WO2023114525A1

WO2023114525A1 - Device and method for surgical incisions and stapling

Info

Publication number: WO2023114525A1
Application number: PCT/US2022/053269
Authority: WO
Original assignee: Asiyanbola, Bolanle
Priority date: 2021-12-17
Filing date: 2022-12-17
Publication date: 2023-06-22

Abstract

A set of end effectors used to staple and resect tissue from an anatomical structure in which each set of end effectors includes an anvil and a cartridge. The end effectors are able to be placed at an angle to each other such that nonlinear shapes can be made in the anatomical structure. The end effector may also have an extended end effector which includes an anvil and a cartridge which can be used to restrict the flow through a duct within the anatomical structure.

Description

TITLE: Device and Method for Surgical Incisions and Stapling

Description

Field

The present invention relates to surgical staplers and more specifically to end effectors used to staple and reset tissue.

Background:

Surgical cutter endostaplers, referred to herein as stapler, to clamp around an anatomical structure to simultaneously resect and staple tissue during both open and minimally invasive procedures. Such staplers typically have one jaw which contains at least two parallel rows of staples, an anvil which has at least two parallel double rows of depressions for deforming the staples, and a longitudinal knife and staple firing mechanism which separates the two parallel rows. These staplers also pivot or translate about a hinge to clamp around the anatomical structure prior to engaging the staples and resecting the tissue.

Surgical endostaplers that have been used for years in various surgical procedures; however, certain anatomical structures like the pancreas have a duct. Pancreatic duct leaks occur when the pancreas is stapled. Indeed pancreatic leaks are a recalcitrant problem that no method of surgery- robotic, laparoscopic, endoscopic, percutaneous, or open and no technique and no method or medication has been shown to reduce the rate.

Notably, the International Study Group for Pancreatic Fistula states that “despite all the advances and technical modifications developed during this past decade(s) to prevent and treat postoperative pancreatic leaks (PL) or pancreatic fistulas, the incidence of this dreaded complication can go up to 45% of pancreatic operations at high-volume centers.” Not only is Pancreatic leak associated with more frequent and earlier pancreatic cancer recurrence after surgery, but pancreatic leaks are considered to be the underlying phenomenon of other major complications (e.g., peripancreatic collections, intra-abdominal abscess, postoperative hemorrhage, sepsis, shock, multiorgan failure), ultimately resulting in prolonged in-hospital stay with literature reports stating that on average, a clinically significant PL takes 40 days to heal with a range of 10-110 days(or more) to resolve, increased costs, and/or death.

Currently most pancreases including pancreatic ducts are resected with staplers. Currently all staplers result in an inverted V shape in tissues and require multiple firings to achieve a "v" shape in the tissues on both sides. Multiple firings result in loss of precision and increased chance of immediate and longer term pancreatic juice leaks with commensurate increase in subsequent complications as detailed above.

Current stapling mechanisms have not solved the problem of pancreatic leaks, the primary target of this method and device, and current stapling mechanisms cannot create the reconstructed tapering of the pancreatic duct without multiple firings, loss of precision and leakage of pancreatic juice from the structure.

Computational fluid dynamics shows that the side branches in the middle part of the duct combined with smaller diameter due to tapering and velocity of flow contribute to high pressures within the duct. The maximum pressure is in the middle part of the duct.

Prior art staplers cut in such a manner that does not affect the flow into the pancreatic duct where flow into shorted duct (after some of it has been resected) and predisposes to leaks Stapling the pancreas and pancreatic duct to reduce the flow means the pressure will be very much reduced and leaks are less likely to happen especially if prevention of leakage as well as precision with a single firing.

The risk of diabetes is a complication of pancreatic resection as well as the risk of exocrine insufficiency. This risk is increased with the amount of pancreatic tissue resected. Thus to maximally limit the amount of pancreatic tissue resected , staples, which may be biodegradable can be used

As such improved methods of stapling are needed. In addition, current staplers also have no method for reducing the flow along these ducts, within the single firing, which can also result in the fluid within the anatomical structure to exude into the surrounding area which can result in complications postoperatively.

Summary:

A tool for use in stapling and cutting an anatomical structure of a patient in an open or minimally invasive procedure which in one embodiment contains at least two sets of a lower jaw and an upper jaw. The lower jaw consists of at least two sets of two parallel rows of staples with each set separated by a gap. The staples may be contained in a replaceable cartridge. The upper jaw consists of an anvil which has depressions for deforming the staples aligned with the staples in the lower jaw and a gap which aligns with the lower jaw. Contained within each set of the upper jaw and lower jaw is a mechanism for extending the staples from the lower jaw to the upper jaw. Also contained within each set of upper jaw and lower jaw is a mechanism for cutting tissue. All mechanisms are remotely operable by an operator outside the patient.

In one embodiment, the lower jaw and upper jaw are able to pivot about an axis to open and close.

In one embodiment, each set of jaws is able to articulate angularly away from each other such that each jaw points along a different direction.

In one embodiment, there are two sets of jaws that open into a V shape.

In one embodiment, a single jaw is able to articulate and modulate its shape into a nonlinear planar shape with an acute point.

In one embodiment, a single jaw is able to articulate and modulate its shape into a nonlinear planar shape with a curve.

In one embodiment, a single jaw is able to articulate and modulate its shape into multiple nonlinear planer shapes. In one embodiment, a single jaw is able to articulate and modulate its shape into multiple nonlinear non-planar shapes.

In one embodiment, the staples are actuated by a longitudinal cam tube in the lower jaw.

In one embodiment, the stapes are actuated simultaneously by a mechanism in the lower jaw.

In one embodiment, the knife is advanced longitudinally along the end effector to resect tissue.

In one embodiment, the knife is advanced transversely between the bottom jaw and the top jaw to resect tissue.

In one embodiment, there is a mechanism which can clamp onto an anatomical structure that is able to staple additional tissue without removing the tool from the patient.

In one embodiment, the separate mechanism for stapling additional tissue contains multiple staplers which are able to expand or contract to different widths.

In one embodiment, the separate mechanism for stapling additional tissue is able to rotate to different angles.

In one embodiment, the separate mechanism for stapling additional tissue contains multiple staplers which are able to rotate to different angles.

In one embodiment, the separate mechanism for stapling additional tissue is able to translate to different positions relative to the base end effector.

In one embodiment the end effector is remotely operable.

In one embodiment multiple sets of end effectors are used.

In one embodiment the sets of end effectors would be able to alter the distance between the end effectors.

In one embodiment the end effector can be deployed into position from a stowed position.

In one embodiment the separate mechanism for stapling can be combined with ultrasound.

In one embodiment the separate mechanism may be used in robotic surgery.

In one embodiment the separate mechanism for stapling can use biodegradable staples.

Technical Drawings Legend: la. Cutting linear stapler cartridge side a lb. Cutting linear stapler cartridge side b a. Cutting linear stapler anvil side a b. Cutting linear stapler anvil side b

3a. Duct linear stapler cartridge side a

3b. Duct linear stapler cartridge side b a. Duct linear stapler anvil side a b. Duct linear stapler anvil side b

5. Laparoscopic extension handle

6. Hinge mount

7. Hinge

8. Anatomical structure

9. Cancerous tissue

10a. Cutting linear stapler side a

10b. Cutting linear stapler side b

11. Duct linear stapler

12. Remaining anatomical structure

13. Resected anatomical structure

14. Resected cancerous tissue

15a. Remaining anatomical structure staples left by cutting linear stapler

15b. Resected anatomical structure staples left by cutting linear stapler

16. Cut line left by cutting linear stapler

17. Duct staples left by duct linear stapler

18. Stowed cutting linear stapler

19a. Clamped hinge

19b. Extension handle for minimally invasive operations through a trocar 20a. Stowed duct linear stapler anvil 20b. Stowed duct linear stapler cartridge 21. Anatomical structure

22. Cancerous tissue

23. Deformed linear cutting stapler 1

24. Deformed linear cutting stapler 2

25. Extension handle for minimally invasive operations through a trocar

26. Anatomical structure

27. Cancerous tissue

28. Deformed linear cutting stapler 1

29. Deformed linear cutting stapler 2

30. Deformed curved duct stapler

31. Extension handle for minimally invasive operations through a trocar

32. Anatomical structure

33. Cancerous tissue

34a. Deployed linear cutting stapler side a

34b. Deployed linear cutting stapler side b

35. Extension handle for minimally invasive operations through a trocar

36. Anatomical structure

37. Cancerous tissue

38a. Deployed curved cutting stapler side a

38b. Deployed curved cutting stapler side b

39. Extension handle for minimally invasive operations through a trocar

40. Anatomical structure

41. Cancerous tissue

42a. Deployed curved cutting stapler side a

42b. Deployed curved cutting stapler side b

43. Extension handle for minimally invasive operations through a trocar

44. Anatomical structure 45. Duct linear stapler

46. Hinge mount

47. Extension handle for minimally invasive operations through a trocar

48. Anatomical structure

49. Duct staples left by duct linear stapler

50a. Stowed duct linear stapler anvil

50b. Stowed duct linear stapler cartridge

51a. Clamped hinge

51b. Extension handle for minimally invasive operations through a trocar

Brief Description of the Drawings:

Fig. 1 is an orthographic view showing various components of a linear stapler with multiple heads combined with a secondary set of staplers to reduce duct flow according to one embodiment of the design.

Fig. 2 is an elevation view of the end effector in Fig. 1.

Fig. 3 is an elevation view of the end effector in Fig. 1 positioned on a portion of a pancreas.

Fig. 4 is an elevation view of the tissue post operative in Fig. 1.

Fig. 5 is an orthographic view of the end effector in Fig. 1 in a stowed position.

Fig. 6 is an elevation view of a stapler clamped on an anatomical structure according to one embodiment of the design.

Fig. 7 is an elevation view of a stapler with a secondary stapler to reduce duct flow clamped on an anatomical structure according to one embodiment of the design.

Fig. 8 is an elevation view of a linear stapler with no secondary staplers clamped on an anatomical structure according to one embodiment of the design.

Fig. 9 is an elevation view of a curved stapler with no secondary staplers clamped on an anatomical structure according to one embodiment of the design.

Fig. 10 is an elevation view of a curved stapler with no secondary staplers clamped on an anatomical structure according to one embodiment of the design. Fig. 11 is an elevation view of a stapler similar to that shown in Fig. 1 with only the duct linear staplers installed.

Fig. 12 is an elevation view of the tissue post operative in Fig. 11

Fig. 13 is an orthographic view of the end effector in Fig. 11 in a stowed position.

Detailed Description:

The embodiment of the indicated invention is towards one or more end effectors towards the goal of creating a resection on an anatomical structure while minimizing loss of fluid within the anatomical structure for example the duct, where the end effector typically includes the ability to securely staple and cut the tissue and the duct. The device may be used during an open or minimally invasive procedure presented through means of a trocar. An example application of the device could be a minimally invasive pancreatic operation for example laparoscopic, robotic or other minimally invasive approach meant to resect cancerous tissue. Additionally, the device can be used in other operations where tissue need be resected and/or operations where ducted anatomical structures are constrained to reduce flow across the structure.

To these and other ends, and with reference to the figures which provide illustrative examples of the design but are are not meat to limit the scope of the present invention to a single embodiment as other embodiments are possible by way of interchange for some or all of the described or illustrated elements, Fig. 1 shows an orthographic view of a double set of linear staplers, la and lb, and anvils, 2a and 2b, which meet at a point with an additional set of linear staples, 3a and 3b, and anvils, 4a and 4b, which are separately deployable. The device is shown in an open and deployed state such that it is ready to receive an anatomical structure. Fig. 2 shows an elevation view of the same device as pictured in Fig. 1 to display the device's ability to open to accept an anatomical structure about the hinge pin, 7. Fig. 2 also shows the device’s base structure, 6, and extension handle, 5, which would enable a minimally invasive and/or laparoscopic procedure. In the open position the device would be advanced onto an anatomical structure and clamped as shown in Fig. 3. Object 8 In Fig. 3 represents the operable anatomical structure with a cancerous tissue, 9, that is to be removed.. The device is positioned over the anatomical structure with the capability of ressecting tissue accomplished by the dual linear staplers, 10a and 10b. The device optionally has the ability to clamp and deploy additional staples into the anatomical structure, 8, using an additional set of linear staplers, 11.

Fig. 4 shows the post operative results from the deployment of the device as shown in Fig. 3 where the remaining anatomical structure, 12, has had some material, 13, resected including the cancerous tissue, 14, about a cut made by a knife, 16, with both sides of the tissue sealed by staples, 15a and 15b, to prevent excretion of fluid from within the anatomical structure. Additionally, linear staples, 17, are deployed within the anatomical structure to reduce the flow of fluid throughout the structure.

Fig. 5 shows the same device as in Fig. 1 in a stowed position where the cutting staplers, 18, are retracted, the device is clamped about the hinge point, 19s, and both the duct linear staple anvils, 20a, and the duct linear staple cartridges, 20b, are retracted towards the goal of minimizing the cross-sectional area of the device for insertion and removal through a trocar by means of the extension handle, 19b.

Fig. 6 shows another embodiment of the device in which the device would be able to deform from a linear orientation of staplers to create two angle adjustable sets of linear staplers, 23 and 24, to accomplish the resection of cancerous tissue, 22, from an anatomical structure, 21. The device as depicted in Fig. 6 would have a minimal diameter towards the goal of minimally invasive and/or laparoscopic procedures executed through a trocar; however, the device could also be used during an open procedure. The device as shown in Fig. 6 would be capable of opening to any novel angle and remotely operable by using the extension handle, 25.

Fig. 6 shows another embodiment of the device in which the device would be able to deform from a linear orientation of staplers to create two angle adjustable sets of linear staplers, 23 and 24, to accomplish the resection of cancerous tissue, 22, from an anatomical structure, 21. The device as depicted in Fig. 6 would have a minimal diameter towards the goal of minimally invasive and/or laparoscopic procedures executed through a trocar; however, the device could also be used during an open procedure. The device as shown in Fig. 6 would be capable of opening to any novel angle and remotely operable by using the extension handle, 25. Fig. 7 shows another embodiment of the device deployed on an anatomical structure, 26, with the target to remove cancerous tissue, 27, similar to that shown in Fig. 6. The device in Fig. 7 has an addition of a curved stapler, 30, on the end of the device which can be deployed to reduce the flow through the ducts of an anatomical structure, 26. Similar to the device shown in Fig. 6, two deployable linear stapler cutters, 28 and 29, are capable of resecting the cancerous material, 27, from the anatomical structure, 26, with a remote operator though the extension handle, 31.

Fig. 8 shows another embodiment of the device deployed on an anatomical structure, 32, similar to that shown in Fig. 1 where there are no additional staplers to reduce the flow of the ducts in the anatomical structure, 32. The linear staplers, 34a and 34b, would be deployable from a fixed linear position to a remote user adjustable angle by use of the extension handle, 35, and capable of resecting cancerous tissue, 33, from the anatomical structure, 32.

Fig. 9 shows another embodiment of the device deployed on an anatomical structure, 36, to resect cancerous tissue, 37, similar to that shown in Fig. 8 where instead of utilizing linear staplers, curved staplers, 38a and 38b, are used. This configuration would be remotely operable using the extension handle, 39.

Fig. 10 shows another embodiment of the device deployed on an anatomical structure, 40, to resect cancerous tissue, 41, similar to that shown in Fig. 9 where the curved linear staplers, 42a and 42b, present concave rather than convex. The curved staplers, 42a and 42b, can be configured such that a single or multiple radii can make up the curve which can path to a remotely adjustable angle either acute or obtuse by use of the extension handle, 43.

Fig. 11 shows another embodiment of the device similar to that shown in Fig. 1 with the use of only the duct linear staplers, 45, clamped on an anatomical structure with a duct, 44. This device is usable to install staples for temporarily restricting flow within the ducts of the anatomical structure, 44.

Fig. 12 shows the post operative results from the deployment of the device as shown in Fig. 11 where the remaining anatomical structure, 48, has duct linear staples, 49, installed to reduce the flow across the anatomical structure. Fig. 13 shows the same device as in Fig. 11 in a stowed position where the duct linear stapler anvils, 50a, and the duct linear stapler cartridges, 50b, are retracted with the hinge, 51a, clamped towards the goal of reducing the cross-sectional area of the device for the insertion and removal through the trocar by means of the extension handle, 51b.

As a comparison to the prior art, the present invention enables a surgeon to complete complex and remotely adjustable resections without the need to

reposition the tool from-in the patient’s body or retract the tool from the patient s body which increases precision. The present invention’s ability to reduce the operating time and reduce the positioning error rate due to multiple clampings required by prior art with the present inventions ability to be remotely operably through a trocar designs to reduce leaking of internal fluid from the operative anatomical structure which therefore should reduce postoperative complications as it relates to fluid leak from anatomical structures with a specific focus on reduction of pancreatic fistulas.

While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the inventor to restrict or in any way limit the scope of the appended claims to such detail. Further, it should be recognized that the spacing and scale of certain elements depicted in the Figures may be exaggerated or reduced to aid in the understanding of the present invention. Consequently, the Figures may be seen as schematic representations rather than exact representations of embodiments. Though the embodiments described herein were primarily directed to a stapler, it is clear that many of the aspects of the present invention may be utilized with additional devices. By way of example, the embodiments described herein may operate as a surgical clamp or a stabilizing device independent of the aspects of the present invention that allow the embodiments to act as a stapler. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in any combination depending on the needs and preferences of the user.

Claims

CLAIMS I claim

1. A set of end effectors for use in a clamping, stapling, and resection of an anatomical structure in which the anatomical structure has a first side and a second side. Each end effector comprises: a cartridge containing staples which is positionable on the first side of the anatomical structure, an anvil that positionable on the second side of the anatomical structure, a mechanism that is operable connecting the anvil and cartridge to each other allowing for the actuation of the device to clamp on both the first and the second side of an anatomical structure, a mechanism that is operable which enables the deployment of staples into the anatomical structure, a mechanism that is operable which enables the resection of tissue, and a mechanism that is operable which enables the end effectors to alter the angle between the different end effector sets.

2. The end effector of claim 1, wherein the procedure is completed open.

3. The end effector of claim 1, wherein the procedure is completed minimally invasive.

4. The end effector of claim 3, wherein the procedure is completed laparoscopically.

5. The end effector of claim 1, wherein two sets of end effectors are able to open to a fixed angle.

6. The end effector of claim 1, wherein two sets of end effectors are able to open to any novel angle.

7. The end effector of claim 1, wherein two sets of end effectors are able to open to an angle that can be set remotely.

8. The end effector in claim 1, wherein the end effectors are linear in shape.

9. The end effector in claim 1, wherein the end effectors are curved in shape.

10. The end effector in claim 1, wherein each set of end effectors utilizes a different shape.

11. The end effector of claim 1, wherein each set of end effector is actuated remotely.

12. The end effector of claim 1, wherein the set of end effectors are in a linear axis that can articulate resulting the effective surfaces no longer being linear

13. The end effector in claim 12, wherein the articulation of the end effector results in a nonlinear planar shape with an acute point.

14. The end effector of claim 12, wherein the articulation of the end effector results in a nonlinear planar shape with a radiused curve.

15. The end effectors in claim 1, which have either or both resection and stapling capabilities, for use in clamping and stapling of an anatomical structure in which the anatomical structure has a first side, a second side, and a duct. The end effector comprises: a cartridge containing staples which is positionable on the first side of the anatomical structure, an anvil that is positionable on the second side of the anatomical structure, a mechanism that is operable connecting the anvil and the cartridge to each other allow for the actuation of the device to clamp on both the first and second side of an anatomical structure restricting the flow of the duct within the anatomical structure, and a mechanism that allows for the deployment of staples into the anatomical structure further restricting the flow of the duct.

16. An end effector of claim 1, wherein an end effector of claim 15 is attached.

17. The end effector of claim 15, wherein the procedure is completed open.

18. The end effector of claim 15, wherein the procedure is completed minimally invasive.

19. The end effector of claim 18, wherein the procedure is completed laparoscopically.

20. An end effector of claim 15, wherein the end effector is remotely operable.

21. An end effector of claim 15, wherein multiple sets of end effectors are used.

22. An end effector of claim 21, wherein the sets of end effectors would be able to alter the distance between the end effectors.

23. An end effector of claim 15, wherein the end effector can be deployed into position from a stowed position.

24. The mechanism of claim 15 where the mechanism can be combined with Ultrasound

25. The mechanism of claim 15 where the mechanism can utilize biodegradable staples

26. The mechanism of claim 1 where the mechanism is combined with Ultrasound.

27. The mechanism of claim 1 mechanism where the mechanism is used in robotic surgery.