to extend the hook 30 distally out of the shaft 18. The hook 30 is manipulated to capture a vessel (not shown) to be clamped and cut (Fig. 7/1) . If necessary, the hook 30 can be rotated to capture the vessel. The lateral beams 34, 36 prevent the vessel from becoming twisted around the hook 30. When the trigger 14 is released, the hook 30 is returned towards its initial position by the spring (not shown) , pulling the vessel backwards towards the shaft 18.

The operating button 16 is actuated against the spring (not shown) to pull the flexible rods 61 back. When the tips 66 of the flexible rods 61 reach the proximal end of the first pair of clamps 46, 48, the tips 66 engage the clamps 46, 48. This can be felt by the user.

When the operating button 16 is released, the spring (not shown) acts to force the flexible rods 61 forward. This forces the first pair of clamps 46, 48 to slide distally along the shaft 18 over the ledge (not shown) and through the narrow portion 39. As the flanged rails 54 are engaged in the outer slots 22, 24 of the first guide part 20 and the flanged rails 56 engage the angled surface 40 of the second guide part, the legs 50, 52 are twisted relative to one another. The locking means 58 of end 56 of each clamp 46, 48 are not aligned, and thus the clamps 46, 48 do not lock (Fig. 6) .

As the first pair of clamps 46, 48 protrudes from the shaft 18, the end 56 relaxes to its open position with the legs 50, 52 parallel to one another such that the flanged rails 56 are engaged in the longitudinal slots 42 of the second guide part 38. The clamps 46, 48 surround the vessel captured by the hook 30 (Fig. 7/2) . The trigger 14 is operated to pull the hook 30 and captured vessel back into the shaft 18 (Fig. 7/3) . The hook cannot be pulled into the shaft 18 before the clamps 46, 48 have been brought forward. This means that the vessel cannot be cut before clamping, which is required to avoid the contents of the vessel (e.g. blood or bile) from flowing into the body cavity.

As the hook 30 is pulled into the shaft 18 the lateral beams 36, 38 act on the clamps 46, 48 so that the clamps 46, 48 slide back along the shaft 18 through the narrow portion 39, forcing the legs 50, 52 together. As the flanged rails 54 are engaged in the outer slots 22, 24 of the first guide part 20 and the flanged rails 56 are engaged in the longitudinal slots 42 of the second guide part, the legs 50, 52 are parallel to one another. The locking means 58 of end 56 of each clamp 46, 48 are aligned, and thus the clamps 46, 48 lock around the vessel.

As the vessel is pulled backwards into the shaft 18 by the hook 30, it is pulled past the blade 44 which cuts the vessel between the clamps 46, 48.

When the trigger 14 is released, the hook 30 is forced out of the shaft 18 by the spring (not shown) . The hook is extended further by operation of the trigger 14. The flexible rods 61 are also forced out of the shaft 18 by the spring (not shown) so that the clamps 46, 48 and the vessel are forced out of the shaft 18 and released (Figs. 7/4, 7/5) . If the clamps 46, 48 and the vessel are not released, the operating button 16 can be actuated to push the flexible rods 61 forward so as to release the clamps 46, 48. The springs 59 act on the support blocks 60 to force the clamps 46, 48 away from the handle 12 towards a small ledge (not shown) . Thus, when the first pair of clamps 46, 48 is released, a second pair of clamps 46, 48 is pushed into position.

The second pair of clamps 46, 48 and further pairs of clamps 46, 48 can be applied as described above. Vessels or organs which have been cut away from the body in this way can be removed from the abdominal cavity via the trocar or via the hole left after removing the trocar. Clamps 46, 48 which are left in the body will degrade over three to four months. The device 10 is then withdrawn from the body via the trocar cannula.

The device of the preferred embodiment has the following advantages:

1. Clamping and cutting can be carried out with a single instrument . Change of instruments is hazardous and time-consuming, and therefore the device makes surgery faster and safer. Faster surgery is inherently safer because the patient can be anaesthetised for a shorter time.

2. The device separates the steps of capturing the vessel and applying the clamps/cutting the vessel. As explained above, if these steps are carried out simultaneously the combination of coarse and fine movement is difficult to achieve successfully.

3. The clamps are placed close to one another, and can therefore be applied in a small space.

4. Because the clamps are biodegradable, no waste products are left in the body. Although the invention has been described with reference to the illustrated preferred embodiment, it will be appreciated that various modifications are possible within the scope of the invention.

Claims

1. A device for endoscopic clamping and cutting of a tubular structure, comprising: a housing having a mouth; engaging means for hooking the tubular structure, drawing the tubular structure into the housing via the mouth and holding the tubular structure while it is clamped and cut; clamping means for clamping the tubular structure at two clamping locations; cutting means for cutting the tubular structure between the two clamping locations; and control means operable to control the engaging means, the clamping means and the cutting means to engage, clamp and cut the tubular structure.

2. A device as claimed in Claim 1, wherein the control means is operable to clamp and then to cut the tubular structure in the same operation.

3. A device as claimed in Claim 2, wherein the control means is operable to draw the tubular structure into the housing in the same operation as clamping then cutting the tubular structure.

4. A device as claimed in any one of the preceding claims, wherein the device comprises more than one clamping means such that more than one tubular structure can be clamped and cut .

5. A device as claimed in Claim 4, wherein the device further comprises means for advancing a second clamping means after a first tubular structure has been clamped and cut .

6. A device as claimed in any one of the preceding claims, wherein each clamping means is biodegradable.

7. A device as claimed in any one of the preceding claims, wherein the housing comprises a tube which can be inserted into a body via a trocar.

8. A device as claimed in any one of the preceding claims, wherein the mouth of the housing has opposed notches for accommodating the tubular structure when it is drawn into the housing.

9. A device as claimed in any one of the preceding claims, wherein the engaging means is moveable between an engaging position in which it extends from the mouth of the housing and a clamping and cutting position in which it lies within the housing.

10. A device is claimed in Claim 9, wherein the engaging means is also moveable to a clamp-applying position intermediate between the engaging position and the clamping and cutting position.

11. A device as claimed in any one of the preceding claims, wherein the engaging means is a hook and is linked to the control means via a control rod.

12. A device as claimed in any one of the preceding claims, wherein each clamping means comprises a pair of clamps each comprising a pair of legs hinged together at one end and open at the other end, the other end being provided with locking means for locking the clamp.

13.A device as claimed in Claim 12, wherein the housing is provided with a pair of clamp receiving channels in each of which one of the clamps is slideably mounted such that the clamps can be slid along the clamp receiving channels in a first direction to lock the clamps and thereby clamp the tubular structure.

14.A device as claimed in Claim 13, wherein sliding of the clamps in the first direction retracts the clamps into the housing.

15.A device as claimed in Claim 14, wherein each clamp is slideably mounted in the respective clamp receiving channel by a rail on one of the clamp and the clamp receiving channel received in a slot on the other of the clamp and the clamp receiving channel .

16.A device as claimed in Claim 14 or Claim 15, wherein the housing is further provided with a pair of clamp distorting surfaces such that the clamps can be slid along the clamp receiving channels in a second direction opposite to the first direction without the clamps being locked.

17.A device as claimed in Claim 16, wherein each clamp distorting surface pivots one leg of the clamp relative to the other leg when the clamps are slid along the clamp receiving channels in the second direction such that the non-aligned open ends of the legs are not locked, but does not pivot the leg when the clamps are slid along the clamp receiving channels in the first direction such that the aligned open ends of the legs are locked.

18.A device as claimed in Claim 17 when dependent on Claim 15, wherein one leg of each clamp is slideably mounted in the respective clamp receiving channel by a rail on one of the clamp and the clamp receiving channel received in a slot on the other of the clamp and the clamp receiving channel, and the other leg of each clamp is pivoted by the clamp distorting surface.

19.A device as claimed in any one of Claims 12 to 18, wherein the cutting means is positioned between the clamp receiving channels such that when the clamps are slid along the clamp receiving channels in the first direction to lock the clamps and thereby clamp the tubular structure, the structure is cut.

20.A device as claimed in any one of the preceding claims, wherein the device is provided with means to prevent the tubular structure from interfering with the clamping means.

21.A method of clamping and cutting a tubular structure using a device as claimed in any one of the preceding claims, comprising the steps of: hooking a tubular structure in the engaging means, drawing the tubular structure into the housing and holding the tubular structure; clamping the tubular structure at two clamping locations with the clamping means; and cutting the tubular structure using the cutting means between the two clamping locations.