Laparoscopic natural tissue plane insinuator ("lntpi")

Abstract

The LNTPI is a surgical instrument used to cut through fibrotic and edematous tissue to define the natural tissue plane of dissection. After defining the natural tissue plane, it is designed to move or carefully insinuate tissues along these natural planes without cutting the tissue, so that targeted organs or parts thereof could be viewed and reached during laparoscopic procedures. The following features make the LNTPI unique compared to standard blunt dissectors used in laparoscopy: 1. The tip of the LNTPI is coarse and not smooth. The tip has diagonal, spiral ridges from the sides which are carried onto the tip converging as a single spiral at the center of the tip, creating a pattern resembling that of a screw; 2. The ridges of the LNTPI are comprised of asymmetrical triangular ridges with an acute angle at the apex that may be leaning along with or against the rotation of the spiral; 3. The tip of the LNTPI is made of tungsten carbide metal instead of stainless steel; 4. Dissection can be done in the usual up, down, left, and right motions as standard dissectors; 5. The side of the LNTPI can be used to "peel" tissue by using the ridges on its side combined with a twisting movement. This maneuver cannot be performed using standard dissectors; and 6. The tip of the LNTPI can perform circumferential dissection when used with a twisting movement causing it to engage tissue like a "drill" along the natural tissue plane. The ridges that converge into a single spiral at the tip of the invention appear like a screw and with the proper twisting movement have a similar effect on tissue. Because of the texture, design, and material used for the tip of the LNTPI, it has the following advantages over standard dissectors: The LNTPI can engage tissues more easily even if the tissues are slippery due to the presence of blood or fluids. The LNTPI can be used to engage tissues through a twisting motion which motion allows the tissues to be engaged in a specific manner that defines natural tissue dissection planes. The LNTPI can insinuate / "peel" tissue by using the side spiral ridges in combination with a twisting movement. The LNTPI can perform circumferential dissection by using the tip and the convergence of the spiral ridges at the center of the tip in combination with a twisting movement. The transfer of lateral shear force to the tissue at various angles (45, 90, and 180 degrees) when using the LNTPI is significantly higher whether the motion is by a sweeping motion or twisting of the instrument, allowing it to insinuate better than standard instruments, especially in a wet field. Hand movements needed in insinuating tissue using the LNTPI are different from the usual hand movements when using standard dissection instruments. The hand movements in using LNTPI require less muscular effort and repetitiveness, thus preventing muscle fatigue and repetitive use injury among surgeons. The instrument is reusable, as compared to dissectors that have fabric at the tip, which must be disposed of and replaced once the fabric tip fully absorbs the blood or other fluid in the wet tissue surface.

Description

[0001] DESCRIPTION

[0002] A. Background of the Invention

[0003] 1. Field of the Invention

[0004] The invention subject of this application relates to laparoscopy, which is a surgical technique in which operations in, or inspection of, the abdomen are performed through small incisions and with the aid of a fiber-optic camera. The invention is a natural tissue plane insinuator that is used for laparoscopy. It is used to cut through fibrotic and edematous tissue to develop the natural tissue plane of dissection and carefully insinuate tissues so that specific organ or part thereof that would be subjected to surgery or inspection could be viewed and reached.

[0005] 2. Discussion of the Related Art

[0006] Minimally invasive medical procedures such as laparoscopy have become widely accepted for surgery and diagnosis due to associated advantages relating to reduced trauma, improved cosmetic outcome, and shorter hospitalization time. To perform laparoscopy, surgeons use specially designed instruments to move organs and tissues and facilitate surgery or inspection of abdominal tissues or organs. The current instruments used for laparoscopy may fall into several of the following categories: [a] graspers; [b] dissectors; [c] suction irrigators; [d] energy delivery devices; and [e] tissue apposition devices such as sutures and staples.

[0007] Graspers as the name implies are instruments that are means to hold tissue.

[0008] Dissectors are instruments that separate tissue from one another. This can be done in any of two ways: (a) along natural tissue planes, or (b) by sharp dissection wherein a plane of dissection is created by cutting into tissue regardless of the natural tissue planes. The difference between the two is that dissection along natural tissue planes is easier and results in a bloodless anatomic dissection of the tissues or organs involved. Dissection along cut tissues may be more difficult as there are no natural tissue planes to serve as a guide for dissection and may result in more bleeding because the dissection is not carried out along natural tissue planes and may not be necessarily anatomic in its manner of isolating tissues and structures. LNTPI2024

[0009] Page 2 of 8

[0010] Suction irrigators are usually hollow tubes that provide the ability to instill fluid such as water into the surgical field and / or provide a means by which fluid is evacuated using negative pressure of suction. This is usually employed in the case of blood or other fluids obscuring the field of view.

[0011] Energy delivery devices generally control bleeding or provide a means to cut tissue and structures by the delivery of energy directly to tissue. Variations in the frequency and amount of energy (“cut” and “coagulate”) applied to tissue give surgeons the ability to control the depth and extent of energy effects on tissue. This may result in varied surface area of involvement or varied depth of involvement or both.

[0012] Tissue apposition instruments are tools that mechanically appose tissue by fixing the edges of the free tissue together. This is accomplished by either the use of sutures, clips, and staples. They are commonly made of metals like stainless steel or titanium, but newer ones are now made of polymers and plastic.

[0013] Dissectors are the most commonly used instrument in surgeries. These instruments facilitate the exposure of tissue and organs as well as enable the surgeon to remove tissue from organ structures. As previously described, dissection can be done along natural tissue planes usually in any of the following manners:

[0014] [a] Blunt dissection. Dissection along natural tissue planes usually by blunt dissection via metal instruments that have smooth tips and are made of stainless steel. There are reusable instruments for dissection that are designed to hold fabric called “peanut dissectors” but are quickly rendered useless as they absorb blood and bodily fluids. As this happens, the absorbed fluids act as lubricants and render the fabric held at the tip of the instruments ineffective requiring frequent change of the “peanut dissector”. Some versions are made with fixed fabric tips which make the instrument disposable.

[0015] Because these blunt dissectors have smooth tips, there is some difficulty in engaging the tissue, especially if the tissue is coated with blood or other fluids. This also holds true for the fabric-tipped blunt dissectors. When dry, fabric-tipped blunt dissectors engage tissue better than smooth-tipped blunt dissectors until the fabric tip gets soaked with blood and other bodily fluids, which renders the blunt dissectors ineffective. LNTPI2024

[0016] Page 3 of 8

[0017] Also, these blunt dissectors can only be used to move tissues or organs up and down or left and right, but not in a twisting motion. Because of the lack of friction generated by the smooth tips, the transmission of force to the tissue is significantly reduced, which necessitates strenuous or repetitive effort that can result in muscle fatigue or repetitive use injury on the part of the surgeon.

[0018] [b] Sharp dissection. Dissection along artificially created planes is sometimes necessary when the natural planes of dissection are obliterated by processes such as fibrosis, edema, inflammation, and direct tissue infiltration. In these cases, sharp dissection either by sharp knives or the application of energy (radiofrequency current - electrocautery) is used to cut through the tissue to facilitate dissection. As this type of dissection is not along natural tissue planes, the dissection results in more bleeding and non-anatomic isolation of structures and organs. As such, surgeons have to be very deliberate and careful as this type of dissection can lead to injury.

[0019] [c] Combination of blunt and sharp dissection. A combination of the two techniques is possible. This means cutting through fibrotic, edematous, and inflamed tissue to a level where the natural tissue plane of dissection can be developed, which will make it easier to separate the tissues.

[0020] B. Summary of the Invention

[0021] 1. Detailed Description of the Invention

[0022] The Laparoscopic Natural Tissue Plane Insinuator (“LNTPI”) is a type of tissue insinuator that is used for laparoscopy.

[0023] It is used to cut through fibrotic, edematous, and inflamed tissue to the level that a natural tissue plane exists. It functions as a sharp dissector to define a tissue plane. As the plane of dissection is defined by the initial sharp dissection, the operation can proceed with less blood loss and a more anatomic insinuation of tissue.

[0024] Once the plane of dissection is defined, the LNTPI has the ability to carefully insinuate tissues along these natural tissue planes without cutting the tissue, so that the specific organ or part thereof could be subjected to surgery or inspection. The tip of the LNTPI LNTPI2024

[0025] Page 4 of 8 is made of tungsten carbide. It is coarse due to diagonal spiraling ridges along its sides. The spiraling ridges on the side of the tungsten carbide tip continue from the side onto the tip and converge as a single pointed spiral resembling a screw pattern. Considerations on the Material used and the Design

[0026] The use of tissue plane insinuators in laparoscopic surgery usually requires a high degree of physical exertion as transfer of force is inefficient and much energy is wasted in dissecting tissues, especially in a wet field. This is due to the lack of friction generated by the tip of standard tissue plane insinuators when engaging tissues. As a result, surgeons may experience muscle fatigue and sometimes suffer repetitive use injury when using standard blunt dissectors. The standard blunt dissectors contribute to the high incidence of muscle fatigue and repetitive use injury.

[0027] In addition, some standard blunt dissectors, particularly those that use fabric at the tip (peanut dissectors), are not reusable and therefore necessitate recurring purchases of blunt dissectors. When dry, these fabric-tipped blunt dissectors are able to engage tissue but absorb blood and other bodily fluids rapidly. When the fabric tips become lubricated with these fluids, the blunt dissectors are rendered ineffective, thus necessitating the change of dry tips in the middle of the operation.

[0028] The material (tungsten carbide metal) and design for the LNTPI (with a coarse, patterned tip) by virtue of a series of spiral ridges that start along the sides and are carried onto and converge at the tip as a single spiral to cut tissue, enable the user to cut fibrotic edematous and inflamed tissue and to define the level at which the plane of dissection is. The LNTPI engages tissues even if the tissues are slippery due to the presence of blood or bodily fluids, as it is able to generate more friction when engaging tissues. The coarse and patterned tip accomplishes greater adhesion to wet tissue than ordinary blunt dissectors with a smooth tip and matches, if not exceeds, the adhesive strength of peanut dissectors without the need to replace the fabric tip. Hence, it is reusable. Proposed Advantages of the Invention

[0029] The LNTPI can be used in two ways: (a) by sweeping the coarse tip across the tissue plane being dissected, and (b) by twisting it once the tip makes contact with the natural tissue plane. (This second feature is unique to the LNTPI.) LNTPI2024

[0030] Page 5 of 8

[0031] Using the LNTPI through a sweeping motion facilitates greater transfer of lateral shear force due to its material and design (i.e., coarse and patterned tip). The LNTPI can engage tissues more easily even if the tissues are slippery due to the presence of blood or fluids, as it is able to generate more friction when engaging tissues without having to replace the tip of the tissue plane insinuator during or after the operation as compared to blunt dissectors with smooth tips or fabric-tipped dissectors.

[0032] Using the LNTPI through a twisting motion results in a more varied tissue plane insinuation along the natural tissue plane at different angles (45, 90, and 180 degrees) while retaining a significantly higher transfer of lateral shear force compared to standard and commonly available instruments, especially in a wet field. When the instrument is twisted at a 90-degree angle, it creates a rotational force (torque) in dissecting tissues akin to a screw or drill. At a 180-degree angle, the twisting motion generates a rotational force parallel to the tissue plane (peeling motion). At a 45- degree angle, a combination of both rotational and peeling force. These different techniques or ways of using the LNTPI allow for greater precision and control of the dissection.

[0033] Hand movements needed in dissecting using the LNTPI require less muscular effort and repetitive movements compared to the use of standard blunt dissectors, thus reducing, or eliminating muscle fatigue or repetitive use injury on the user.

[0034] The tip is reusable, as compared to blunt dissectors that have fabric at the tip. Possible Problems in the Field of Invention being Addressed

[0035] Standard blunt dissectors in laparoscopic surgery are built and designed for a sweeping motion to dissect the tissue along natural tissue planes, with the smooth tip of the dissector generating a pull or push force onto the tissue. While these allow for dissection of the tissue, blunt dissectors ordinarily have a poor engagement of the tissue especially wet tissues, thus, the use of blunt dissectors in laparoscopic surgery usually requires repetitive movements with a high degree of physical exertion, as transfer of force is inefficient and much energy is wasted in dissecting tissues, especially in a wet field. This is due to the lack of friction generated by the tip of standard blunt dissectors when engaging tissues. LNTPI2024

[0036] Page 6 of 8

[0037] LNTPI reduces the wastage of muscular effort by facilitating higher efficacy in tissue engagement. Incidentally, surgeons may experience muscle fatigue and sometimes suffer repetitive use injury when using standard blunt dissectors. With the two (2) methods of using the LNTPI, [a] defining the natural plane of dissection in fibrotic, edematous, and inflamed tissue is accomplished; [b] less effort and muscle exertion are used for better tissue engagement, and [c] muscle fatigue and repetitive use injury on the part of the surgeon are avoided.

[0038] The use of disposable blunt dissectors (e.g. peanut dissectors) requires the constant purchase of new ones because these are quickly rendered ineffective by blood and other bodily fluids on the surgical field. The reusable property of the LNTPI dispenses with frequent replacement of the coarse tip making the same instrument reusable over time.

[0039] C. Brief Description of the Drawings

[0040] Figures 1 a and 1 b - Overall view of the LNTPI devices for 5mm and 3.5mm variants respectively, with the shaft being 36 cm in length according to the present invention;

[0041] Figure 2 - Fragmentary view of the LNTPI, the dissecting tip showing a 5mm thick shaft with a 5mm burr with a coarse patterned tip or ridges that spirals to the tip in a counter-clockwise direction. The Burr may be soldered or glued with conductive epoxy resin glue;

[0042] Figure 3 - Fragmentary view of the LNTPI 3.5 mm shaft with a 3.5mm burr with a coarse patterned tip or ridges that spirals to the tip in a clockwise direction. The Burr may be soldered or glued with conductive epoxy resin glue;

[0043] Figure 4a and 4b - Fragmentary view of the distal end opposite the dissecting tip of the LNTPI for 5mm and 3.5mm variants. This is the connecting point of the dissector to the Monopolar Banana Pin. The Monopolar Banana Pin may be soldered or glued with conductive epoxy resin glue;

[0044] Figure 5a and 5b - Top View, the Burr which is 15 mm in length with a thick stainless- steel rod connected to the Burr for both 5mm and 3.5mm variants; LNTPI2024

[0045] Page 7 of 8

[0046] Figure 6a and 6b - Cross-sectional side view of the device for 5mm and 3.5mm variants showing the stainless-steel rod which is coated by a polyolefin insulation according to the present invention. The polyolefin insulation allows the invention to be held; and prevents unintended lateral collateral thermal tissue injury.

[0047] D. Description of the Preferred Embodiments

[0048] 1. The LNTPI is a multifunctional tissue dissecting instrument, as illustrated in Figure 1 , the components of which are a burr with ridges spiraling towards the tip in either a clockwise or counter-clockwise direction, a thin shaft, and a monopolar banana pin for purposes of cautery.

[0049] 2. The multifunction capabilities of the LNTPI are seen as illustrated in Figures 6a and 6b as the LNTPI is a tissue insinuator that cuts through fibrotic, edematous, and inflamed tissue to enable the development of the natural plane of tissue dissection.

[0050] 3. The LNTPI provides for more effective adhesion to tissue or organs lubricated by blood and other bodily fluids due to the burr having ridges or a coarse or patterned tip as illustrated in Figures 2a-5b.

[0051] 4. The invention’s shaft as illustrated in Figures 6a and 6b is covered by polyolefin insulation allowing the user to hold the invention and avoid unintended lateral collateral thermal tissue injury.

[0052] 5. The invention’s shaft as further illustrated in Figures 1-6b is a cylindrical shaft that is 3.5 or 5 mm thick. The ergonomic design is intended to ensure that less effort and muscle exertion is needed to use the device while maintaining a higher transfer of shear force in the use of the LNTPI by a sweeping motion and through a twisting motion.

[0053] 6. The two (2) variants of sizes of the cylindrical shaft and the dissecting tip as illustrated in Figures 2-5b are designed for the surgeon to choose which dissector is needed for his operation for broad (5mm) or finer dissection (3.5mm).

[0054] 7. The two (2) variants of the direction of the ridges as illustrated in Figures 2-5b are designed to give more options to the surgeon on how to dissect the tissue plane and in what motion.

[0055] 8. The LNTPI cutting and dissecting tip is built from tungsten carbide as illustrated in Figures 2-5b. The property of this chemical compound exploited in the making of the dissecting tip is its durability. This property ensures that the LNTPI remains to be lasting and reusable. LNTPI2024

[0056] Page 8 of 8 The dissecting tip of the LNTPI maintains a round tip, as opposed to a pointed tip, as illustrated in Figures 2-5b. The round tip allows the surgeon to conduct the tissue insinuation at various angles (45, 90, and 180 degrees) using the same shaft. The proximal end opposite the dissecting tip of the LNTPI has an attached Monopolar Banana Pin as illustrated in Figures 4a and 4b. The Ridged Burr is connected to a stainless-steel rod as illustrated in Figures 5a and 5b. The dissecting tip and the monopolar banana pin as illustrated in Figures 5a and 5b and 4a and 4b may be soldered to the stainless-steel rod conductor or may be glued together using a conductive epoxy glue.

Claims

LNTPI2024CLAIMS1. A purpose-built laparoscopic instrument for use in laparoscopy, specifically to cut fibrotic, edematous, and inflamed tissue to develop the natural tissue plane of dissection.

2. A purpose-built laparoscopic instrument for use in laparoscopy, specifically to insinuate tissue along natural tissue planes to facilitate less bloody and anatomic dissection;3. A purpose-built laparoscopic instrument as recited in Claim 1 with a tip made of tungsten carbide metal;4. A purpose-built laparoscopic instrument as recited in Claims 1 and 2 which is a tissue insinuator with a tip that can be used to cut tissue and with the use of textured with spiral ridges (clockwise or counter-clockwise spiral) along the sides and converging onto the tip as a single spiral pattern or coarse tip establish the proper plane of dissection;5. A purpose-built laparoscopic instrument as recited in Claims 1 , 2, and 3 that has asymmetrical spiral ridges with an acute angle at its apex leaning along with or against the direction of the spiral ridges (clock-wise or counter clock-wise);6. A purpose-built laparoscopic instrument as recited in Claims 1 , 2, 3, and 4 that can cut through tissue at depth wherein the proper plane of dissection can be established. Once the plane of dissection is established or found, the instrument has the ability to insinuate tissue not only through a sweeping motion but in addition, a twisting motion at varied angles, with the side spiral ridges as well as the spiral tip; and7. A reusable purpose-built laparoscopic instrument as recited in Claims 1 , 2, 3, 4, 5, and 6as a reusable instrument.

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