CA2028896A1 - Apparatus for sealing around members extending there-through - Google Patents
Apparatus for sealing around members extending there-throughInfo
- Publication number
- CA2028896A1 CA2028896A1 CA002028896A CA2028896A CA2028896A1 CA 2028896 A1 CA2028896 A1 CA 2028896A1 CA 002028896 A CA002028896 A CA 002028896A CA 2028896 A CA2028896 A CA 2028896A CA 2028896 A1 CA2028896 A1 CA 2028896A1
- Authority
- CA
- Canada
- Prior art keywords
- sealing
- seal
- housing
- disposed
- seal material
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0613—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof with means for adjusting the seal opening or pressure
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16J—PISTONS; CYLINDERS; SEALINGS
- F16J15/00—Sealings
- F16J15/02—Sealings between relatively-stationary surfaces
- F16J15/021—Sealings between relatively-stationary surfaces with elastic packing
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16J—PISTONS; CYLINDERS; SEALINGS
- F16J15/00—Sealings
- F16J15/56—Other sealings for reciprocating rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/0084—Material properties low friction
- A61B2017/00845—Material properties low friction of moving parts with respect to each other
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S604/00—Surgery
- Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
Abstract
IMPROVED APPARATUS FOR SEALING AROUND MEMBERS
EXTENDING THERETHROUGH
Abstract An apparatus is provided for sealing around shafts or tubes of varying diameter. Its basic element comprises an elastomeric sealing body with an axial passage which is radially compressed from more than two sides to compress the passage into sealing engagement with a member extending through the passage. Radial compression is achieved by cams and followers disposed around the body which cooperate with angularly spaced radially extending lugs formed integrally with the body. The cams are spring biased to normally compress the axial passage of the sealing body. Levers operable by one hand of the user are provided to selectively release the apparatus.
EXTENDING THERETHROUGH
Abstract An apparatus is provided for sealing around shafts or tubes of varying diameter. Its basic element comprises an elastomeric sealing body with an axial passage which is radially compressed from more than two sides to compress the passage into sealing engagement with a member extending through the passage. Radial compression is achieved by cams and followers disposed around the body which cooperate with angularly spaced radially extending lugs formed integrally with the body. The cams are spring biased to normally compress the axial passage of the sealing body. Levers operable by one hand of the user are provided to selectively release the apparatus.
Description
8 8 9 ~
. 1 ,,.
., Backyro~und of the Invent_ a Field of the Invention ~ he present invention relates generally to an improved device for forming a seal aroumd shafts or tubes and, more specifically, to a hemostasis valve for sealing around elongate objects of varying sizes.
Discussion of the Prior Art : 10 Historically, seals and seal materials have been selected from materials having a high modulus. The theory was that a seal must fill a gap between two objects, thus permitting no gas or fluid to find or generate a path around the object. It was thought that ` if the seal material had a low moduIus, such a path would form. Accordingly, seals designed ~or retaining pressure were deliberate~ly manufactured out of high modulus - materials. As a consequence, the seals had little or no compliance or conformance to accommodate variations in the shape of an object around which a seal was required.
O-rings, for example, accommvdate one external and one internal diameter, with slight allowances for manufacturing tolerances of the shaft or gland. If deviations from the tolerances are encountered~ or if the shaft or gland is out of round, the o-ring is likely to fail or leak unless a deforming compressive forca is applied to the O-ring to cause it to come into closer contact with the shaft or gland wall.
~28~
The latter approach creates siynificant problems, not the least of which is the limits it plac~s on the range of deformation. A major drawback associated with the seal materials of the past has been the compressive force that the O-ring or seal transmits to the traversing shaft, especially if the shaft is of a fragile nature.
Seals having a high modulus also fail -to work if the traversing shaft is not relatively round, or if there are more than one traversing shaft extending through the seal at the same time.
Other types of seals used in the medical field are the "septum" and "duck-bill" seal. While satisfactory for certain limited purposes, these seals do not provide the advantages of the present invention.
In the septum seal, a septum or diaphragm is used as the s~aling element. In order to transverse the seal, a preformed puncture is provided or a needle is used to generate a puncture within the septum and the traversing shaPt is introduced into this puncture. Puncturing the septum is an added step that is often disliked in busy clinical settings. Finding the puncture hole is also difficult, particularly where lighting is sparse. The introduction of new shafts may require new punctures.
This type of seal also fails to provide for locking the traversing shaft in place. These deficiencies of the septum eal have become well known so that it is now customary to provide more than one such seal in series.
The duck-bill seal is commonly used as a one way valve. It consists of a circular passage that flattens towards the tip, forming an area where two surfaces co-act to seal flow from outside the valve. The seal is effective around a shaft only so long as the pressure 2~2~
causing closure of the seal is sufficiently large. It is very difficult to purge air bubbles out of a valve incorporating a duck-bill seal. Such seals also have difficulty in sealing around a traversing shaft of an irregular shape. The shape o~ the seal which forms around a traversing shaft is commonly referred to as the "cat-eye" and permits leakage at two opposing points along the shaft. A duck-bill seal also tends to invert when a bulky shaft is pulled back through it.
. 10 The prior art also suggests de~lectable tubular elements which are deformed to effect a seal. U. S.
~; Patent Nos. 3,977,400 and 4,243,034 teach such arrangements where the tubular alements are clamped from opposite sides by cam like actuators. In both of these patents, the clamping is effected from two sides only.
U. S. Patent 3,970,089 teaches an arrangement wherein the ~- tubular element takes the form of a toroid which is inflated to effect a seal. U. S. Patent No. 4,580,573 teaches an arrangement wherein the tubular element is twisted to effect the seal.
The prior art also teaches stoppers for ampoules and the like wherein the stopper takes the form of an elastomeric member having a preformed opening which may be pinched shut. U. S. Patent No. 2,797,837 discloses such a device. As shown in that patent, pinching is effected by either biasing the opening from one side, or clamping it from opposite sides.
Summary of the Invention ., ... .
In the apparatus of the present invention, an elastomeric sealing body having a passage extending axially therethrough is radially clamped from more than two sides. The preferred embodiment employs a sealing body having radially extending lugs disposed at substantially equal angularly spaced locations therearound and a clamp disposed at least partially around the sealing body to compress the lugs. The preferred embodiment also includes biasing means associated with the clamp to normally compress the sealing body and release means operable by one hand of a human operator to selectively release the sealing body from compression by the biasing means.
~In accordance with one aspect of the invention, a `;seal assembly includes an elastomeric element defining an opening adapted to receive a shaft having a cross-sectional dimension and an outer sur~ace. The assembly also includes means for compressing the element against the outer surface of the~shaft to form with the shaft a seal having a particular area. ~eans is provided for applying a force to the element to produce a pressure on the particular area, the magnitude of the appIied force being variable directly with the size of the particular area. In this aspect of the invention, the pressure on the particular area tends to be independent of the cross-sectional dimension of the shaft. In a particular embodiment the force applying means in ludes more than two dogs movable radially to produce the applied force.
Means can be provided for biasing the opening of the elastomeric element toward a decreasing dimension.
2 ~
In another aspect of the invention, a seal assembly includes a housing with two portions which are movable relative to each other. A compressive element is disposed in the housing and adapted to form a seal with an object, the element having properties responsive to an applied force to create a resultant force on the object.
The two housing portions are movable rslative to each other to vary the applied force Oll the compressive element and the resultant force on the object. The compressive element has properties such that ~he resultant force is greater than 80% of the applied force so that very little energy is lost in compressing the element. First and second opposed surfaces are associated with the respective portions of the housing and support opposite ends of a spring which biases the housing to decompress the seal element.
In still a further aspect of the invention, a seal material disposed in the housing has an outer surface and an inner surface which defines a central bore adapted to receive the object. Pressurizing means is disposed to exert an applied pressure from more than two directions against the outer surface of the seal material. By operation of the pressurizing means, the seal material produces a resultant pressure on the object thereby creating a seal. In a particular em~odiment the seal material is provided with four projections which extend radially in cross-section to form the configuration of a cross.
The concept of this invention is particularly useful in combination with an access device adapted to be p2rcutaneously inserted to provide an access channel into the body of a patient, thP channel being adapted to receive an elongate object extending through the access 2 ~
device. An elongate tube includes a distal end and a proximal end, and portions defining t:he access channel along a longitudinal axis of the tube. Sealing means is disposed in proximity to the proximal end of the elongate tube ~or sealing the access device around the object. A
seal material included in the sealing means is movable radially of the tube to ~orm the seal between the tube portions and the elongats object.
:
It follows from these different aspects, that a principal object of the invention is to provide a seal that facilitates gentle sealing around shafts and tubes of varying diametersO
Another object is to provide such a seal capable of conforming to objects of irregular shape and/or simultaneously sealing around more than one object extending through the seal.
A further object of the invention is to provide such a seal which functions to axi~lly retain an element extended therethrough.
An additional object of the invention i5 to provide an atraumatic seal which produces a substantially constant low pressure on the fragile wall of an object regardless of the cross-sectional dimension of the object.
Still another object of the invention is to provide such a seal which normally assumes a closed condition and may be operated and selectively released by one hand of a human operator.
The foregoing and other o~jects will become more apparent when viewed in light of the and following detail~d description and reference to the associated drawings.
Brief Descri~tion of the Drawings Figure l is a perspective view of the apparatus;
Figure 2 is a cross-sectional view taken on the ~ plane designated by line 2-2 of Fig. 1, showing the ; apparatus with the sealing member in the normally closed condition;
Figure 3 is a cross-sectional view taken on the plane designated by line 3-3 of Fig. 2;
Figure 4 is a cross~sectional view similar to Fig.
2, showing the apparatus with the sealing member in the open condition;
Figure 5 is a cross-sectional view taken on the plane designated by line 5-5 of Fig. 4; and Figure 6 is an exploded perspective view of the apparatus.
Figure 7 is a cross-sectional view of a particular embodiment of the sealing member taken along lines 7-7 of Fig. 6; and Figure 8 is a perspective view of a medical access device with the sealing apparatus of tha present invention disposed at the proximal end of the device.
2 ~ 2 ~, '`' ', Descri~tion of the Pr f r~ed :Embodiments : The sealing apparatus is designated in its entixety ":, S by the letter "S" and comprises, as its basic element: a ,. housing body "H", a cam body "C" and an end cap "E". The ',, housing Body "H'l includes an enlarged open-ended cavity 10 having a tubular conduit fitting 12 communicating .~" therewith. In a preferred embodiment, a side port 14 is ~ 0 formed in the body ~H~ and communicates with the interior :,~ of the fitting 12. A suture loop 16 is formed integrally with the housing and connects to the fitting 12. A
~ stationary lever 18 is formed integrally with and extends .:, laterally of the housing body "H". An elongate arcuate ,i 15 slot 20 extends through the housing body "H" to one side .~ of the lever 18 for accommodation of a cam lever 22 :.~ forming part of the cam body "C". The slot opens through ,', one end of the body "H" to facilitate assembly of the .~ apparatus.
... 20 ,~ In the assembled,condition, the cam body "C'i is .,;; concentrically received within the housing body "H", with ,./ the lever 22 extending through the slot 20. The exterior ~ surfaces of the cam body are of an arcuate configuration ,: 25 and configured to slide on the interior surface of the ,i~ cavity 10 (see Figs. 2 and 4). Interiorally, the cam body "C" is formed with four cam surfaces 24. The cam ,~ surfaces are associated a plurality of pawls or cam ',~ follower pins 26 which are spaced relative to one another '. 30 by a distance approximately equal to the width of the pins. As viewed in Figs. 2 and 4, counterclockwise ~, movement of the cam body "C" relative to the housing body "H" functions to force the pins 26 inwardly to the : position shown in Fig. 2. Clockwise movement functions ',~ 35 to release the pins for extension, as shown in Fig. 4.
~u~
~ 9 A compression coil spring 28 is engaged between the -levers 18 and 22 to normally bias the lever 22 in the counterclockwise direction, toward an inwardly positisn as shown in Fig. 2.
The pins 26 engage lugs 30 formed on an elastomeric sealing member 32. This sealing member 32, which is best illustrated in Fig. 6, includes a c~entral ~ection 33 which extends longitudinally of the sealing member 32 between a pair of annular end flanges 36 and 38.
Portions of the central section 33 and the end flanges 36, 38 define a central bore or passage 34 which extends axially through the sealing member 32 in a preferred embodiment.
The lugs 30 extend longitudinally of the sealing member 32 between the end flanges 36, 3$. These lugs 30 are formed by removing material or longitudinal cut-outs from the exterior surface of the central section 33. In Fig. 6, one of these cut-outs is shown generally at the arrow 39.
As illustrated in the cro s-section of Fig. 7, the sealing element 32 can have a plurality of the lugs 30 angularly spaced around the bore 34. In the illustrated embodiment each of the lugs is defined by a width which is approximately the diameter of the bore 34. Each of the longitudinal cut-outs, illustrated by the arrow 39, is defined by an adjacent pair of the lugs 30. In a preferred embodiment, the sealing member 32 includes four radially extending lugs 30 equally spaced at ninety degree intervals around the bore 34. This provides the sealing member 32 with a central portion 33 which in radial cross-section appears to have the configuration of a cross.
9 ~
ThP material associated with at least the central portion 33 of the sealing member 32 is of particular interest to tha present invention. This material is preferably very soft and pliable so that a pressure applied to the sealing member 32 will force the central section 33 into the regions defining the bore 34. With an appropriate material, this pressure on the sealing element 32 will force it into contact with any object, such as a catheter or surgical instrument, extending through the bore 34. In this manner the sealing element 32 tends to form a seal with the exterior surface of any such object or objects.
If the material is appropriately selected, the member 32 can form a seal even around objects or shafts which have irregular cross-sectional configurations.
Such an object may include a single shaft having an irregular configuration or multiple shafts each of which has a regular configuration.
The material of at Ieast the central section 33 of the sealing member 32 preferably has a Shore A hardness less than twenty (20~. A~material with this degree of softness will tend to function with characteristics similar to that of a fluid. Thus the pressure applied to the outer surface of the central portion 33 will be transmitted with very little loss of energy to the portions defining the bore 34. It follows that any energy required to deform such a material can be minimized. A soft material is also similar to a fluid in that it is highly compliant so that it can "flow" into narrow crevices as might be required to form a tight seal around an irregular shaft or object. A soft material with these significant fluid properties can be chosen to 8 ~
`, 11 ` effect a high degree of conformity to any shape of object ; extending through the bore 34.
Another fluid characteristic associated with the material of the sealing member 32 is the property it has for transferring substantially all of the applied force to the region defining the hore 34. Thus, a pressure applied by the cam follower pins 26 to the lugs 30 is substantially the same pressure exerted by the portions defining the bore 34 against an object extending through the bore. With a material of low ~urometer, very little ~ energy is lost in deforming the sealing member 32. In ; fact, a suitable material is substantially non-~i compressible so that the resultant pressure at the bore 34 is at least eighty percent (80%) of the pressure applied to the lugs 30.
Under particular circumstances, it may be desirable that the material forming the bore 34 have particular surface characteristics. In some cases, a degree of impermeability may be required. In other cases, a high or low coe~ficient of friction may be desired to either facilitate axial movement or prevant axial movement of the object respectively. These characteristics can be provided in at least two manners. In the first case, the material forming the sealing member 32 can be chosen with homogeneous properties which can provide the surface characteristics desired. Thus a hydromer material can be incorporated into an elastomer to provide a lubricous surface defining the bore 34. In other casPS/ a coating can be applied to the portions defining the bore 34.
This coating might include polytetrafloroethylene when a biocompatible surface is desired. Suitable coatings can be grafted or otherwise bonded to provide a lubricous surface. By way of example, a hydromer or hydrogel 2~2~89~
coating might provide the surface of the bore with a coefficient of friction less than 0.25.
In a preferred embodiment, the makerial selected for the sealing member 32 is silicone rubblar. This material has a Shore A hardness less than twenty (20) and can be molded to a monolithic construction including not only the ~entral portions 33 but also the flanges 36 and 38.
It has been demonstrated that materials exhibiting a Shore A hardness as low as five ~5~ are suitable for application to this concept. The material forming the seal member 34 preferably has compression characteristics defined by a Poisson's ~atio in a range between 0.45 and 0.50.
In another embodiment, the central portions 33 of the sealing member 32 are formed from foam rubber. This material can also be configured to provide a very low Shore hardness factor such as twenty (20) or even lower.
In a preferred embodiment, foam rubber is extruded to : form the central portions 33, and the end flanges 36 and 38 (which may be formed from a non-foam material) are glued or otherwise attached to extend radially from the ends of the central portion 33.
In a particular application, foam rubber may be particularly advantageous for the sealing member 32. The rubber forming the foam will typically be stronger than a homogeneous material so it will tend to resist tearing and propagation of cracks. It is the dispersion of a multiplicity of air holss in this foam which can provide the stronger rubber material with the soft compression characteristics previously discussed.
~ ~ 2 ~
If the material forming the sealing member 32 is constructed of ~oam, it may be desirable to remove the foam "skin" which is typical of this material. Such a `~skin may tend to interfere with thQ compression characteristics of the sealing member 32 or otherwise "impair the ability o~ the material to con~orm to an ~,irregularly shaped object.
,~ .
Before being assembled into the housing body "H", a retainer ring 40 and a spacer ring 42 are engaged around the sealing member 32. Both of these rings have arcuate outer surfaces designed to complimentally engage the interior surface of the recess 10. A cross-shaped passage 44 is formed in the ring 40 for receipt around the lugs 30 of the sealing member. The opening 46 shown by the arrow 39 extend radially through the ring 40 in alignment with the lug receiving recesses of the passage 44. These openings 46 as will become more apparent from the subsequent discussion/ slidably receive the pin 26.
The spacer ring 42 is formed with a cross-shaped passage 4~ adapted to be received around the lugs 30 of tha sealing member 32. Fingers 50 extend from the distal ends of the passage 48 in a longitudinal direction '-; 25 relative to the ring 42. These fingers, together with the recesses 46, provide radial passages for slidable receipt of the pins 26. An arcuate segment 52 is formed on the outside o~ the spacer ring 42 for engagement in the slot 20 to ~ocate the fingers 50 and pins 26 relative to the cam body "C".
Referring again to the material forming the sealing member 32, it will be apparent that any material having a low duro~eter, must be confin2d in order that a pressure applied to the material will force it into the 9 ~
, :.
desired region such as the bore 34. In the illustrated embodiment the housing ~I and end cap E, as well as the retainer ring 40 and spacer ring 42 prc~vide the confining means and are configured to define a cavity similar in shape to the exterior surface of the sealing member 32.
Then as the cam follower pins 26 are moved radially against the lugs 30 of the sealing member 32, this ~; pressure forces the material of the central portions 33 ~ into the region of the bore 34.
,, 10 Prior to being inserted into the housing body "H", the rings 40 and 42 and the cam body 'IC", with the pins , 26 in place, are assembled around the sealing member 32.
During this assembly, flanges 36, 38 of the sealing , 15 member 32 can be resiliently deflected to pass through the various elements. The arrangement of this subassembly can be seen from the center line extending through the exploded view of Fig. 6.
,,.
The assembly of the sealing member 32, rings 40 and 42, cam body i.c~ and pins 2~ creates a subassembly which is then slid into the housing body "H" so as to engage ~: the segment 52 in the slot 20 and position the cam lever 22 in apposition to the stationary lever 18. The end cap "E" is then snapped into place, as seen in Figs. 3 and 5.
The arcuate segment 52 serves to lock the spacer ring 42 against rotation relative to the housing body "H". This, in turn, locks the sealing member 32 and the retainer ring 40 against rotation relative to the housing, while - 30 leaving the cam body "C" free for rotation about the longitudinal axis of the housing body. After the stationary lever 18 and cam lever 22 are disposed in apposition, the compression coil spring 28 is interposed therebetween, thus forcing the levers apart and moving the pins inwardly, as shown in Fig. 2.
2~8~
The surface on the stationary lever 18 and the surface on the cam lever 22, both oP which contact the spring 28, are angularly disposed with respect to each other. In a preferred embodiment, each of these surfaces is disposed in a plane which is generally parallel to the axis of the bore 34. As these surfaces are moved toward each other, the spring 28 is compre-;sed and tends to exert a force which increases as the spring 28 is ~ compressed. As the spring 28 is permitted to relax, ; lO these two opposing surPaces separate angularly and the force of the spring 28 tends to decrease. It wiIl be apparent that the spring 28 can be chosen with a spring constant which is suitable to provide a particular sealing pressure for a specific application.
It is of particular advantage that the force applied to the lugs 30 of the sealiny member 32 be directed radially of the bore 34. This tends to insure that the material of the sealing member 32 is pushed most directly to fill the space of the bore 34. By guiding the cam follower pins 26 radially, the fingers 50 togPther with the recesses 46 provide means for translating the rotational movement of the cam surface 24 into a radial, linear movement of the cam follower pins 26.
It is believed to be important that the force applied against the sealing member 32 be directed from more than two radial ;directions. Only with the application of an applied ~orce from three or more radial directions, can one avoid the cat-eye which is typical of the seals of the prior art. The conformity of the sealing member 32 to irregularly shaped objects extending through the bore 34 is greatly increased by the provision of four of the lugs 30 in the preferred embodiment.
Particularly large diameters of the bore 34 may be 2~$
.... .
:. 16 accommodated with more than four o~ the lugs 30. With ; a radial force applied along each of these lugs 30 the material tends to flow with little pressure into the . region v~ the bore 34 thereby creating a compliant seal. 5 with any shaft or object extending through the bore 34.
. ., : The compression spring 3~ is of significant interest .~ to the present invention as it provides means for biasing the sealing member 32 against any object extending ; 10 through the bore 34. If there i~ no such object, the. spring will bias the sealing member 32 to entirely close the bore 34. Thus the sealing member 32 can close to a ~` diameter of zero (0), that is to say it can actually form a ~eal against itself. This is certainly one of the most ~. 15 significant advantage~ associated with the present . invention as it permits objects to be entirely removed . from the bore 3~ without permitting a loss of gas .~ pressure or liquids which might otherwise past through ................ the unoccupied bore 34. At the same time, resistance .: 20 applied against the compression spring 28 can open the :, bore to significant diameters such as sixty French (60 ., Fr.~ to permit the insertion of objects with .~. substantially no frictional resistance from the sealing ~;~ member 32. Then by releasing pressure on the spring 28, ;, 25 the sealing member 32 can close against the exterior,. surface of the object to again seal the bore 34.
~: : The range of sealin~ diameters which can ~e achieved with this concept are indeed significant in view of prior . 30 art grommets and seals which were generally incompetent for forming seals over a range of more than fourteen French (14 Fr.). The punctured or slit septums oP the . prior art which were the only seals that could provide for closure against themselves, generally leaked with diameters greater than eleven French ~l1 Fr.). Thus seals which could achieve zero diameter could accommodate a range of only eleven French ~11 Fr.).
Another feature associated with the present invention related to the amount of pressure which is axerted on an object extending through the bore 34. In some cases these objects are ~uite ~ragile. For example, j a catheter is typically constructed with a thin wall so that significant forces on the catheter can actually result in occluding the lumens or otherwise impactincJ the performance of the catheter. Fragile optical fibers can also be easily broken with septum seals and elevated sealing pressures. With the present invention, this sealing pressure can not only b~ limited but can be carefully controlled. This is due to some extent to the nature of the material forming the sealing member 32.
With the significant fluid characteristics previously discussed, the pressure applied to the material 34 is substantially equal to the resultant pressure applied by the material 32 against the object.
In spite of the fact that a spring is used to create ths applied force, and a spring tends to exhibit a greater force when compressed than when relaxed, the pressure created by khe material 32 against an object can be maintained generally constant. Thus regardless of the cross-sectional dimension of the object, the pressure exerted -to form the seal need not vary significantly.
This is true regardless of the surface area of the seal because the highest spring force is applied to the seal material 32 when the bore has its largest diameter. Thus the spring exerts a force which in general is directly proportional to the area of the sealO Where that area is formed against a larger diameter object, the force is increased so that the pressure against the greater 2~288~
surface area remains substantially constant. Thus the spring 28 provides means for biasing the sealing member 32 with a decreasing force toward a decreasing bore dimension.
The sealing assembly associated with the present invention is particularly advantageous when used in combination with access devices. These devices commonly vascular introducers, surgical trocars, and other cannula which provide percutaneous access to the body of a patient. In these environments, the access channel provided by the access device can be sealed by the seal assembly to inhibit any loss of fluid. This fluid may be gas which is used to achieve pneumoperitoneum in a laproscopic procedure. It may also include body fluids such as blood in the case of a vascular access device such as an introducer.
An exemplary access dsvice is illustrated in Fig. 8 and is designated generally by the reference numeral 60.
This device could, for example, be either an introducer or a surgical trocar which typically includes a distal end 62 and a proximal end 64. The seal assembly S is preferably mounted at the proximal end 64 of the device and remains exterior of the patient after the distal end 62 of the device 60 is introduced percutaneously of the skin 66 of the patient. In this manner, the seal assembly S provides means for sealing a working channel or bore of the access device 60 around objects such as catheters and instruments, collectively designated by the reference numeral 68, which are operatively inserted through the working channel of the device 60.
lg OPER~TION
Once the sealing apparatus is assembled, its operation is very simple. To condition the apparatus for passage o~ an element therethrough, it is simply necessary to squeeze the levers 18 and 22 together, thus opening the passage 34 as shown in Fig. 4. The element may then be ~reely extend through the passage. Upon being positioned as desired, the levers 18 and 22 are ~ released, thus closing the passage into sealed engayement ,~ 15 with the element. The latter operation also functions to grip the element and hold it at the desired location.
Release of the element is achieved by simply again squeezing the levers 18 and 22 together against the biasing force of the spring 28.
It should be appreciated that the solid line representations shown in Fig. 2 and 3 illustrate the ~; sealing member in the fully closed condition, without an elongate element extending therethrough. This is intended to demonstrate that the apparatus will provide a seal, even in the absence of an element extending therethrough. The phantom lines shown in Fig. 3 illustrate how the s~aling element accommodates an elongate element 54 extended therethrough.
- 2~28~
Conclusion From the ~oregoing detailed descr:iption, it will be apparent that the present invention provides an apparatus for sealing around elongate slements of various sizes and shapes, which apparatus may be operated with ease by one hand of the user. It should be apprecia~ed, howev~r, that the apparatus is not intended to ~e limited to the specifics of the illustrated embodiment, but rather is : defined by the accompanying claims.
. 1 ,,.
., Backyro~und of the Invent_ a Field of the Invention ~ he present invention relates generally to an improved device for forming a seal aroumd shafts or tubes and, more specifically, to a hemostasis valve for sealing around elongate objects of varying sizes.
Discussion of the Prior Art : 10 Historically, seals and seal materials have been selected from materials having a high modulus. The theory was that a seal must fill a gap between two objects, thus permitting no gas or fluid to find or generate a path around the object. It was thought that ` if the seal material had a low moduIus, such a path would form. Accordingly, seals designed ~or retaining pressure were deliberate~ly manufactured out of high modulus - materials. As a consequence, the seals had little or no compliance or conformance to accommodate variations in the shape of an object around which a seal was required.
O-rings, for example, accommvdate one external and one internal diameter, with slight allowances for manufacturing tolerances of the shaft or gland. If deviations from the tolerances are encountered~ or if the shaft or gland is out of round, the o-ring is likely to fail or leak unless a deforming compressive forca is applied to the O-ring to cause it to come into closer contact with the shaft or gland wall.
~28~
The latter approach creates siynificant problems, not the least of which is the limits it plac~s on the range of deformation. A major drawback associated with the seal materials of the past has been the compressive force that the O-ring or seal transmits to the traversing shaft, especially if the shaft is of a fragile nature.
Seals having a high modulus also fail -to work if the traversing shaft is not relatively round, or if there are more than one traversing shaft extending through the seal at the same time.
Other types of seals used in the medical field are the "septum" and "duck-bill" seal. While satisfactory for certain limited purposes, these seals do not provide the advantages of the present invention.
In the septum seal, a septum or diaphragm is used as the s~aling element. In order to transverse the seal, a preformed puncture is provided or a needle is used to generate a puncture within the septum and the traversing shaPt is introduced into this puncture. Puncturing the septum is an added step that is often disliked in busy clinical settings. Finding the puncture hole is also difficult, particularly where lighting is sparse. The introduction of new shafts may require new punctures.
This type of seal also fails to provide for locking the traversing shaft in place. These deficiencies of the septum eal have become well known so that it is now customary to provide more than one such seal in series.
The duck-bill seal is commonly used as a one way valve. It consists of a circular passage that flattens towards the tip, forming an area where two surfaces co-act to seal flow from outside the valve. The seal is effective around a shaft only so long as the pressure 2~2~
causing closure of the seal is sufficiently large. It is very difficult to purge air bubbles out of a valve incorporating a duck-bill seal. Such seals also have difficulty in sealing around a traversing shaft of an irregular shape. The shape o~ the seal which forms around a traversing shaft is commonly referred to as the "cat-eye" and permits leakage at two opposing points along the shaft. A duck-bill seal also tends to invert when a bulky shaft is pulled back through it.
. 10 The prior art also suggests de~lectable tubular elements which are deformed to effect a seal. U. S.
~; Patent Nos. 3,977,400 and 4,243,034 teach such arrangements where the tubular alements are clamped from opposite sides by cam like actuators. In both of these patents, the clamping is effected from two sides only.
U. S. Patent 3,970,089 teaches an arrangement wherein the ~- tubular element takes the form of a toroid which is inflated to effect a seal. U. S. Patent No. 4,580,573 teaches an arrangement wherein the tubular element is twisted to effect the seal.
The prior art also teaches stoppers for ampoules and the like wherein the stopper takes the form of an elastomeric member having a preformed opening which may be pinched shut. U. S. Patent No. 2,797,837 discloses such a device. As shown in that patent, pinching is effected by either biasing the opening from one side, or clamping it from opposite sides.
Summary of the Invention ., ... .
In the apparatus of the present invention, an elastomeric sealing body having a passage extending axially therethrough is radially clamped from more than two sides. The preferred embodiment employs a sealing body having radially extending lugs disposed at substantially equal angularly spaced locations therearound and a clamp disposed at least partially around the sealing body to compress the lugs. The preferred embodiment also includes biasing means associated with the clamp to normally compress the sealing body and release means operable by one hand of a human operator to selectively release the sealing body from compression by the biasing means.
~In accordance with one aspect of the invention, a `;seal assembly includes an elastomeric element defining an opening adapted to receive a shaft having a cross-sectional dimension and an outer sur~ace. The assembly also includes means for compressing the element against the outer surface of the~shaft to form with the shaft a seal having a particular area. ~eans is provided for applying a force to the element to produce a pressure on the particular area, the magnitude of the appIied force being variable directly with the size of the particular area. In this aspect of the invention, the pressure on the particular area tends to be independent of the cross-sectional dimension of the shaft. In a particular embodiment the force applying means in ludes more than two dogs movable radially to produce the applied force.
Means can be provided for biasing the opening of the elastomeric element toward a decreasing dimension.
2 ~
In another aspect of the invention, a seal assembly includes a housing with two portions which are movable relative to each other. A compressive element is disposed in the housing and adapted to form a seal with an object, the element having properties responsive to an applied force to create a resultant force on the object.
The two housing portions are movable rslative to each other to vary the applied force Oll the compressive element and the resultant force on the object. The compressive element has properties such that ~he resultant force is greater than 80% of the applied force so that very little energy is lost in compressing the element. First and second opposed surfaces are associated with the respective portions of the housing and support opposite ends of a spring which biases the housing to decompress the seal element.
In still a further aspect of the invention, a seal material disposed in the housing has an outer surface and an inner surface which defines a central bore adapted to receive the object. Pressurizing means is disposed to exert an applied pressure from more than two directions against the outer surface of the seal material. By operation of the pressurizing means, the seal material produces a resultant pressure on the object thereby creating a seal. In a particular em~odiment the seal material is provided with four projections which extend radially in cross-section to form the configuration of a cross.
The concept of this invention is particularly useful in combination with an access device adapted to be p2rcutaneously inserted to provide an access channel into the body of a patient, thP channel being adapted to receive an elongate object extending through the access 2 ~
device. An elongate tube includes a distal end and a proximal end, and portions defining t:he access channel along a longitudinal axis of the tube. Sealing means is disposed in proximity to the proximal end of the elongate tube ~or sealing the access device around the object. A
seal material included in the sealing means is movable radially of the tube to ~orm the seal between the tube portions and the elongats object.
:
It follows from these different aspects, that a principal object of the invention is to provide a seal that facilitates gentle sealing around shafts and tubes of varying diametersO
Another object is to provide such a seal capable of conforming to objects of irregular shape and/or simultaneously sealing around more than one object extending through the seal.
A further object of the invention is to provide such a seal which functions to axi~lly retain an element extended therethrough.
An additional object of the invention i5 to provide an atraumatic seal which produces a substantially constant low pressure on the fragile wall of an object regardless of the cross-sectional dimension of the object.
Still another object of the invention is to provide such a seal which normally assumes a closed condition and may be operated and selectively released by one hand of a human operator.
The foregoing and other o~jects will become more apparent when viewed in light of the and following detail~d description and reference to the associated drawings.
Brief Descri~tion of the Drawings Figure l is a perspective view of the apparatus;
Figure 2 is a cross-sectional view taken on the ~ plane designated by line 2-2 of Fig. 1, showing the ; apparatus with the sealing member in the normally closed condition;
Figure 3 is a cross-sectional view taken on the plane designated by line 3-3 of Fig. 2;
Figure 4 is a cross~sectional view similar to Fig.
2, showing the apparatus with the sealing member in the open condition;
Figure 5 is a cross-sectional view taken on the plane designated by line 5-5 of Fig. 4; and Figure 6 is an exploded perspective view of the apparatus.
Figure 7 is a cross-sectional view of a particular embodiment of the sealing member taken along lines 7-7 of Fig. 6; and Figure 8 is a perspective view of a medical access device with the sealing apparatus of tha present invention disposed at the proximal end of the device.
2 ~ 2 ~, '`' ', Descri~tion of the Pr f r~ed :Embodiments : The sealing apparatus is designated in its entixety ":, S by the letter "S" and comprises, as its basic element: a ,. housing body "H", a cam body "C" and an end cap "E". The ',, housing Body "H'l includes an enlarged open-ended cavity 10 having a tubular conduit fitting 12 communicating .~" therewith. In a preferred embodiment, a side port 14 is ~ 0 formed in the body ~H~ and communicates with the interior :,~ of the fitting 12. A suture loop 16 is formed integrally with the housing and connects to the fitting 12. A
~ stationary lever 18 is formed integrally with and extends .:, laterally of the housing body "H". An elongate arcuate ,i 15 slot 20 extends through the housing body "H" to one side .~ of the lever 18 for accommodation of a cam lever 22 :.~ forming part of the cam body "C". The slot opens through ,', one end of the body "H" to facilitate assembly of the .~ apparatus.
... 20 ,~ In the assembled,condition, the cam body "C'i is .,;; concentrically received within the housing body "H", with ,./ the lever 22 extending through the slot 20. The exterior ~ surfaces of the cam body are of an arcuate configuration ,: 25 and configured to slide on the interior surface of the ,i~ cavity 10 (see Figs. 2 and 4). Interiorally, the cam body "C" is formed with four cam surfaces 24. The cam ,~ surfaces are associated a plurality of pawls or cam ',~ follower pins 26 which are spaced relative to one another '. 30 by a distance approximately equal to the width of the pins. As viewed in Figs. 2 and 4, counterclockwise ~, movement of the cam body "C" relative to the housing body "H" functions to force the pins 26 inwardly to the : position shown in Fig. 2. Clockwise movement functions ',~ 35 to release the pins for extension, as shown in Fig. 4.
~u~
~ 9 A compression coil spring 28 is engaged between the -levers 18 and 22 to normally bias the lever 22 in the counterclockwise direction, toward an inwardly positisn as shown in Fig. 2.
The pins 26 engage lugs 30 formed on an elastomeric sealing member 32. This sealing member 32, which is best illustrated in Fig. 6, includes a c~entral ~ection 33 which extends longitudinally of the sealing member 32 between a pair of annular end flanges 36 and 38.
Portions of the central section 33 and the end flanges 36, 38 define a central bore or passage 34 which extends axially through the sealing member 32 in a preferred embodiment.
The lugs 30 extend longitudinally of the sealing member 32 between the end flanges 36, 3$. These lugs 30 are formed by removing material or longitudinal cut-outs from the exterior surface of the central section 33. In Fig. 6, one of these cut-outs is shown generally at the arrow 39.
As illustrated in the cro s-section of Fig. 7, the sealing element 32 can have a plurality of the lugs 30 angularly spaced around the bore 34. In the illustrated embodiment each of the lugs is defined by a width which is approximately the diameter of the bore 34. Each of the longitudinal cut-outs, illustrated by the arrow 39, is defined by an adjacent pair of the lugs 30. In a preferred embodiment, the sealing member 32 includes four radially extending lugs 30 equally spaced at ninety degree intervals around the bore 34. This provides the sealing member 32 with a central portion 33 which in radial cross-section appears to have the configuration of a cross.
9 ~
ThP material associated with at least the central portion 33 of the sealing member 32 is of particular interest to tha present invention. This material is preferably very soft and pliable so that a pressure applied to the sealing member 32 will force the central section 33 into the regions defining the bore 34. With an appropriate material, this pressure on the sealing element 32 will force it into contact with any object, such as a catheter or surgical instrument, extending through the bore 34. In this manner the sealing element 32 tends to form a seal with the exterior surface of any such object or objects.
If the material is appropriately selected, the member 32 can form a seal even around objects or shafts which have irregular cross-sectional configurations.
Such an object may include a single shaft having an irregular configuration or multiple shafts each of which has a regular configuration.
The material of at Ieast the central section 33 of the sealing member 32 preferably has a Shore A hardness less than twenty (20~. A~material with this degree of softness will tend to function with characteristics similar to that of a fluid. Thus the pressure applied to the outer surface of the central portion 33 will be transmitted with very little loss of energy to the portions defining the bore 34. It follows that any energy required to deform such a material can be minimized. A soft material is also similar to a fluid in that it is highly compliant so that it can "flow" into narrow crevices as might be required to form a tight seal around an irregular shaft or object. A soft material with these significant fluid properties can be chosen to 8 ~
`, 11 ` effect a high degree of conformity to any shape of object ; extending through the bore 34.
Another fluid characteristic associated with the material of the sealing member 32 is the property it has for transferring substantially all of the applied force to the region defining the hore 34. Thus, a pressure applied by the cam follower pins 26 to the lugs 30 is substantially the same pressure exerted by the portions defining the bore 34 against an object extending through the bore. With a material of low ~urometer, very little ~ energy is lost in deforming the sealing member 32. In ; fact, a suitable material is substantially non-~i compressible so that the resultant pressure at the bore 34 is at least eighty percent (80%) of the pressure applied to the lugs 30.
Under particular circumstances, it may be desirable that the material forming the bore 34 have particular surface characteristics. In some cases, a degree of impermeability may be required. In other cases, a high or low coe~ficient of friction may be desired to either facilitate axial movement or prevant axial movement of the object respectively. These characteristics can be provided in at least two manners. In the first case, the material forming the sealing member 32 can be chosen with homogeneous properties which can provide the surface characteristics desired. Thus a hydromer material can be incorporated into an elastomer to provide a lubricous surface defining the bore 34. In other casPS/ a coating can be applied to the portions defining the bore 34.
This coating might include polytetrafloroethylene when a biocompatible surface is desired. Suitable coatings can be grafted or otherwise bonded to provide a lubricous surface. By way of example, a hydromer or hydrogel 2~2~89~
coating might provide the surface of the bore with a coefficient of friction less than 0.25.
In a preferred embodiment, the makerial selected for the sealing member 32 is silicone rubblar. This material has a Shore A hardness less than twenty (20) and can be molded to a monolithic construction including not only the ~entral portions 33 but also the flanges 36 and 38.
It has been demonstrated that materials exhibiting a Shore A hardness as low as five ~5~ are suitable for application to this concept. The material forming the seal member 34 preferably has compression characteristics defined by a Poisson's ~atio in a range between 0.45 and 0.50.
In another embodiment, the central portions 33 of the sealing member 32 are formed from foam rubber. This material can also be configured to provide a very low Shore hardness factor such as twenty (20) or even lower.
In a preferred embodiment, foam rubber is extruded to : form the central portions 33, and the end flanges 36 and 38 (which may be formed from a non-foam material) are glued or otherwise attached to extend radially from the ends of the central portion 33.
In a particular application, foam rubber may be particularly advantageous for the sealing member 32. The rubber forming the foam will typically be stronger than a homogeneous material so it will tend to resist tearing and propagation of cracks. It is the dispersion of a multiplicity of air holss in this foam which can provide the stronger rubber material with the soft compression characteristics previously discussed.
~ ~ 2 ~
If the material forming the sealing member 32 is constructed of ~oam, it may be desirable to remove the foam "skin" which is typical of this material. Such a `~skin may tend to interfere with thQ compression characteristics of the sealing member 32 or otherwise "impair the ability o~ the material to con~orm to an ~,irregularly shaped object.
,~ .
Before being assembled into the housing body "H", a retainer ring 40 and a spacer ring 42 are engaged around the sealing member 32. Both of these rings have arcuate outer surfaces designed to complimentally engage the interior surface of the recess 10. A cross-shaped passage 44 is formed in the ring 40 for receipt around the lugs 30 of the sealing member. The opening 46 shown by the arrow 39 extend radially through the ring 40 in alignment with the lug receiving recesses of the passage 44. These openings 46 as will become more apparent from the subsequent discussion/ slidably receive the pin 26.
The spacer ring 42 is formed with a cross-shaped passage 4~ adapted to be received around the lugs 30 of tha sealing member 32. Fingers 50 extend from the distal ends of the passage 48 in a longitudinal direction '-; 25 relative to the ring 42. These fingers, together with the recesses 46, provide radial passages for slidable receipt of the pins 26. An arcuate segment 52 is formed on the outside o~ the spacer ring 42 for engagement in the slot 20 to ~ocate the fingers 50 and pins 26 relative to the cam body "C".
Referring again to the material forming the sealing member 32, it will be apparent that any material having a low duro~eter, must be confin2d in order that a pressure applied to the material will force it into the 9 ~
, :.
desired region such as the bore 34. In the illustrated embodiment the housing ~I and end cap E, as well as the retainer ring 40 and spacer ring 42 prc~vide the confining means and are configured to define a cavity similar in shape to the exterior surface of the sealing member 32.
Then as the cam follower pins 26 are moved radially against the lugs 30 of the sealing member 32, this ~; pressure forces the material of the central portions 33 ~ into the region of the bore 34.
,, 10 Prior to being inserted into the housing body "H", the rings 40 and 42 and the cam body 'IC", with the pins , 26 in place, are assembled around the sealing member 32.
During this assembly, flanges 36, 38 of the sealing , 15 member 32 can be resiliently deflected to pass through the various elements. The arrangement of this subassembly can be seen from the center line extending through the exploded view of Fig. 6.
,,.
The assembly of the sealing member 32, rings 40 and 42, cam body i.c~ and pins 2~ creates a subassembly which is then slid into the housing body "H" so as to engage ~: the segment 52 in the slot 20 and position the cam lever 22 in apposition to the stationary lever 18. The end cap "E" is then snapped into place, as seen in Figs. 3 and 5.
The arcuate segment 52 serves to lock the spacer ring 42 against rotation relative to the housing body "H". This, in turn, locks the sealing member 32 and the retainer ring 40 against rotation relative to the housing, while - 30 leaving the cam body "C" free for rotation about the longitudinal axis of the housing body. After the stationary lever 18 and cam lever 22 are disposed in apposition, the compression coil spring 28 is interposed therebetween, thus forcing the levers apart and moving the pins inwardly, as shown in Fig. 2.
2~8~
The surface on the stationary lever 18 and the surface on the cam lever 22, both oP which contact the spring 28, are angularly disposed with respect to each other. In a preferred embodiment, each of these surfaces is disposed in a plane which is generally parallel to the axis of the bore 34. As these surfaces are moved toward each other, the spring 28 is compre-;sed and tends to exert a force which increases as the spring 28 is ~ compressed. As the spring 28 is permitted to relax, ; lO these two opposing surPaces separate angularly and the force of the spring 28 tends to decrease. It wiIl be apparent that the spring 28 can be chosen with a spring constant which is suitable to provide a particular sealing pressure for a specific application.
It is of particular advantage that the force applied to the lugs 30 of the sealiny member 32 be directed radially of the bore 34. This tends to insure that the material of the sealing member 32 is pushed most directly to fill the space of the bore 34. By guiding the cam follower pins 26 radially, the fingers 50 togPther with the recesses 46 provide means for translating the rotational movement of the cam surface 24 into a radial, linear movement of the cam follower pins 26.
It is believed to be important that the force applied against the sealing member 32 be directed from more than two radial ;directions. Only with the application of an applied ~orce from three or more radial directions, can one avoid the cat-eye which is typical of the seals of the prior art. The conformity of the sealing member 32 to irregularly shaped objects extending through the bore 34 is greatly increased by the provision of four of the lugs 30 in the preferred embodiment.
Particularly large diameters of the bore 34 may be 2~$
.... .
:. 16 accommodated with more than four o~ the lugs 30. With ; a radial force applied along each of these lugs 30 the material tends to flow with little pressure into the . region v~ the bore 34 thereby creating a compliant seal. 5 with any shaft or object extending through the bore 34.
. ., : The compression spring 3~ is of significant interest .~ to the present invention as it provides means for biasing the sealing member 32 against any object extending ; 10 through the bore 34. If there i~ no such object, the. spring will bias the sealing member 32 to entirely close the bore 34. Thus the sealing member 32 can close to a ~` diameter of zero (0), that is to say it can actually form a ~eal against itself. This is certainly one of the most ~. 15 significant advantage~ associated with the present . invention as it permits objects to be entirely removed . from the bore 3~ without permitting a loss of gas .~ pressure or liquids which might otherwise past through ................ the unoccupied bore 34. At the same time, resistance .: 20 applied against the compression spring 28 can open the :, bore to significant diameters such as sixty French (60 ., Fr.~ to permit the insertion of objects with .~. substantially no frictional resistance from the sealing ~;~ member 32. Then by releasing pressure on the spring 28, ;, 25 the sealing member 32 can close against the exterior,. surface of the object to again seal the bore 34.
~: : The range of sealin~ diameters which can ~e achieved with this concept are indeed significant in view of prior . 30 art grommets and seals which were generally incompetent for forming seals over a range of more than fourteen French (14 Fr.). The punctured or slit septums oP the . prior art which were the only seals that could provide for closure against themselves, generally leaked with diameters greater than eleven French ~l1 Fr.). Thus seals which could achieve zero diameter could accommodate a range of only eleven French ~11 Fr.).
Another feature associated with the present invention related to the amount of pressure which is axerted on an object extending through the bore 34. In some cases these objects are ~uite ~ragile. For example, j a catheter is typically constructed with a thin wall so that significant forces on the catheter can actually result in occluding the lumens or otherwise impactincJ the performance of the catheter. Fragile optical fibers can also be easily broken with septum seals and elevated sealing pressures. With the present invention, this sealing pressure can not only b~ limited but can be carefully controlled. This is due to some extent to the nature of the material forming the sealing member 32.
With the significant fluid characteristics previously discussed, the pressure applied to the material 34 is substantially equal to the resultant pressure applied by the material 32 against the object.
In spite of the fact that a spring is used to create ths applied force, and a spring tends to exhibit a greater force when compressed than when relaxed, the pressure created by khe material 32 against an object can be maintained generally constant. Thus regardless of the cross-sectional dimension of the object, the pressure exerted -to form the seal need not vary significantly.
This is true regardless of the surface area of the seal because the highest spring force is applied to the seal material 32 when the bore has its largest diameter. Thus the spring exerts a force which in general is directly proportional to the area of the sealO Where that area is formed against a larger diameter object, the force is increased so that the pressure against the greater 2~288~
surface area remains substantially constant. Thus the spring 28 provides means for biasing the sealing member 32 with a decreasing force toward a decreasing bore dimension.
The sealing assembly associated with the present invention is particularly advantageous when used in combination with access devices. These devices commonly vascular introducers, surgical trocars, and other cannula which provide percutaneous access to the body of a patient. In these environments, the access channel provided by the access device can be sealed by the seal assembly to inhibit any loss of fluid. This fluid may be gas which is used to achieve pneumoperitoneum in a laproscopic procedure. It may also include body fluids such as blood in the case of a vascular access device such as an introducer.
An exemplary access dsvice is illustrated in Fig. 8 and is designated generally by the reference numeral 60.
This device could, for example, be either an introducer or a surgical trocar which typically includes a distal end 62 and a proximal end 64. The seal assembly S is preferably mounted at the proximal end 64 of the device and remains exterior of the patient after the distal end 62 of the device 60 is introduced percutaneously of the skin 66 of the patient. In this manner, the seal assembly S provides means for sealing a working channel or bore of the access device 60 around objects such as catheters and instruments, collectively designated by the reference numeral 68, which are operatively inserted through the working channel of the device 60.
lg OPER~TION
Once the sealing apparatus is assembled, its operation is very simple. To condition the apparatus for passage o~ an element therethrough, it is simply necessary to squeeze the levers 18 and 22 together, thus opening the passage 34 as shown in Fig. 4. The element may then be ~reely extend through the passage. Upon being positioned as desired, the levers 18 and 22 are ~ released, thus closing the passage into sealed engayement ,~ 15 with the element. The latter operation also functions to grip the element and hold it at the desired location.
Release of the element is achieved by simply again squeezing the levers 18 and 22 together against the biasing force of the spring 28.
It should be appreciated that the solid line representations shown in Fig. 2 and 3 illustrate the ~; sealing member in the fully closed condition, without an elongate element extending therethrough. This is intended to demonstrate that the apparatus will provide a seal, even in the absence of an element extending therethrough. The phantom lines shown in Fig. 3 illustrate how the s~aling element accommodates an elongate element 54 extended therethrough.
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Conclusion From the ~oregoing detailed descr:iption, it will be apparent that the present invention provides an apparatus for sealing around elongate slements of various sizes and shapes, which apparatus may be operated with ease by one hand of the user. It should be apprecia~ed, howev~r, that the apparatus is not intended to ~e limited to the specifics of the illustrated embodiment, but rather is : defined by the accompanying claims.
Claims (25)
1. An improved apparatus for sealing around shafts or tubes, said apparatus comprising:
an elastomeric sealing body having a passage extending axially therethrough and an external surface with more than two radially extending lugs disposed at substantially equal angularly spaced locations therearound; and clamp means disposed at least partially around the sealing body, said clamp means being operable to radially compress the lugs to at least partially close the passage in the sealing body.
an elastomeric sealing body having a passage extending axially therethrough and an external surface with more than two radially extending lugs disposed at substantially equal angularly spaced locations therearound; and clamp means disposed at least partially around the sealing body, said clamp means being operable to radially compress the lugs to at least partially close the passage in the sealing body.
2. An apparatus according to Claim 1 wherein the lugs are four in number and angularly spaced at ninety degree intervals around the sealing body.
3. An apparatus according to Claim 1 or 2 further comprising biasing means operatively associated with the clamp means to normally compress the sealing body.
4. An apparatus according to Claim 3 further comprising manual release means operatively associated with the clamp means and operable by the hand of a human operator to selectively release the sealing body from compression by the biasing means.
5. An apparatus according to Claim 1 or 2 further comprising a housing extending around the clamp means.
6. An apparatus according to Claim 5 further comprising biasing means operatively associated with the clamp means to normally compress the sealing body,
7. An apparatus according to Claim 6 wherein the biasing means comprises:
a first lever fixed to and extending laterally from the housing;
a second lever operatively associated with the cam means for movement relative to the housing, said second lever extending laterally from the housing in apposition to the first lever; and a spring disposed between the first and second levers to normally force the levers apart.
a first lever fixed to and extending laterally from the housing;
a second lever operatively associated with the cam means for movement relative to the housing, said second lever extending laterally from the housing in apposition to the first lever; and a spring disposed between the first and second levers to normally force the levers apart.
8. A seal assembly, comprising:
an elastomeric element defining a opening adapted to receive a shaft having a cross sectional dimension and an outer surface;
means for compressing the elastomeric element against the outer surface of the shaft to form with the shaft a seal having a particular area;
means for applying a force to the compressed elastomeric element to produce a pressure at the particular area on the outer surface of the shaft, the magnitude of the applied force being variable directly with the size of the particular area; whereby the pressure on the particular area tends to be independent of the dimension of the shaft.
an elastomeric element defining a opening adapted to receive a shaft having a cross sectional dimension and an outer surface;
means for compressing the elastomeric element against the outer surface of the shaft to form with the shaft a seal having a particular area;
means for applying a force to the compressed elastomeric element to produce a pressure at the particular area on the outer surface of the shaft, the magnitude of the applied force being variable directly with the size of the particular area; whereby the pressure on the particular area tends to be independent of the dimension of the shaft.
9. The seal assembly recited in Claim 8 wherein the force applying means is disposed radially of the elastomeric element and the force is directed generally radially of the elastomeric element to compress the elastomeric element and to produce the particular pressure on the outer surface of the shaft.
10. The seal assembly recited in Claim 9 wherein the force applying means includes more than two pawls movable generally radially of the elastomeric element to produce the force on the elastomeric element.
11. The seal assembly recited in Claim 8 wherein the elastomeric element has fluid properties such that the pressure of the applied force on the elastomeric element is less than 20% greater than the particular pressure.
12. The seal assembly recited in Claim 8 wherein the force applying means further comprises means for biasing the opening of the elastomeric element toward a decreasing dimension.
13. A sealing apparatus adapted to form a seal with a particular surface of an object, comprising:
a seal material having a Shore hardness less than 20;
means for pressurizing the seal material to facilitate a flow of the seal material into contact with the particular surface of the object; and means for containing the flow of the seal material except in proximity to the particular surface.
a seal material having a Shore hardness less than 20;
means for pressurizing the seal material to facilitate a flow of the seal material into contact with the particular surface of the object; and means for containing the flow of the seal material except in proximity to the particular surface.
14. The sealing apparatus recited in Claim 13 wherein the object includes a shaft having an outer surface, and the sealing apparatus further comprises:
the sealing material including portions defining a central bore extending through the seal material; and the particular surface is the outer surface of the shaft.
the sealing material including portions defining a central bore extending through the seal material; and the particular surface is the outer surface of the shaft.
15. A sealing apparatus disposed to form a seal with a particular surface of an object, comprising:
a housing;
a seal material disposed in the housing and having an outer surface and an inner surface defining a central bore adapted to receive the object; and pressurizing means disposed to exert an applied pressure from more than two directions on the outer surface of the seal material and to produce a resultant pressure on the particular surface of the object.
a housing;
a seal material disposed in the housing and having an outer surface and an inner surface defining a central bore adapted to receive the object; and pressurizing means disposed to exert an applied pressure from more than two directions on the outer surface of the seal material and to produce a resultant pressure on the particular surface of the object.
16. The sealing apparatus recited in Claim 15 wherein the resultant pressure is greater than 80% of the applied pressure.
17. The sealing apparatus recited in Claim 16 wherein the cross-section of the seal material has the general configuration of a circle with at least three projections.
18. The sealing apparatus recited in Claim 17 wherein the seal material in radial cross-section includes four radial projections and has the general configuration of a cross.
19. The sealing apparatus recited in Claim 17 wherein the projections are equally angularly disposed in spaced relationship around the circumference of the circle.
20. The sealing apparatus recited in Claim 15 wherein the seal material include foam and the inner surface defining the central bore of the sealing material is free of any surface skin.
21. The sealing apparatus recited in Claim 15 further comprising a coating applied to at least the inner surface of the seal material to provide the inner surface with particular characteristics compatible with the outer surface of the object.
22. The sealing apparatus recited in Claim 21 wherein the coating is hydrophilic and the particular characteristic is a coefficient of friction less than 0.25.
23. The sealing apparatus recited in Claim 15 wherein the pressurizing means includes:
a cam disposed on the housing;
a cam follower disposed between the cam and at least one of the projections on the seal material, and the follower being slidable on the cam to exert the applied pressure on the seal material.
a cam disposed on the housing;
a cam follower disposed between the cam and at least one of the projections on the seal material, and the follower being slidable on the cam to exert the applied pressure on the seal material.
24. The sealing apparatus recited in Claim 23 further comprising a plurality of the cam followers each disposed relative to an associated one of the projections.
25. The sealing apparatus recited in Claim 15 wherein the housing includes first portions and second portions;
the cam being disposed on the first portions of the housing;
the cam followers movable radially relative to the second portions of the housing; and the first portions of the housing being movable relative to the second portions of the housing to move the cam into slidable engagement with the cam followers and to urge the cam followers radially the projections of the seal material.
the cam being disposed on the first portions of the housing;
the cam followers movable radially relative to the second portions of the housing; and the first portions of the housing being movable relative to the second portions of the housing to move the cam into slidable engagement with the cam followers and to urge the cam followers radially the projections of the seal material.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US42985489A | 1989-10-31 | 1989-10-31 | |
| US429,854 | 1989-10-31 | ||
| US07/590,181 US5127626A (en) | 1989-10-31 | 1990-10-02 | Apparatus for sealing around members extending therethrough |
| US590,181 | 1990-10-04 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2028896A1 true CA2028896A1 (en) | 1991-05-01 |
Family
ID=27028367
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002028896A Abandoned CA2028896A1 (en) | 1989-10-31 | 1990-10-30 | Apparatus for sealing around members extending there-through |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5127626A (en) |
| EP (1) | EP0426407B1 (en) |
| JP (1) | JPH03184566A (en) |
| CA (1) | CA2028896A1 (en) |
| DE (2) | DE69020686T2 (en) |
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| US729423A (en) * | 1900-11-03 | 1903-05-26 | Eugen Scheiber | Compression stop-cock. |
| FR1023320A (en) * | 1950-06-20 | 1953-03-17 | Oxhydrique Francaise L | Sophisticated faucet |
| US3086797A (en) * | 1958-11-13 | 1963-04-23 | Ernest C Webb | Coupling device |
| US3197173A (en) * | 1960-07-12 | 1965-07-27 | John H Van Dyke | Pinch valve |
| US3438607A (en) * | 1966-03-28 | 1969-04-15 | Omark Air Controls Inc | Valve for evacuator |
| US3920215A (en) * | 1973-02-09 | 1975-11-18 | Dieter W Knauf | Valve |
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| LU77252A1 (en) * | 1976-05-06 | 1977-08-22 | ||
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| SE414272B (en) * | 1978-10-17 | 1980-07-21 | Viggo Ab | CANNEL OR CATETER DEVICE |
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-
1990
- 1990-10-02 US US07/590,181 patent/US5127626A/en not_active Expired - Lifetime
- 1990-10-29 EP EP90311822A patent/EP0426407B1/en not_active Expired - Lifetime
- 1990-10-29 DE DE69020686T patent/DE69020686T2/en not_active Expired - Lifetime
- 1990-10-29 DE DE199090311822T patent/DE426407T1/en active Pending
- 1990-10-30 CA CA002028896A patent/CA2028896A1/en not_active Abandoned
- 1990-10-31 JP JP2295183A patent/JPH03184566A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| DE69020686T2 (en) | 1995-11-02 |
| JPH03184566A (en) | 1991-08-12 |
| EP0426407B1 (en) | 1995-07-05 |
| US5127626A (en) | 1992-07-07 |
| EP0426407A3 (en) | 1991-12-04 |
| EP0426407A2 (en) | 1991-05-08 |
| DE69020686D1 (en) | 1995-08-10 |
| DE426407T1 (en) | 1992-07-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |