Patent Application
20060135977
1. Field of the Invention
The invention relates to trocar assemblies. More particularly, the invention relates to a circumferential trocar sealing structure.
2. Description of the Prior Art
A trocar assembly is a surgical instrument that is used to gain access to a body cavity. A trocar assembly generally comprises two major components, a trocar sleeve, composed of a trocar housing and a trocar cannula, and a trocar obturator. The trocar cannula, having the trocar obturator inserted therethrough, is directed through the skin to access a body cavity. Once the body cavity is accessed, laparoscopic or arthroscopic surgery and endoscopic procedures may be performed. In order to penetrate the skin, the distal end of the trocar cannula is placed against the skin that has been previously cut with a scalpel and the trocar obturator is used to penetrate the skin and access the body cavity. By applying pressure against the proximal end of the obturator, the sharp point of the obturator is forced through the skin until it enters the body cavity. The trocar cannula is inserted through the perforation made by the trocar obturator and the trocar obturator is withdrawn, leaving the trocar cannula as an access way to the body cavity.
The proximal end portion of the trocar cannula is typically joined to a trocar housing that defines a chamber having an open distal end portion in communication with the interior lumen defined by the trocar cannula. An obturator, or other elongate surgical instruments or tools, axially extend into and are withdrawn from the trocar cannula through the proximal end portion of the chamber defined by the trocar housing.
Current trocar assemblies are commonly designed with a seal mechanism positioned within the chamber of the trocar housing. The sealing mechanisms are commonly a sealing grommet or gasket through which the obturator or other instruments extend. The sealing mechanism seals against the outer surface of the inserted instruments and thereby prevents fluids and insufflation gas from leaving or entering the body cavity through the trocar cannula. It is desired that such seals provide for good tear resistance, resistance to snagging and low friction with respect to insertion of a device such as a rod, shaft or cylinder.
Seal assemblies are designed to maintain a seal before the insertion of an instrument and after the removal of the instrument. As a result, many trocar assemblies provide double sealing systems. That is, a top, or proximal, seal is used to seal around the tool/instrument when present and a flapper door or duckbill seal is requited below the top seal for sealing the trocar cannula when the instrument is not present.
In contrast, other trocar assemblies employ a single sealing mechanism. Many of these trocar seal assemblies simply employ a silicone seal with a small hole slightly smaller than the smallest tool/instrument to be used in conjunction with the trocar assembly. This type of seal is often referred to as a lip seal. Surgical instruments of various diameters are passed through the lip seal. As such, these seals are often required to provide a seal for use with a full range of instruments. The opening diameter of the seals is, therefore, small relative the largest diameter instruments.
In fact, it is not uncommon for lip seals to be pushed to 400% strain. By forcing these large diameter instruments through a relatively small diameter lip seal, these large diameter instruments are subjected to a significant increase in the normal force upon the instrument shaft. The surgeon feels this increased force as increased drag or resistance to instrument insertion/movement. It is also required that the material properties of the seal be such that the seal does not rip or tear as the seal is stretched to its limit. As a result, a need currently exists for an improved trocar seal assembly overcoming the deficiencies of the prior art.
The present invention overcomes these deficiencies by providing a seal assembly which eliminates the hoop/high stress issues associated with prior art seals and provides a seal assembly which may be utilized either as a single sealing method (reducing the overall complexity of the trocar) or as a proximal seal assembly in a multiseal system.
It is, therefore, an object of the present invention to provide a seal assembly adapted for use in conjunction with a trocar assembly. The seal assembly includes a plurality of seal segments. Each seal segment includes a peripheral edge and a seam edge. At least a first seal segment and a second seal segment are connected along their respective peripheral edges to form a first seal layer having a seam defined by the seam edge of the first seal segment and the seam edge of the second seal segment. At least a third seal segment and a fourth seal segment are connected along their respective peripheral edges to form a second seal layer having a seam defined by the seam edge of the third seal segment and the seam edge of the fourth seal segment. The seam of the first seal layer has a first longitudinal axis and the seam of the second seal layer has a second longitudinal axis, and the first seal layer is oriented relative to the second seal layer such that the first longitudinal axis is angularly oriented relative to the second longitudinal axis.
It is also an object of the present invention a trocar assembly including a trocar cannula having a proximal end and distal end. The trocar assembly further includes a trocar housing coupled to the proximal end of the trocar cannula for receiving and guiding an obturator through the trocar cannula. The trocar housing includes an open proximal end portion defining an opening provided with a seal assembly. The seal assembly is constructed as described
Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as the basis for the claims and as a basis for teaching one skilled in the art how to make and/or use the invention.
With reference to
Apart from the seal assembly 10 in accordance with the present invention, the general structure of trocar assembly 12 does not form part of the present invention. For example, and by way of explaining the present seal assembly 10, the trocar assembly 12 may take a variety of forms without departing from the spirit of the present invention.
With that in mind, and by way of example, the trocar assembly 12 includes a trocar cannula 14, a trocar obturator 16 and a trocar housing 18. The trocar cannula 14 defines an interior lumen having an open distal end portion and an open proximal end portion. The proximal end portion extends into and is mounted in the distal end portion of trocar housing 18. The trocar housing 18 has an open proximal end portion that defines an opening 20. The opening 20 is provided with a proximal seal assembly 10 constructed in accordance with the present invention and described in detail hereinbelow. The opening 20 is further provided with a duckbill seal assembly 22 positioned beneath the proximal seal assembly 10. While the present seal assembly 10 is disclosed as a proximal seal assembly 10 forming part of a dual sealing system, the present seal assembly may be utilized in a single seal system without departing from the spirit of the present invention.
The trocar obturator 16 is slidably and removably extendable within the trocar cannula 14 and is inserted into the trocar housing 18 and the trocar cannula 14 through the proximal seal assembly 10, the duckbill seal assembly 22 and the opening 20 of the trocar housing 18. An obturator handle 24 is provided at the proximal end of the trocar obturator 16 and a sharpened point or blade (not shown) is formed at the distal end thereof. As is well known in the art, the seal assembly 10 cooperates with the trocar obturator 16, or another surgical instrument extending through the trocar cannula 14, to sealingly engage the outer surface thereof and thereby preclude the passage of fluids through the trocar housing 18.
With reference to the various embodiments in accordance with the present invention, the proximal seal assembly 10 is composed of multiple overlapping seal segments 26a, 26b, 26a′, 26b′ assembled so as to minimize leakage between the seal assembly 10 and the insertable rod, shaft or collar of various instruments. In particular, four seal segments 26a, 26b, 26a′, 26b′ are arranged to create the seal body 28 of the seal assembly 10. While four seal segments are utilized in accordance with a preferred embodiment of the present invention, the seal assembly may ultimately be formed with different numbers of seal segments without departing from the spirit of the present invention.
With reference to
As will be discussed below in greater detail, the present seal assembly 10 uses a series of interlocking seal segments 26a, 26b, 26a′, 26b′. The preferred embodiment disclosed herein employs four seal segments 26a, 26b, 26a′, 26b′, although more than four seal segments may be utilized without departing from the spirit of the present invention. All four seal segments 26a, 26b, 26a′, 26b′ are molded individually and then assembled into the final configuration.
The hoop stress of the present seal assembly 10 is reduced by providing a single seal assembly 10 with multiple layers, that is, seal segments 26a, 26b, 26a′, 26b′, lapped over each other in a manner creating a through hole. The layers form contact zones with the inserted probe. The sum of the contact zones provides contact around the full diameter of the inserted instrument. Without a probe inserted, the seal segments 26a, 26b, 26a′, 26b′ remain in contact with each other so that the seal assembly 10 allows for no air passage.
The proximal seal assembly 10 is composed of a seal body 28 constructed from two seal layers 34, 34′ respectively composed of a pair of seal segments 26a, 26b, 26a′, 26b′. Once the two seal layers 34, 34′ are properly constructed, the second seal layer 34′ is placed beneath the first seal layer 34 with the seal seam 36′ of the second seal layer 34′ rotated 90° from the seal seam 36 of the first seal layer 34. In this way, the seal seams 36, 36′ of the first and second seal layers 34, 34′ create a double seamed seal providing for improved circumferential sealing within the trocar housing 18.
Apertures 37, 37′ are formed along a peripheral edges 35a, 35b, 35a′, 35b′ of the respective seal segments 26a, 26b, 26a′, 26b′ and are spaced such that the apertures 37, 37′ will align when the seal layers 34, 34′ are properly aligned and rotated 90 degrees. As such, a male retaining ring 44 and a female retaining ring 46 are positioned on opposite sides of the juxtaposed first and second seal layers 34, 34′. The male retaining ring 44 includes a series of connecting prongs 45 that extend through the apertures 37, 37′ of the seal layers 34, 34′ and are connected with the female openings 47 formed in the female sealing ring 46. In this way, the seal body 28 composed of the first and second seal layers 34, 34′ is securely positioned between the male and female retaining rings 44, 46, and ultimately supported for attachment to the trocar housing 18.
In practice, when a device such as rod or shaft is inserted through the seal assembly 10, the overlapping segments of the first and second seal layers 34, 34′ deflect both downward and around the device inserted. This deflection creates a cat-eye effect on the first seal layer 34, leaving gaps between the inserted device and the first and second seal segments 26a, 26b making up the first seal layer 34. The second seal layer 34′, with its seam 36′ rotated 90° from the seam 36′ of the first seal layer 34′, counters the gaps between the inserted device and the seal segments 26a, 26b of first seal layer 34, creating a circumferential seal around the inserted device.
As will be described below in substantial detail, various embodiments in accordance with the present invention are contemplated. The various embodiments describe the application of the concept underlying the present invention to flat seal segments with straight seam edges, flat seal segments with sigmoidal seam edges, cone shaped seal segments with straight seam edges and cone shaped seal segments with sigmoidal seam edges.
While the present seal assembly 10 is specifically adapted for use in conjunction with trocar assemblies, it will be appreciated by those skilled in the art that the present seal assembly may be employed for different functions without departing from the spirit of the present invention.
With reference to
Referring to
As mentioned above, the radially extending angled sections 30a, 30b are tapered as they extend toward the tip thereof. The underside of each seal segment 26a, 26b opposite the angled section 30a, 30b is similarly formed with a matching taper 32a, 32b to that of the angled section 30a, 30b. In this way, the angled section 30a of the first seal segment 26a is seated within the matching taper 32b along the underside of the second seal segment 26b and the angled section 30b of the second seal segment 26b is seated within the matching taper 32b along the underside of the first seal segment 26a. The matching tapers 32a, 32b permit the formation of a first seal layer 34 including no undesirable ridges or bumps along its underside due to the coupling of the first seal segment 26a to the second seal segment 26b.
In practice, and with reference to
As was mentioned above, the concepts underlying the present invention may be practiced through the utilization of a variety of seal layer constructions without departing from the spirit of the present invention. Some of these contemplated constructions are disclosed below. Since it is believe those skilled in the art will appreciate the seal layer will be assembled in a manner similar to that described above with reference to
With reference to
Referring to
In accordance with a preferred embodiment of the present invention, the outer peripheral edge 135a, 135b of each seal segment 126a, 126b defines an arc of approximately 200-220 degrees. The outer peripheral edges 135a, 135b further include a series of apertures 137 that function as a means of attachment for the seal segments 126a, 126b. The seal segments 126a, 126b further include respective tapered angled sections 130a, 130b extending radially for connecting adjacent seal segments 126a, 126b in the manner discussed above. The angled sections 130a, 130b are respectively tapered on one side. A matching taper 132a, 132b is also formed along the underside of each seal segment 126a, 126b opposite the angled section 130a, 130b. The angled sections 130a, 130b of the seal segments 126a, 126b allow for increased contact between assembled seal segments 126a, 126b.
In practice, and with reference to
A further embodiment is disclosed with reference to
In accordance with a preferred embodiment of the present invention, the outer peripheral edges 235a, 235b of each of the seal segments 226a, 226b define an arc of approximately 200-220 degrees. The outer peripheral edges 235a, 235b further include a series of apertures 237 that function as a means of attachment for the seal segments 226a, 226b. The seal segments 226a, 226b further include respective tapered angled sections 230a, 230b extending radially for connecting adjacent seal segments 226a, 226b in the manner discussed above. A matching taper 232a, 232b is also formed along the underside of each of the seal segments 226a, 226b opposite the angled sections 230a, 230b. The angled sections 230a, 230b of the seal segments 226a, 226b allow for increased contact between assembled seal segments 226a, 226b.
In practice, and with reference to the figures, two seal segments 226a, 226b are connected in an overlapping relationship to create a first seal layer 234. As such, the resulting first seal layer 234 defines a complete circular outer periphery with a sigmoidal seal seam 236 extending between the first and second seal segments 226a, 226b. As will be discussed below, the sigmoidal shape of the seam edges 238a, 238b of the respective seal segments 226a, 226b ultimately define the shape of the seal seam 236 extending between the first and second seal segments 226a, 226b making up the first seal layer 234.
Still a further embodiment is disclosed with reference to
In accordance with a preferred embodiment of the present invention, the outer peripheral edge 335a, 335b of each of the seal segments 326a, 326b defines an arc of approximately 200-220 degrees. The outer peripheral edge 335a, 335b further includes a series of apertures 337 that function as a means of attachment for the seal segments 326a, 326b. The seal segments 326a, 326b further include respective tapered angled sections 330a, 330b extending radially for connecting adjacent seal segments 326a, 326b in the manner discussed above. A matching taper 332a, 332b is also formed along the underside of each of the seal segments 326a, 326b opposite the angled portions 330a, 330b. The angled portions 330a, 330b of the seal segments 326a, 326b allow for increased contact between assembled seal segments 326a, 326b.
In practice, and with reference to the figures, two seal segments 326a, 326b are connected in an overlapping relationship to create a first seal layer 334. As such, the resulting first seal layer 334 defines a complete circular cone with a straight seal seam 336 extending between the first and second seal segments 326a, 326b. As will be discussed below, the shape of the seam edge 338a, 338b of the seal segments 326a, 326b ultimately defines the shape of the seal seam 336 extending between the first and second seal segments 326a, 326b making up the first seal layer 334.
Yet a further embodiment is disclosed with reference to
As is shown in
In accordance with a preferred embodiment of the present invention, the outer peripheral edges 435a, 435b of the seal segments 426a, 426b define an arc of approximately 200-220 degrees. The outer peripheral edges 435a, 435b further include a series of apertures 437 that function as a means of attachment for the seal segments 426a, 426b. The seal segments 426a, 426b further include tapered angled sections 430a, 430b extending radially for connecting adjacent seal segments 426a, 426b in the manner discussed above. A matching taper 432a, 432b is also formed along the underside of each of the seal segments 426a, 426b opposite the angled sections 430a, 430b. The angled sections 430a, 430b of the seal segments 426a, 426b allow for increase contact between assembled seal segments 426a, 426b.
In practice, two seal segments 426a, 426b are connected along their respective peripheral edges 435a, 435b in an overlapping relationship to create a first seal layer 434. As such, the resulting first seal layer 434 defines a complete circular cone with a seal seam 436 extending between the first and second seal segments 426a, 426b. As will be discussed below, the shape of the seam edge 438a, 438b of the seal segments 426a, 426b ultimately defines the shape of the seal seam 436 extending between the first and second seal segments 426a, 426b making up the first seal layer 434.
The cone feature of the seal assembly reduces the possibility of seal inversion upon instrument retraction. Seal inversion can cause binding of the instrument during retraction creating difficulty when removing instruments from the trocar. The cone feature also provides a natural lead in towards the center of the seal assembly. This guides the instrument inserted towards the center of the seal assembly and reduces the potential of puncturing through the seal at location towards the outer periphery of the cone.
In accordance with a preferred embodiment of the present invention, the seal segments are composed of an elastomer or a cross-linked polymer such as, but not restricted to, silicone or a polyisoprene. However, those skilled in the art will appreciate the possibility that other materials may be employed without departing from the spirit of the present invention.
While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention as defined in the appended claims.
