Endoscopic shaver

ES 2 323 943 T3

DESCRIPTION

Endoscopic razor.

The present invention relates to a surgical cutting instrument. More particularly, it relates to a surgical micro-shaving instrument whose distal tip is configured to aid in tissue dissection and is particularly useful for lower turbinate reduction procedures.

Instruments for surgical resection in which an elongated inner member is rotated or oscillated within an elongated outer tubular member have become well accepted in surgical procedures in which access to the surgical site is obtained through a narrow entrance or passage. . Typically, the outer tubular member includes a distal end that defines a cutting window or hole, and the inner member includes a distal end with a cutting tip for engaging and resecting body tissue through the cutting window. The proximal ends of the inner and outer elements are commonly attached to cylinders which, in turn, are attached to a handpiece. The handpiece may have a motor to rotate and / or oscillate the inner member relative to the outer tubular member. The cutting tip of the inner tubular element can have various configurations specific to the surgical procedure in question (eg, resection, cutting, shaving, abrasion, etc.), with the cutting window being suitably configured to co-operate with the configuration. particular of the cutting tip. Typically, the inner tubular member defines a lumen so that loose tissue resulting from a cutting, resection, or abrasion procedure can be aspirated from the target site.

The surgical cutting instruments described above are useful for various surgical procedures, especially ear-nose-throat (ENT) operations. One particular ENT intervention concerns a treatment of a lower turbinate in the sinus cavity. The role of inferior turbinate pathology and reduced nasal airflow are well understood. In summary, the inferior turbinate of the sinus cavity can become enlarged or inflamed (eg, hypertrophy of the inferior turbinate) for a variety of reasons. This inflammation obstructs the patient's nasal passages, causing breathing difficulties. In cases where pharmacological treatment fails, a preferred surgical treatment involves resecting submucosal tissue of the inferior turbinate, thus reducing the size of the inferior turbinate. In this regard, available techniques for turbinate reduction include turbinectomy, submucosal turbinectomy, inferior turbinoplasty, cryotherapy, submucosal electrosurgery, and laser turbinoplasty. Unfortunately, short-term and long-term complications such as bleeding, scabbing, synechiae formation, and atrophic rhinitis are frequently associated with each of the techniques listed above, due to sacrifice of mucosa to gain access to the target site. In light of these potential complications, surgeons have recently begun using the previously described surgical cutting instruments, and in particular a 2mm surgical shaving instrument, to resect or shave tissue over an inner part of the inferior turbinate by piercing the turbinate. anteriorly and then moving the cutting tip posteriorly while resecting the target tissue. By drying out the inner tissue, the turbinate heals by contracting internally, thereby allowing better nasal airflow.

The use of a surgical shaving or micro-resection instrument for the treatment of inferior turbinate enlargement or inflammation in the sinus cavity appears to be quite promising. Indeed, a micro-shaving instrument can best achieve a primary goal of volumetric reduction of submucosal vascular stromal tissue with preservation of the overlying respiratory epithelium. Unfortunately, currently available instruments for performing lower turbinectomies have a blunt, distal end that is not conducive to puncture-type action. In addition, available surgical micro-shaving instruments are configured such that the surgeon must rely solely on the cutting window to resect bone tissue within the turbinate of the sinus cavity. This is a difficult and time-consuming procedure, as the tissue in question is generally “tight” against the bone.

Lower turbinate reduction with a surgical micro-shaving instrument appears to be highly feasible and may eliminate complications otherwise associated with other turbinate reduction techniques. Unfortunately, however, currently available micro-shaving instruments are not designed to meet the needs of the inferior turbinate site. Thus, there is a need for a surgical micro-shaving instrument for the inferior turbinate.

In US 4,530,356, a surgical micro-shaving instrument according to the preamble of claim 1 is described.

The present invention provides a surgical micro-shaving instrument as defined in claim 1.

In a preferred embodiment, the elevator tip ends in a knife edge. Regardless, the elevator tip defines an upper surface that extends from the elevator window. In a preferred embodiment, the top surface extends angularly, coplanar with a plane of the cutting window. In another preferred embodiment, the upper surface includes a proximal part and a distal part. With this configuration, the proximal portion is coplanar with a plane of the cutting window. In addition, the distal portion extends upward at an angle from the proximal portion, defining an obtuse angle between them.

ES 2 323 943 T3

During use, the surgical micro-shaving instrument is directed towards the inferior turbinate. The elevator tip is used to puncture the turbinate as well as to remove tissue by dissecting the turbinate, thereby creating an improved tissue / instrument coupling.

Preferred embodiments will now be described by way of example only, with reference to the drawings.

Figure 1 is a side view of a surgical micro-shaving instrument according to the present invention;

Figure 2 is an exploded side view of the instrument of Figure 1;

Figure 3A is an enlarged, perspective view of an elevator tip portion of the instrument of Figure 1;

Figure 3B is an enlarged cross-sectional view of Figure 3A;

Figure 4A is an enlarged, perspective view of an elevator tip of an alternative embodiment in accordance with the present invention;

Figure 4B is an enlarged cross-sectional view of Figure: 4A;

Figure 5A is an enlarged, perspective view of an elevator tip of another alternate embodiment in accordance with the present invention;

Figure 5B is an enlarged cross-sectional view of Figure 5A;

Figure 6A is an enlarged, perspective view of an elevator tip of another alternate embodiment in accordance with the present invention; and Figure 6B is an enlarged cross-sectional view of Figure 6A.

Description of the preferred embodiments

A preferred embodiment of a surgical micro-shaving instrument or blade 10 is illustrated in FIG.

1. The micro-shaving instrument 10 includes an outer blade assembly 12 and an inner blade assembly 14. The outer blade assembly 12 includes an outer cylinder 16 and an outer tubular element 18, while the inner blade assembly 14 includes an inner cylinder 20 and an inner elongated element 22 (illustrated in Figure 2). Similar to other available micro-shaving instruments, internal elongated element 22 is dimensioned to coaxially housed within external tubular element 18. However, as described in greater detail below, the micro shaving instrument 10 is specifically configured to optimally perform a lower turbinate reduction procedure.

As is known in the art, outer tubular member 18 extends distally from outer cylinder 16. To this end, the outer cylinder 16 can take a wide variety of shapes known in the art and can form, for example, an irrigation hole 24. Alternatively, in an alternative embodiment, the micro-shaving instrument 10 may be configured to operate without the external cylinder 16.

With further reference to Figure 2, outer tubular element 18 is an elongated, tubular body defining a proximal section 30, an intermediate section 32, a distal section 34, and a central lumen 36. The outer tubular member 18 is formed of a relatively rigid, surgically safe material, preferably 304 stainless steel. The central lumen 36 extends from the distal section 34 to the proximal section 30. In this regard, and as described in greater detail below, the distal section 34 forms a cutting window 38 (shown generally in Figure 2) in fluid communication with the central lumen 36. Similarly, proximal section 30 forms an irrigation inlet 40 in fluid communication with central lumen 36. With final assembly, the irrigation inlet 40 is aligned with the irrigation port 24 otherwise formed by the outer cylinder 16 so that fluids can be irrigated to the cutting window 38 through the central lumen 36.

The proximal section 30 is shown in Figure 2 as having a slightly enlarged diameter to facilitate assembly with the outer cylinder 16. However, the remainder of the outer tubular element 18 is preferably sized for a lower turbinate reduction procedure. In particular, the intermediate section 32, as well as the majority of the distal section 34 immediately proximal to the cutting window 38, has, in a preferred embodiment, an external diameter of 2 mm. Alternatively, the intermediate section 32, as well as most of the distal section 34 immediately proximal to the cutting window 38, may have an outer diameter of 2.9 mm.

A preferred embodiment of distal section 34 is shown in greater detail in Figures 3A and 3B. As previously described, distal section 34 forms cutting window 38, otherwise in fluid communication with central lumen 36. The cutting window 38 is defined by a cutting window wall 39. In addition, the distal section 34 forms an elevator tip 42 that extends distally from the cutting window 38. The elevator tip 42 includes opposite upper and lower surfaces 44, 46, as best shown in FIG. 3B. Surfaces 44, 46 are tapered in width distally, and terminate at an end 48 which is of the blade type or

ES 2 323 943 T3 relatively sharp. Thus, end 48 serves as a blade that can easily puncture tissue on contact with it. As a point of reference, in a preferred embodiment, the blade end 48 has a thickness of 0.127 mm (0.005 inches). Unlike currently available micro-shaving instruments, the elevator tip 42, and in particular the blade-like end 48, is not blunt.

To facilitate improved tissue interaction at cut window 38, distal section 34 preferably forms a recessed portion 50 around the majority of cut window 38. More particularly, and as best shown in Figure 3B, the cutting window wall 39 is preferably shaped and oriented such that the cutting window 38 extends distally in an angular fashion, whereby the distal section 34 It has a decreasing section in height (with respect to the horizontal orientation of Figure 3B). This angular taper of shear window wall 39, and hence shear window 38, is represented by angle θ in Figure 3B, whereby θ is preferably in the range of about 10-16 °. , more preferably 13 °. The recessed portion 50 is defined around the shear window wall 39 such that the wall 39 effectively protrudes outward from the recessed portion 50. This outward protrusion provides a distinct surface with sharp edges for engaging and / or dissecting tissue.

The recessed portion 50 is preferably concave in shape distal to the cutting window 38, as best illustrated in Figure 3B. With this in mind, the upper surface 44 preferably extends linearly from the recessed portion 50, having a section decreasing in height with respect to the lower surface 46. More particularly, a plane of the upper surface 44 is preferably aligned with the plane defined by the cutting window wall 39. Thus, with respect to the horizontal, the upper surface 44 defines an angle corresponding to angle θ. Finally, the lower surface 46 is preferably curved to the end 48.

The above-described construction of distal section 34, and in particular elevator tip 42, is but an acceptable configuration. For example, an alternative distal section 60 is shown in Figures 4A and 4B.

Once again, distal section 60 forms cutting window 62 and distal elevator tip 64 forms cutting window 62. The cutting window 62 is defined by a cutting window wall 63. A recessed portion 65 is formed around most of the wall 63. The riser tip 64 includes a proximal region 66 and a distal region 68, with the proximal region 66 extending from the recessed portion 65. The recessed portion 65 is formed around, and extends below, most of the shear window wall 63, with the shear window wall 63 tapering distally as with the embodiment of FIG. 3A. The recessed portion 65, in combination with the tapered extension of the cutter window 62, provides enhanced exposure to a cutter tip (not shown) otherwise disposed within the center lumen 36 with final assembly. In addition, the protrusion of the wall 63 above the recessed portion 65 provides a distinct surface with relatively sharp edges conducive to tissue engagement.

The proximal region 66 of the elevator tip 64 has a relatively uniform width, generally defined by an upper surface 70 and a lower surface 72. Top surface 70 extends from recessed portion 65 which is otherwise concave distal to cutting window 62. As shown in Figure 4B, the upper surface 70 extends angularly from the recessed portion 65, exhibiting a tapered section in height relative to the lower surface 72. The angular orientation of the upper surface corresponds to the angular taper defined by the shear window wall 63. Thus, the top surface 70 is generally aligned, or coplanar, with a plane defined by the cutting window wall 63.

Distal region 68 extends from proximal region 66 and terminates at a blade end 80. As best shown in FIG. 4A, distal region 68 is tapered in width, such that blade end 80 is a relatively sharp point that can pierce or puncture body tissue with minimal applied force. As with proximal region 66, distal region 68 includes an upper surface 82 and a lower surface 84. As best shown in FIG. 4B, the upper surface 82 of the distal region 68 extends angularly upward from the upper surface 70 of the proximal region 66. In a preferred embodiment, the upper surface 82 of the distal region 68 and the upper surface 70 of the proximal region 66 form an obtuse angle in the range of about 130 ° -160 °, more preferably 147 °. The lower surface 84 of the distal region 68 extends from the lower surface 72 of the proximal region 66 in a curved or arcuate manner to the blade end 80. With this configuration, the elevator tip 64, and in particular the distal region 68, is optimally shaped to promote deployment of the surgical micro-shaving instrument 10 (Figure 1) into the inferior turbinate (not shown), as well as to resect tissue. In addition, the curved lower surface 84 of the distal region 68 facilitates reciprocating movement of the distal section 60 within the lower turbinate during a resection or shaving procedure.

A distal section 90 of yet another alternative embodiment is shown in Figures 5A and 5B. The distal section 90 forms a cutting window 92 and an elevator tip 94 distal to the cutting window 92. The cutting window 92 is defined by a cutting window wall 96. A recessed portion 98 is formed around most of the wall 96, as best illustrated in FIG. 5A. Unlike the distal sections 34, 60 previously described, the recessed portion 98 extends only slightly distal to the cutting window wall 96. In other words, distal section 90 creates a transition from cutting window 92 to elevator tip 94 immediately distal to cutting window 92. In this regard, the elevator tip 94 is defined by an upper surface 100 and a lower surface 102. The upper surface 100 is preferably concave, extending downward from the

ES 2 323 943 T3 shear window wall 96. Indeed, the downward extension of the upper surface 100 corresponds to the recessed portions 50 (Figure 3A), 65 (Figure 4A) previously described. The concave nature of upper surface 100, in combination with the distal taper of cutting window 92, provides improved exposure of a cutting tip (not shown) otherwise disposed within central lumen 36 with final assembly. .

The elevator tip 94 provides additional preferred features. First, the elevator tip 94 terminates at a blade end 104. As best shown in FIG. 5A, the elevator tip 94 is distally tapered in width, so that the blade end 104 is a relatively sharp point that can pierce or puncture body tissue with minimal applied force. . In addition, the lower surface 102 is preferably curved so as to facilitate reciprocating movement of the distal section 90 within the lower turbinate (not shown) during a resection or shaving procedure. Furthermore, the upper surface 100 is defined by opposite edges 106. As best shown in FIG. 5B, one or more jagged areas 108 are formed at the edges 106. These serrated areas 108 are configured to easily resect or shave tissue with which they come into contact.

A distal section 120 of yet another alternative embodiment is shown in Figures 6A and 6B. The distal section 120 forms a cutting window 122 and an elevator tip 124 distal to the cutting window 122. The cutting window 122 is defined by a cutting window wall 126. A recessed portion 128 is formed around most of the wall 126, as best illustrated in Figures 6A. Similar to distal section 90 (Figures 5A and 5B), recessed portion 128 extends only slightly distal to cutting window wall 126. In other words, distal section 120 creates a transition from cutting window 122 to elevator tip 124 immediately distal to cutting window 122. Also, as with previous embodiments, shear window wall 126 is tapered distally relative to a central axis of distal section 120.

The elevator tip 124 includes an upper surface 130 and a lower surface 132 that extend along a first section 134 and a second section 136. The elevator tip 124 terminates at a blade end 138. As best shown in FIG. 6A, elevator tip 124 is distally tapered in width, such that blade end 138 is a relatively sharp tip that can pierce or puncture body tissue with minimal applied force.

With respect to the first section 134 of the elevator tip 124, the upper surface 130 is preferably concave, forming a depression with respect to a distal end of the cutting window wall 126. For example, in a preferred embodiment, the top surface 130 in the first section 134 defines, in longitudinal cross section, a concave curve having a radius of approximately 1,524 mm (0.06 inches), although other dimensions are acceptable. Regardless, this preferred attribute provides improved exposure of a cutting tip (not shown) otherwise disposed within center lumen 36 with final assembly.

Bottom surface 132 is curved along first and second sections 134, 136. However, unlike previous embodiments, the bottom surface 132 forms a concave curve in longitudinal cross section (as shown in Figure 6B) as the bottom surface 132 transitions from the first section 134 to the second. section 136. This preferred configuration promotes advancement of the elevator tip 124 posteriorly through the lower turbinate (not shown). In a preferred embodiment, a curve of the bottom surface 132 is such that, relative to the cross-sectional view of Figure 6B, the bottom surface 132 rises from the first section to the blade end 138 a distance (or height ) preferred in the range of 1.4223-1.524 mm (0.056-0.06 inches), most preferably 1.4732 mm (0.058 inches). Alternatively, other dimensions may be employed.

Regardless of the exact shape, in a preferred embodiment, the distal section 34 (Figure 3A), 60 (Figure 4A), 90 (Figure 5A), or 120 (Figure 6A) is formed separate from the remainder of the outer tubular element 18 (Figure 2). ), and later mounted with it. With this fabrication technique, the distal section 34,60,90,120 can be formed of a material more suitable for precise fabrication tolerances. For example, in a preferred embodiment, the distal section 34, 60, 90, 120 is formed of heat-treated 17-4 stainless steel, while the remainder of the outer tubular element 18 is a 304 stainless steel material. distal section 34, 60, 90, 120 thus formed is attached to the intermediate section 32 of the outer tubular member 18, such as by laser welding.

Returning to Figure 2, the inner blade assembly 14 is of a type commonly known in the art, whereby the inner tubular member 22 extends from the inner cylinder 20. In a preferred embodiment, the inner cylinder 20 is configured for selective attachment to a handpiece (not shown) that can be operated to automatically handle the inner blade assembly 14 during use.

The inner tubular member 22 forms a cutting tip 150 at a distal end thereof. With final assembly, and with respect to the embodiment of FIG. 1, inner tubular member 22 is coaxially disposed within outer tubular member 18 such that cutting tip 150 is exposed through cutting window 38. Cutting tip 150 forms a series of desired teeth to engage and resect (or shave) tissue.

As previously described, the surgical micro-shaving instrument 10 of the present invention is particularly useful for a lower turbinate reduction procedure. In a preferred embodiment, the instru

ES 2 323 943 T3 The assembled ment 10 is deployed to the sinus cavity, inserting the blade end 48 (Figure 3A), 80 (Figure 4A), 104 (Figure 5A) or 138 (Figure 6A) into the anterior face of the lower turbinate just half way to the mucocutaneous junction. The blade end 48, 80, 104 or 138 is then pushed firmly towards the turbinate, piercing through the mucosa of the turbinate. In this regard, since the blade end 48, 80, 104, 138 is relatively sharp, tissue is punctured rapidly, in direct contrast to currently available blunt-ended instruments. The distal section 34 (Figure 3A), 60 (Figure 4A), 90 (Figure 5A), 120 (Figure 6A) is then moved posteriorly to resect submucosa of the inferior turbinate. In a preferred embodiment, the submucosal cavity is dissected by tunneling at the distal section 34, 60, 90, 120 in a sweeping motion from anterior to posterior and from top to bottom. Once a suitable cavity has been established, tissue resection is initiated, preferably with the cutting tip 150 oriented laterally and moving back and forth in a sweeping motion analogous to liposuction. Independently, both the cutting tip 150 of the inner tubular element 22, and the cutting window wall 39 (Figure 3A), 63 (Figure 4A), 96 (Figure 5A) or 122 (Figure 6A) that otherwise protrudes with relative to the rest of the elevator tip 42 (Figure 3A), 64 (Figure 4A) or 94 (Figure 5A) or 124 (Figure 6A), respectively, aid in the engagement and resection of the tissue with which they come into contact. Furthermore, with the embodiment of Figures 5A and 5B, the serrated areas 108 formed by the edges 106 further assist in engagement and resection of the tissue with which they come into contact. In effect, the elevator tip 42, 64, 94, 124 removes tissue by dissecting the bone within the turbinate, so that the cutting tip 150 of the internal tubular element 22 can more easily come into contact, and therefore resect or shave, the desired tissue. The handpiece (not shown) is operated to cause the cutting tip 150 to rapidly dry out or shave the tissue with which it comes into contact, with the removed tissue removed from the target site by suction.

The surgical micro-shaving instrument of the present invention provides a marked improvement over previous designs. With respect to inferior turbinate reduction procedures, the use of a micro-shaving tool provides a definite advantage over other available techniques (such as cryosurgery, electrocautery, laser, etc.) as the tool does not destroy mucosa in order to to have access to the submucosal tissue to be resected. Furthermore, compared to the available 2mm and 2.9mm micro-shaving tools, the elevator tip associated with the present invention rapidly pierces the inferior turbinate, as well as dissecting target tissue from the turbinate, promoting that turbinate. way a more efficient and effective cut.