Staples, staplers, anastomosis devices, and methods for their applications

A stapling element is provided, operative to pierce and penetrate a tissue by a first end, and close around the tissue. Three factors help prevent local necrosis: 1. The self-closing feature of the staple does not lead to tissue crushing. 2. Edge seams are applied generally perpendicular to the tissue edge, allowing for blood supply to the tissue edge. 3. Excess tissue is cut off at the seam, minimizing the amount of tissue that may undergo local necrosis. A physical feature prevents the staple from rotating, when in an application shaft, to maintain a predetermined closing direction. The stapling element may be formed of an alloy, a pure metal, a polymer, or a composite of at least two materials. Additionally, staplers, anastomosis devices, and methods for their applications are described.

RELATED APPLICATIONS

This Application is a National Phase of PCT Patent Application No. PCT/IL2006/000142 having International Filing Date of Feb. 5, 2006, which claims the benefit of U.S. Provisional Patent Application No. 60/649,542 filed on Feb. 4, 2005. The contents of the above Applications are all incorporated herein by reference.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates generally to surgical staples, staplers, anastomosis devices, and methods for their applications.

The surgical uniting of tissues or tendons with sutures is a demanding skill, requiring dexterous ease in performance. Post operation healing is best facilitated by as short as possible operation time, minimal blood loss, and least tissue manipulation and trauma. Yet, often, sutures are to be placed in difficult to reach places, and their specific location, size, and tautness must be carefully controlled and delicately manipulated. In addition, fatigue and loss of patience may have an effect on the quality of the sutures. Furthermore, there is great variance in the quality of sutures between highly skilled and lesser skilled surgeons.

Generally, fine threads are used to surgically close a wound or join tissues. Alternatively, surgical staples, for example, Auto Suture of U.S. Surgical, 150 Glover Avenue, Norwalk, Conn. 06856, may be employed.

FIGS. 1A-1Dschematically illustrate skin closure by an Auto-Suture instrument10and shape-memory-alloy staples12, which form figure-eight staples after insertion. For operation, the surgeon must maintain first and second fascia edges14and16taut, abut against each other, and hold instrument10substantially at a right angle to the fascia surface.

There are several disadvantages to the Auto-Suture system:

maintaining fascia edges14and16taut and abut against each other requires at least two additional tools, such as tools18A,18B and18C ofFIG. 1A. It would be advantageous, if the surgeon could grip first fascia edge14, as if by needle, and bring it to second fascia edge16, so that the overall number of tools be reduced;

Staple ejection by Auto Suture device10may be crushing to the tissue, possibly leading to local necrosis;

additionally, the figure eight that is formed by staples12may further crush the tissue, as seen inFIG. 1D, and may interfere with blood and nutrient flow, possibly leading to local necrosis; and

when the Auto-Suture device is held at 90° to the fascia, as recommended, the surgeon's elbow makes an angle α of about 120° with the his arm; the hand is thus near the end of its rotational travel in that orientation, and its maneuverability is limited.

While the present example is based on skin staples, which are later removed, the principles of operation are similar for internal Auto-Sutures.

Additionally,FIGS. 1E-1Fschematically compare internal body seams made by Auto-Suture staples12and those made by hand, with a surgical thread, for example, for transverse anastomosis for a stomach13. As seen inFIG. 1E, sutures12, made by Auto-Suture staples and forming seams11, are parallel with the surgical cut. In contrast, as seen inFIG. 1F, sutures15, made by hand, using a surgical thread and forming seams17, are generally perpendicular to the cut. The situation ofFIG. 1Fof sutures that are perpendicular to the cut is preferred, since inFIG. 1E, the sutures may block blood flow across to tissue on the far side f the seam.

U.S. Pat. No. 6,113,611 to Allen et al., “Surgical fastener and delivery system,” whose disclosure is incorporated herein by reference, describes a surgical fastener preferably made from a shape memory alloy, which can access internal tissue or other synthetic material through a small surgical access port or incision. After the fastener is deployed through layers of tissue, it assumes a shape of a plurality of closes, that automatically applies to the layers of tissue an appropriate haemostatic compression which is relatively independent of tissue thickness. A delivery instrument for deploying the fastener is also provided. In essence, the surgical fastener, according to U.S. Pat. No. 6,113,611, is a staple-like device, and the delivery instrument for deploying the fastener operates as a stapler, having a rigid bottom plate. The staple pierces the tissue and then encounters the rigid bottom plate, which forces it to close over the tissue.

Yet, because it is designed to apply a haemostatic compression to the layers of tissue, the surgical fastener of U.S. Pat. No. 6,113,611 may cause tissue trauma, by interfering with blood and nutrient flow. In consequence, local necrosis can occur. Furthermore, in some embodiments, one or two sharp leading edges may be exposed, and may cause internal injury.

U.S. Pat. No. 6,517,584, to Lecalve, “Flexible prosthesis in particular for curing hernias by colioscopy,” whose disclosure is incorporated herein by reference, describes a flexible prosthesis, in particular for curing hernias by colioscopy. The prosthesis includes at least one anchor device, made of a shape memory material, designed to be deformed merely under temperature control from a storage position into a fixing position, in which the anchor device interferes with the surrounding tissue. The device pierces the tissue at two ends, and forms a loop.

U.S. Pat. No. 5,002,563, to Pyka, et al., “Sutures utilizing shape memory alloys,” whose disclosure is incorporated herein by reference, describes a suture and a method for suturing a wound in the tissue. In the preferred embodiment, Pyka, et al. use a needle, of a greater stiffness then the suture, to pierce the tissue. The needle is then cut off, and the suture may be tied, for example, by hand. In consequence, it requires considerable handling, and does not offer a solution to applying sutures in hard-to-reach places, taughtness control, fatigue, and less-skilled surgeons. Furthermore, it does not teach the simultaneous application of multiple sutures. Additionally, the preferred embodiment utilizes a needle, which is generally coarser than the suture, and in consequence, may be traumatic to the tissue.

Endoanchor™, of Johnson and Johnson Co. is a shape memory anchor having a delivery device. However, its application is limited to fixing a mesh or a patch to the tissue.

A shortcoming of the entire available prior art systems are that in order to change the direction of closing, one must change the orientation of application device.

There is thus a widely recognized need for, and it would be highly advantageous to have staplers, staplers, anastomosis devices, and methods for their applications devoid of the above limitations.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, there is provided a stapling element, comprising:

a first shape, adapted for insertion into a tissue, and comprising:a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue;an elongated body, distal to and integral with the tapered portion; anda physical feature of the elongated body, for preventing the stapling element from rotating, when in an application shaft, thus maintaining a predetermined closing direction; and

a second shape, assumed when the stapling element issues from the application shaft and is inserted into the tissue, the second shape being designed to close into a loop, for forming a staple in the tissue

According to an additional aspect of the present invention, the stapling element further comprises a phase of moreover closing the loop, after forming a staple in the tissue.

According to an additional aspect of the present invention, the stapling element has a blunt distal end.

According to an additional aspect of the present invention, the stapling element is adapted for piercing the tissue with minimal tissue crushing.

According to an additional aspect of the present invention, the stapling element is adapted for forming the staple between at least two layers of the tissue.

According to an additional aspect of the present invention, the stapling element is adapted for forming an edge seam.

According to an additional aspect of the present invention, the stapling element is adapted for joining at least two tissue edges, arranged end to end.

According to an additional aspect of the present invention, the stapling element is adapted for joining a tissue and an artificial material, selected from the group consisting of a mesh, a patch, or another material.

According to an additional aspect of the present invention, the stapling element is between about 4 mm and about 140 mm in length.

According to an additional aspect of the present invention, the second shape, designed to close into the loop, forms substantially a closed loop, with the tapered portion, at the proximal end, fitting into a cavity of the distal end.

According to an alternative aspect of the present invention, the second shape, designed to close into the loop, forms substantially a closed loop, with the tapered portion, at the proximal end, arranged against the distal end.

According to an additional aspect of the present invention, the second shape, designed to close into the loop, forms substantially a closed loop, with the tapered portion, at the proximal end, arranged against the distal end, while maintaining the cross sectional diameter of the elongated body.

According to an alternative aspect of the present invention, the second shape, designed to close into the loop, forms an open loop.

According to an alternative aspect of the present invention, the second shape, designed to close into the loop, forms a spiral.

According to an additional aspect of the present invention, the elongated body has a circular cross section, and the physical feature of the elongated body is selected from the group consisting of a rim and a notch, located at least along a distal portion of the elongated body.

According to an alternative aspect of the present invention, the elongated body has a cross section selected from the group consisting of an elliptical cross section and a polygonal cross section, and wherein the cross section is operative as the physical feature of the elongated body, for preventing the stapling element from rotating, when in the application shaft.

According to an additional aspect of the present invention, the tapered portion, forming the sharp, pointed edge is curved in the direction of closing, in the first shape, for piercing the tissue at the angle of closing.

According to an alternative aspect of the present invention, the tapered portion, forming the sharp, pointed edge, has a triangular cross section, adapted for piercing hard tissue.

According to an alternative aspect of the present invention, the tapered portion, forming the sharp, pointed edge, has a circular cross section and a screw thread.

According to an additional aspect of the present invention, the second shape is further designed to close around its longitudinal axis, for piercing the tissue, essentially by self-threading into it.

According to an additional aspect of the present invention, the stapling element is formed of a shape memory alloy.

According to an additional aspect of the present invention, the first shape, adapted for insertion into the tissue, is constrained in a stress-induced martensite phase.

According to an additional aspect of the present invention, the stapling element is formed of a resilient material, wherein the first shape, adapted for insertion into the tissue, is constrained in the first shape.

According to an additional aspect of the present invention, the resilient material is a pure metal.

According to an additional aspect of the present invention, the resilient material is a polymer.

According to an alternative aspect of the present invention, the stapling element is formed as a composite of at least two materials.

According to another aspect of the present invention, there is provided a device for applying staples to a tissue, comprising:a cartridge, adapted for receiving at least one stapling element, the stapling element comprising:a first shape, adapted for insertion into a tissue, and comprising:a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue;an elongated body, distal to and integral with the tapered portion; anda physical feature of the elongated body, for preventing the stapling element from rotating, when in an application shaft, thus maintaining a predetermined closing direction; anda second shape, assumed when the stapling element issues from the application shaft and is inserted into the tissue, the second shape being designed to close into a loop, for forming a staple in the tissue,wherein the cartridge is adapted for maintaining the at least one stapling element at a fixed orientation, with respect to a direction of closing of the stapling element;a mechanism, in mechanical communication with the cartridge, for issuing the at least one stapling element from the cartridge; anda proximal end, with respect to the tissue, having a rigid, proximal-end frame, which defines an opening from which the at least one stapling elements issues.

According to an additional aspect of the present invention, the stapling element further comprises a phase of moreover closing the loop, after forming a staple in the tissue.

According to an additional aspect of the present invention, the device includes a handle, with a finger lever, for controlling the mechanism, wherein the handle is arranged at an angle to the application shaft, to allow a surgeon maximum maneuverability, with a full range of elbow bending.

According to an additional aspect of the present invention, the finger lever is connected to a gripping portion of the handle with a swivel pin, for optimal ease of finger-lever maneuverability.

According to an additional aspect of the present invention, the mechanism for issuing the at least one stapling element from the device is further adapted to issue the at least one stapling element gradually.

According to an additional aspect of the present invention, the rigid, proximal-end frame, which defines the opening from which the at least one stapling element issues, is at angle, which is smaller than 90° to the at least one stapling element.

According to an additional aspect of the present invention, the device includes a counter frame, on a proximal side of the rigid, proximal-end frame, for holding the tissue between the application and counter frames.

According to an additional aspect of the present invention, the counter frame further includes a casing, which defines an inner space, within which the at least one stapling element is designed to close.

According to an additional aspect of the present invention, the device is adapted for endoscopy.

According to an additional aspect of the present invention, the cartridge, adapted for receiving at least one stapling element, is further adapted for receiving a plurality of stapling elements, arranged in a file, and issued one by one, each forming a staple, so that the device is operative as a Self-Closing Stapling, Intermittent-Firing (SCS-IF™) device.

According to an additional aspect of the present invention, the device is adapted for endoscopy, operative as a Self-Closing Stapling, Intermittent-Firing (SCS-IF-ENDO™) device.

According to an alternative aspect of the present invention, the cartridge, adapted for receiving at least one stapling element, is further adapted for receiving a plurality of stapling elements, arranged parallel to each other, as a row, and issued simultaneously, for forming a single seam of a plurality of staples, so that the device is operative as a Self-Closing Stapling-Transverse Anastomosis (SCS-TA™) device.

According to an additional aspect of the present invention, the device is adapted for endoscopy, operative as a Self-Closing Stapling-Transverse Anastomosis Endoscopy (SCS-TA-ENDO™) device.

According to an additional aspect of the present invention, the device includes a knife, for cutting excess tissue along the seam.

According to an alternative aspect of the present invention, the cartridge, adapted for receiving at least one stapling element, is further adapted for receiving a plurality of stapling elements, arranged parallel to each other, as two rows, and issued simultaneously, for forming two parallel seams, each of a plurality of staples, so that the device is operative as a Self-Closing Stapling-Gastro-Intestinal Anastomosis (SCS-GIA™) device.

According to an additional aspect of the present invention, the device is adapted for endoscopy, operative as a Self-Closing Stapling-Gastro-Intestinal Anastomosis Endoscopy (SCS-GIA-ENDO™) device.

According to an additional aspect of the present invention, the device includes a knife, arranged between the two parallel seams, for separating the two parallel seams.

According to an alternative aspect of the present invention, the device is adapted for receiving at least one stapling element, is round, adapted for receiving a plurality of stapling elements, arranged in a circle, parallel to each other, and issued simultaneously, for forming a circular seam of a plurality of staples, so that the device is operative as a Self-Closing Stapling-End-to-End Anastomosis (SCS-EEA™), adapted for endoscopy.

According to an additional aspect of the present invention, the device includes a circular knife, internal to the circular seam.

According to an alternative aspect of the present invention, the cartridge, adapted for receiving at least one staple element, comprises a plurality of staples, and the mechanism is adapted to issue the plurality of staples in parallel, for applying a row of staples simultaneously and gradually, so that device is operative as a Self-Closing Stapling, Simultaneous-Gradual-Firing (SCS-SGF™) device.

According to an additional aspect of the present invention, the device is operative as a Self-Closing Stapling, Simultaneous-Gradual-Firing-Endoscopy (SCS-SGF-ENDO™) device, for applying a row of staples simultaneously and gradually.

According to an additional aspect of the present invention, the device is adapted for the application of a single staple.

According to an alternative aspect of the present invention, the device is operative as a Self-Closing Stapling, Single-Shot (SCS-SS™) device.

According to an additional aspect of the present invention, the device is operative as a Self-Closing Stapling, Single-Shot Endoscopy (SCS-SS-ENDO™) device.

According to an alternative aspect of the present invention, the device has a gripping position and is adapted for changing the predetermined closing direction without changing the gripping position.

According to one aspect of the present invention, there is provided a method of staple application, comprising:providing at least one stapling element having:a first shape, adapted for insertion into a tissue, and comprising:a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue;an elongated body, distal to and integral with the tapered portion; anda physical feature of the elongated body, for preventing the stapling element from rotating, when in an application shaft, thus maintaining a predetermined closing direction; anda second shape, assumed when the stapling element issues from the application shaft and is inserted into the tissue, the second shape being designed to close into a loop, for forming a staple in the tissue;inserting the stapling element into the tissue, via the pointed edge; and allowing the stapling element to close and form the staple

According to an additional aspect of the present invention, the stapling element further comprises a phase of moreover closing the loop, after forming a staple in the tissue.

According to an additional aspect of the present invention, the inserting further includes inserting gradually, hence, with minimal tissue crushing.

According to an additional aspect of the present invention, the inserting further includes inserting at angle, which is smaller than 90° to the stapling element.

According to an additional aspect of the present invention, the inserting further includes inserting while maintaining the closing direction of the at least one stapling element.

According to another aspect of the present invention, there is provided a device for applying staples to a tissue, comprising:

a cartridge, adapted for storing at least one stapling element, in a coiled position, the stapling element having a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue;

a mechanism, in mechanical communication with the at least one stapling element, for issuing the at least one stapling element from the cartridge; and

a proximal end, with respect to the tissue, having a rigid, proximal-end frame, which defines an opening from which the at least one stapling elements issues.

According to an additional aspect of the present invention, the at least one staple comprises a plurality of staples, and the mechanism is adapted to issue the plurality of staples in parallel.

According to an alternative aspect of the present invention, the at least one staple comprises a plurality of staples, and the mechanism is adapted to issue the plurality of staples in series.

According to another aspect of the present invention, there is provided a stapling element, comprising:

a coiled shape, adapted for coiling in a tissue, so as to form a loop; and a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue,

the staple being formed of a resilient material.

According to another aspect of the present invention, there is provided a method of applying a stapling element into a tissue, comprising:

providing a stapling element, formed of a resilient material and having:a coiled shape, adapted for coiling in a tissue, so as to form a loop; anda tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue; and

applying the stapling element into the tissue, while the stapling element remains in a coiled shape.

The present invention successfully addresses the shortcomings of the presently known configurations by providing a stapling element, operative to pierce and penetrate a tissue by a first end, and close around the tissue. The staple is adapted for joining tissue of diverse geometries, for example, joining edge to edge, joining two or more layers together, and joining a mesh, or a patch to the tissue. Three factors help prevent local necrosis: 1. The self-closing feature of the staple does not lead to tissue crushing. 2. Edge seams are applied generally perpendicular to the tissue edge, allowing for blood supply to the tissue edge. 3. Excess tissue is cut off at the seam, minimizing the amount of tissue that may undergo local necrosis. A physical feature prevents the staple from rotating, when in an application shaft, to maintain a predetermined closing direction. The application devices provide ergonomic means for staple application in difficult-to-reach places. In addition, they provide standardization, so that the skilled and the less so may reach results of comparable quality, and the effects of fatigue and loss of patience will be minimized. The wide variety of stapling elements, which come in different sizes and shapes, and the wide variety of devices that are disclosed provide solutions to many surgical problems, for open and minimally invasive surgeries. The stapling element may be formed of an alloy, a pure metal, a polymer, or a composite of at least two materials. Additionally, staples, staplers, anastomosis devices, and methods for their applications are described.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is a stapling element, operative to pierce and penetrate a tissue by a first end, and close around the tissue. The staple is adapted for joining tissue of diverse geometries, for example, joining edge to edge, joining two or more layers together, and joining a mesh, or a patch to the tissue. Three factors help prevent local necrosis: 1. The self-closing feature of the staple does not lead to tissue crushing. 2. Edge seams are applied generally perpendicular to the tissue edge, allowing for blood supply to the tissue edge. 3. Excess tissue is cut off at the seam, minimizing the amount of tissue that may undergo local necrosis. A physical feature prevents the staple from rotating, when in an application shaft, to maintain a predetermined closing direction. The application devices provide ergonomic means for staple application in difficult-to-reach places. In addition, they provide standardization, so that the skilled and the less so may reach results of comparable quality, and the effects of fatigue and loss of patience will be minimized. The wide variety of stapling elements, which come in different sizes and shapes, and the wide variety of devices that are disclosed provide solutions to many surgical problems, for open and minimally invasive surgeries. The stapling element may be formed of an alloy, a pure metal, a polymer, or a composite of at least two materials. Additionally, staples, staplers, anastomosis devices, and methods for their applications are described.

The principles and operation of the device and method according to the present invention may be better understood with reference to the drawings and accompanying descriptions.

Referring now to the drawings,FIGS. 2A-2Eschematically illustrate a stapling element20, in accordance with a preferred embodiment of the present invention. Stapling element20includes an elongated body28and proximal and distal ends22and24, respectively, with respect to the tissue (not shown). FIGS.2A-2D illustrate proximal, side, distal, and pictorial views, respectively, of stapling element20, when in a first shape34, whileFIG. 2Eillustrates a side view, when in a second shape36. Stapling element20is adapted to close, in the direction of an arrow38(FIG. 2E), from first shape34into second shape36, upon release.

As seen inFIGS. 2B and 2D, stapling element20includes a tapered portion26at proximal end22, forming a sharp, pointed edge32, operative as a needle, for piercing a tissue. Generally, stapling element20is blunt at distal end24. However, in accordance with the present invention, this condition is not necessary, as will be illustrated hereinbelow, for example, in conjunction withFIG. 7A.

As seen inFIGS. 2B and 2C, stapling element20may further include a cavity30, at distal end24, adapted for receiving tapered portion26, so as to form a closed loop.

As seen inFIG. 2E, as proximal and distal ends22and24come together, in second shape36, tapered portion26may fit into cavity30, forming a closed loop, with no exposed sharp edges.

A physical feature, such as a rim27, which appears as a protrusion on cross sectional views2A and2C, and which may extend the length of elongated body28, as seen inFIGS. 2B and 2D, or cover a portion of its distal end, ensures that stapling element20is inserted into the tissue at a specific, predetermined orientation with respect to its memorized closing. For example, as seen inFIG. 2E, rim27may form an outer ring over closed second shape36. Rim27may fulfill two purposes:i. it serves as a visible indicator of the direction of closing; andii. it prevents stapling element20from rotating away from its predetermined orientation, within an application shaft.

It will be appreciated that a notch or any other means for ensuring a specific, orientation-dependent insertion, by fulfilling purposes (i) and (ii), may similarly be used. It will be further appreciated that stapling element20may include two or more physical features, such as two rims27or two notches (for example, as shown in conjunction withFIG. 15D, hereinbelow. It will be appreciated that the application shaft compliments the at least one physical feature of stapling element20, as will be described hereinbelow, for example, in conjunction withFIG. 16D, hereinbelow.

A total length L of stapling element20depends on the required application, and may vary, for example, between about 4 mm and about 200 mm. A length T of tapered portion26may be, for example, between about 0.5 mm and about 5 mm. A diameter d similarly depends on the application, and may vary, for example, between about 0.1 and about 3 mm, and preferably between about 0.5 and about 2 mm. It will be appreciated that other values, which may be smaller or larger, are similarly possible.

It will be appreciated that generally in the art, for blood vessels, stapling elements of 4 mm are used, and they are color coded white. For the gastrointestinal tract, stapling elements of 5 mm are used, and they are color coded blue. For the stomach, stapling elements of 6 mm are used, and they are color coded green. It will be appreciated that the stapling elements of the present invention may follow the color code that is used in the art. Additionally, stapling elements of other sizes may be used, and may be color coded by other colors.

Stapling element20may be formed of a shape memory alloy, wherein first shape34is its martensitic shape, either in the martensitic phase, in the fully martensitic temperature range, or in a constrained state, as stress-induced martensite, in the fully austenitic temperature range.

In accordance with a preferred embodiment of the present invention, stapling element20is fully austenitic at room temperature, and is maintained at a constrained state, as stress-induced martensite, for insertion into the body, so that adjustment from first shape34to second shape36may be substantially instantaneous.

Preferably, second shape36is in the fully austenitic phase and temperature range.

In accordance with an alternative embodiment of the present invention, stapling element20is designed as a resilient spring, formed of a biologically compatible material, such as titanium, tantalum, or stainless steel, a tough, resilient polymer, or another suitable material, which may be constrained into first shape34, and which is adapted to close into second shape36, upon release.

While the present embodiment illustrates both elongated body28and tapered portion26of circular cross sections, it will be appreciated that many other cross sections are possible.

Referring further to the drawings,FIGS. 3A-3Hschematically illustrate stapling elements20of other cross sections, in accordance with other embodiments of the present invention.

As seen inFIGS. 3A-3D, elongated body28has a circular cross section, and tapered portion26has a triangular cross section. Cavity30is thus also triangular, for receiving triangular tapered portion26. The triangular cross section of tapered portion26is operative to cut into a hard tissue, such as a tendon or a bone.

As seen inFIGS. 3E-3H, elongated body28may have a rectangular cross section, and tapered portion26may have a triangular cross section. It will be appreciated that the geometry of the present embodiment inherently ensures that stapling element20is inserted into the tissue at a specific, predetermined orientation with respect to its memorized closing, since the rectangular cross section prevents stapling element20from rotating away from its predetermined orientation, within an application shaft. Additionally, triangular cavity30, shaped as an arrow head (FIG. 3G), may serve as a visible indicator of the direction of closing. Additionally or alternatively, a visible marking44may be applied to distal end24, as an indicator of the direction of closing. Thus rim27(FIGS. 2A-2E) need not be used. It will be appreciated that visible marking44need not be applied, since in general, stapling elements20are loaded onto the cartridge or application shaft at the factory.

It will be appreciated that elongated body28may have other cross sections, for example, elliptical, triangular, or of other polygons, and generally, these cross sections will prevent stapling element20from rotating away from its predetermined orientation, within an application shaft. Similarly, tapered portion26may have other cross sections, for example, elliptical, triangular, or of other polygons. Furthermore, elongated body28and tapered portion26may have similar cross sections or different cross sections.

In general, the different cross sections are adapted for different applications. For example, a circular cross section causes minimal trauma, but an elliptical cross section has greater strength, and a triangular cross section is operable for penetrating hard tissue, such as tendon or bone.

Referring further to the drawings,FIGS. 4A-4Eschematically illustrate stapling element20, of circular cross sections, wherein tapered portion26has a screw thread42, in accordance with an embodiment of the present invention.

Accordingly, the release from first shape34into second shape36involves both a closing motion, in the direction of arrow38(FIG. 4E) and a threading motion, around the longitudinal axis, in the direction of an arrow40. Screw-thread42, when rotating in the direction of arrow40, facilitates piercing the tissue with greater ease, both for hard and soft tissue, essentially by self-threading into it.

Referring further to the drawings,FIG. 5schematically illustrates stapling element20, of circular cross sections, with screw thread42along most of its length, for self-threading into a tissue, in accordance with an embodiment of the present invention. To accommodate thread42, rim27is provided only at the distal portion of elongated body28. The present embodiments may be applicable to a hard tissue, such as tendon and bone.

Referring further to the drawings,FIGS. 6A-6Bschematically illustrate stapling element20, wherein tapered portion26, forming the sharp, pointed edge, is curved in the direction of closing, in first shape34, in accordance with an embodiment of the present invention. The advantage of this design is that proximal end22pierces the tissue at the angle of closing, even when only partially, and perhaps only slightly issued from the application shaft. Additionally, tapered portion26, which is pointed in the direction of closing, may also be used as a visible indication of the direction of closing.

Referring further to the drawings,FIGS. 7A-7Fschematically illustrate stapling element20, wherein cavity30(FIGS. 6A-6B) is not provided at distal end24. Rather, tapered portion26and distal end24are arranged to overlap, in accordance with other embodiments of the present invention.

As seen inFIGS. 7A-7B, proximal and distal ends22and24come together, while substantially maintaining the cross sectional size of elongated body28. It will be appreciated that the line of overlap between proximal and distal ends22and24may be perpendicular to the plane of the closed staple, as shown inFIG. 7B, or at any angle thereof.

Thus, in accordance with the embodiment ofFIGS. 7A and 7B, stapling element20is symmetrical with respect to its proximal and distal ends, and may be inserted from either.

Referring further to the drawings,FIGS. 8A-8Cschematically illustrate stapling element20, wherein again, cavity30(FIGS. 6A-6B) is not provided at distal end24, and tapered portion26and distal end24are arranged to overlap, in accordance with another embodiment of the present invention. As seen inFIG. 8B, tapered portion26is internal to the loop. Alternatively, it may be external to the loop. As seen inFIG. 8C, tapered portion26is alongside distal portion24. Alternatively, stapling element20may form an open loop or an open spiral.

Referring further to the drawings,FIGS. 9A-9Ischematically illustrate various manners of closure of stapling elements20when in second shape36, in accordance with the present invention.

As seen inFIG. 9C, proximal and distal ends22and24are symmetric. They overlap, while substantially maintaining the cross section of elongated body28.

As seen inFIG. 9D, distal end24is slightly blunt, and proximal and distal ends22and24overlap, while substantially maintaining the cross section of elongated body28.

As seen inFIG. 9E, proximal and distal ends22and24overlap to form a closed loop, and are arranged end to end. This embodiment is applicable regardless of whether cavity30is provided.

As seen inFIG. 9F, proximal and distal ends22and24overlap to form a closed loop, with distal end24being internal to the loop. Again, this embodiment is applicable regardless of whether cavity30is provided.

As seen inFIG. 9G, proximal and distal ends22and24overlap to form a closed loop, with distal end24being external to the loop. As before, this embodiment is applicable regardless of whether cavity30is provided.

As seen inFIG. 9H, proximal and distal ends22and24overlap to form an open spiral. This embodiment is applicable regardless of whether cavity30is provided.

As seen inFIG. 9I, stapling element20forms an open loop. This embodiment is applicable regardless of whether cavity30is provided.

It will be appreciated that the embodiments ofFIGS. 9A-9Irelate to any cross section, such as circular, square, triangular, elliptical or any other may be used.

Referring further to the drawings,FIGS. 10A-10Gschematically illustrate stapling elements20, with elongated bodies28and tapered portions26of various geometrical cross sections, such as square, rectangular, tetrahedron, circular with a rim, elliptical, and triangular, in accordance with other embodiments of the present invention. In accordance with the present embodiments, the cross sections of elongated bodies28and tapered portions26are similar, for example, both may be triangular, or square. In accordance with other embodiments of the present invention, they may be different.

It will be appreciated that these geometrical cross sections inherently prevent stapling element20from rotating within an application shaft. In some cases, for example, with regard to any triangle, especially one that is not isogonic, the pointed edge may be further used as a visible indicator of the direction of closing. Additionally or alternatively, a visible marking44(FIG. 3G) may be applied to distal end24as an indicator of the direction of closing.

Referring further to the drawings,FIGS. 11A-11Gschematically illustrate stapling elements20of various geometrical cross sections, as inFIGS. 10A-10G, wherein tapered portions26are as was taught hereinabove, byFIG. 7A, in accordance with embodiments of the present invention.

Referring further to the drawings,FIGS. 12A-12Cschematically illustrate a first shaft54of a staple device, in accordance with embodiments of the present invention. In essence, first shaft54is operative as a cartridge for stapling elements20.

As seen inFIG. 12A, illustrating a side view, in an x;y plane, first shaft54has a cladding55, which defines a lumen51and proximal and distal ends60and62, with respect to the tissue (not shown). First shaft54further defines an opening70, encased within a first frame74, at proximal end60. First frame74includes a preferably spring-operated gate72, for preventing stapling elements20from issuing, unintentionally.

First shaft54is adapted to receive at least one, and preferably, several stapling elements20, arranged in file, so that distal end24of a first stapling element20A is abut against proximal end22of a second stapling element20B.

Furthermore, first shaft54is adapted to receive a driving component64, distal to the file of stapling elements20, and having two pegs66, arranged 180° apart. A cap68closes or locks first shaft54, at distal end62, to prevent an accidental exist of stapling elements20and driving component64.

Pegs66of driving component64are adapted for transferring a motion, in the −x direction (from distal end62to proximal end60) to stapling elements20, thus forcing them to issue. It will be appreciated that many alternative mechanical means are known for producing such a motion, and these are also within the scope of the present invention.

As seen inFIG. 12B, illustrating a cross-sectional view A-A, in a y;z plane, first shaft54defines lumen51whose cross section substantially complements that of elongated body28of stapling element20. Thus, first shaft54maintains the specific, predetermined, orientation-dependent insertion of stapling element20.FIG. 12Bfurther illustrates two slits58, arranged 180° apart, along the length of first shaft54, for pegs66(FIG. 12A).

As seen inFIG. 12C, illustrating a view from proximal end60, first shaft54includes spring-operated gate72at proximal end60. Preferably, spring-operated gate72is formed as an arc, that may open under pressure, as stapling element20is forced towards proximal end60. When closed, spring-operated gate72prevents the exit of stapling elements20.

In accordance with the embodiment ofFIGS. 12A-12C, elongated body28of stapling element20has a circular cross section and includes a feature, formed as rim27, and first shaft54has a complementary circular lumen and includes a complementary shaft feature56, such as a notch56, adapted to receive rim27. It will be appreciated that other cross sections and complementary lumens of first shaft54are possible.

It will be appreciated that a feature of stapling element20may be formed as a notch, and complementary shaft feature56, may be formed as protrusion56, adapted to fit into a notch. It will be appreciated that other complementary systems may similarly be used.

Referring further to the drawings,FIGS. 13A-13Cand14A-14C schematically compare circular and rectangular cross-sections, in accordance with embodiments of the present invention. As seen inFIGS. 13A-13C, elongated body28is circular, and includes rim27, while cladding55of first shaft54defines circular lumen51, and includes notch56for receiving rim27. As seen inFIGS. 14A-14C, elongated body28is rectangular, and cladding55of first shaft54defines rectangular lumen51, adapted to receive it. Additionally, distal end24of rectangular stapling element20(FIG. 14A) may include visible marking44, to indicate the direction of closing.

Referring further to the drawings,FIGS. 15A-15Hschematically illustrate stapling elements20of various cross sections for elongated bodies28, in accordance with embodiments of the present invention, whileFIGS. 16A-16Hschematically to illustrate application shafts54of matching cross sections of lumens51.

Referring further to the drawings,FIGS. 17A and 17Dillustrate first shaft54with first frame74arranged so that opening70forms an angle β, different than 90°, with stapling element20. Angle β may be, for example, 75°, 45°, or 15°, or any other angle. As seen inFIGS. 17C-17D, angle β may be 0. It will be appreciated that gate72(FIG. 12A) is adapted to the angle of frame74.

The present embodiments are applicable to situations where the tissue is not at a right angle to the application shaft.

Referring further to the drawings,FIGS. 18A-18Kschematically illustrate the components of an application shaft110, in accordance with an embodiment of the present invention.

FIGS. 18A and 18Bare pictorial views of first shaft54, illustrating its components:

at proximal end60, opening70is encased within first frame74, which includes gate72, preferably spring-operated;

along the body of first shaft54, a plurality of stapling elements20are arranged in a single file, for issuing in series, one after the other, each being engaged with first shaft54by a staple feature and complementary shaft feature56;

more distal to plurality of stapling elements20, and abut against them, driving component64is engaged with first shaft54, via pegs66, which are inserted into slits58; and

at distal end62, cap68which may include a locking mechanism, locks the components within.

Note that a proximal portion63does not include slits58, thus maintaining the integrity of first shaft54as a tube.

As seen inFIG. 18C, a second shaft80, having a cladding85with an internal threaded groove86, defines proximal and distal ends82and84and a lumen. Second shaft80is adapted to receive first shaft54within, so that pegs66of driving component64engage with internal threaded groove86. Second shaft80has a second frame90, defining an opening at proximal end82. It will be appreciated that second frame90is arranged so as to accommodate the angle of first frame74in the embodiments of FIGS.12A and17A-17D.

Additionally, second shaft80includes a gear88, at distal end84. Preferably, the teeth of gear88are at an acute angle δ to the y-axis. Gear88is fixed onto second shaft80. As gear88rotates, second shaft80rotates with it.

As seen inFIG. 18D, a third shaft100has a cladding105and defines proximal and distal ends102and104, respectively, and a lumen, adapted to receive second shaft80. A third frame103defines an opening at distal end102. It will be appreciated that both third frame103and second frame90, are arranged so as to accommodate the angle of first frame74in any one of the embodiments of FIGS.12A and17A-17D.

As seen inFIG. 18E, first shaft54is adapted for insertion into second shaft80, which in turn is adapted for insertion into third shaft100.

As seen inFIGS. 18F and 18G, third shaft100includes a locking device108, at proximal end102, which locks third shaft100with first shaft54, to prevent first shaft54from rotation, as gear88(FIG. 18C) rotates second shaft80. It will be appreciated that any locking mechanism, as known, may be used.

As seen inFIGS. 18I,18J and18D, a dial106, rigidly connected to third shaft100, has an indication, for example “UP,” which is designed to show the direction of closing of stapling element20. As stapling element20issues from third shaft100, it will close in the direction of the indication, such as, “UP.” Since third shaft100and first shaft54are rigidly connected by closure device108, rotating dial106will rotate first shaft54with third shaft100, so as to maintain the correspondence between the direction of the indication, such as, “UP” and the direction of closing.

As seen inFIGS. 18H-18I, gear88of second shaft80is not engaged with dial106of third shaft100, and its rotation does not affect the orientation of dial106.

FIGS. 18H-18Jschematically illustrate application shaft110, formed of first, second and third shafts54,80and100. Application shaft110defines proximal and distal ends112and114with respect to the tissue, and a rigid, proximal-end frame116, which defines an opening, from which stapling elements20issue.FIGS. 18H-18Jillustrate tapered portion26of a first stapling element20, as it issues from application shaft110. It will be appreciated that rigid, proximal-end frame116is arranged so as to accommodate the angle of first frame74in any one of the embodiments ofFIGS. 12A,17A, and17B.

FIG. 18Kschematically illustrates a cross-sectional view of application shaft110, formed of first, second and third shafts54,80and100, and driving component64, with pegs66inserted into slits58. Note that in the present embodiment, driving component64, like stapling elements20, includes a notch into which protrusion56is inserted.

In accordance with the present invention, the design of first, second and third shafts54,80and100is adapted for transferring a motion in the x direction to pegs66, as illustrated byFIG. 18H. As gear88is made to rotate, as shown by an arrow118, second shaft80rotates with it. Pegs66are engaged with internal threaded groove86of second shaft80(FIG. 18C), but are prevented from rotating with second shaft80, since they are inserted into through, longitudinal slits58of first shaft54(FIG. 18A), which is fixed by locking device108(FIGS. 18F-18G). Hence, pegs66must travel along rotating threaded groove86, sliding in longitudinal slits58of first shaft54, and pushing stapling elements20, in the −x direction, with them.

It will be appreciated that many alternative mechanical means are known for producing such a motion, and these are also within the scope of the present invention. For example, a piston-cylinder arrangement, or a belt arrangement, which may be a time belt arrangement, or any other known mechanism for producing a linear motion, may be used.

Referring further to the drawings,FIGS. 19A-19Fschematically illustrate a Self-Closing Stapling, Intermittent-Firing (SCS-IF™) device120, formed of application shaft110and a gripping handle130, in accordance with an embodiment of the present invention.

As seen inFIGS. 19A and 19B, while application shaft110is parallel to the x-axis, a length axis D of handle130is designed at an angle γ to the x-axis. Recalling fromFIG. 1Athat when the Auto-Staple device of the prior art is held at 90° to the fascia, as recommended, the surgeon's elbow makes an angle α of about 120° with the his arm. The hand is thus near the end of its rotational travel in that orientation, and its maneuverability is limited. The present design is intended to correct this.

In accordance with a preferred embodiment of the present invention, an angle γ is designed between length axis D and application shaft110, so that when application shaft110is held at 90° to the surface of tissue46, the surgeon's hand is outstretched, with substantially no bending at the elbow. This allows the surgeon maximum maneuverability, since the full range of elbow bending is available to him.

Preferably, angle γ is about 60°. Alternatively, another angle, for example, 300, 450, or 750 may be used. Additionally or alternatively, a ball-bearing arrangement may be provided, for allowing a variable angle setting, wherein the desired angle will be predetermined and set specifically for each operation.

It will be appreciated that SCS-IF™ device120, for which length axis D and application shaft110are aligned is also within the scope of the present invention.

As seen inFIG. 19A, gripping handle130includes a gripping portion129, and a spring-operated finger lever132, connected to gripping portion129by a swivel pin127. In this manner optimal ease of maneuverability for of finger-lever132is achieved. Preferably, finger lever132is adapted for operation by four fingers, thus being ergonomically designed. Alternatively, only the index finger, or only two or three fingers may be used.

Although only a schematic construction is provided inFIG. 19A, some features are worth noting. Finger lever132is in communication with a spring134, and with a gear system136, having gears136A and136B, arranged to rotate in opposite directions. Leaf springs133,137and139ensure that gears136A and136B rotate in their desired directions.

The pressing of finger lever132causes gear136B to rotate in the direction of an arrow136C, so as to rotate gear88of second housing80(FIG. 18C), thus rotating internal thread86, for issuing of stapling element20.

Additionally, spring134provides for a controlled gradual motion of gear136B and for a gradual insertion of stapling element20. The gradual control may be stepwise, correlated with the gear teeth. It will be appreciated that the gradual insertion prevents tissue crushing, characteristic to the staple ejection of the prior-art device ofFIG. 1A.

A return path is made possible by a button131. On the return path, finger lever132communicates with gear136A, which rotates in the direction of arrow136D.

FIG. 19Bschematically illustrates the exterior of handle130of SCS-IF™ device120. As previously noted, application shaft110is preferably arranged on swivel dial106, which provides a 360° rotation. The direction of closing of stapling element20, which issues from SCS-IF™ device120, corresponds to the indication “UP”, and may be thus controlled by rotating dial106.

It will be appreciated that a surgeon may apply a first stapling element20, then rotate dial106, and apply a second stapling element20, closed in another direction.

In accordance with the present invention, SCS-IF™ device120may be adapted for Endoscopy, and may be referred to as SCS-IF-ENDO™ device120. A length LSHAFTmay be between about 37 and 40 cm, and a diameter DSHAFTmay be between about 3 mm and 5 mm. Alternatively, the diameter DSHAFTmay be up to about 12 mm. It will be appreciated that other dimensions, which may be larger or smaller, may similarly be used and are also within the scope of the present invention.

Alternatively, SCS-IF™ device120may be adapted for open surgery, and the length LSHAFTmay be about 10-20 cm.

In accordance with an alternate embodiment of the present invention, a miniature motor may be provided, within handle130, activated by finger lever132, for providing the rotational motion of gear88, in place of gear system136. Preferably, finger lever132is further adapted to control the motor speed, thus the rate at which stapling elements20issue from application shaft110.

FIGS. 19C-19Fschematically illustrate stages of insertion of stapling elements20, via application shaft110, in accordance with an embodiment of the present invention.

As stapling element20issues from application shaft110, it begins to close, and when completely out, it forms the closed loop of second shape36(FIG. 19F), enclosing on a tissue46. A second stapling element20may then issue from application shaft110.

It will be appreciated that for piercing tissue46, a second tool (not shown) may be used, for pressing tissue46against stapling element20, thus providing a counterforce to stapling element20.

It will be appreciated that unlike the staple ejection of prior art (FIG. 1A), which may cause tissue crushing, stapling elements20issues gradually, and when the second tool is used for a counterforce, it provides a gentle counterforce, so as to cause minimal tissue crushing.

It will be further appreciated that unlike the figure-eight staples of the prior art, that press on the tissue (FIG. 1D), and may cause crushing, the loop formed by stapling element20causes little damage, other than the piercing action.

WhileFIGS. 19C-19Fillustrate stapling element20of a circular cross section and rim27, it will be appreciated that any other cross section and embodiment described hereinabove, or a combination thereof, may be used.

It will be appreciated that application shaft110(FIGS. 19C-19F) may be rotated as a whole, allowing the surgeon control over the direction of closing of stapling element20. Thus, a surgeon may apply a first stapling element20, then rotate the application shaft, and apply a second stapling element20, closed in another direction.

Referring further to the drawings,FIGS. 20A-20Cschematically illustrate example applications of stapling elements20, by SCS-IF™ device120(FIGS. 19A-19F), in accordance with embodiments of the present invention. For simplicity, only application shaft110is shown.

FIG. 20Aillustrates an abdominal hernia repair, by joining an artificial mesh48, for example, of PPP, as known, and tissue46, using stapling elements20. The surgery may be an open surgery, or a minimally invasive surgery, such as laparoscopic repair.

It will be appreciated that patches, for example, of Dacron or PTFE, as known, may be used in a similar manner.

It is important that while the prior art uses staples at key points and sutures elsewhere, stapling elements20may be used for the entire mesh seam. For example, stapling elements20of about 22 mm may be used at key locations, to form heavy-duty staples142, and stapling elements20of about 15 mm may be used elsewhere along the mesh seam, to form standard staples144. Heavy-duty staples142may form elliptical closes, as compared to the circular closes of standard staples144. It will be appreciated that other dimensions and cross sections may similarly be used.

FIG. 20Billustrates a stitching of a gastric tube150, using stapling elements20, to join two tissue edges, arranged end to end, and to form staples152. As before, the surgery may be an open surgery, or a minimally invasive surgery.

FIG. 20Cillustrates a Nissen Fundoplication, wherein a proximal stomach160is wrapped around the anastomosis, using stapling elements20, to join two tissue edges, arranged end to end, and to form staples162. Again, the surgery may be an open surgery, or a minimally invasive surgery.

Referring further to the drawings,FIGS. 21A-21Bschematically illustrate a cartridge170, for a parallel application of a plurality of stapling elements20, in accordance with an embodiment of the present invention. As seen inFIG. 21A, the plurality of stapling elements20are arranged parallel to each other, as a row, and may issue simultaneously. As seen inFIG. 21B, when issued, they are designed to close together, in a same direction. Cartridge170includes a rigid, proximal-end frame172, at its proximal most end, with respect to the tissue. Rigid, proximal-end frame172defines the openings from which stapling elements20issue.

It will be appreciated that stapling elements20are placed within cartridge170at a fixed orientation, with respect to their direction of closing. Physical features prevent stapling elements20from rotating, in manners similar to those used in conjunction with first shaft54, hereinabove (FIGS. 13A-13C,14A-14C).

Referring further to the drawings,FIGS. 22A-22Hschematically illustrate a Self-Coiling Staple-Transverse Anastomosis (SCS-TA™) device180, for using stapling elements20, in accordance with an embodiment of the present invention.

As seen inFIGS. 22G-22H, SCS-TA™ device180includes an gripping handle179, a shaft175, which may be straight, as inFIG. 22G, curved, as inFIG. 22H, or flexible, and an applicator177, which houses cartridge170, for a parallel application of a plurality of stapling elements20. In general, SCS-TA™ device180is applicable to open surgery.

As seen inFIG. 22A, applicator177defines proximal and distal ends182and184with respect to the tissue, an x-axis, parallel to the line of the plurality of stapling elements20, and a y-axis, parallel to the length axis of each stapling element20.

Additionally, applicator177includes a housing186, within which cartridge170is arranged, as seen inFIG. 21B. Cartridge170defines rigid, proximal-end frame172, adapted to make contact with the tissue. In general, the tissue is to be placed between rigid, proximal-end frame172and a counter frame192, within a space193.

A proximal-most casing190, defining an inner space within which stapling elements20may close, is provided. Proximal-most casing190includes counter to frame192which may further include rigid support slats191. Preferably, casing190includes a knife track181, for cutting excess tissue, as will be illustrated hereinbelow, in conjunction withFIGS. 23A-23D.

The operation of SCS-TA™ device180is controlled by gripping handle179, as follows:

The turning of a knob195, for example, in the direction of an arrow194, causes a rod171to press down cartridge170, bringing it to substantial contact with tissue46(not shown in these figures, but seen inFIGS. 23A-23D, hereinbelow), in space193.

When substantial contact with tissue46is made, a lever196is pressed in the direction of an arrow197, and rod171or another rod pushes a plate198in the −y direction, within a grove187, as seen by an arrow173A, pressing on a plate199, which in turn pushes pistons189in the −y direction, in channels183, as seen by an arrow173B, so as to force stapling elements20out.

As seen inFIGS. 22B and 22C, closing takes place within casing190.

Side views of applicator177are provided inFIGS. 22D-22F, illustrating the stages of ejection of stapling elements20by plates198and199and pistons189. Knife tract181is designed for cutting the tissue after the stapling elements are inserted into the tissue.

SCS-TA™ device180is applicable to open surgery, for example, for gastric tube closures.

Referring further to the drawings,FIGS. 23A-23Dschematically illustrate the joining of at least two layers of the tissue,200and202, arranged back to back, by staples204, to form a seam205, for example, during an open surgery, for example, via SCS-TA™ device180.

In some cases, it may be desired to cut off excess tissue, so that staple seam205is made into an edge seam205. Preferably, a knife207, that can be as well a part of the device, is used, as seen inFIGS. 23A-23D, for cutting along the seam of staples204, along knife tract181. Preferably, the cut exposes edges206of staples204. By eliminating excess tissue beyond the seam, local necrosis, which may take place in the excess tissue, is prevented, and healing is promoted. It will be appreciated that the prior art has no staple, applicable as an edge seam (similar, for example, to the edge of a tablecloth or of a rug), whereas stapling elements20may be used for forming an edge seam.

It will be appreciated that in some cases, the tissues may be left uncut.

It will be appreciated that SCS-TA™ device180may be used to apply more than one seam, for example, two or three seams, parallel to each other.

It will be further appreciated that in some cases, for example, in gastric fundus cases, two seams may be applied, parallel to each other, and the tissue, for example the stomach, may be cut between the parallel seams.

Referring further to the drawings,FIGS. 24A-24Ischematically illustrate a Self-Coiling Staple-Gastro-Intestinal Anastomosis (SCS-GIA™) device210, for using stapling elements20, in accordance with an embodiment of the present invention. SCS-GIA™ device210contains two cartridges221, for a two, parallel line application of stapling elements20. Preferably, the two parallel lines, while applied in tandem, close at opposite directions, 180° apart (FIG. 24C).

SCS-GIA™ device210is adapted for forming two edge seams, similar, for example, to the edges of a tablecloth or of a rug, as illustrated inFIG. 24I, wherein the two edge seams are arranged end to end. The edge seams promote heating and allow the flow of flood and nutrients to the tissue edge.

Cartridges221include a rigid, proximal-end frames213. SCS-GIA™ device210further includes a counter frame215and a casing224, defining a proximal inner space, which may be divided into compartments225.

In accordance with the present embodiment, the tissue (not shown) is placed between rigid, proximal-end frames213and counter frame215. Device210closes over the tissue by bringing counter frame215against proximal-end frame213, in the direction of arrow222. Preferably, closing takes place within casing224, preferably, within compartments225.

A lever214(FIG. 24A), adapted to move in the direction of an arrow216, moves a triangular block239, in the direction of an arrow237, causing a plate227to force stapling elements20, out, in the direction of arrow220. Additionally, lever214moves a knife235, along with triangular block239, with a predetermined delay, so that when stapling elements20are inserted, knife235cuts the tissue between the two rows of staples that are formed (FIG. 24I).

As seen inFIGS. 24D and 24F, triangular block239presses on a flexible plate227, in the y direction, which in turn applies pressure on pistons229and forces stapling elements20to issue.

Alternatively, as seen inFIGS. 24E and 24G, pistons229include hat-like portions231, inclined at an angle that complements the angle of triangular block239. Thus, triangular block239presses down on hat-like portions231of pistons229, in the −y direction, which in turn applies pressure on pistons229and forces stapling elements20to issue.

As seen inFIGS. 24H and 24I, two seams230of staples233are formed on tissue232and234. Knife235then slices the tissue between the parallel lines of seams230. It will be appreciated that when desired, the tissue may remain uncut.

Referring further to the drawings,FIGS. 25A-25Fschematically illustrate a Self-Coiling Staple-End to End Anastomosis (SCS-EEA™) device240, for using stapling elements20, in accordance with an embodiment of the present invention. SCS-EEA™ device240has an overall diameter of up to 35 mm, and may be used for endoscopy.

SCS-EEA™ device240is formed of two portions, a body251and an end-casing259, which are connected via a central rod269, of body251. Central rod269has a sharp pointed edge and a screw thread169, and is adapted to fit into screw hole167of end-casing259. In general, body251is inserted from a first side of the tissue, and end-casing259is inserted from the other side. Central rod269is then fitted into screw hole167, thus connecting the two portions.

SCS-EEA™ device240includes a release mechanism of a lever245and a knob241. Additionally, SCS-EEA™ device240includes a round cartridge244, wherein a plurality of stapling elements20are parallel to each other, in a circular arrangement. A round plate273and pistons277are adapted to push stapling elements20in the −y direction.

Round cartridge244includes a round frame236, on its proximal side with respect to the tissue. Additionally, SCS-EEA™ device240includes a counter frame238and end-casing259, defining an inner space, which may be divided to compartments271.

Rotation of knob241in the direction of arrow243brings round frame236ageist counter frame238, with the tissue between them.

Pressing lever245in the direction of an arrow247forces round plate273down in the −y direction, pushing pistons277, in the −y direction, and forcing stapling elements20out.

A circular knife242(FIG. 25C) may be used for cutting excess tissue within a circular seam246that is formed, when desired, as seen inFIG. 25D. Preferably, a diameter dEEA(FIG. 25F) of the cut is between about 18 and about 25 mm. It will be appreciated that other values are similarly possible.

Referring further to the drawings,FIG. 26schematically illustrates a Self-Closing Stapling-Transverse Anastomosis Endoscopy (SCS-TA-ENDO™) device250, for using stapling elements20, in accordance with an embodiment of the present invention. SCS-TA-ENDO™ device250includes a gripping handle265, and a shaft267, preferably, with an overall diameter DSHAFTof between about 12 and about 35 mm, and may generally be 12 mm, or 16 mm or 35 mm, adapted for endoscopy. Shaft267has an extracorporeal portion261and an intracorporeal portion263. A TRUCAR endoscopic valve254may be provided, between portions263and261, for endoscopic insertion. It will be appreciated that other diameters may similarly be used.

At a proximal end with respect to the tissue, intracorporeal portion263includes a cartridge258, having a single row of stapling elements20and a rigid, proximal-end frame256, orthogonal to the row of stapling elements20. Additionally, it includes a counter frame252, parallel to rigid, proximal-end frame256.

The operation of SCS-TA-ENDO™ device250is controlled by a knob255a lever257, and a slide253, arranged to slide within a channel251. In essence, knob255determines the width of the gap, between proximal-end frame256and counter frame252, and lever257brings counter frame252towards proximal-end frame256. Slide253then pushes a triangular block282that forces stapling elements20to issue. Preferably, a knife288(FIG. 26), also in mechanical communication with slide253, follows behind triangular block283, for slicing the excess of tissue along the edge seam. It will be appreciated that knife288may be removed.

It will be appreciated that TRUCAR endoscopic valve254may similarly be provided for application shaft110of SCS-IF-ENDO™ device120(FIGS. 19A-19F), or SCS-EEA™ device240, or for any other device of the present invention, adapted for endoscopic insertion.

Referring further to the drawings,FIG. 27schematically illustrates a Self-Coiling Staple-Endoscopic, Gastro-Intestinal Anastomosis (SCS-GIA-ENDO™) device260, for using stapling elements20, in accordance with an embodiment of the present invention.

SCS-GIA-ENDO™ device260includes gripping handle265, and shaft267, having a shaft diameter preferably of about 12 mm, adapted for endoscopy. Shaft267includes extracorporeal portion261, intracorporeal portion263, and preferably also TRUCAR endoscopic valve254between portions263and261, for endoscopic insertion. It will be appreciated that other shaft diameters may similarly be used.

At a proximal end with respect to the tissue, intracorporeal portion263includes a cartridge268, having two parallel rows of stapling elements20and a rigid, proximal-end frame266, orthogonal to the rows of stapling elements20. Additionally, it includes a counter frame262, parallel to rigid, proximal-end frame. The operation of SCS-GIA-ENDO™ device260is controlled by knob255lever257, and slide253.

The operation of SCS-GIA-ENDO™ device260is controlled by knob255lever257, and slide253, arranged to move within channel251, as in the case of device250(FIG. 26). In essence, knob255determines the width of the gap, between proximal-end frame266and counter frame262, and lever257brings counter frame262towards proximal-end frame266. Slide253then pushes a triangular284block that forces stapling elements20to issue. Preferably, a knife288, also in mechanical communication with slide253, follows behind triangular284, for slicing the tissue, along the edge seam. It will be appreciated that knife288may be removed.

Referring further to the drawings,FIGS. 28A-28Jschematically illustrate a Self-Closing Stapling, Simultaneous-Firing (SCS-SF™) device270, using stapling elements20, in accordance with an embodiment of the present invention.

SCS-SF™ device270may be used for open surgery, and as such it may have a straight shaft, as illustrated inFIG. 28A, or a curved shaft, as inFIG. 28C. Additionally, it may be used for endoscopic surgery, operative as a Self-Closing Stapling, Simultaneous-Firing Endoscopy (SCS-SF-ENDO™) device, preferably, with a straight shaft, as illustrated inFIG. 28B.

At a proximal end with respect to the tissue, intracorporeal portion263includes a cartridge274, having a row of stapling elements20and a rigid, proximal-end frame276, orthogonal to the row of stapling elements20. However, a counter frame is not provided. Rather, in some cases, a second tool (not shown) may be used to gently provide a counter force to stapling elements20.

The operation of SCS-SF™ device270is controlled by a spring-operated lever272, for issuing the row of stapling element20simultaneously.

Preferably, lever272provides gradual control over the extent of issuing of stapling elements20.

As seen inFIG. 28F, stapling elements may be arranged at an angle to shaft175, when longer stapling elements are desired.

FIGS. 28I and 28Jillustrate a handle with a gradual controlled release mechanism of the staples, as follows:

FIG. 28Iillustrates SCS-SF™ device270, with handle130, similar to that ofFIGS. 19A-19B, but aligned with the application shaft.

FIG. 28Jillustrates SCS-SF™ device270, with handle130, similar to that ofFIGS. 19A-19B, at an angle γ to the application shaft.

As seen inFIGS. 28G and 28H, SCS-SF™ device270may be used in a manner similar to SCS-IF™ device120ofFIGS. 20B and 20C, hereinbelow, while speeding up the operation (over device120), by applying several staples simultaneously.

FIG. 28Gillustrates the stitching of gastric tube150, using SCS-SF™ device270and stapling elements20, for forming staples152. The surgery may be an open surgery, or a minimally invasive surgery.

FIG. 28Hillustrates the Nissen Fundoplication, wherein proximal stomach160is wrapped around the anastomosis, using SCS-SF™ device270and stapling elements20, for forming staples162. Again, the surgery may be an open surgery, or a minimally invasive surgery.

Referring further to the drawings,FIG. 29schematically illustrates a Self-Closing Stapling, Single-Shot (SCS-SS™) device300, arranged as a syringe312, having a piston310, adapted to apply a single stapling element20, in accordance with an embodiment of the present invention. Preferably, device300is for a single use.

It will be appreciated that device300may also be a Self-Closing Stapling, Single-Shot Endoscopy (SCS-SS-ENDO™) device.

Referring further to the drawings,FIGS. 30A-30Dschematically illustrate a stapling element, formed as a composite of at least two materials, in accordance with another embodiment of the present invention.

FIGS. 30A-30B, show side and cross-sectional views of a stapling element410, formed as a composite of materials412and414, bonded side by side. Stapling element410is shown in first shape34, adapted for insertion, and further includes a tapered portion416for piercing the tissue. It will be appreciated that stapling element410also includes second shape36(FIG. 2E), essentially as a closed loop.

FIGS. 30C-30D, show side and cross-sectional views of a stapling element420, formed as a composite of materials412and414, bonded as a core section formed of material412, and a cladding section formed of material414. Stapling element420further includes a tapered portion418for piercing the tissue. Although shown in first shape34, it will be appreciated that stapling element420also includes second shape36(FIG. 2E), essentially as a closed loop.

It will be appreciated that other arrangements of the two materials,412and414, along the length of the stapling elements may be used.

While one of materials412and414may be a shape memory alloy, having a memorized shape, as a loop, for closing around the tissue, the other may be a metal or a polymer, to provide added strength to the composite, for greater penetration power. The optimal ratio of materials412and414in the composite is preferably such as to ensure optimal penetration power and optimal memory.

Preferably, stapling elements410and420include physical features that prevent their rotation within an application shaft.

Preferably, stapling elements410and420include a cavity at their distal end, to accommodate the tapered portion.

Referring further to the drawings,FIGS. 31A-31Cschematically illustrate an application shaft400for inserting staples while in a coiled shape, in accordance with still another embodiment of the present invention. A mechanism for insertion may engage, for example, with a feature, such as rim27, for forcing stapling elements20to issue. Alternatively, it may engage with distal portion24. In accordance with the present embodiment, stapling element20is formed of a resilient material, such as alloys, pure metals, polymers and (or) composites, but does not include a clearly defined first shape34(FIG. 2A).

Additionally, application shaft400may be adapted for inserting one stapling element20or a plurality.

For inserting a plurality of stapling elements20in series, they may be stored in the application shaft in a snail-like, spiraling tunnel. Alternatively, For inserting a plurality of stapling elements20in parallel, they may be stored in the application shaft in individual circular tunnels.

Important advantages of the present invention, when compared to the prior art, for example, as illustrated inFIGS. 1A-1F, are worth noting:

As seen inFIG. 1Aof the prior art, maintaining fascia edges14and16taut and abut against each other requires three tools, such as tools18A,18B and18C ofFIG. 1A. However, in accordance with the present invention, the surgeon may catch the first fascia edge, by stapling element20, operative as a needle, as seen inFIG. 19Eand bring it to the second fascia edge, as seen inFIG. 20B. Thus stapling element20is operative also as a tool, and the overall number of tools that are needed is reduced.

As seen inFIG. 1Aof the prior art, the staple ejection of Auto Staple device10may crush tissue, and possibly lead to local necrosis. However, in accordance with the present invention, for example, as taught in conjunction withFIGS. 19A-19F,28A-28J, and29, hereinabove, stapling elements20issues gradually, possibly against a second tool that provides a gentle counter force, so as to cause little tissue crushing and minimize local necrosis.

As seen inFIG. 1Dof the prior art, the figure eight that is formed by staples12may further crush the tissue, and may interfere with blood and nutrient flow, possibly leading to local necrosis. However, in accordance with the present invention, for example, as taught in conjunction withFIG. 19F, hereinabove, stapling element20closes due to its self-coiling property, to form a loop that does not press on the tissue, to further minimize local necrosis.

The prior art has no staple, which is applicable as an edge seam (similar, for example, to an edge seam of a tablecloth or of a rug.) However, in accordance with the present invention, for example, as taught in conjunction withFIGS. 23A-23D,24I and25F, hereinabove, stapling elements20may be used for forming an edge seam. By eliminating excess tissue beyond the seam, local necrosis, which may take place in the excess tissue, is prevented, and healing is promoted.

Further with regard to the edge seam ofFIGS. 23A-23D,24I and25F, stapling element20of the present invention is applied perpendicular to the tissue edge, enabling blood and nutrients to pass between staples to the tissue edge, in a manner similar to a suture applied manually, as illustrated inFIG. 1F, to prevent local necrosis.

As seen inFIG. 1Aof the prior art, when the Auto-Staple device is held at 90° to the fascia, as recommended, the surgeon's elbow makes an angle α of about 120° with the his arm; the hand is thus near the end of its rotational travel in that orientation, and its maneuverability is limited. However, in accordance with the present invention, for example, as taught in conjunction withFIGS. 19A-19B, hereinabove, an angle γ is designed between length axis D of handle130and application shaft110, so that when application shaft110is held at 90° to the tissue, the surgeon's hand is outstretched, with substantially no bending at the elbow. This allows the surgeon maximum maneuverability, since the full range of elbow bending is available to him.

When joining an artificial mesh and a tissue, the prior art generally uses staples at key points such as at the corners and midpoints of the mesh seam, and staples elsewhere along the mesh seam. However, in accordance with the present invention, for example, as taught in conjunction withFIG. 20A, hereinabove, stapling elements20may be used for the entire mesh seam. For example, stapling elements20of about 22 mm may be used at key locations, to form heavy-duty staples142, and stapling elements20of about 15 mm may be used elsewhere along the mesh seam, to form standard staples144. Heavy-duty staples142may form elliptical closes, as compared to the circular closes of standard staples144. It will be appreciated that other dimensions and cross sections may similarly be used.

The prior art has no devices operable as SCS-IF™, SCS-IF-ENDO™, SCS-SF™, SCS-SF-ENDO™, SCS-SS™, SCS-SS-ENDO™, SCS-TA-ENDO™, and SCS-GIA-ENDO™. However, in accordance with the present invention, for example, as taught in conjunction withFIGS. 19A-19B,26-29, and28A-28J, hereinabove, such devices are provided.

It will be appreciated that any stapling element20, described in conjunction withFIGS. 2A-11Gand30A-30B, hereinbelow, may be used with any of the application shafts, cartridges, and devices, described in conjunction withFIGS. 12A-31C, hereinbelow.

It will be appreciated that any seam of stapling element20, described in conjunction withFIGS. 2A-11Ghereinbelow, and (or) any seam provided by any of the application shafts, devices, and cartridges, described in conjunction withFIGS. 12A-31Chereinbelow, may be made into an edge seam, by cutting the excess tissue with a knife.

It will be appreciated that TRUCAR endoscopic valve254may be provided for any of the devices, adapted for endoscopy. Additionally, entry diameters smaller or greater than 12 mm may be provided with valve254.

It will be appreciated that the devices described herein may be disposable. Alternatively, the cartridge containing stapling elements20may be disposable, but the device may be placed in an autoclave and reused. It will be appreciated that during an operation, cartridges may be replaced in a device in use—an empty cartridge may be removed, and a new one inserted.

It will be appreciated that for each device, different cartridges may be provided, for different applications. The different cartridges may be of different stapling-element materials, cross-sections, lengths, and number. For example, for a given device, there may be cartridges, with stapling elements of a circular cross section, for minimal trauma, or of an elliptical cross section, for maximum strength, or of a triangular cross section, for penetrating hard tissue. Additionally, there may be cartridges, with stapling elements formed of an alloy, for a relatively greater flexibility, or of a composite, for a relatively greater strength. Additionally, other cross sections may be used. Furthermore, for a given device, there may be cartridges of different stapling-element lengths, for example, 4 mm, 7 mm, 9 mm, 15 mm, or of another length, which may be larger or smaller, and may even be as large as 200 mm. Moreover, for a given device, there may be cartridges, with different numbers of stapling elements in each, for example, 10, 15, 30 or another number of stapling elements per cartridge.

Thus, it will be appreciated that the device may be fitted with a cartridge in the factory, or on the site, at the operation room.

It will be appreciated that for invasive surgery, the length of the stapling element may depend on the device. For example, when using device120ofFIGS. 19A and 19B, device240ofFIGS. 25A-25E, or device300ofFIG. 29, hereinabove, the length of stapling element20is not limited by the device, and lengths as large as for example, 15 mm, 20 mm, 45 mm or larger may be used. However, when using devices250or260ofFIG. 26or27, the size DSHAFT(FIG. 26) is limiting, and is limited by TRUCAR endoscopic valve254, for example, to about 12 mm, and the maximum lengths of stapling elements20may be about 6 mm. Somewhat larger stapling elements20may be used in conjunction with device20ofFIGS. 28A-28J, since stapling elements20may be arranged at an angle to the tissue, as seen inFIG. 28F.

It will be appreciated that generally, for blood vessels, stapling elements of 4 mm are used, and they are color coded white. For the gastrointestinal tract, stapling elements of 5 mm are used, and they are color coded blue. For the stomach, stapling elements of 6 mm are used, and they are color coded green. It will be appreciated that the stapling elements of the present invention may follow the color code that is used in the art. Additionally, stapling elements of other sizes may be used, and may be color coded by other colors.

It will be appreciated that various alternative mechanical means are known for producing the motions described in conjunction with the devices ofFIGS. 19A-29. The mechanical means described hereinabove, in conjunction with these figures were for the purpose of illustrations. In accordance with the present invention, other mechanical means, as known, which may be manual or motorized, may similarly be used.

It will be further appreciated that any combination of the embodiments ofFIGS. 2A-29, hereinabove is within the scope of the present invention.

It will be appreciated that while these device have predetermined gripping positions, they may be adapted for changing the predetermined closing direction of stapling element20without changing the gripping position. For example, shaft175(FIGS. 22H,22G), attached to gripping handle179, or shaft267(FIGS. 26 and 27) attached to gripping handle265, or shaft275(FIGS. 28A-28C) attached to gripping handle278may be attached to their respective gripping handles with dial106(FIGS. 18D and 19A), for changing the predetermined closing direction of stapling element20without changing the gripping position on the respective gripping handle.

It will be appreciated that shaft175(FIGS. 22H,22G), shaft267(FIGS. 26 and 27) and shaft275(FIGS. 28A-28C) may be flexible.

It will be appreciated that the devices described herein for minimally invasive procedures, such as endoscopic surgery or laparoscopic repair may also be used via body lumens, by insertion via the rectum, the vagina, the urinary tract, the respiratory tract, or any other body lumen.

It will be appreciated that the staples may be formed of a shape memory alloy. Alternatively, they may be formed of a resilient material, which may be a pure metal, an alloy, or a polymer. Alternatively, they may be formed as a composite of two or more materials. It will be further appreciated that when formed of a resilient material, the staples may be loaded into the application shaft in the operation room, shortly before insertion.

Alternatively, the stapling elements may be formed of a composite of two materials.

It is expected that during the life of this patent many relevant devices and methods for stapling elements and their application will be developed and the scope of the terms stapling elements and staple devices are intended to include all such new technologies a priori.

As used herein the term “about” refers to +30%.