High pressure pumping cartridges for medical and surgical pumping and infusion applications

Abstract

Pumping cartridges useful for medical and surgical pumping and infusion procedures are disclosed. Methods for manufacturing and utilizing such pumping cartridges and methods for pumping or infusing liquids for delivery to the body of a patient or a surgical or medical instrument for performing a medical treatment are also described. The invention includes, in one aspect, a series of pumping cartridges comprising cylinders and pistons constructed and arranged for sliding or reciprocating motion within the cylinders. The pistons and/or cylinders can comprise a sealing component including a circumferential, flared sealing flange and can be configured to enable the pumping cartridge to generate high liquid pumping pressures, for example above 1,000 psig. Many of the pumping cartridges disclosed can be relatively easily manufactured at a low cost per unit and can be configured to be detachable from a pump drive unit and disposable after a single use. Various compact flow path configurations are provided in the several pumping cartridge embodiments described, including a Y-shaped configuration, a T-shaped configuration, and an axial configuration. Some pumping cartridges disclosed include pistons including or at least partially forming a valve and/or pistons that are relatively movable with respect to a piston rod to which they are connected. Valve including a valve seat and a movable sealing element able to create a seal capable of withstanding differences in fluid pressures thereacross of at least about 1,000 psi, and in some cases up to in excess of 10,000 psi, without substantial fluid leakage therethrough are disclosed. In some of the disclosed valves, the movable sealing element is concave in shape, and can be curved, to create a mechanical advantage for improved sealing performance. Methods for manufacturing axially-configured pumping cartridges from thin-walled tubing are also disclosed, as well as a series of methods for pumping or infusing a liquid for delivery to the body of a patient or a surgical or medical instrument for performing a medical treatment using the above-mentioned pumping cartridges and devices.

What is claimed is:  
     
         1 . A method for supplying a high-pressure liquid to a surgical or medical instrument, the method comprising: 
 delivering a liquid to a pumping cartridge comprising therein a cylinder and a piston rod constructed and arranged for sliding motion within the cylinder, the pumping cartridge including therein a sealing component shaped to include a flared sealing flange portion constructed and arranged to create a fluid-tight seal within the pumping cartridge during operation;    creating a sliding motion of the piston rod relative to the cylinder so as to increase the pressure of liquid within the cylinder to a pressure of at least about 1000 psig; and    flowing the pressurized liquid from the pumping cartridge to the surgical or medical instrument.    
     
     
         2 . The method as in  claim 1 , wherein the pumping cartridge further comprises a piston coupled to or forming part of the piston rod.  
     
     
         3 . The method as in  claim 1 , wherein creating a sliding motion of the piston rod relative to the cylinder includes sliding the piston rod within the cylinder.  
     
     
         4 . The method as in  claim 1 , wherein creating a sliding motion of the piston rod relative to the cylinder includes sliding the cylinder with respect to the piston rod.  
     
     
         5 . The method as in  claim 2 , wherein the sealing component is positioned on the piston.  
     
     
         6 . The method as in  claim 5 , wherein the pumping cartridge further comprises a supporting ring configured to support the piston.  
     
     
         7 . The method as in  claim 1 , wherein the sealing component is positioned on the cylinder.  
     
     
         8 . The method as in  claim 1 , wherein the pumping cartridge comprises a valve including a poppet comprising the sealing component thereon.  
     
     
         9 . The method as in  claim 2 , wherein the piston is coupled to the piston rod, which, in turn is coupled to a mechanical pump drive unit and wherein the piston includes, or at least partially forms a valve, the method further comprising the step of: 
 detachably coupling the pumping cartridge to the pump drive unit.    
     
     
         10 . The method as in  claim 9 , wherein during the creating step, there is substantially no leakage of the liquid through the valve included in or at least partially formed by the piston.  
     
     
         11 . The method as in  claim 9 , wherein the piston is coupled to the piston rod such that the piston is movable relative to the piston rod during operation.  
     
     
         12 . The method as in  claim 9 , further comprising, after or concurrent with the delivering step, the step of: 
 flowing the liquid through the piston to fill a region of the cylinder downstream of the piston with the liquid.    
     
     
         13 . The method as in  claim 1 , wherein during the flowing step, the liquid is delivered to a surgical handpiece positioned remote from the pumping cartridge through a length of flexible tubing.  
     
     
         14 . The method as in  claim 13 , wherein a liquid jet is formed by the surgical handpiece;  
     
     
         15 . The method as in  claim 14 , wherein the liquid jet is directed onto tissue of the patient and cuts, ablates, delaminates, abrades, emulsifies, or macerates the tissue.  
     
     
         16 . The method as in  claim 14 , wherein the liquid jet is utilized by the handpiece for powering a rotating cutting or abrading tool of the handpiece.  
     
     
         17 . The method as in  claim 1 , wherein the flared sealing flange portion is integrally formed with a sealing component support element and has a predefined length and extends away from the sealing component support element so as to form a cantilevered circumferential flange thereon.  
     
     
         18 . The method as in  claim 17 , wherein the sealing component support element is a main body portion of a piston coupled to the piston rod.  
     
     
         19 . The method as in  claim 17 , wherein the sealing component support element is a cylinder-engaging main body portion of a sealing ring coupled to the cylinder.  
     
     
         20 . The method as in  claim 17 , wherein the main body portion and the flared sealing flange are formed of a non-elastomeric polymeric material.  
     
     
         21 . The method as in  claim 20 , wherein the non-elastomeric polymeric material has a tensile strength of between about 5,000 psi and about 50,000 psi at the temperature of operation of the pumping cartridge.  
     
     
         22 . The method as in  claim 20 , wherein the non-elastomeric polymeric material has a flexural modulus of between about 100,000 psi and about 700,000 psi at the temperature of operation of the pumping cartridge.  
     
     
         23 . The method as in  claim 20 , wherein the non-elastomeric polymeric material has a tensile strength of between about 5,000 psi and about 50,000 psi and a flexural modulus of between about 100,000 psi and about 700,000 psi at the temperature of operation of the pumping cartridge.  
     
     
         24 . The method as in  claim 20 , wherein the non-elastomeric polymeric material is selected from the group consisting of: nylon-6,6, and DELRIN™(polyoxymethylene).  
     
     
         25 . The method as in  claim 1 , wherein during the creating step, the pressure of the liquid within the cylinder is increased to a pressure of at least about 5,000 psig.  
     
     
         26 . The method as in  claim 25 , wherein during the creating step, the pressure of the liquid within the cylinder is increased to a pressure of at least about 8,000 psig.  
     
     
         27 . The method as in  claim 1 , further comprising prior to the delivering step, the step of: 
 sterilizing the pumping cartridge via a sterilization method selected from the group consisting of heat sterilization, radiation sterilization, and chemical sterilization.    
     
     
         28 . The method as in  claim 1 , further comprising after the flowing step, the step of: 
 disposing of at least a portion of the pumping cartridge after a single use.    
     
     
         29 . A pumping cartridge comprising: 
 a cylinder; and    a piston rod constructed and arranged for reciprocating motion with respect to the cylinder, the pumping cartridge including therein a sealing component shaped to include a circumferential, flared sealing flange portion extending away from a portion, to which it is attached, of a sealing component support element, such that a first surface of the flared sealing flange portion adjacent to and facing a surface with which it is in sliding contact forms a first angle with respect to the longitudinal axis of the cylinder and a second surface of the flared sealing flange portion facing away from the surface with which it is in sliding contact forms a second angle with respect to the longitudinal axis of the cylinder, where    the first angle exceeds 0 degrees,    the second angle does not exceed 90 degrees,    the second angle exceeds the first angle, and    the sealing flange portion of the sealing component is constructed of a non-elastomeric material.    
     
     
         30 . The pumping cartridge as in  claim 29 , further comprising a piston coupled to the piston rod, wherein the piston includes the sealing component shaped to include the circumferential, flared sealing flange portion, the flared sealing flange portion extending away from a portion, to which it is attached, of a main body of the piston, such that the first surface of the flared sealing flange portion is adjacent to and faces an inner surface of the cylinder to form the first angle with respect to the longitudinal axis of the cylinder and the second surface of the flared sealing flange portion faces the cylinder bore to form the second angle with respect to the longitudinal axis of the cylinder.  
     
     
         31 . The pumping cartridge as in  claim 29 , wherein the cylinder includes the sealing component shaped to include the circumferential, flared sealing flange portion, the flared sealing flange portion extending away from a portion, to which it is attached, of a cylinder-engaging main body portion of a sealing ring coupled to the cylinder, such that the first surface of the flared sealing flange portion is adjacent to and faces the piston to form the first angle with respect to the longitudinal axis of the cylinder and the second surface of the flared sealing flange portion faces an inner surface of the cylinder to form the second angle with respect to the longitudinal axis of the cylinder.  
     
     
         32 . The pumping cartridge as in  claim 29 , wherein the cylinder includes the sealing component shaped to include the circumferential, flared sealing flange portion, the flared sealing flange portion extending away from a portion, to which it is attached, of an inner surface of the cylinder, such that the first surface of the flared sealing flange portion is adjacent to and faces the piston to form the first angle with respect to the longitudinal axis of the cylinder and the second surface of the flared sealing flange portion faces an inner surface of the cylinder to form the second angle with respect to the longitudinal axis of the cylinder.  
     
     
         33 . The pumping cartridge as in  claim 29 , further comprising a piston coupled to the piston rod, such that inner, piston rod-facing surfaces of the piston are shaped and arranged such that upon coupling of the piston to the piston rod, essentially all of the inner surfaces of the piston are in direct contact with the piston rod or a securing member that is in contact with the piston rod.  
     
     
         34 . The pumping cartridge as in  claim 33 , wherein the piston rod is constructed and positioned to apply a force to the piston to drive the motion of the piston during operation and the piston is coupled to the piston rod via a coupling permitting relative motion between the piston and the piston rod during at least part of the reciprocating motion of the piston within the cylinder.  
     
     
         35 . The pumping cartridge as in  claim 29 , wherein the non-elastomeric material is polymeric.  
     
     
         36 . The pumping cartridge as in  claim 35 , wherein the non-elastomeric material has a tensile strength of between about 5,000 psi and about 50,000 psi at the temperature of operation of the pumping cartridge.  
     
     
         37 . The pumping cartridge as in  claim 35 , wherein the non-elastorneric material has a flexural modulus of between about 100,000 psi and about 700,000 psi at the temperature of operation of the pumping cartridge.  
     
     
         38 . The pumping cartridge as in  claim 29 , further comprising at least one valve including a valve seat and a sealing component, the sealing component including an occluding surface positioned to face the valve seat when the valve is assembled in an operative configuration.  
     
     
         39 . The pumping cartridge as in  claim 38 , wherein the occluding surface is constructed and positioned to make sealing contact with the valve seat thereby creating a seal, when the valve is positioned in a closed configuration, where the seal is capable of withstanding a pressure differential of at least about 1,000 psi, without substantial fluid leakage therethrough.  
     
     
         40 . The pumping cartridge as in  claim 39 , wherein at least a portion of the occluding surface is concave and curved.  
     
     
         41 . The pumping cartridge as in  claim 30 , wherein the piston includes or forms at least part of a valve.  
     
     
         42 . The pumping cartridge as in  claim 41 , wherein the valve included in or at least partially formed by the piston is constructed and positioned to act as an inlet valve to the cylinder of the fluid being pumped by the pumping cartridge when it is in operation.  
     
     
         43 . The pumping cartridge as in  claim 29 , wherein a proximal end of the cylinder has a beveled inner surface.  
     
     
         44 . The pumping cartridge as in  claim 30 , wherein the sealing component is integrally formed with the main body of the piston and both the main body of the piston and the sealing component are formed of the same polymeric material.  
     
     
         45 . The pumping cartridge as in  claim 44 , wherein the sealing component and the main body of the piston are injection molded as one piece.  
     
     
         46 . The pumping cartridge as in  claim 29 , wherein the flared sealing flange portion extends axially away from the portion of the sealing component support element to which it is attached.  
     
     
         47 . The pumping cartridge as in  claim 46 , wherein the flared sealing flange portion extends distally away from the portion of the sealing component support element to which it is attached.  
     
     
         48 . The pumping cartridge as in  claim 47 , wherein the portion of the sealing component support element to which the flared sealing flange portion is attached is the distal-most portion of the sealing component support element.  
     
     
         49 . The pumping cartridge as in  claim 29 , wherein the flared sealing flange portion extends radially away from the portion of the sealing component support element to which it is attached.  
     
     
         50 . The pumping cartridge as in  claim 29 , wherein the flared sealing flange portion has a predefined length and extends both axially and radially away from the portion of the sealing component support element to which it is attached so as to form a cantilevered circumferential flange thereon.  
     
     
         51 . The pumping cartridge as in  claim 50 , wherein the sealing flange portion extends axially away from the portion of the sealing component support element to which it is attached by a distance of between about 0.01 inch and about 0.2 inch.  
     
     
         52 . The pumping cartridge as in  claim 30 , wherein the maximum axial thickness of the piston is between about 0.04 inch and about 0.32 inch.  
     
     
         53 . The pumping cartridge as in  claim 30 , wherein the pumping cartridge is constructed and arranged so that the piston reciprocates within an essentially immobile cylinder.  
     
     
         54 . The pumping cartridge as claimed in  claim 53 , wherein the flared sealing flange portion of the piston has a predefined length and extends both axially and radially away from the portion of the main body of the piston to which it is attached so as to form a cantilevered circumferential flange thereon, and wherein the sealing flange portion of the piston has a maximum outer diameter large enough to enable at least a portion of the sealing flange to be in essentially continuous contact with an inner surface of the cylinder during reciprocation of the piston.  
     
     
         55 . The pumping cartridge as in  claim 54 , wherein the sealing flange portion of the piston has a maximum outer diameter, when in a relaxed configuration prior to insertion into the cylinder upon assembly of the pumping cartridge, exceeding a maximum outer diameter of the main body of the piston.  
     
     
         56 . The pumping cartridge as in  claim 55 , wherein the sealing flange portion of the piston has a maximum outer diameter, when in a relaxed configuration prior to insertion into the cylinder upon assembly of the pumping cartridge, exceeding a maximum outer diameter of the main body of the piston by at least about 1%.  
     
     
         57 . The pumping cartridge as in  claim 54 , wherein a portion of the cylinder in which the piston reciprocates has an inner diameter exceeding the maximum outer diameter of the main body of the piston.  
     
     
         58 . The pumping cartridge as in  claim 57 , wherein the portion of the cylinder in which the piston reciprocates has an inner diameter less than a maximum outer diameter of the sealing flange portion of the piston, by at least about 1% when it is in a relaxed configuration prior to insertion into the cylinder upon assembly of the pumping cartridge.  
     
     
         59 . The pumping cartridge as in  claim 50 , wherein the sealing flange portion is pivotally flexible with respect to the sealing component support element.  
     
     
         60 . The pumping cartridge as in  claim 54 , wherein the piston is annular in shape with a centrally disposed bore therethrough defining a fluid flow path.  
     
     
         61 . The pumping cartridge as in  claim 29 , wherein the first angle is between about 1 degree and about 20 degrees.  
     
     
         62 . The pumping cartridge as in  claim 29 , wherein the second angle is between about 10 degrees and about 80 degrees.  
     
     
         63 . The pumping cartridge as in  claim 61 , wherein the second angle is between about 10 degrees and about 80 degrees.  
     
     
         64 . The pumping cartridge as in  claim 61 , wherein the first angle is between about 3 degrees and about 12 degrees and the second angle is between about 15 degrees and about 30 degrees.  
     
     
         65 . The pumping cartridge as in  claim 30 , further comprising a proximal flange positioned on one of the piston and the cylinder to prevent contaminants from reaching the sealing flange portion.  
     
     
         66 . A valve comprising: 
 a valve seat; and    a movable sealing element comprising a valve seat-facing occluding surface including a circumferential sealing lip projecting away from a portion of the occluding surface, the sealing lip being constructed and positioned to make sealing contact with the valve seat thereby creating a seal, when the valve is positioned in a closed configuration, the seal being capable of withstanding a pressure differential of at least about 1,000 psi, without substantial fluid leakage therethrough.    
     
     
         67 . The valve as in  claim 66 , wherein the movable sealing element further comprises a rigid insert.  
     
     
         68 . A method for fabricating a pump cartridge from a length of thin-walled tubing, comprising: 
 inserting at least a portion of a body portion of a valve at least partly into the tubing; and    securing the valve within the tubing by crimping the tubing onto the body portion of the valve, thereby creating a circumferential, essentially leak-tight seal between the tubing and the body of the valve, without the need for any supplemental seals.